Docstoc

Kaiser Foundation Research Institute

Document Sample
Kaiser Foundation Research Institute Powered By Docstoc
					                                           Kaiser Permanente Southern California
                                             Institutional Review Board (IRB)
                                                  Research Application

 Do not use abbreviations, please spell out all acronyms in study title, protocol and participant documents
                                               Use font that is 11 pt. or higher




                                 Research Application Coversheet (Pages 2-3)

                                 Abstract, Significance, and Methods (Page 4)

                                 Research Questionnaire (Pages 5-8)

                                 Conflict of Interest Policy for Research (Page 9)

                                 Policies and Regulations Agreement Form (Page 10)

                                 Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule
                                      Questionnaire (Pages 11-14)




SCPMG Research Application 01/13/09                                                            Page 1
               Research Application Coversheet (must be typed and submitted electronically to the IRB)
                   Do not use abbreviations in your application and use a readable font (11pt or higher)
Study Title



Kaiser Permanente Southern California (KPSC) Principal Investigator (PI)
Name                                        Phone                                Fax
Tam Le                                      323-783-6922
Facility (Please Include Street Address)    Department.                          E-mail
Kaiser Permanente LAMC                      Ob/Gyn                               tam.x.le@kp.org
Is P.I. a resident or fellow?    yes     no

Signature                                   Date

Project Manager or Research Coordinator
Name                                             Phone                           Fax

Facility                                         Department                      E-mail

Signature                                   Date

Non KPSC Co-Investigator (Co-I)
Name                                             Phone                           Fax
Cara Krulewitch, CNM PhD                         240-276-2291                    240-276-3377
Affiliation                                      Department Epidemilogy          E-mail
Office of Surveillance and Biometrics                                            cara.krulewitch@fda.hhs.gov
Address

Signature                                   Date

Kaiser Permanente Southern California (KPSC) Co-Investigators
[Append additional page to accommodate additional investigators]
Name                                       Phone                                 Fax

Facility (Please Include Street Address)         Department OB/GYN               E-mail

Signature                                   Date

Name                                             Phone                           Fax

Facility (Please Include Street Address)         Department OB/GYN               E-mail
                                                                                 J
Signature                                   Date

Funding Information
Name of Study Sponsor/source of study funding              Sponsor/source of funding is
[N/A if none]                                                 pharmaceutical company
FDA                                                           device manufacturer
                                                              for-profit entity
                                                              federal funding
                                                              Regional Research Committee (RRC) $
                                                              KP Operating budget

SCPMG Research Application 01/13/09                                                                        Page 2
Approval Signatures: Investigators may submit approval signatures from their area research chair, the chief of
service/manager and the department administrator via hardcopy or email. Investigators who choose to submit signature
approval via email, must have their area research chair, chief of service/manager and department administrator send an
email to the Institutional Review Board (IRB)office at kpsc.irb@kp.org that includes the title of the study, the principal
investigator’s name and medical center affiliation, and a statement that reads: “I have reviewed this application and the
research is appropriate for conduct within KPSC, the source and amount of funds and physician time are
appropriate and the needed facility space and support can be made available, without undue disruption of
service.”
                        Area Research Chair   Name (print)                       Signature             Date

                   Chief of Service/Manager   Name (print)                       Signature             Date

                   Department Administrator   Name (print)                       Signature             Date




SCPMG Research Application 01/13/09                                                                           Page 3
                                  Abstract, Significance, and Methods (must be typed)



  Instructions: Provide the information requested below. This section should not exceed eight pages single
  sided. Please use a readable font (11 pt. or larger).


1. Study Abstract: Summarize answers to the following two questions concerning your proposed study in 300 or
    fewer words (total). (a) What is your research question or hypothesis? (b) Summarize your methods.

The aim of this project are to develop a method to assess the safety and effectiveness of these synthetic
surgical mesh devices via analyses of data from the Southern California Kaiser Permanente datatbase. From
this data, we can develop a pilot study to evaluate the feasibility to conduct a randomized controlled trial to
compare the traditional surgeries for prolapse and incontinence to these surgical mesh kits.




