MCW_Human_Research_Orientation_packet by PoOwbFh

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									                     Welcome to MCW Human Research
          Offered by Research Education, Office of Research, MCW
For: Human Research Team members with responsibilities for Human Research at MCW
Today’s orientation – big picture – administration of Human Research at MCW
Objectives: Participants in this orientation will;
         Identify MCW Research Office contacts for human research (IRB and Human Quality
             Assurance/Improvement)
         Identify MCW required and optional training for human research team members
         Discuss components of 45 CFR 46 (Protection of Human Subjects), and compare with
             MCW SOP’s for Human Research
         Locate MCW websites and links to information relevant to human research
Table of Contents:                                                              Page
Objectives                                                                       1
Office of Research Contacts                                                      2
Human Research Education
 Requirements                                                                    3
 CITI Instructions                                                               5
Human Research Education Optional Offerings                                      8
 IRB Open Houses                                                                 8
 Core Education for Human Research Team Members                                  9
 Modules A, B, C – part of Human Research Orientation                           10
 Human Research Professionals Monthly Meeting                                   13
 Office of Research Newsletter                                                  15
 eBridge – Human Research Training                                              17
 ANGEL - Distance Learning Tool                                                 23
 Research Banks at MCW (an ANGEL on-line training)                              25
 HSP 2007 – (formerly required) ANGEL                                           25
Children’s Corporate Center (CCC) Monthly Meeting                               26
Shipping Infectious Substances Training (Pg 2 also)                             27 + 28
ClinicalTrials.gov – registering your research                                  29
Acronyms                                                                        31
Where to find Human Research related regulations                                33
Parts of 45 CFR 46 Content (Also known as “The Common Rule”)                    37
Key Components of 45 CFR 46 – relate to MCW                                     39
Froedtert Hospital Office of Clinical Research and Innovative Care Compliance   61
      (OCRICC)
Computer Infoscope Scavenger Hunt                                               65
Evaluation ONLINE VERSION HERE                                                  67



May 2009 MCW Human Research Orientation packet                                               1
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May 2009 MCW Human Research Orientation packet   2
MCW Office of Research
David Gutterman, MD, Senior Associate Dean for Research

Human Research Website Contacts

Institutional Review Board Administration (Human Research Protection Program, or HRPP)
David Clark, PhD, Assistant Dean for Clinical Research
Primary Contact - Jennifer Ward, 456-8422, jward@mcw.edu

            IRB Coordinator, Faye Overly, foverly@mcw.edu
            IRB Coordinator, Ranbir (Bobbie) Saini, rsaini@mcw.edu
            IRB Coordinator, Kristin Bastian, kbastian@mcw.edu
            IRB Coordinator, DeEtte Burns, dburns@mcw.edu
            IRB Coordinator, Ken Howe, khowe@mcw.edu

        - IRB Operations
           Connie Byrne, 456-8455, cbyrne@mcw.edu
            Kate Gaudreau, 456-8337, kgaudrea@mcw.edu
            Ann Marie Lessner, 456-8288, alessner@mcw.edu
            Patricia Witt, PhD, 456-4585, pwitt@mcw.edu

Research Education (Contact page)
         – Deb Gans, Training Specialist III, 456-4019, dgans@mcw.edu
         – Robert Mautz, Training Specialist II 456-8139, rmautz@mcw.edu
         – Nancy Larrick, Administrative Assistant III, 456-7365, nlarrick@mcw.edu

Human Research Quality Improvement
       – Roxanne Pritchard, Program Coordinator III, 456-8844
       – Bridget Psicihulis, Program Coordinator II, 456-8447
       – Jackie Tekiela, Program Coordinator, 456-4687
       – Melinda Hantke, Program Coordinator, 456-5717

Radiation Safety         456-4347
          – Marc Martz, Director

Grants and Contracts
         – April Haverty, Director
         – Cheryl Frank, Research Support Specialist, 456-4196


PUBLIC SAFETY OFFICE - MCW
Safety & Environmental Health Office
          – Shannon McGinley 414-456-8060
          – For MCW/FH training on Shipping Infectious Materials, Diagnostic Specimens, and
             Dry Ice contact Brittany Buffalo at 955-8274 or bbuffalo@mcw.edu

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May 2009 MCW Human Research Orientation packet                                            3
Research Education - Programs Offered to Research Faculty and Staff
Required (2 items, an annual component and the on-line CITI)
    1. Collaborative Institutional Training Initiative (CITI) – Human Research - On line – Within
       90 days of Human Research activities and refresher every 2 years afterward (refresher
       is much shorter) – tracked electronically
    2. Annually - Three other trainings per year related to human subjects research
                  Honor system for tracking
          Options for annual requirement – meets one training requirement:
               o 1 CITI Basic Course module not done for initial certification (from either track)
               o 1 CITI Refresher Course 1 module not required for bi-ennial (every two years)
                  recertification
               o Attend 1 hour MCW program in conducting human research
                  (such as the MCW monthly meeting of human research professionals)
               o Attend 1 hour of external program in conducting human research
               o Complete NIH computer based training

Human Research Teams are responsible for documenting their human research
training completions.

Other training alert!
           – Shipping Hazardous Material – REQUIRED if shipping hazardous material -
              For questions about hazardous or infectious shipping training or how to obtain
              certification at MCW/FH please contact Brittany Buffalo at 955-8274 or
              bbuffalo@mcw.edu or Shannon McGinley at 414-456-8060




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May 2009 MCW Human Research Orientation packet                                                       4
                       Human Research Protection Required Coursework
                                                     Updated January 2009
There are 2 ONGOING required educational elements to maintain in order to remain current for
the conduct of Human Research at MCW
  1. On-line CITI – Human Research – Basic within 90 days of hire and refresher every 2 years from basic
     completion date. THIS INCLUDES reading the following MCW Specific research documents and
     policies (honor system) on the following site (MCW Infoscope Access required):
           http://infoscope.mcw.edu/router.asp?docid=13792
         When done with the on-line CITI training, please complete the on-line MCW Evaluation Form (Basic) or
         MCW Refresher Evaluation. If the on-line version is not available, use this Word Doc
         MCW Evaluation Form (for basic) or MCW Refresher Evaluation and send to nlarrick@mcw.edu or
         fax, 414-456-6565.

  2. Annually - Investigators and coordinators must complete three (3) human research protection educational
     modules from among the options listed below. All others must complete one (1). The individual and/or
     department should keep a file with a list and dates of the completed modules (honor system). This record
     may be checked during an audit.
          Options for annual requirement:
                     1 CITI Basic Course module not done for initial certification (from either track)
                     1 CITI Refresher Course 1 module not required for bi-ennial (every two years) recertification
                     Attend 1 hour MCW program in conducting human research
                      (such as the MCW Human Research Professionals Monthly Meeting)
                     Attend 1 hour of external program in conducting human research (such as the Children’s Clinical Research
                      Forum – call 414-337-7701 to be placed on the e-mail list)
                     Complete NIH computer based training

Frequently Asked Questions
INSTRUCTIONS FOR CITI BASIC REGISTRATION AND COURSE WORK
    1. Go to http://www.citiprogram.org
    2. Click on “Register Here”
                st
    3. In the 1 section under “Participating Institutions” select Medical College of Wisconsin
    4. Enter information for all other required registration questions and “Submit”
    5. “Select Curriculum” Page
          First question: Select the group that most closely matches your role and type of research (Group 1 – 6)
          Second question: Select “Yes” or “No”, depending on if you conduct research either at CHW or using the
                               CHW HRRB for your review
          If a third question pops up, choose “No I have not completed my Basic Course Training Previously.”
    6. Submit
    7. Under “My Courses” you should see Human Research Not Started-Enter
    8. Click on Enter, and begin course work.

INSTRUCTIONS FOR REFRESHER COURSES
Everyone must review the documents required for initial certification and take the CITI Refresher Course for Human
Research, completing similar although shorter modules as required in the Basic Course. The Refresher Modules
usually take less than 2 hours to complete. CITI sends a reminder to take the refresher 6 months and 30 days prior
to expiration. CITI also sends a notice 1 day after expiration. You can check your own expiration date by logging
into your CITI account and checking the date. Expiration occurs 2 years after Basic completion.
     1. Go to http://www.citiprogram.org
     2. If you have forgotten your user name and/or password, click on “Forgot username or password?” and follow
        the instructions. It is a very simple process to acquire either or both.
May 2009 MCW Human Research Orientation packet                                                                              5
    3. Under “My Courses, the Refresher Course should be listed with either a “Not Started-Enter” or
    Incomplete - Re-enter. Click on either of those to enter the Refresher.
        a. Click on the Gradebook link from the Learner’s Menu. The Refresher Course should be listed.
        b. If you do not see a link for the Refresher, verify that you are within 6 months of the expiration date.

INSTRUCTIONS FOR CITI; CHANGING AFFILIATED INSTITUTIONS OR ADDING MCW
    1. Go to http://www.citiprogram.org
    2. Enter username & password originally registered with at previous or other institution
    3. If you have forgotten your user name and/or password, click on “Forgot username or password?” and follow
        instructions. It is a very simple process to acquire either or both.
    4. Once on the Learner’s Menu, edit or change your email address as needed.
    5. On the “Learners’ Menu” select “Affiliate with another institution”
             a. In the 1st section under “Participating Institutions” select Medical College of Wisconsin
             b. Enter information for all other registration questions and “Submit”
    6. You will now be on the “Select Curriculum – Medical College of Wisconsin” Page
             a. Question 1: Select the group that most closely matches your role and type of research (Group 1 –
                 6)
             b. Question 2: Choose “No I have not completed my Basic Course Training Previously.”
    7. Submit
    8. Go to the “Learner’s Menu” page
    9. Under “My Courses” you should see a new grade book for MCW, Human Research Not Started-Enter (or
        Incomplete-Re-enter)
    10. Click on Enter, and verify previous CITI completed modules are displayed and then begin course work for
        modules which still require to be completed for MCW.
    11. Please note: Institutions choose from a wide variety of modules and overlap with MCW modules will vary.
        All modules required for MCW certification must be completed.

CHANGING LEARNER GROUPS ON CITI
    1. Go to http://www.citiprogram.org
    2. Enter username & password
    3. If you have forgotten your user name and/or password, click on “Forgot username or password?” and follow
        instructions. It is a very simple process to acquire either or both.
    4. On the “Learners’ Menu” select “Add a course or update your learner groups for Medical College of
        Wisconsin
    5. You will now be on the “Groups” page and it will confirm the group you are currently enrolled into for MCW.
        If this is incorrect – click on “Update Groups”
    6. You will now be on the “Select Curriculum – Medical College of Wisconsin” Page
              a. Question 1: Select the group that most closely matches your role and type of research (Group 1 –
                   6)
              b. Question 2: Choose “No I have not completed my Basic Course Training Previously.”
    7. Submit
    8. Go to the “Learner’s Menu” page
    9. Under “My Courses” you should see a new grade book for MCW, Human Research Not Started-Enter (or
        Incomplete-Re-enter)
    10. Click on Enter, and verify previous CITI completed modules are displayed and then begin course work for
        modules which still require to be completed for the new learner group which was selected.

FREQUENTLY ASKED QUESTIONS
        Who is required to be certified in human research protections?
        Why is certification necessary?
        When do I need to complete the Basic course?
        What score is considered passing?
        How long will it take to complete the certification program?
        Which modules do I take?
        How do I change my Learner Group?
        What is the annual, ongoing requirement for Human Research Education?
        Can I just skip to the refresher course?
        Who do I contact if I have questions?

Who is required to be certified in human research protections?

May 2009 MCW Human Research Orientation packet                                                                       6
    Everyone involved in the design, conduct, or review of human research carried out by MCW faculty investigators
    at any location or reviewed by MCW or FMLH IRBs must be certified. This includes, and is not limited to, IRB &
    DSMB committee members, investigators, coordinators, pharmacists, fellows, students, and any other research
    team members who interact with study participants and/or access their protected health information (PHI =
    tissue/data + any identifier). NOTE: Investigators, coordinators and study team members with active VA
    studies should complete the annual VA training in human subject protection that serves as a substitute for
    the MCW program.
Why is certification necessary?
 The purpose of certification is threefold:
        Responsible Conduct in Research - to assure a thorough and universal foundation of the ethical and
           legal principles guiding human participant research.
        Scientific Integrity - to enhance the awareness of, and sensitivity to research integrity issues such as
           conflict of interest.
        Public Duty - to demonstrate to our study volunteers, the community, and research sponsors that we
           have the training and expertise necessary to protect the rights and welfare of research participants.
When do I need to complete the Basic course?
    Faculty and Staff involved in the conduct of human research must complete the basic training within 90 days
    from date of hire. During this time all conduct of research activities must be supervised. An investigator may not
    be a Principal Investigator until certification is completed.
What score is considered passing?
    An overall score of ≥ 80% is required. The quizzes are open book.
How long will it take to complete the certification program?
    The total time is approximately 4 to 6 hours for the basic course. You may complete it multiple sittings. The
    certification program is web-based and can be accessed from any computer via the internet. The Refresher
    Course typically takes less than 2 hours.
Which modules do I take?
    The required modules depend on the type of research and your role in that research. Biomedical Research
    includes studies that involve investigational drugs, devices, or “basic” research with humans. Social/Behavioral
    Research involves observational and survey research, and work with population and/or epidemiological studies.
    This type of research does not involve any drugs or devices (investigational or marketed). You will be asked to
    select a group that most closely matches your role in the human research.
How do I change my Learner Group?
  Go to “Add a course or update your learner group” (midway down on the Learner’s Menu).
What is the ongoing requirement for Human Research Education?
There are 2 parts to this answer
   Annually - Investigators and coordinators must complete three (3) human research protection educational
   modules from among the options listed below. All other Human Research Staff must complete one (1). The
   individual and/or department should keep a file with a list and dates of the completed modules. This record may
   be checked during an audit.
        Options for annual requirement:
                    1 CITI Basic Course module not done for initial certification (from either track)
                    1 CITI Refresher Course 1 module not required for bi-ennial (every two years) recertification
                    Attend 1 hour MCW program in conducting human research
                     (such as the MCW monthly meeting of human research professionals)
                    Attend 1 hour of external program in conducting human research
                    Complete NIH computer based training
    Biennially (Every two years) an on-line CITI refresher course is required. and take the CITI Refresher Course,
    completing the same modules as required in the Basic Course. Everyone must read the documents required for
    initial certification The Refresher Modules are much shorter than in the Basic Course, and usually takes less
    than 2 hours to complete.
Can I just skip to the refresher course?
 MCW Human Research Protection Program requires ALL participants to complete the Basic CITI Course prior to
 beginning the Refresher Course.
May 2009 MCW Human Research Orientation packet                                                                       7
  Who do I contact if I have questions?
  Contact Nancy Larrick in Research Education at 414-456-7365 or nlarrick@mcw.edu.
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May 2009 MCW Human Research Orientation packet                                       8
Research Education - Programs Offered to Research Faculty and Staff

Optional – program descriptions are on following pages

               Core Education for Human Research Team Members: Key Elements of Day to
                     Day Operations
               Human Research Orientation – additional 3 modules – Modules A, B, C
                         o For employees new to human research
                         o One per month on a rotating basis – register by email to
                              nlarrick@mcw.edu
               Monthly Human Research Professionals Meeting
                         o On line registration
               eUpdate – every other month publication
               eBridge – Human Research Training
                     • on line (on IRB web site)
                     • 2 times per month – see schedule
                     • Call eBridge help desk to schedule other times 456-8476
               Special Topics Meetings
               ANGEL (On-line distance learning tool) – archived material stored here (click on
                       this link, look for Electronic Systems, and choose Angel eLearning
                       Systems), including the previously required HSP 2007 and Human
                       Research Professionals Monthly Meeting PowerPoints and audio (no log on
                       name or password required – instructions on page 19)




Other optional training
      IRB Open House - 1st and 3rd Monday of every month – first 15 – 30 minutes is a
presented topic, the rest of the time is devoted to your specific questions
      Location MFRC either room 3095 or 3075
      Time: noon – 1:00pm


Other optional training – Children’s

Children’s Monthly Meeting Schedule for Coordinators –
       contact Sue Newlin, (414) 337-7701 to be placed on the e-mail list
The Investigator, A MONTHLY PUBLICATION FROM THE CHILDREN’S RESEARCH INSTITUTE -
       contact Sue Newlin, (414) 337-7701 to be placed on the e-mail list



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May 2009 MCW Human Research Orientation packet                                                 9
                          Core Education for Human Research Team Members:
                                Key Elements of Day to Day Operations
Date:              See web site for date         Time: 8:00 am – 4:00 pm
Location:          MACC Fund Research Center Conference Room MFRC 3075
Purpose: The purpose of this educational component is to provide resources to the human research
team member (coordinator role) that will expedite their ability to perform their job responsibilities in a
manner consistent with institutional and federal guidance and/or policy. Emphasis is placed on providing
tools and practical information that can be used immediately. Focus is on the practical aspects of
conducting a protocol, answering the fundamental question “How is an approved IRB protocol
implemented?”
Who should attend? Human Research Team members including; Clinical Research Coordinators,
Clinical Research Assistants, Research Nurses, and other positions responsible for conduct of human
research protocols. Course content is geared toward those with limited experience in their roles.
Experienced human research team members seeking to broaden their knowledge base and acquire
additional human research management skills are welcome.
Cost (pre-payment is required): $55; includes texts, lunch, thumb drive with templates/course material,
                                folder templates
Texts Included: The CRC’s Guide to Coordinating Clinical Research by Karen E Woodin, PhD
                2008 Code of Federal Regulations & ICH Guidelines GCP Reference Guide
Topics:                - Types of Research                         - Informed Consent
                       - Staff Responsibilities Overview          - Study Documents
                       - Budgets                                   - Reportable Events and Safety Monitoring
                       - IRB and Ethics Committees                - Data Checks
                       - Working with Human Subjects
Instructors:               Greg Anderson, MHA, CCRC                          Roxanne Pritchard, RN, BSN, CIP
                           Diane Bauer, BA, CCRC
Registration: On-Line Registration http://www.mcw.edu/researcheducation/CoreEd/Registration.htm
              Web Page with this brochure
               http://www.mcw.edu/researcheducation/CoreEducationforHumanResearchTeamMembers.htm
Payment Options: Direct transfer of funds (MCW departments) or check (non-MCW only – check made
out to MCW). For on-line direct transfers, an actual account number is required that includes the Cost
Center, Natural Account #, Fund * (or grant #(not NIH)), and Activity Code. The department administrator
or Business Manager can provide this number. For check payment, first submit an electronic registration,
then send the check to Tie Fleming, Office of Research, MFRC. Registration is complete upon receipt of
check.
Class Size: Enrollment is limited to 30 attendees. Future classes will be held in May, August and November. Due
to the limited class size and cost of materials, refunds will not be provided for cancellations. However,
substitutions will be accepted.
Other information: Lunch, water and soda will be provided
Directions: From MCW HRC lobby: Take the elevator in the main lobby to the 3rd floor. Turn left off of the elevators and
follow the hallway until you see the library on your right. Continue straight through the double doors ahead of you into the MACC
Fund Research Building. Room 3075 will be on your left. From Children’s Hospital: Follow the skywalk past the deli and turn
right just past the coffee stand (before the pharmacy) and go through the double doors to the MACC Fund Research Center (you
                 rd
will be on the 3 floor). Room 3075 will be on your right, about halfway down the hall.

Coordinated and supported by: Office of Research, MCW and Children’s Research Institute, CHW
Contact:    Roxanne Pritchard, rpritcha@mcw.edu, 456-8844

May 2009 MCW Human Research Orientation packet                                                                                10
MODULES A, B, C
The human research series, intended for MCW employees whose job responsibilities include
any aspect of human research, are optional modules that can be taken in any order.
Individuals are welcome to choose which modules to attend, according to their job needs.
There are currently three modules (modules A, B, C) held quarterly on a rotating monthly
basis, lasting 1 - 1.5 hours each. Topics are "IRB Processes", "IRB News Hour" (changing
topics), and "Conducting Human Research at Froedtert Hospital: What You Need to
Know". Sessions are typically small in size, allowing time for questions, interaction,
and networking. Register by e-mailing nlarrick@mcw.edu. A meeting reminder will be sent
to new employees. Everyone engaged in Human Research are welcome to self select to
come to any or all of these meetings. Thank you!

IRB Processes
Module A of Human Research Employee Orientation

Please RSVP (yes OR no) to Nancy Larrick, 456-7365 or nlarrick@mcw.edu
Date: Held in March, June, September and December
       Date will be e-mailed and posted on web page
Time: 12:00 – 1:30 pm
Location: Location posted on web page (typically MFRC 3095)

Purpose: This interactive session focuses on the MCW IRB submission process and the use
of eBridge for human study submissions. Elements of the MCW IRB process, common
misconceptions, Smart Form content for submission, reportable events, and insight into the
protocol review process by the IRB committee will be covered. Use of eBridge system for
Human Research Submissions is recommended prior to attending this class.
Audience: Optional module for all Human Research Team Members.
          Individuals can choose to attend any module in any order.
Instructor: Faye Overly, IRB Coordinator II for MCW/FMLH IRB Committee
Objectives: Participants of this module will:
   Discuss key issues underlying the questions in the Main application form and Continuing
      Progress Reports
   Identify reportable events and the required timeframe for submission to the IRB
   Describe the amendment application process, and what research activities require an
      amendment to the protocol
   Identify key issues for the informed consent document
   Discuss individualized scenarios
This is an informal session with time for individual questions and discussion
Dessert will be provided. Feel free to bring a lunch.
Sponsored by: Research Education, Office of Research, MCW
Please RSVP (yes OR no) to Nancy Larrick (Research Education Admin Ass’t), 456-7365 or
nlarrick@mcw.edu




May 2009 MCW Human Research Orientation packet                                            11
IRB News Hour
Module B of the Human Research Series
Today’s topic – Research Banks at MCW and Froedtert Hospital: IRB Training for Bank
Personnel (This is an updated repeat of the October 2008 Human Research Professionals
Monthly Meeting)
Date: Held in January, April, July, and October
        Date will be e-mailed and posted on web page
Time: noon – 1:30 p.m.
Location: MFRC 3095
Purpose: This educational session focuses on elements of banking for human research
purposes. Individual questions are welcome in this small group session.
Objectives:
   Review MCW IRB policy on banking data and bio-specimens
   Discuss definition of “data”
   Differentiate among identified, coded, de-identified and anonymous (anything) and its
      relationship to banks
   Compare banking consent documents and study consent documents
   Define role and responsibilities of the bank custodian
   Review IRB requirements for conducting research with banked data or specimens

Instructor: David Clark, PhD, Assistant Dean for Clinical Research
Audience: Optional module for all Human Research Team Members.
          Individuals can choose to attend any module in any order.
This is an informal session with time for individual questions and discussion
Dessert will be provided. Feel free to bring a lunch.
Sponsored by: Research Education, Office of Research, MCW
Please RSVP (yes OR no) to Nancy Larrick (Research Education Admin Ass’t), 456-7365 or
nlarrick@mcw.edu

Conducting Human Research at Froedtert Hospital:
What You Need to Know
Module C of the Human Research Series

Date: Held in February, May, August, and November
        Date will be e-mailed and posted on web page
Time: noon – 1:30 p.m.
Location: MFRC 3095
Purpose: This session provides an opportunity to learn directly from the source about the
services provided and required by Froedtert Hospital, Office of Clinical Research and Innovative
Care Compliance (OCRICC).
Objectives:
   Overview of Froedtert Office of Clinical Research & Innovative Care Compliance
      (OCRICC)
   What and When: Clinical Research Trials that need to obtain approval from OCRICC
   How to get started at OCRICC, FH

May 2009 MCW Human Research Orientation packet                                                12
Instructors: Nancy Schallert, Director, Corporate Compliance, Internal Audit, & OCRICC, FH
             Roberta Navarro, Manager, Froedtert Office of Clinical Research and Innovative
Care Compliance (OCRICC)
Audience: Optional module for all Human Research Team Members conducting research at
FH. This information is required for research staff wanting to conduct clinical trials at Froedtert,
and members of OCRICC are available to present this content outside this time. Individuals can
choose to attend any module in any order.
This is an informal session with time for individual questions and discussion
Dessert will be provided. Feel free to bring a lunch.
Please RSVP (yes OR no) to Nancy Larrick (Research Education Admin Ass’t), 456-7365 or
nlarrick@mcw.edu

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May 2009 MCW Human Research Orientation packet                                                    13
                 MCW HUMAN RESEARCH PROFESSIONALS MONTHLY MEETING
                                 2009 SCHEDULE
              Meetings are typically on the last Tuesday of the month in the room indicated
                    11:45 Room opens for seating, refreshments and announcements
                                            Program: noon-1:00 p.m.
                     Alzheimer’s Disease, Decisional Capacity, and Informed H1210-H1250
    January 27th                           Consent to Research                               confirmed
                                             Diana Kerwin, MD
                                      Assistant Professor of Medicine
                                  Division of Geriatrics and Gerontology
                                MCW Corporate Compliance: Roles and              Kerrigan Auditorium
    February 24th                             Responsibilities                              confirmed
                         Dan Wickeham, Vice President Corporate Compliance &
                                 Risk Management, HIPAA Privacy Officer
                         Sandi J Stoflet, Program Manager, Research Compliance