2. Background/Significance: Briefly state why this study is important to Kaiser Permanente Southern California
   and/or the community. List formal references to appropriate publications.

    Defects of the pelvic floor, such as pelvic organ prolapse (POP), stress urinary incontinence (SUI),
    overactive bladder, and anal incontinence are among the most common conditions experienced by women
    worldwide [1-5]. The direct cost of prolapse surgery is greater the $1 billion per year [5]. A 1997study by
    Olsen found that by the age of 79 years, women have an 11-12% chance of undergoing at least one
    operation for prolapse and/or incontinence, with a reoperation rate of 29.2% [4]. Therefore, it has become
    increasingly important to improve surgical strategies to decrease the incidence of surgical failure and
    recurrent prolapse.

    The use of surgical mesh for pelvic floor reinforcement has gained increasing popularity in recent years,
    with over 400,000 pelvic floor repair procedures performed yearly in the US. Many materials have been
    used without the type of clinical trials needed to answer important questions regarding efficacy,
    effectiveness, and safety including objectively-measured impact on QOL and rates or persistence or
    recurrence rates. A review of adverse events related to mesh use for pelvic floor repairs, reported to the
    FDA, indicates that serious medical complications and other detrimental health consequences including
    negative impact on health related quality of life (QOL) can result from mesh implantation [6]. The
    incidence of such adverse events remains unclear, and making it difficult to appropriately guide surgeons
    and counsel patients regarding the short term, intermediate, and long term implications of surgical mesh
    when used for repair of pelvic organ prolapse (POP) and treatment of stress urinary incontinence (SUI).
    The lack of quality data on the safety and effectiveness of surgical mesh is the motivation for this study
    proposal.

     Surgical mesh devices used in POP and SUI repair procedures have recently received increased interested
    in the Center for Devices and Radiological Health (CDRH) due to the large numbers of reports of serious
    adverse events, with detrimental health consequences, such as mesh erosion and extrusion, organ
    perforation, hematoma, and death. Design of a system requires a large age and ethnically diverse patient
    volume, with a group of appropriately-trained surgeons using surgical mesh for POP and SUI, and the
    ability to reliably measure clinically-relevant outcomes relating to effectiveness, complications, and impact
    on QOL. The Kaiser Permanente Southern California system has the opportunity to provide the patients
    and data infrastructure for such a project and the design and testing of such a database or reporting
    system is the principal goal of this pilot or introductory study. In subsequent projects, and suitably
    modified and enhanced, data collected from this study, using the methods outlined below, will provide
    comparative rates of safety and effectiveness of surgical mesh use that can aid in both FDA pre-market
    review and post-market surveillance of these devices.

    While the current application covers the design and pilot interpretation of a small subset of data, the
    outcome of the overall project is expected to have an impact on both FDA regulation and women's health
    and the results may be used to modify performance expectations during pre-market review and may lead

SCPMG Research Application 01/13/09                                                                   Page 4
     to the revision of the current FDA guidance on pre-market notification of surgical mesh devices.
     Furthermore, the project may provide support to instilling changes to current labeling practices for
     surgical mesh devices. Results may also provide guidance to analysis of post-market surveillance data and
     monitoring device performance through adverse event reporting.

     References:
     1. Weber, A.M. and Richter H.E. Pelvic organ prolapse. Obstet Gynecol, 2005, 106(3): 615-34.
     2. Emrute, K.V. and Badlani, G.H. Female incontinence: a review of biomaterials and minimally invasive
     techniques. Curr Opin Urol, 2006, 16 (2): 54-9.
     3. Begley, J.S. and Kobashi, K.C. The use of graft materials in anterior compartment pelvic
     reconstruction. Curr Urol Rep, 2004, 5 (5): 397-402
     4. Oslen, A.L. et. al. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence.
     Obstet Gynecol, 1997, 89(4): 501-6.
     5. Subak, L.L. et. al. Cost of pelvic organ prolapse surgery in the United States. Obstet Gynecol, 2001.
     98(4): 646-51.
     6. www.fda.gov: MAUDE adverse effect report