     March 31th
                             Ethical Considerations in Clinical Research         Alumni Center
                                            Laura Roberts, MD                    Confirmed - Joy Ehlenbach
                                Chairman and Charles E. Kubly Professor          jehlenba@mcw.edu
                                  of Psychiatry and Behavioral Medicine
                             Department of Psychiatry and Behavioral Medicine
                                      Medical College of Wisconsin
                            New VA Initiatives: Documentation and Informed       Alumni Center
      April 28th                                 Consent                         confirmed
                                            David Rickaby, PhD
                               Research Compliance Officer, Milwaukee VA
       May 26th                                  No Meeting

      June 30th                   2008 MCW QIP findings/scenarios                Kerrigan Auditorium
                                   Roxanne Pritchard, RN, BSN, CIP               confirmed
                                   Quality Improvement Specialist III
                                Human Research Protection Program, MCW
                                           MCW IRB updates                       Alumni Center
       July 28th
                                            David Clark, PhD                     confirmed
                                Assistant Dean for Clinical Research, MCW


                                     Human Research Ethical Topic                Confirmed
     August 25th                             Kris Tym, MS
                               Bioethics, MCW, IRB Member, MCW/FH IRB




                                           Guest Speaker                         confirmed
     September
        30th                              Tom Puglisi, PhD
   (Wednesday, and                       VA – Washington, DC
    different time)
                                     Innovative Care or Research?                confirmed
    October 27th                         J Paul Scott, MD, CHW
                                        David C Clark, PhD, MCW
                                                 QI with IRB                     confirmed
     November             Roxanne Pritchard, Mark Rusch, PhD, Linda Blust, MD
       24th
     December                            No Meeting
       29th

         All Network meetings are typically on the last Tuesday of the month in the room indicated:
                            11:45     Doors open for seating, refreshment, and announcements

May 2009 MCW Human Research Orientation packet                                                               14
                                   12:00 – 1:00         Speaker
  Attendants will receive one category 1 CME credits for physicians, one APA CE credits for psychologists and one Contact
   Hours for other research personnel. In order to receive credit, you MUST fill out an evaluation form for each speaker.
  Transcripts of credits awarded can be obtained by calling Patti Nelson at 456–4896. Certificates will not be issued, if you
                                require a certificate a fee will be assessed. Program # 09012




Back to Table of Contents




May 2009 MCW Human Research Orientation packet                                                                              15
May 2009 MCW Human Research Orientation packet   16
    eUpdate – the Office of Research’s Electronic Newsletter – comes out every other month –
                e-mailed and archived on website




    MAY 2009                                  A bi-monthly news bulletin for research faculty and staff

         Office of Research Highlights                                        Upcoming Events
    - ARRA Funding Opportunities on InfoScope -      May 4, 18 IRB Open House
                                                     May 15 Core Education for Human Res. Team
                                                     May 20 Module C: Human Research at FH
                                                     May 21, June 17 eBridge Training for Animal Research
                                                     June 3 Module A: IRB Processes
                                                     June 16 eBridge Training for Human Subject Research
    - IRB: Steps to Take When Studies are
    Complete -                                       June 30 Human Research Professionals Monthly Meeting
                                                     July 8 Module B: IRB News Hour




    - NEW eUpdate Survey -




    FEATURE ARTICLES FOR MAY

           eUpdate Survey
           REMINDER: NIH Public Access Policy Compliance Required of Investigators with
                     NIH Funded Research




    NEWS FROM THE OFFICE OF GRANTS & CONTRACTS
           ARRA Funding Opportunities Now Posted on InfoScope
           Collaborators' Training




    NEWS YOU CAN USE FROM THE BRC
           AAALAC is Coming to Your Laboratory




    May 2009 MCW Human Research Orientation packet                                                  17
    HRPP/IRB NEWS
           Steps to Take When Your Study Activities are Complete
           eBridge IRB Basic Training Schedule
           Outside Organizations for the Research Professional




      Back to Table of Contents




    May 2009 MCW Human Research Orientation packet                  18
                                          Initial Steps in the eBridge –
                                        Human Research Training Process
                                               For New Employees
How to register with eBridge [Registration, Logging In, and Account Management [Table of Contents]
To register with the eBridge system, please follow the directions below.
1. Type into the address bar of an Internet Explorer browser: http://ebridge.mcw.edu
2. Click on the "Registration" link on the upper right side of the screen.
3. Complete the Self Registration form.
4. All fields with a red asterisk are required fields.
5. Click "Register" to submit the application to the Help Desk.
6. The eBridge Help Desk will process your registration and email you your account information.

        FREQUENTLY ASKED QUESTIONS About eBridge
Registration, Logging In, and Account Management
- How do I register?
- How do I log in?
- How do I change my Password?
- How do I change my contact information in the system?
- How do I access eBridge on my Mac?
- “Folder for [my name]” is not right
- eBridge asks for my password when I am on the MCW Secure Network

Navigating eBridge
- How can I contact the eBridge Help Desk?
- How do I get training on the eBridge system?
- Where can I find training materials?
- How do I access the BRC and IACUC internal websites from eBridge?
- How do I attach documents to a submission?
- How do I run a report of studies by Principal Investigator (PI)?

Grants & Contracts Forms
- How do I create a Funding Proposal?
- How do I create a subcontract budget?
- How do I attach documents to a submission?

Human Subject Research Submissions
- How do I create a Study Protocol?
- How do I create a consent in Consent Builder?
- How do I attach documents to a submission?
- Where can I find printed copies of the IRB SmartForms?
- Where is my submission in the eBridge workflow?
- Why is the formatting wrong when I copy and paste text into the eBridge system text fields?
- Why does the Principal Investigator have to submit the study, CPR, Amendment or Reportable Event?
- Why can only one Amendment be opened at a time?
- Why does the Department have to review new studies?




May 2009 MCW Human Research Orientation packet                                                        19
eBridge Training - Human Submissions
Research Education offers introductory training sessions on the eBridge System for
new users who are conducting human subject research at Froedtert/MCW. The two
hour session focuses on five areas:

       Navigating within the eBridge System.
       Creating a new study using the Study SmartForm.
       Creating a consent in Consent Builder.
       Making required change requests in the eBridge System.
       Creating Amendments, Continuing Progress Reports & Reportable Events



To register, please call 414-456-4019 or email to dgans@mcw.edu and provide your name, phone number and the class date
you will be attending.




                         eBRIDGE Basic Training Schedule
                        (scroll down to Human Submissions)
                           for Human Subject Research

Type of Training       Date                                 Time                                   Room
Introduction           Check on-line schedule               Usually held 2 times per month         South Lab, M3520
Introduction           Classes are 2 hours                                                         South Lab, M3520
Introduction           Days and times vary by month                                                South Lab, M3520



To register, please call Deb Gans at 414-456-4019 or email to dgans@mcw.edu and provide your
name, phone number and the class date you wish to attend.


Back to Table of Contents




May 2009 MCW Human Research Orientation packet                                                                           20
eBridge Training Materials - Human Submissions
Online Training Videos (11-01-05)

PI Navigation (12-01-06)

PI Creating a New Study (12-01-06)

PI Building & Submitting a Consent Form (12-01-06)

PI Change Requests (02-09-07)

Legacy Study Process (3-14-07)

Rich Text Box Copy and Paste Guidelines (05-10-06)

How to Inform IRB when Consents Change (04-28-06)

How to Create a PDF File of the SmartForm (04-26-06)

Editing Consent Builder (04-27-06)

Upload Document with Security Warnings (06-15-06)

Paper Consent Changes (09-25-06)


eBridge SmartForms PDF Files
Electronic copies of the eBridge SmartForms are now available in PDF format. The documents are for review purposes only, and
will not be accepted in place of an electronic submission.

  New Study PDF file (06-30-06)

  Behavioral Consent PDF file (11-22-06)

  Clinical Consent PDF file (11-22-06)

  Amendment PDF file (06-30-06)

  Continuing Progress Report PDF file (06-30-06)

  Reportable Events PDF file (06-30-06)




eBridge Workflows PDF Files
Electronic copies of the eBridge Workflows are now available in PDF format. The workflow documents are for
navigation purposes only.

 New Study Workflow PDF file (09-20-06)

 CPR/Amendment Workflow PDF file (10-03-06)

 Reportable Event Workflow PDF file (10-03-06)



May 2009 MCW Human Research Orientation packet                                                                           21
                      eBridge Help Desk Policies & Procedures


CONTACT
eBridge help is available by telephone, email, and drop-in computer lab office hours as follows:

Telephone: 414-456-8476

Hours:          Monday – Friday from 8 am to 5 pm excluding holidays and College closures.

Voicemail:      Clients may leave voicemail at the help desk telephone number at any time.
                eBridge staff will respond to these messages within 4 hours of receipt during
                normal business hours.

E-mail:         Requests for assistance may be sent by e-mail to: Help-eBridge@mcw.edu.
                eBridge staff will respond to these messages within 4 hours of receipt during
                normal business hours.

Office Hours: Friday 12 – 2pm by appointment. Call or email the eBridge Help Desk to schedule
             an appointment.

eBridge help desk staff can provide assistance with use of the eBridge software, usernames and
passwords for the eBridge system, and IRB-related content and study preparation questions.

eBridge help desk staff cannot answer questions on use of your computer and web browser,
remote connection questions through your internet service provider (i.e. RoadRunner or SBC
DSL), or provide technical/repair assistance for personal computer systems.


TRAINING
eBridge staff will conduct individual and small group training on use of the eBridge system upon
request. Please call 414-456-8476 to schedule a training time.

On-line training videos and copies of all printed materials used in eBridge training will be
available for download at http://www.mcw.edu/display/router.asp?docid=13118 or through the
eBridge system http://ebridge.mcw.edu > Home > Web Page Links > Human Research
Protection Office-IRB > eIRB Training Materials & FAQs.




Back to Table of Contents




May 2009 MCW Human Research Orientation packet                                                     22
COMPUTER SPECIFICATIONS
To successfully use the eBridge application, you will need the following:
     The most current version of your operating system (please apply patches and updates
      from the vendor at weekly intervals).
     An up-to-date virus scanner. Ideally, this should be updated on a daily basis.

       A current web browser. Many features of this system have been optimized for Internet
        Explorer but eIRB can be used with other browsers such as Firefox, Opera, and
        Netscape.
       Adobe Acrobat Reader. A free download at http://www.adobe.com. Click on the

                     icon.
       Java. A free download at http://www.java.com.
       A fast connection to the internet/Web. Standard modem dial-up connections will not
        perform at the needed level to attach or review documents. We strongly suggest use of a
        broadband connection such as a cable modem (i.e. RoadRunner from Time Warner
        Cable) or a digital subscriber line (DSL) from a telephone company (i.e. SBC).
       A word processor such as Microsoft Word or Word Pad will be needed for you to create
        text and spell-check your work before pasting information into the eIRB application.


CONTACT LOGGING
To help us improve our service for you, the eBridge help desk will log all requests for assistance.
These logs will be used to develop and revise training materials and programs, will influence
future system features and enhancements, and will guide outreach efforts by the Office of
Research.




Back to Table of Contents




May 2009 MCW Human Research Orientation packet                                                   23
Research Education ANGEL

Research Education ANGEL sign on instructions (to access Human Research
Professionals Monthly Meeting archived material, or the annual meeting
topics)

ANGEL is the distance learning tool used by MCW for course content for the
Graduate and Medical Schools, and many other departments.           Research
Education has created a public site available to access archived information
pertinent to Human Research
Select “ANGEL” from the home page of InfoScope or enter the following into your web address window

https://campus.mcw.edu

Select “Community Search” under Public Information (ignore the login name and password)
Enter into “Keyword Search”, “
Type in “Research Education” and select “Search”
When “Research Education” pops up, select it.
When the calendar of Research Education meetings pops up, select “Content” from the top of the
screen.
From here, you can navigate to the “Human Research Professionals Monthly Meeting” folder or the
“Annual Meeting” folder

Select the folder of your choice by topic/month.

Each folder contains a PP with audio. The audio is compatible with MP3 players, or Windows Media
Player.




Back to Table of Contents




On-Line
Research Banks at MCW and Froedtert Hospital: IRB Training for Bank Personnel
By David Clark, PhD, Assistant Dean for Clinical Research, MCW
May 2009 MCW Human Research Orientation packet                                                  24
Audience: those with record-keeping responsibility and every person with access
to banks or solicits banking consents)
                 Click on top folder and top file
                 Listen to entire presentation (51 minutes)
                 Complete the required survey (second item in folder)
            o NO LOG ON OR PASSWORD NEEDED!




On-Line Human Subjects Protection (HSP) 2007 Training - BrightLines
by David Clark, PhD, Assistant Dean for Clinical Research

Previously required – no longer required – is optional and will count toward one
of the annual requirements
SIGN – ON Instructions
Select “ANGEL” from the home page of InfoScope or enter the following into your web address window

https://campus.mcw.edu

Select “Community Search” under Public Information (ignore the login name and password)
Enter into “Keyword Search”, “
Type in “Research Education” and select “Search”
When “Research Education” pops up, select it.
When the calendar of Research Education meetings pops up, select “Content” from the top of the
screen.
From here, you can navigate to the “HSP 2007” folder
Select the “HSP 2007” folder.

Select “BrightLines” to begin the PP with audio

REQUIRED: Fill out the survey once you have completed the training – this is the only way to
capture your name and contact information.




Back to Table of Contents




May 2009 MCW Human Research Orientation packet                                                  25
Children’s Coordinator Research Forum Meetings at Children’s Corporate Center

CCRF Meeting Schedule for 2009
Usually First Tuesday of each month

CCRF Meeting Schedule for 2009

     January 6       (Tues)                CCC, Suite 440, Room 130   12:00 – 1:00 pm
     February 3      (Tues)                CCC, Suite 440, Room 130   12:00 – 1:00 pm
     March 3         (Tues)                CCC, Suite 440, Room 130   12:00 – 1:00 pm
     April 7         (Tues)                CCC, Suite 440, Room 130   12:00 – 1:00 pm
     May 5           (Tues)                CCC, Suite 440, Room 130   12:00 – 1:00 pm
     June 2          (Tues)                CCC, Suite 440, Room 130   12:00 – 1:00 pm
     July - No Meeting
     August 5   WEDNESDAY                  CCC, Suite 440, Room 130   12:00 – 1:00 pm
     September 2 WEDNESDAY                 CCC, Suite 440, Room 130   12:00 – 1:00 pm
     October 7 WEDNESDAY                   CCC, Suite 440, Room 130   12:00 – 1:00 pm
     November 3      (Tues)                CCC, Suite 440, Room 130   12:00 – 1:00 pm
     December 1       (Tues)               CCC, Suite 440, Room 130   12:00 – 1:00 pm

Other optional training – Children’s

Children’s Monthly Meeting Schedule for Coordinators –
      contact Sue Newlin, (414) 337-7701 to be placed on the e-mail list
The Investigator, A MONTHLY PUBLICATION FROM THE CHILDREN’S RESEARCH INSTITUTE -
      contact Sue Newlin, (414) 337-7701 to be placed on the e-mail list




Back to Table of Contents




May 2009 MCW Human Research Orientation packet                                          26
May 2009 MCW Human Research Orientation packet   27
May 2009 MCW Human Research Orientation packet   28
        Shipping Infectious Materials, Diagnostic Specimens, and Dry Ice

Current Federal regulations require anyone who ships infectious materials, dry ice, or other
hazardous materials must be trained and certified. Those shipping blood, dry ice, lab
samples, diagnostic specimens, etc. need to be trained and certified. Training
Certification is good for a two year period. If training is not completed, consequences
include:

-Up to $250,000 and up to a year jail for individuals
-Up to $500,000 per incident for organizations

MCW S&EH Office has a CD-Rom (Saf-T-Pak®) that will provide the training necessary to
become a certified shipper. To check out these materials contact Brittany Buffalo at 414-
955-8274 or e-mail at bbuffalo@mcw.edu. Training materials will need to be picked up and
signed out from the S&EH Office in room M0740.




Back to Table of Contents




CLINICAL TRIALS. GOV



May 2009 MCW Human Research Orientation packet                                             29
May 2009 MCW Human Research Orientation packet   30
May 2009 MCW Human Research Orientation packet   31
ACRONYM List           (feel free to copy this and add to it for your own use)
AAHRPP          Association for the Accreditation of Human Research Protections Programs
ACRP            Association of Clinical Research Professionals
ADR             Adverse Drug Reaction
AE              Adverse Event
ATTC            Addiction Technology Transfer Center

BRI             Blood Research Institute

CE              Covered Entity
CFR             Code of Federal Regulations
CHW             Children’s Hospital of Wisconsin
CIM             Certified IRB Manager
CIP             Certified IRB Professional
COC             Certificate of Confidentiality
COI             Conflict of Interest
CPA             Cooperative Project Assurance
CPR             Continuing Progress Review (Report)
CR              Common Rule
CRA             Clinical Research Associate
CRF             Case Report Form
CRI             Children’s Research Institute
CRO             Clinical Research Organization/Contract Research Organization
CRC             Clinical Research Coordinator
CTSI            Clinical and Translational Science Institute

DHEW            Department of Health, Education and Welfare (no longer exists)
DHHS            Department of Health and Human Services (replaced DHEW)
DIA             Drug Information Association
DMC             Data Monitoring Committee
DSMB            Data and Safety Monitoring Board

ECOG            Eastern Co-operative Oncology Group
EQUIC           Enhancing Quality of Informed Consent

FDA             Food and Drug Administration
FH              Froedtert Hospital
FWA             Federal Wide Assurance

GCP             Good Clinical Practice
GOG             Gynecologic Oncology Group

HDE             Humanitarian Device Exemption
HIPAA           Health Insurance Portability and Accountability Act
HMO             Health Maintenance Organization
HRP             Human Research Protections
HRPP            Human Research Protection Program
HSR             Health Services Research
HUD             Humanitarian Use Device

IACUC           Institutional Animal Care and Use Committee
IB              Investigator's Brochure
IBC             Institutional Biohazard Committee
ICF             Individual Consent Form or Institutional Consent Form
ICH             International Conference on Harmonization of Technical Requirements for
                    Registration of Pharmaceuticals
IDE             Investigational Device Exemption
IEC             Institutional Ethics Committee/Independent Ethics Committee
IND             Investigational New Drug
IO              Institutional Official
IRB             Institutional Review Board
May 2009 MCW Human Research Orientation packet                                             32
JCAHO           Joint Commission on Accreditation of Healthcare Organizations
JIT             Just in Time (procedure)

MCW             Medical College of Wisconsin
MPA             Multiple Projects Assurance

NAIM            National Association of IRB Managers
NCPHSBBR        National Commission for the Protection of Human Subjects of Biomedical and
                    Behavioral Research
NBAC            National Bioethics Advisory Commission
NCQA            National Committee for Quality Assurance
NDA             New Drug Application
NIH             National Institutes of Health
NHRPAC          National Human Research Protections Advisory Committee
NIA             Nonaffiliated Investigator Agreement
NSR             Non significant Risk
NRMI            National Registry of Myocardial Infarction

OHRP            Office for Human Research Protections (formerly OPRR)
OPRR            Office of Protection from Research Risks
ORA             Office of Regulatory Affairs
ORCA            Office of Research Compliance & Assurance
ORI             Office of Research Integrity
OSHA            Occupational Safety and Health Administration

PI              Principal Investigator
PHI             Private Healthcare Information/Public Health Information/Protected Health Info.
PHS             Public Health Service (USPHS United States Public Health Service)
PMA             Pre Market Approval
POG             Pediatric Oncology Group
PRIMR           Public Responsibility in Medicine and Research

QA              Quality Assurance
QC              Quality Control
QI              Quality Improvement

RAPS            Regulatory Affairs Professionals Society
RCO             Regulatory Compliance Officer
REB             Research Ethics Board
RCT             Randomized Control Trial
RCR             Responsible Conduct of Research
RTOG            Radiation Therapy Oncology Group

SAE             Serious Adverse Events
SAP             Suspect Adverse Reaction
SMO             Site Management Organization
SOP             Standard Operating Procedure
SoCRA           Society for Clinical Research Associates
SPA             Single Project Assurance
SR              Safety Report/Significant Risk
SRO             Sponsored Research Office
SWOG            South West Oncology Group

TRU             Translational Research Unit (at MCW and CHW)

VA              Veteran's Affairs
VPR             Vice President for Research

WMA             World Medical Association
Back to Table of Contents
May 2009 MCW Human Research Orientation packet                                                    33
Where to find the regulations?

The Federal Register (FR): Main Page

Published by the Office of the Federal Register, National Archives and Records Administration (NARA), the Federal Register is
the official daily publication for rules, proposed rules, and notices of Federal agencies and organizations, as well as executive
orders and other presidential documents.

http://www.gpoaccess.gov/fr/index.html


Code of Federal Regulations (CFR): Main Page

The Code of Federal Regulations (CFR) is the codification of the general and permanent rules published in the Federal Register
by the executive departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas
subject to Federal regulation. Each volume of the CFR is updated once each calendar year and is issued on a quarterly basis.

http://www.gpoaccess.gov/cfr/index.html



Federal Regulations for DHHS
   FDA            21 CFR (Code of Federal Regulations)
                 Part 11 – Electronic Records; Electronic Signatures
                 Part 50 – Protection of Human Participants
                 Part 54 – Financial Disclosure by Clinical Investigators
                 Part 56 – Institutional Review Boards (IRB)
                 Part 312 – Investigational New Drug Application (IND)
                 Part 314 – Applications for FDA Approval to Market a Drug (NDA)
                 Part 601 – Applications for FDA Approval of a Biologic License
                 Part 812 – Investigational Device Exemptions (IDE)
                 Part 814 – Premarket Approval of Medical Devices (PMA)
   FDA Information Sheets – Guidance for IRBs & Clinical Investigators (1998)
    OCR                 45 CFR       Parts 160 & 164 - HIPAA Final Rule
    OHRP          45 CFR Part 46 – Protection of Human Research Participants
                                     (The Common Rule)
                  63 FR Pages 60364-60367 – Revised Expedited Review Criteria



And there are More!!

Back to Table of Contents




May 2009 MCW Human Research Orientation packet                                                                                  34
I. Ethical Codes
  Belmont Report – Ethical principles and guidelines by the National Commission for the Protection of Human
                  Subjects of Biomedical & Behavioral Research. April 18, 1979.
                  http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm

  Declaration of Helsinki – World Medical Association’s recommendation for ethical principles for medical research
                            involving humans. June 1964 - September 1989.
                            http://www.fda.gov/oc/ohrt/IRBs/helsinki89.html

  Nuremburg Code – Directives for human experimentation from the Trials of War Criminals before the Nuremburg
                   Military Tribunals under Control Council Law. April 1949.
                   http://www.hhs.gov/ohrp/references/nurcode.htm
II. Federal Agencies
    DHHS (or HHS) Department of Health & Human Services http://www.dhhs.gov/
       FDA Food & Drug Administration http://www.fda.gov/
              CBER Center for Biologics Evaluation & Research - Regulates biological and related products
                     including blood, allergenics, vaccines, tissue, and biological therapeutics.
                     http://www.fda.gov/cber/
              CDER Center for Drug Evaluation & Research – Regulates drugs to ensure their safety &
                     effectiveness. http://www.fda.gov/cder/
              CDRH Center for Devices & Radiological Health – Regulates medical device research to ensure
                     their safety & effectiveness. http://www.fda.gov/cdrh/index.html
       NIH          National Institutes of Health http://www.nih.gov/
              CBT Computer Based Training – Human Participant Protections: Education for Research Teams
                     - http://www.cancer.gov/clinicaltrials/learning/page3
              OHSR Office of Human Subjects Research - Assist Intramural Research Program investigators
                     understand and comply with ethical guidelines and regulatory requirements for human
                     research.
                     http://www.nihtraining.com/ohsrsite/
       OCR Office for Civil Rights (HIPAA compliance office) http://www.hhs.gov/ocr/
       OHRP Office of Human Research Protections http://www.hhs.gov/ohrp/
       ORI          Office of Research Integrity http://ori.dhhs.gov/
III. Federal Regulations for DHHS
    FDA                  21 CFR (Code of Federal Regulations) http://www.fda.gov/
                       Part 11 – Electronic Records; Electronic Signatures
                       http://www.fda.gov/ora/compliance_ref/part11/default.htm
                       Part 50 – Protection of Human Participants
                       http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50
                       Part 54 – Financial Disclosure by Clinical Investigators
                       http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=54
                       Part 56 – Institutional Review Boards (IRB)
                       http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=56.103
                       Part 312 – Investigational New Drug Application (IND)
                       http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312
                       Part 314 – Applications for FDA Approval to Market a Drug (NDA)
                       http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=314
                       Part 601 – Applications for FDA Approval of a Biologic License
                       http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=601
                       Part 812 – Investigational Device Exemptions (IDE)
                       http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=812
                       Part 814 – Premarket Approval of Medical Devices (PMA)
                       http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=814
May 2009 MCW Human Research Orientation packet                                                                 35
    FDA Information Sheets – Guidance for IRBs & Clinical Investigators (1998)
                     http://www.fda.gov/oc/ohrt/irbs/default.htm
    OCR                  45 CFR Parts 160 & 164 - HIPAA Final Rule
                      http://www.hhs.gov/ocr/hipaa/finalreg.html
    OHRP        45 CFR         Part 46 – Protection of Human Research Participants
                      http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
                63 FR Part 60364-60367 – Revised Expedited Review Criteria
                      http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm
IV. Good Clinical Practices (GCP)
    FDA GCP – U.S. standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and
               reporting of FDA-regulated clinical trials (see also 21 CFR). http://www.fda.gov/oc/gcp/
    ICH GCP – International and ethical quality standard for the design, conduct, recording, and reporting of
               research involving human participants.
               http://www.fda.gov/cder/guidance/959fnl.pdf
V. Health Insurance Portability and Accountability Act (HIPAA)
    Laws & Regulations
    Federal ‘Security & Privacy’ Regulation – 45 CFR § 164
    Entire Federal Regulation – 45 CFR § 160 – general administrative requirements
                                       § 162 – administrative requirements
                                       § 164 – security and privacy
    Wisconsin Statutes on Privacy – Chapter 146. See § 81, 815, 819, 82, 83, 836