3.       Methods:

         A. What are the Study Objectives?

             The study objectives are:
             1. Determine the incidence/prevalence of POP and SUI in the Southern California Region between
             Jan 1, 2008 and December 31, 2009 using available databases
             2. In a six-month subset, determine the rates and types of complications experienced by women
             who have received a POP or SUI with and without graft prosthesis?
             3. In the same subset, determine the rates of reoperation and/or mesh explantation?
             4. Determine the steps necessary to conduct a larger, ongoing study of women to determine the
             impact of various mesh products on symptoms, complication rates, recurrence/prevalence of
             disease, and health related QOL.

Describe the following:

         A1. Study design (including study type, i.e. retrospective, prospective, etc.)


             Retrospective data collection and selected chart review.
         B. Study Procedures (including recruitment, proposed compensation for study participation and patient
            population selection including study inclusion and exclusion criteria)

             All women at institutions in Kaiser Permanente's Southern California Region (KPSC), who are over
             18 years of age who have a diagnostic code reflecting a pelvic floor disorder (SUI and POP) will be
             identified electronically using the International Classification of Diseases (ICD-9) diagnostic codes
             between Jan 1, 2008 and December 21, 2009. This will provide an estimate of prevalence in this
             population. The query will include a search for procedure codes that identify those who have
             undergone a surgical procedure designed to treat the pelvic floor. A subset of approximately 10
             percent of patients who had sought care for pelvic floor disorder, operated on between January 1,
             2008 and June 30, 2008 will be selected for further evaluation. Manual chart review will be
             performed to validate the diagnoses and procedures performed, identify comorbid conditions and
             other historical parameters of note, and to determine, based on subsequent followup visits, the
             efficacy, effectiveness, and complications of the procedure, and complications. Patient will be
             identified in the KPSC electronic databases using or procedure codes (see attached sheet for
             variable definitions, diagnostic codes, procedure codes.) Gap analysis will be included to aid in the
             design of future prospective data collection tools and systems within HealthConnect.

             In our preliminary data analysis, there were approximately 6000 patients evaluated for prolapse
             yearly and it is estimated that approximately 10% undergo surgical repair with graft. Therefore, we
             anticipate that the pilot 6-month "sample size" will be approximately 300 surgical patients.


SCPMG Research Application 01/13/09                                                                    Page 5
             Descriptive satistics: demographic data, types of surgical procedures, types of complications , and
             date of last follow-up. We also will query the operating room database to comfirm that we have
             identified all cases of mesh usage.

             Covariates: race, age, obstetric history, medical history, previous surgical history, types of
             surgeries, combined gynecologic surgery.
         C. Statistical analysis plan(including rationale for number of subjects)

             All data analysis will be conducted using SAS 9.1 for Windows.
             Bivariate satistics: chi squared analysis using Fisher's exact test where appropriate.
             Cox proportional hazard models will be developed to examine the association of various
             independent variables with the propability and time to complication among groups.
             A Kaplan-Meier survival curve can be used to compare (log-rank) overall differeces in the rate of
             complications among the various surgical procedures.

         D. Study timeline

             Month#1: submit IRB request
             Month#2-5: identify subjects and collect and begin analyze data.
             Month# 6: prepare and submit manuscripts for publication, presentation at professional meeting.
4. Performance Sites:

         A. List the Kaiser Permanente regions and facilities in which this study will take place.

             Southern California Kaiser Permanente
         B. Are other institutions participating? If yes, describe their roles.

                                      Yes              No

         C. If this study will be conducted under subcontract to another institution, describe this relationship and name
            the institution and study sponsor.

             FDA sponsor.




SCPMG Research Application 01/13/09                                                                       Page 6
                                        Research Questionnaire (must be typed)

If you are completing this form in Word, click on the square box or type in the shaded box, as appropriate.