    Federal Guidance & Fact Sheets regarding Human Research
Clinical Research and the HIPAA Privacy Rule (Includes information on activities preparatory to research,
FAQ’s)
        http://privacyruleandresearch.nih.gov/clin_research.asp
    HIPAA Privacy Rule Booklet for Research - NIH Booklet, 4/14/03 (revised 7/13/04)
        http://privacyruleandresearch.nih.gov/pr_02.asp
    HIV & HIPAA - HIV/AIDS Bureau of HRSA Guidance for HIV services providers, 4/04
        http://hab.hrsa.gov/publications/hippa04.htm
    Impact of HIPAA on the NIH Process – NIH Guidance, 2/5/03
        http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html
    IRBs and the HIPAA Privacy Rule - NIH Publication Number 03-5428 August 2003
        http://privacyruleandresearch.nih.gov/irbandprivacyrule.asp
    IRB Review of Stand-alone Authorization Forms – FDA Guidance, 11/7/03
        http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-28044.htm
    Privacy Boards and the HIPAA Privacy Rule - NIH Fact Sheet, 9/25/03 (reformatted 7/12/04)
        http://privacyruleandresearch.nih.gov/privacy_boards_hipaa_privacy_rule.asp
    Guidance on Research & Coded Private Information or Biological Specimens 8/10/04
       http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf
    Research Repositories, Databases and the HIPAA Privacy Rule - NIH Fact Sheet, 1/12/04 (reformatted
                                                       7/2/04)
       http://privacyruleandresearch.nih.gov/research_repositories.asp
    HIPAA Research Standards - OCR Guidance, 12/3/02 (revised 4/3/03)
        http://www.hhs.gov/ocr/hipaa/guidelines/research.pdf
    Other Resources
    Research & HIPAA – NIH website for the research community http://privacyruleandresearch.nih.gov/
    Healthcare & HIPAA – OCR website for medical privacy: national standards
    http://www.hhs.gov/ocr/hipaa/

May 2009 MCW Human Research Orientation packet                                                                 36
May 2009 MCW Human Research Orientation packet   37
                                                  Title 45 CFR Part 46

                                               Code of Federal Regulations

                                                       TITLE 45
                                                    PUBLIC WELFARE

                                  DEPARTMENT OF HEALTH AND HUMAN SERVICES

                                                     PART 46
                                          PROTECTION OF HUMAN SUBJECTS

                                                            ***
                                                  Revised June 23, 2005
                                                  Effective June 23, 2005

                                                            ***

Subpart A               Basic HHS Policy for Protection of Human Research Subjects
Sec.
46.101                  To what does this policy apply?
46.102                  Definitions.
46.103                  Assuring compliance with this policy--research conducted or supported by any Federal
                        Department or Agency.
46.104-
                        [Reserved]
46.106
46.107                  IRB membership.
46.108                  IRB functions and operations.
46.109                  IRB review of research.
46.110                  Expedited review procedures for certain kinds of research involving no more than minimal risk, and for
                        minor changes in approved research.
46.111                  Criteria for IRB approval of research.
46.112                  Review by institution.
46.113                  Suspension or termination of IRB approval of research.
46.114                  Cooperative research.
46.115                  IRB records.
46.116                  General requirements for informed consent.
46.117                  Documentation of informed consent.
46.118                  Applications and proposals lacking definite plans for involvement of human subjects.
46.119                  Research undertaken without the intention of involving human subjects.
46.120                  Evaluation and disposition of applications and proposals for research to be conducted or supported by
                        a Federal Department or Agency.
46.121                  [Reserved]
46.122                  Use of Federal funds.
46.123                  Early termination of research support: Evaluation of applications and proposals.
46.124                  Conditions.




Subpart B               Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in
                        Research
Sec.
46.201                  To what do these regulations apply?
46.202                  Definitions.
46.203                  Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.
46.204                  Research involving pregnant women or fetuses.
46.205                  Research involving neonates.
46.206                  Research involving, after delivery, the placenta, the dead fetus or fetal material.
46.207                  Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate
                        a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates.


May 2009 MCW Human Research Orientation packet                                                                              38
Subpart C                 Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners
                          as Subjects
Sec.
46.301                    Applicability.
46.302                    Purpose.
46.303                    Definitions.
46.304                    Composition of Institutional Review Boards where prisoners are involved.
46.305                    Additional duties of the Institutional Review Boards where prisoners are involved.
46.306                    Permitted research involving prisoners.




Subpart D                 Additional Protections for Children Involved as Subjects in Research
Sec.
46.401                    To what do these regulations apply?
46.402                    Definitions.
46.403                    IRB duties.
46.404                    Research not involving greater than minimal risk.
46.405                    Research involving greater than minimal risk but presenting the prospect of direct benefit to the
                          individual subjects.
46.406                    Research involving greater than minimal risk and no prospect of direct benefit to individual subjects,
                          but likely to yield generalizable knowledge about the subject's disorder or condition.
46.407                    Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate
                          a serious problem affecting the health or welfare of children.
46.408                    Requirements for permission by parents or guardians and for assent by children.
46.409                    Wards.

Authority: 5 U.S.C. 301; 42 U.S.C. 289(a).

Editorial Note: The Department of Health and Human Services issued a notice of waiver regarding the requirements set forth in
part 46, relating to protection of human subjects, as they pertain to demonstration projects, approved under section 1115 of the
Social Security Act, which test the use of cost--sharing, such as deductibles, copayment and coinsurance, in the Medicaid
program. For further information see 47 FR 9208, Mar. 4, 1982.

Note: As revised, Subpart A of the HHS regulations incorporates the Federal Policy for the Protection of Human Subjects (56 FR
28003). Subpart D of the HHS regulations has been amended at Section 46.401(b) to reference the revised Subpart A.
The Federal Policy for the Protection of Human Subjects is also codified at
7 CFR Part 1c                   Department of Agriculture

10 CFR Part 745                 Department of Energy

14 CFR Part 1230                National Aeronautics and Space Administration
15 CFR Part 27                  Department of Commerce
16 CFR Part 1028                Consumer Product Safety Commission

22 CFR Part 225                 International Development Cooperation Agency, Agency for International Development


24 CFR Part 60                  Department of Housing and Urban Development

28 CFR Part 46                  Department of Justice

32 CFR Part 219                 Department of Defense

34 CFR Part 97                  Department of Education

38 CFR Part 16                  Department of Veterans Affairs

40 CFR Part 26                  Environmental Protection Agency
45 CFR Part 690                 National Science Foundation
49 CFR Part 11                  Department of Transportation


May 2009 MCW Human Research Orientation packet                                                                                 39
45 CFR 46 Protection of Human Subjects (The Common Rule)

Review parts of 45 CFR 46

46.101 To what does this policy apply?

46.103(a) Assuring compliance with this policy – research conducted or supported
by any Federal Department or Agency

46.102 Definitions

45 CFR 46.107 IRB membership

45 CFR 46.101 (b) (1 - 6)            pages 3 and 4

45 CFR 46.110 Expedited review procedures for certain kinds of research……

45 CFR 46.108 b IRB functions and operations

45 CFR 46.109 IRB review of Research

45 CFR 46.111 Criteria for IRB approval of research

45 CFR 46.116 General requirements for informed consent

45 CFR 46.117 Documentation of informed consents


The following quotes the Federal Regulation and MCW Policy, and then offers an
explanation of how it works at MCW.



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May 2009 MCW Human Research Orientation packet                                   40
May 2009 MCW Human Research Orientation packet   41
46.101 To what does this policy apply?
 (a) Except as provided in paragraph (b) of this section, this policy applies to all research
involving human subjects conducted, supported or otherwise subject to regulation by any federal
department or agency which takes appropriate administrative action to make the policy
applicable to such research.


46.103(a) Assuring compliance with this policy – research conducted
or supported by any Federal Department or Agency

 (a) Each institution engaged in research which is covered by this policy and which is conducted
or supported by a federal department or agency shall provide written assurance satisfactory to
the department or agency head that it will comply with the requirements set forth in this policy.
In lieu of requiring submission of an assurance, individual department or agency heads shall
accept the existence of a current assurance, appropriate for the research in question, on file with
the Office for Human Research Protections, HHS, or any successor office, and approved for
federalwide use by that office. When the existence of an HHS-approved assurance is accepted in
lieu of requiring submission of an assurance, reports (except certification) required by this policy
to be made to department and agency heads shall also be made to the Office for Human Research
Protections, HHS, or any successor office.



MCW Assurance
Federalwide Assurances

The Medical College of Wisconsin Human Research Review Committee has been assigned the
Federalwide Assurance number FWA#00000820.

The Froedtert Hospital Institutional Review Board has been assigned the Federalwide Assurance
number FWA#00002157.

Under the "Assurance," the Federal Policy (Common Rule) for the protection of human subjects
Section 103(a) requires that each institution engaged in federally supported human subject
research file an Assurance of Protection for Human Subjects. The Assurance formalizes the
Medical College of Wisconsin's commitment to protect human subjects. The Assurance facilitates
HHS's effort to establish effective communication with the IRBs working to protect human
subjects, especially when the research is HHS regulated or HHS supported.

Under Federal Policy (Common Rule) Section 102(f), awardees and their collaborating
institutions become engaged in human subject research whenever their employees or agents
intervene or interact with living individuals for research purposes or obtain, release or access
individually identifiable private information for research purposes. In addition, awardee
institutions are automatically considered to be engaged in human subject research whenever they
receive an HHS award to support such research.


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May 2009 MCW Human Research Orientation packet                                                    42
45 CFR 46.102 Definition of Research

(d) Research means a systematic investigation, including research development, testing and
evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet
this definition constitute research for purposes of this policy, whether or not they are conducted
or supported under a program which is considered research for other purposes. For example,
some demonstration and service programs may include research activities.



MCW Definition of Research
Research is an original investigation undertaken to acquire knowledge and understanding. It typically involves
inquiry of an experimental or critical nature driven by hypotheses or intellectual positions capable of rigorous
assessment. It is an independent*, creative, cumulative and often long-term activity conducted by specialists
with knowledge about the theories, methods and information concerning the field of inquiry. Research findings
must be open to scrutiny and formal evaluation by others in the field, which may be achieved through
publication or public presentation.

Research includes contributions to the knowledge base of subjects and disciplines. It also includes the
experimental development of solutions, as well as investigation that leads to new or substantially improved
materials, devices, products or processes.

The following activities are excluded from the definition of research:


         preparation for teaching;
         the provision of advice or opinion, except where it is consistent with the definition of research;
         scientific and technical information services;
         general purpose or routine data collection;
         standardization and routine testing;
         feasibility studies (except into research and experimental development projects);
         routine medical care;
         a single-case presentation based on retrospective (not pre -planned) review of routine medical car
         the commercial, legal and administrative aspects of patenting, copyrighting or licensing activities;
         routine computer programming, systems work or software maintenance (but research and experimental
         development of
         applications software, new programming languages and new operating systems is research); and
         any other routine professional practice


*The interpretation of "independent" does not exclude collaborative research.


Updated May 20, 2004


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May 2009 MCW Human Research Orientation packet                                                                     43
45 CFR 46.102 Definition of Human Subject

(f) Human subject means a living individual about whom an investigator (whether professional
or student) conducting research obtains

(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information.


MCW Definition of Human Subject
                                                                                                               Policy No. IRB 001
                                                                                                          Revision Date: 5/15/2006
                                                                                                            Effective Date: 5/22/06

1. POLICY : Human Subject Definition

Specific Policies

   1.1 MCW definition of a human subject:

        1.1.1 Human subject means a living individual who is or becomes a participant in research, either as a recipient of the test
article or as a control about whom an investigator (whether professional or student) conducting research obtains: 1) data through
intervention or interaction with the individual or 2) identifiable private information. A subject may be either a healthy individual or
a patient.

   1.2 Review of research regarding decedents:

     1.2.1 Research protocols involving decedents do not require IRB review; however, based upon federal regulations at 45
CFR 160 and 164, a review by the Institution's Privacy Board is required.

      1.2.2 MCW/FH IRBs also serve as the MCW Privacy Boards. There is a separate process for Privacy Board review
submissions. The actions of the Privacy Board are documented in the minutes of the IRB meeting under the Administrative
Report.

2. SCOPE

This definition applies to all research involving human subjects, which is conducted at the Medical College of Wisconsin and
Froedtert Hospital.

3. RESPONSIBILITY

It is the responsibility of the Institutional Review Board (IRB) staff and committee members to ensure the proper application of the
definition in reviewing submissions. It is the responsibility of principal investigators to ensure the proper application of the
definition to their research projects and submit an application to the IRB for its review.

4. APPLICABLE REGULATIONS AND GUIDELINES

Citations from Federal Regulations pertaining to the definition of "Human Subject":

   21 CFR 56.102(e) defines a human subject:
Human subject means an individual who is or becomes a participant in research, either as a recipient of the test article or as a
control. A subject may be either a health individual or a patient.

   45 CFR 46.102(f) defines a human subject:
Human subject means a living individual about whom an investigator (whether professional or student) conducting research
obtains 1) data, 2) identifiable private information.


May 2009 MCW Human Research Orientation packet                                                                                      44
  45 CFR 46.160 and 164, HIPAA defines research:
Research is any systematic investigation, including research development, testing, and evaluation, designed to develop or
contribute to generalizable knowledge and involving human subjects. Note: Unlike the Common Rule, HIPAA protections do
extend to protected healthcare information of decedents.

5. REFERENCES TO OTHER APPLICABLE SOPs

Current SOP Related to Definition of Human Subjects
MCW Standard Operating Procedures definition (9/28/00, 1/2/02):

  (y) "Human Subject" or "Subject" means an individual who is or becomes a participant in a Research Study. A Subject may
be either a healthy individual or a patient.

Historically Relevant Policy Statement which Conflicted with SOP (9/28/00, 1/2/02)
This statement is rescinded by this document – Policy # IRB 001
Memo Sent 8/12/03 Changes Definition of "Human Subject":

   "Human participant means a living individual or decedent about whom an investigator (whether professional or student)
conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information."


6. ATTACHMENTS

Application information for Privacy Board review:
  Request for Waiver of Authorization for PHI

7. PROCESS OVERVIEW

Research projects involving decedents shall be reviewed by an MCW Privacy Board. The principal investigator will submit
research projects involving decedents to the IRB using the required application for review and determination.

8. PROCEDURES EMPLOYED TO IMPLEMENT THIS POLICY

Who         Task                                                                      Tool
                                                                                      IRBC 1
IRBC1       Reviews submission to determine if the study involves decedents.
                                                                                      Checklist
            Confirm IRBC1 determination. Review Privacy Board application
                                                                                      IRBC2
IRBC2       and determine if modifications are required. Communicate with
                                                                                      Checklist
            study staff as needed. Schedule for review.
Privacy     Review and determine status of application, based on HIPAA
                                                                                      IRB Checklist
Board       requirements, for research involving decedents.
                                                                                      Meeting
                                                                                      Minutes
            Document review and determination in IRB meeting minutes under            Template.
IRBC2       the Administrative Report. Issue a determination letter to the
            principal investigator.
                                                                                      Letter
                                                                                      Template.




    If the definition of Human Subjects AND research are met,
           then the protocol must be submitted to the IRB
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May 2009 MCW Human Research Orientation packet                                                                                      45
45 CFR 46.107 IRB membership

 (a) Each IRB shall have at least five members, with varying backgrounds to promote complete
and adequate review of research activities commonly conducted by the institution. The IRB shall
be sufficiently qualified through the experience and expertise of its members, and the diversity of
the members, including consideration of race, gender, and cultural backgrounds and sensitivity
to such issues as community attitudes, to promote respect for its advice and counsel in
safeguarding the rights and welfare of human subjects. In addition to possessing the professional
competence necessary to review specific research activities, the IRB shall be able to ascertain the
acceptability of proposed research in terms of institutional commitments and regulations,
applicable law, and standards of professional conduct and practice. The IRB shall therefore
include persons knowledgeable in these areas. If an IRB regularly reviews research that involves
a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped
or mentally disabled persons, consideration shall be given to the inclusion of one or more
individuals who are knowledgeable about and experienced in working with these subjects.

                                           At MCW
        Four Institutional Review Board Committees (IRB’s)
         Meets twice per month
         Approximately eleven members with diverse backgrounds

        One devoted Expedited Review Committee

Studies involving minors are reviewed by Children’s Hospital of WI IRB (HRRC)

VA, Blood Research Institute, Milwaukee County Behavioral Health Division each has its own
IRB

MCW has an electronic submission process – eBridge – Human Studies



***IMPORTANT*** EACH INSTITUTION REQUIRES A SEPARATE SUBMISSION
USING THEIR OWN FORMS

If you plan to conduct human research at more than one institution, it is advisable
to have a discussion with each IRB administrative office prior to submission.




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May 2009 MCW Human Research Orientation packet                                                   46
MCW Committees

 IRB Committee Meeting agendas are frozen three weeks in advance of each IRB meeting for all
 submissions and documents sent to the IRB Committee members for review. We are unable to add
 anything to the agenda after that time.

 In order for the IRB to conduct timely continuing review, CPR's must be received by the IRB 60 days
 in advance of the expiration date.


                                 IRB Committee Meeting Dates

 MCW/FH #1              MCW/FH #2                MCW/FH #3            MCW/FH #4
 5:00 p.m.              11:00 a.m.               4:00 p.m.            12 noon
 Faye Overly            Ranbir (Bobbie) Saini    AnnMarie Lessner     Kristin Bastian
 foverly@mcw.edu        rsaini@mcw.edu           alessner@mcw.edu     kbastian@mcw.edu

 January 5, 2009        January 12, 2009         January 13, 2009     January 14, 2009
 January 19, 2009       January 26, 2009         January 27, 2009     January 28, 2009
 February 2, 2009       February 9, 2009         February 10, 2009    February 11, 2009
 February 16, 2009      February 23, 2009        February 24, 2009    February 25, 2009
 March 2, 2009          March 9, 2009            March 10, 2009       March 11, 2009
 March 16, 2009         March 23, 2009           March 24, 2009       March 25, 2009
 April 6, 2009          April 13, 2009           April 14, 2009       April 8, 2009
 April 20, 2009         April 27, 2009           April 28, 2009       April 22, 2009
 May 4, 2009            May 11, 2009             May 12, 2009         May 13, 2009
 May 18, 2009           June 8, 2009             May 26, 2009         May 27, 2009
 June 1, 2009           June 22, 2009            June 9, 2009         June 10, 2009
 June 15, 2009          July 13, 2009            June 23, 2009        June 24, 2009
 July 6, 2009           July 27, 2009            July 14, 2009        July 8, 2009
 July 20, 2009          August 10, 2009          July 28, 2009        July 22, 2009
 August 3, 2009         August 24, 2009          August 11, 2009      August 12, 2009
 August 17, 2009        September 14, 2009       August 25, 2009      August 26, 2009
 September 21, 2009     September 28, 2009       September 8, 2009    September 9, 2009
 October 5, 2009        October 12, 2009         September 22, 2009   September 23, 2009
 October 19, 2009       October 26, 2009         October 13, 2009     October 14, 2009
 November 2, 2009       November 9, 2009         October 27, 2009     October 28, 2009
 November 16, 2009      November 23, 2009        November 10, 2009    November 11, 2009
 December 7, 2009       December 14, 2009        November 24, 2009    November 25, 2009
 December 21, 2009      December 28, 2009        December 8, 2009     December 9, 2009




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May 2009 MCW Human Research Orientation packet                                                         47
                  What are the levels or types of committee review?
                                      1. Exempt
                                    2. Expedited
                                 3. Full Committee
1. Exempt
45 CFR 46.101 (b) (1 - 6)            To what does this policy apply?

(b) Unless otherwise required by department or agency heads, research activities in which the
only involvement of human subjects will be in one or more of the following categories are exempt
from this policy:

(1) Research conducted in established or commonly accepted educational settings, involving
normal educational practices, such as (i) research on regular and special education instructional
strategies, or (ii) research on the effectiveness of or the comparison among instructional
techniques, curricula, or classroom management methods.

(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement),
survey procedures, interview procedures or observation of public behavior, unless:
(i) information obtained is recorded in such a manner that human subjects can be identified,
directly or through identifiers linked to the subjects; and (ii) any disclosure of the human
subjects' responses outside the research could reasonably place the subjects at risk of criminal or
civil liability or be damaging to the subjects' financial standing, employability, or reputation.

(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement),
survey procedures, interview procedures, or observation of public behavior that is not exempt
under paragraph (b)(2) of this section, if:
(i) the human subjects are elected or appointed public officials or candidates for public office; or
(ii) federal statute(s) require(s) without exception that the confidentiality of the personally
identifiable information will be maintained throughout the research and thereafter.

(4) Research involving the collection or study of existing data, documents, records, pathological
specimens, or diagnostic specimens, if these sources are publicly available or if the information is
recorded by the investigator in such a manner that subjects cannot be identified, directly or
through identifiers linked to the subjects.

(5) Research and demonstration projects which are conducted by or subject to the approval of
department or agency heads, and which are designed to study, evaluate, or otherwise examine:
(i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under
those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv)
possible changes in methods or levels of payment for benefits or services under those programs.

(6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods
without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or
below the level and for a use found to be safe, or agricultural chemical or environmental
contaminant at or below the level found to be safe, by the Food and Drug Administration or
approved by the Environmental Protection Agency or the Food Safety and Inspection Service of
the U.S. Department of Agriculture.



May 2009 MCW Human Research Orientation packet                                                    48
1. Exemptions (continued)

21 CFR 56.104 Exemptions from IRB requirement.

The following categories of clinical investigations are exempt from the requirements of this part
for IRB review:

(a) Any investigation which commenced before July 27, 1981 and was subject to requirements for
IRB review under FDA regulations before that date, provided that the investigation remains
subject to review of an IRB which meets the FDA requirements in effect before July 27, 1981.

(b) Any investigation commenced before July 27, 1981 and was not otherwise subject to
requirements for IRB review under Food and Drug Administration regulations before that date.

(c) Emergency use of a test article, provided that such emergency use is reported to the IRB
within 5 working days. Any subsequent use of the test article at the institution is subject to IRB
review.

(d) Taste and food quality evaluations and consumer acceptance studies, if wholesome foods
without additives are consumed or if a food is consumed that contains a food ingredient at or
below the level and for a use found to be safe, or agricultural, chemical, or environmental
contaminant at or below the level found to be safe, by the Food and Drug Administration or
approved by the Environmental Protection Agency or the Food Safety and Inspection Service of
the U.S. Department of Agriculture.

[46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28028, June 18, 1991]

Sec. 56.102 Definitions.

(d) Emergency use means the use of a test article on a human subject in a life-threatening
situation in which no standard acceptable treatment is available, and in which there is not
sufficient time to obtain IRB approval.




MCW IRB SOP’s section 5.2 addresses Exemptions


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May 2009 MCW Human Research Orientation packet                                                       49
2. Expedited (does not mean fast)
Actual expedited categories are listed in 63 FR 60364-60367



45 CFR 46.110 Expedited review procedures for certain kinds of research involving
no more than minimal risk, and for minor changes in approved research.

(a) The Secretary, HHS, has established, and published as a Notice in the FEDERAL
REGISTER, a list of categories of research that may be reviewed by the IRB through an
expedited review procedure. The list will be amended, as appropriate, after consultation with
other departments and agencies, through periodic republication by the Secretary, HHS, in the
FEDERAL REGISTER. A copy of the list is available from the Office for Human Research
Protections, HHS, or any successor office.

(b) An IRB may use the expedited review procedure to review either or both of the following:

(1) some or all of the research appearing on the list and found by the reviewer(s) to involve no
more than minimal risk,

(2) minor changes in previously approved research during the period (of one year or less) for
which approval is authorized.

Under an expedited review procedure, the review may be carried out by the IRB chairperson or
by one or more experienced reviewers designated by the chairperson from among members of
the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB
except that the reviewers may not disapprove the research. A research activity may be
disapproved only after review in accordance with the non-expedited procedure set forth in
§46.108(b).




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May 2009 MCW Human Research Orientation packet                                                     50
May 2009 MCW Human Research Orientation packet   51
                                   63 FR 60364-60367, November 9, 1998

                      Categories of Research That May Be Reviewed by the

                              Institutional Review Board (IRB) through an

                                                    Expedited Review

                                                          Procedure1
Applicability

           (A) Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures
listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized
by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are
included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review
procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.

         (B) The categories in this list apply regardless of the age of subjects, except as noted.

          (C) The expedited review procedure may not be used where identification of the subjects and/or their responses would
reasonably place them at risk of criminal or civil liability or be damaging to the subjects= financial standing, employability,
insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks
related to invasion of privacy and breach of confidentiality are no greater than minimal.

         (D) The expedited review procedure may not be used for classified research involving human subjects.

         (E) IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply
regardless of the type of review--expedited or convened--utilized by the IRB.

         (F) Categories one (1) through seven (7) pertain to both initial and continuing IRB review.

Research Categories

         (1) Clinical studies of drugs and medical devices only when condition (a) or (b) is met.

                  (a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required.
         (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks
         associated with the use of the product is not eligible for expedited review.)

                  (b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part
         812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in
         accordance with its cleared/approved labeling.

         (2) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

                 (a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn
         may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or

                                                     2
                  (b) from other adults and children , considering the age, weight, and health of the subjects, the collection
         procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the
         amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more
         frequently than 2 times per week.




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May 2009 MCW Human Research Orientation packet                                                                                  52
         (3) Prospective collection of biological specimens for research purposes by noninvasive means.

                  Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if
         routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for
         extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an
         unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f)
         placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
         (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than
         routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic
         techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum
         collected after saline mist nebulization.

           (4) Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed
in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be
cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not
generally eligible for expedited review, including studies of cleared medical devices for new indications.)

                   Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not
         involve input of significant amounts of energy into the subject or an invasion of the subject=s privacy; (b) weighing or
         testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography,
         thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging,
         doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition
         assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

          (5) Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected
solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be
exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research
that is not exempt.)

         (6) Collection of data from voice, video, digital, or image recordings made for research purposes.

         (7) Research on individual or group characteristics or behavior (including, but not limited to, research on perception,
cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing
survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
(NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR
46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)

         (8) Continuing review of research previously approved by the convened IRB as follows:

                  (a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have
         completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of
         subjects; or

                  (b) where no subjects have been enrolled and no additional risks have been identified; or

                  (c) where the remaining research activities are limited to data analysis.

         (9) Continuing review of research, not conducted under an investigational new drug application or investigational device
exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened
meeting that the research involves no greater than minimal risk and no additional risks have been identified.
         _______________________

1
 An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or
more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the
requirements set forth in 45 CFR 46.110.

2
 Children are defined in the HHS regulations as "persons who have not attained the legal age for consent to treatments or
procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted." 45 CFR
46.402(a).

May 2009 MCW Human Research Orientation packet                                                                                    53
Source: 63 FR 60364-60367, November 9, 1998.


3. Full Committee Review
45 CFR 46.108 b IRB functions and operations

(b) Except when an expedited review procedure is used (see §46.110), review proposed research
at convened meetings at which a majority of the members of the IRB are present, including at
least one member whose primary concerns are in nonscientific areas. In order for the research to
be approved, it shall receive the approval of a majority of those members present at the meeting



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May 2009 MCW Human Research Orientation packet                                                54
IRB Decisions – What happens after the discussion?
45 CFR 46.108 IRB review of research

(a) An IRB shall review and have authority to approve, require modifications in (to secure
approval), or disapprove all research activities covered by this policy.

(b) An IRB shall require that information given to subjects as part of informed consent is in
accordance with §46.116. The IRB may require that information, in addition to that specifically
mentioned in §46.116, be given to the subjects when in the IRB's judgment the information
would meaningfully add to the protection of the rights and welfare of subjects.

(c) An IRB shall require documentation of informed consent or may waive documentation in
accordance with §46.117.

(d) An IRB shall notify investigators and the institution in writing of its decision to approve or
disapprove the proposed research activity, or of modifications required to secure IRB approval of
the research activity. If the IRB decides to disapprove a research activity, it shall include in its
written notification a statement of the reasons for its decision and give the investigator an
opportunity to respond in person or in writing.

(e) An IRB shall conduct continuing review of research covered by this policy at intervals
appropriate to the degree of risk, but not less than once per year, and shall have authority to
observe or have a third party observe the consent process and the research.

MCW Decisions (in FH/MCW Standard Operating Procedure)
(a) Decisions
      Approve
      Require modifications (to secure approval)
      Table (MCW decision)
      Disapprove
(b) Continuing progress review (CPR) (PI must submit report)
Occurrence - Often times more frequently than once per year – from per patient for high risk, or
every 6 month, 9 months, etc. At discretion of IRB. Watch the due dates!! They are often 11
weeks
        Exempt (contact committee coordinator regarding study updates)
        Expedited
        Full committee
           Decisions
              Approve
              Require modifications (to secure approval – not necessarily tied to CPR)
              Table (MCW decision)
              Disapprove
  Suspend (can occur with audit / complaint)
  Terminate (can occur with audit / complaint – not necessarily tied to CPR)

STUDY CAN BEGIN/CONTINUE ONLY IF IT HAS AN APPROVED
STATUS
May 2009 MCW Human Research Orientation packet                                                    55
45 CFR 46.111 Criteria for IRB approval of research
(a) In order to approve research covered by this policy the IRB shall determine that
all of the following requirements are satisfied:

(1) Risks to subjects are minimized: (i) By using procedures which are consistent with sound
research design and which do not unnecessarily expose subjects to risk, and (ii) whenever
appropriate, by using procedures already being performed on the subjects for diagnostic or
treatment purposes.

(2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the
importance of the knowledge that may reasonably be expected to result. In evaluating risks and
benefits, the IRB should consider only those risks and benefits that may result from the research
(as distinguished from risks and benefits of therapies subjects would receive even if not
participating in the research). The IRB should not consider possible long-range effects of
applying knowledge gained in the research (for example, the possible effects of the research on
public policy) as among those research risks that fall within the purview of its responsibility.

(3) Selection of subjects is equitable. In making this assessment the IRB should take into account
the purposes of the research and the setting in which the research will be conducted and should
be particularly cognizant of the special problems of research involving vulnerable populations,
such as children, prisoners, pregnant women, mentally disabled persons, or economically or
educationally disadvantaged persons.

(4) Informed consent will be sought from each prospective subject or the subject's legally
authorized representative, in accordance with, and to the extent required by §46.116.

(5) Informed consent will be appropriately documented, in accordance with, and to the extent
required by §46.117.

(6) When appropriate, the research plan makes adequate provision for monitoring the data
collected to ensure the safety of subjects.

(7) When appropriate, there are adequate provisions to protect the privacy of subjects and to
maintain the confidentiality of data.

(b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence,
such as children, prisoners, pregnant women, mentally disabled persons, or economically or
educationally disadvantaged persons, additional safeguards have been included in the study to
protect the rights and welfare of these subjects.



MCW’s protection for vulnerable populations

        Representative IRB member considers special issues


Back to Table of Contents


May 2009 MCW Human Research Orientation packet                                                      56
45 CFR 46.116 General requirements for informed consent

Except as provided elsewhere in this policy, no investigator may involve a human being as a
subject in research covered by this policy unless the investigator has obtained the legally effective
informed consent of the subject or the subject's legally authorized representative. An investigator
shall seek such consent only under circumstances that provide the prospective subject or the
representative sufficient opportunity to consider whether or not to participate and that minimize
the possibility of coercion or undue influence. The information that is given to the subject or the
representative shall be in language understandable to the subject or the representative. No
informed consent, whether oral or written, may include any exculpatory language through which
the subject or the representative is made to waive or appear to waive any of the subject's legal
rights, or releases or appears to release the investigator, the sponsor, the institution or its agents
from liability for negligence.

(a) Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section,
in seeking informed consent the following information shall be provided to each subject:

(1) A statement that the study involves research, an explanation of the purposes of the research
and the expected duration of the subject's participation, a description of the procedures to be
followed, and identification of any procedures which are experimental;

(2) A description of any reasonably foreseeable risks or discomforts to the subject;

(3) A description of any benefits to the subject or to others which may reasonably be expected
from the research;

(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might
be advantageous to the subject;

(5) A statement describing the extent, if any, to which confidentiality of records identifying the
subject will be maintained;

(6) For research involving more than minimal risk, an explanation as to whether any
compensation and an explanation as to whether any medical treatments are available if injury
occurs and, if so, what they consist of, or where further information may be obtained;

(7) An explanation of whom to contact for answers to pertinent questions about the research and
research subjects' rights, and whom to contact in the event of a research-related injury to the
subject; and

(8) A statement that participation is voluntary, refusal to participate will involve no penalty or
loss of benefits to which the subject is otherwise entitled, and the subject may discontinue
participation at any time without penalty or loss of benefits to which the subject is otherwise
entitled.

(b) Additional elements of informed consent. When appropriate, one or more of the following
elements of information shall also be provided to each subject:

(1) A statement that the particular treatment or procedure may involve risks to the subject (or to
the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;

May 2009 MCW Human Research Orientation packet                                                       57
(2) Anticipated circumstances under which the subject's participation may be terminated by the
investigator without regard to the subject's consent;

(3) Any additional costs to the subject that may result from participation in the research;

(4) The consequences of a subject's decision to withdraw from the research and procedures for
orderly termination of participation by the subject;

(5) A statement that significant new findings developed during the course of the research which
may relate to the subject's willingness to continue participation will be provided to the subject;
and

(6) The approximate number of subjects involved in the study.

(c) An IRB may approve a consent procedure which does not include, or which alters, some or all
of the elements of informed consent set forth above, or waive the requirement to obtain informed
consent provided the IRB finds and documents that:

(1) The research or demonstration project is to be conducted by or subject to the approval of state
or local government officials and is designed to study, evaluate, or otherwise examine: (i) public
benefit or service programs; (ii) procedures for obtaining benefits or services under those
programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv)
possible changes in methods or levels of payment for benefits or services under those programs;
and

(2) The research could not practicably be carried out without the waiver or alteration.

(d) An IRB may approve a consent procedure which does not include, or which alters, some or all
of the elements of informed consent set forth in this section, or waive the requirements to obtain
informed consent provided the IRB finds and documents that:

(1) The research involves no more than minimal risk to the subjects;

(2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;

(3) The research could not practicably be carried out without the waiver or alteration; and

(4) Whenever appropriate, the subjects will be provided with additional pertinent information
after participation.

(e) The informed consent requirements in this policy are not intended to preempt any applicable
federal, state, or local laws which require additional information to be disclosed in order for
informed consent to be legally effective.

(f) Nothing in this policy is intended to limit the authority of a physician to provide emergency
medical care, to the extent the physician is permitted to do so under applicable federal, state, or
local law.




May 2009 MCW Human Research Orientation packet                                                    58
45 CFR 46.117 Documentation of informed consent

(a) Except as provided in paragraph (c) of this section, informed consent shall be documented by
the use of a written consent form approved by the IRB and signed by the subject or the subject's
legally authorized representative. A copy shall be given to the person signing the form.

(b) Except as provided in paragraph (c) of this section, the consent form may be either of the
following:

(1) A written consent document that embodies the elements of informed consent required by
§46.116. This form may be read to the subject or the subject's legally authorized representative,
but in any event, the investigator shall give either the subject or the representative adequate
opportunity to read it before it is signed; or

(2) A short form written consent document stating that the elements of informed consent
required by §46.116 have been presented orally to the subject or the subject's legally authorized
representative. When this method is used, there shall be a witness to the oral presentation. Also,
the IRB shall approve a written summary of what is to be said to the subject or the
representative. Only the short form itself is to be signed by the subject or the representative.
However, the witness shall sign both the short form and a copy of the summary, and the person
actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be
given to the subject or the representative, in addition to a copy of the short form.

(c) An IRB may waive the requirement for the investigator to obtain a signed consent form for
some or all subjects if it finds either:

(1) That the only record linking the subject and the research would be the consent document and
the principal risk would be potential harm resulting from a breach of confidentiality. Each
subject will be asked whether the subject wants documentation linking the subject with the
research, and the subject's wishes will govern; or

(2) That the research presents no more than minimal risk of harm to subjects and involves no
procedures for which written consent is normally required outside of the research context.

In cases in which the documentation requirement is waived, the IRB may require the investigator
to provide subjects with a written statement regarding the research.




MCW’s submission process contains the items required by the Federal Regulations
and the MCW Standard Operating Procedures for IRB and Research Team in a
format that is uniform.




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May 2009 MCW Human Research Orientation packet                                                      59
MCW/FH New Consent Form Templates

Eliciting Truly Informed Consent “Primer”

Is a Research Study for You? (for the subject)

ClinicalTrials.gov

OHRP Informed Consent Guidance
   http://www.hhs.gov/ohrp/policy/index.html#informed

OHRP Informed Consent Frequently Asked Questions

OHRP Investigator Responsibility Frequently Asked Questions

FDA Informed Consent – Protection of Human Subjects

MCW Quality Improvement web site
   Audit Information




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May 2009 MCW Human Research Orientation packet                60
Office of Clinical Research and Innovative Care Compliance
                                                       (OCRICC)
                                   PROGRAM DOCUMENT
                                                       Spring 2008




Corporate Compliance Program, Froedtert Hospital
414-805-2895

OCRICC Contact Information
Sena Linden, Coordinator, 805-3039, slinden@froedtertcommunityhealth.org
Roberta Navarro, Manager, 805-6530, rnavarro@froedtertcommunityhealth.org


http://intranet.fchhome.com/Froedtert

Click on “Campus Services” tab on top left of screen

Click on FCH OCRICC option

fch_ocricc@fmlh.edu




May 2009 MCW Human Research Orientation packet                              61
Over the past several years, the federal government has placed greater emphasis on regulations related to
financial accountability for the conduct and payment of clinical research. Many academic medical centers have
begun assembling programs to address the concerns of the government, and have implemented safeguards to
ensure the clinical care provided to subjects in research studies is paid by and billed to the appropriate party.

Froedtert Hospital (FH) has approved funding a program that will promote compliance by implementing
policies and procedures to comply with federal regulations related to the coverage of investigational research
and the national coverage determinations enacted by the Centers for Medicare and Medicaid Services (CMS).
The new program is called the Office of Clinical Research and Innovative Care Compliance (OCRICC) and
will oversee the administrative compliance functions associated with performing clinical research utilizing
Froedtert Hospital space, staff, resources, services, and/or equipment. OCRICC will be a central office that
will have dedicated staff to work with Principle Investigators and Study Coordinators to assist with activities
such as coordinating budget and pricing requests for hospital services, coverage and financial analysis, and
activities related billing compliance.

I. Overview and Purpose of the Office of Clinical Research and Innovative Care Compliance

The Office of Clinical Research and Innovative Care Compliance (OCRICC) will oversee the administrative
compliance functions associated with performing clinical research at Froedtert Hospital. This program will
work in collaboration with MCW Compliance, MCW Grants and Contracts, the IRB, and with the Medical
College of Wisconsin physicians and clinical research coordinators which deliver the clinical care provided
during the conduct of a clinical trial. This program will be responsible for establishing uniform policies and
operational procedures for billing clinical services provided to subjects who participate in research studies and
thereby help ensure that Froedtert Hospital adheres to the laws and regulations that govern medical billing
practices in this region. Research billing compliance is relatively new on the regulatory front. The standards
are not as clearly defined by external regulatory agencies as other billing rules. However, the basis for these
rules and the audits that the Office of Inspector General (OIG) and the Department of Justice (DOJ) have
conducted are that:

    1. CMS and other third party payors should not be billed for items or services that are paid for by the
       sponsor or grant.
    2. CMS should not be billed for items or services that are not generally available to Medicare
       beneficiaries outside of the clinical trial (i.e., there exists a benefit category, it is reasonable and
       necessary, it is not statutorily excluded, and there is not a national/local non-coverage decision).

The program will also review care that is not research but “innovative” or leading edge. When a drug or
device is used for an indication outside of the approved labeling, there can be issues for third party coverage
where there is no or limited reimbursement. As these reimbursement issues or questions are raised, the Office
of Clinical Research and Innovative Care Compliance will help the clinical department and/or physician
determine options for reimbursement and make sure we have compliant billing practices.

OCRICC has a dedicated staff of Coordinators and Billing Specialists that will assist the investigator with the
following types of activities:

    Operational Feasibility: Many times Froedtert Hospital (FH) department leadership do not receive a
    copy of the clinical protocol and do not always understand the space, staff, equipment, time, and resources
    required. This activity will include a review of the clinical protocol documents completed by a
    Coordinator from OCRICC. The purpose of this review is to:

       Identify all Froedtert Service Departments being asked to provide services as part of the clinical study.

May 2009 MCW Human Research Orientation packet                                                                    62
       Collaborate with the principle investigator/clinical research coordinator, and the Froedtert operational
        departments so that everyone understands what they are being asked to do and that they can manage
        what is required by the protocol (volume, staff, equipment, timeframe, etc).

    Budget Development: Until now, there has been no central function responsible for providing FH
    pricing for services provided as part of a clinical research protocol. As a result, there have been
    inconsistencies and errors in pricing. In addition, there have also been:

           delays in providing discounts
           under-funding due to inaccurate prices used to create budgets for sponsors/grants,
           unfunded services where a third party payor denies payment, and the denial results in Froedtert
            either billing the patient or the patients insurance, or results in Froedtert writing-off the
            charges.

    In an effort to streamline and improve the budget development process on the hospital side, we have
    centralized the coordination of pricing FH services related to a clinical protocol. The PI/delegate is
    responsible for completing a OCRICC Clinical Trial Application Form and a Schedule of Events Form
    that will list all clinical services that are required as part of the clinical trial. They will be responsible for
    identifying the place of service (dept/MCW or FH) and the funding source (billable to a sponsor or grant,
    or routine care billed to third party payor) for each service. OCRICC Staff will then review the Clinical
    Trial Agreement (CTA) and the Clinical Protocol to confirm the information is complete and accurate, and
    then if required, provide pricing for each Froedtert service listed. This activity will also include facilitating
    requests for additional review for any services that are not funded by a third party to identify potential
    opportunities to cover hospital costs.

    Coverage Analysis:
    Any FH services that will be billed to a 3rd party payor will be required to go through a coverage analysis.
    These services will be reviewed to see if they meet the Medicare definition of “routine care” and to make
    sure that it is a covered service according to Medicare Policy. Coverage analysis review occurs prior to
    IRB review.
           Coverage analysis review may identify that a letter to the Medicare Fiscal Intermediary may be
             required for a request of notification or a request of coverage. This activity must occur after IRB
             approval and before first study enrollment and requires a signed CTA.
           It may also require FH to work with the MCW Grants and Contracts Office if the CTA has terms
             and conditions listed for the Institutional Site, and based on the site of service, the Institutional
             Site is Froedtert Hospital.
           Coverage analysis will review commercial carriers and may be handled through a pre-
             authorization process.

    Charge Capture/Billing Process: OCRICC staff will set up both an Operational Plan and Billing Work
    Plan in coordination with the Froedtert department and the PI/delegate specific to the protocol reviewed.
    This will include setting up a process to assure the correct accounts, making sure the correct charges are
    billed to the appropriate funding source, set up of the correct charge codes, ensuring all the necessary
    billing codes are on the claim as required and that a process for pre-authorization or an Advanced
    Beneficiary Notice/Hospital Issued Notice of Non-Coverage is established for the hospital when
    necessary.

    Monitoring: A process will be put in place to monitor that the clinical departments are billing according
    to the billing plan and Froedtert Hospital is obtaining the expected reimbursement. The first few claims
    will be reviewed for accuracy, and a longer-term department monitoring plan will be determined. If there


May 2009 MCW Human Research Orientation packet                                                                     63
    are unexpected denials, the OCRICC will coordinate the appeal with the Patient Financial Services
    Department, the clinical department and the physician.

II. Benefits of F&CH the OCRICC Program

The Office of Clinical Research and Innovative Care Compliance (OCRICC) helps F&CH support an
environment that can reduce the likelihood of conduct that is prohibited by the Centers of Medicare and
Medicaid Services, State, or Federal law or regulation. The existence of an effective research billing
compliance program within F&CH may not only prevent violations of the Medicare, Medicaid billing
regulations, as well as prevent violations of other federal and state regulations but may also reduce the liability
and risk should a violation of the regulations occur. In addition, an effective research billing compliance
program will also benefit the clinical research activities conducted at Froedtert Hospital by:

       Centralizing pricing so timely and accurate charges are provided to develop a budget.
       Requiring that all operational departments provide the requested services according to the clinical
        trial protocol and to confirm they have the resources, space, and equipment needed before IRB
        approval so there are no delays in enrollment after approval.
        Providing a framework in which everyone knows what the financial commitment and
        contributions are; including the department, hospital, and most importantly the subject if third
        party payors exclude clinical research activities or routine care provided as part of a clinical trial.
       Reducing the risk for the hospital and the Principle Investigator/delegate of double billing or
        submitting false claims which can result in personal liability and penalties.
       Providing a single point of contact at the hospital to be an advocate for clinical research and help
        assist Clinical Coordinators and Principle Investigators.

III. Reporting Structure

The Office of Clinical Research and Innovative Care Compliance will report directly to the Director of
Corporate Compliance and Internal Audit. The Vice President responsible for this program is the Vice
President, Chief Compliance and Project Management Officer.

An ongoing evaluation process, including thorough monitoring of the Office of Clinical Research and
Innovative Care Compliance program implementation and regular reporting to senior management and the
Research Steering Committee (chaired by Senior Vice President of Medical Affairs (FH) and the Associate
Dean of Research (MCW), is critical to a successful program. Progress Reports created by this ongoing
monitoring, including reports of suspected non-compliance, will be maintained by the VP Chief Compliance
Officer and shared with the appropriate senior leadership.

IV. Communication and Training Program

Froedtert Hospital will take steps to communicate effectively its standards and procedures. Consequently,
face-to-face training, as well as, written training materials will be developed as part of the implementation of
this program.




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May 2009 MCW Human Research Orientation packet                                                                    64
Infoscope Scavenger Hunt

Main Page

1. Find the phone/paging link that allows one to find contact information for MCW, CHW and FH
staff

2. Find the Jump Starts links for
       College Affliliates
          o Find the Children’s IRB (HRRB) Office Page
       eBridge
          o Locate the help desk phone number and e-mail

3. Find the Departments link
       Institutional Review Boards
       Research Education, Office of Research
       Research, Office of
             Quality Improvement
       Human Research Protection Program (HRPP)

4. IRB site (HRPP Site)
          a) Find Policies & Guidelines
          b) Identify the recruiting policy
          c) Find Eliciting Truly Informed Consent Training Modules
          d) Find “Is a Research Study for You? Training Modules
          e) Flowchart for External & Internal SAEs
          f) New & Draft Policies & Procedures
              1) Banking Policy

5. Quality Improvement
          a) Checklists
          b) Common Findings of Noncompliance
          c) Current Tip Sheet
          d) Request a for cause audit

6. Research Education
        a) Find Angel eLearning Systems
        b) Find most current archived Monthly Meeting audio and PP
        c) Find CME transcript Line (Continuing Medical Education)
        d) Education for Human Research Teams
        e) Human Research Orientation for new employees or new to human research

    7. Find CITI website –
          a. From www.citiprogram.org
          b. Linking through Research Education web site




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May 2009 MCW Human Research Orientation packet                                             65
On Line Evaluation HERE



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May 2009 MCW Human Research Orientation packet   66
                  Orientation Evaluation                 Back to Table of Contents
                  Title: Human Research Orientation
                  Please Return to: Roxanne Pritchard, rpritcha@mcw.edu or fax to 414-456-8844

Today’s Date:__________________________________ ONLINE VERSION HERE (preferred)

Objectives:
         Identify Research Office contacts for human research (especially IRB and Human Quality
             Assurance/Improvement)
         Identify required training and optional training for human research team members
         Locate MCW websites with information and links to information relevant to human research
         Locate key websites regarding research education, IRB SOP’s, IRB committees and IRB
             website, informed consent, and links to federal agencies and key documents
         Compare key components of 45 CFR 46, a Federal Regulation that governs Human Subjects
             Protection in Research, with MCW SOP’s for Human Research

1 = no, very poor      5 = yes, excellent            1          2        3          4            5

1. Did this packet achieve its stated objectives?

2. Did the packet contain useful information?
4. Overall value of handout:

5. Would you prefer a personal meeting to
   discuss the packet content?

6. Overall course rating:

7. What information did you acquire that you plan to use on the job: __________________________
______________________________________________________________________________________________
______________________________________________________________________________________________
8. Best feature(s): _________________________________________________________________
______________________________________________________________________________________________
______________________________________________________________________________________________

9. What is missing? _________________________________________________________________
______________________________________________________________________________________________

10. What other classes or information would you like to appear in this format? __________________
______________________________________________________________________________________________
______________________________________________________________________________________________

11. Additional comments/suggestions are welcome: ______________________________________
________________________________________________________________________________
________________________________________________________________________________

(Optional)
Name: _____________________________________________________________________________________
Department: ___________________________________________________ Phone: _____________________
May 2009 MCW Human Research Orientation packet                                                       67

								
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