Study Title                   Developing Feasibility of Pilot Study to Evaluate Safety and Effectiveness of Mesh
                              Implantation in Surgical Interventions for the Treatment of Pelvic Floor Disorders



         1. Is this a data-only (no direct member contact by mail, phone, or in person) study?
                    Yes               No

         2. Is this study based solely on data that already exist (e.g., computer stored or paper charts)?
                    Yes             No

         3. If existing data will be used in this study, from which sources will data or records be retrieved?
                     Kaiser Permanente electronic databases / Specify all here:
                     Kaiser Permanente disease registries / Specify all here:
                     Patient charts (medical records)
                     Data from studies previously conducted at Kaiser Permanente
                     Other:         (e.g., previous studies or publications)
         Please note, you must obtain permission for access to the data from the KPSC data owner.
              A. Will data or records be extracted from any of the above sources?
                                    Yes Submit a Data Abstraction Sheet
                                    No

         4. Please describe the methods you will use to 1) ensure protection of confidential information, 2)
            send out and transfer research participant identifying information, also its content and to whom.
            (Patient identifying information is individual-level health information plus any information that
            could be used to link the identity of an individual with his/her health information.)
                         No access to databases or medical records is required for this study.

                  Data Confidentiality will be assessed by maintenance of both public use and confidential
                  data at Kaiser Permanente.
                  Data will be kepted by password protected by Kaiser Permanente's Health connect. Those
                  submitted data to the FDA will be anynomized .

         5. Check any of the following special populations that may be included as study subjects.
            NOTE: Special attention is required for minors and pregnant women per federal regulations.
                     Minors (under age 18)                            Persons who are mentally ill
                      Persons who are cognitively impaired            Pregnant women
                      Persons unable to speak and read English        Other:        (e.g., employees)
                  If yes, specify language:                             None
         6. If there will be direct contact with human subjects, what will be the method of the contact?
                   Telephone                  Internet/e-mail       Other:
                   Letter                    In-person
                   None, no direct contact IF NO DIRECT CONTACT, SKIP TO Q9
         7. Which subject contact documents are being submitted now for review with this application:
                  Consent Form          Study Questionnaire             Telephone Script
                  Recruitment Flyer     Subject Contact Letter          None
                  Reply Post Card       Provider Contact Letter         Other (Specify):


SCPMG Research Application 01/13/09                                                                          Page 7
         8. How many participants do you plan to enroll in this study through direct contact (members, non-
         members, KPSC employees, physicians, etc.)? N/A

         9. How many KPSC medical records do you plan to review for this study (For electronic data-only
         studies, identify the number of health plan members about whom data will be accessed)? 300
                         None, no medical records will be reviewed.

         10. If subjects will be recruited into the study, describe the recruitment method(s). Identify who
         (organizational affiliation and position) will invite member participation in the study. Append to your
         application copies of proposed recruitment material(s) (e.g., introduction letter, e-mail, flyers).
                         N/A, no direct contact


         10a Will the internet or e-mail be used to either communicate with participants or transmit Protected
             Health Information (PHI) inside or outside of Kaiser Permanente Southern California?
                         Yes Complete the Research Use of Internet Questionnaire            No

         11. Will the study require a written informed consent document?

                         Yes ANSWER Q12 a-d, THEN SKIP TO Q14a                               No SKIP TO Q13

         12. Please describe the aspects of the consent process as follows:

              a. Specify the organizational affiliation, position and licensure of the person(s) who will approach the
                 member to obtain consent


              b.        Describe the informed consent process.


              c. Will the member's primary care physician be asked for permission to contact/recruit the member?

              d. Include the procedures that will be used to allow the member to decline to participate.

         13. Please answer the following four questions to determine waiver of Informed consent.
                   A.     Does the research involve no more than minimal risks to subjects?
                                  Yes              No
                   B.     Will the waiver adversely affect the rights and welfare of the subjects?
                                  Yes              No
                   C.     Can the research be practicably carried out without the waiver?
                                  Yes              No
                   D.     If appropriate to the study, will the subjects be provided with additional pertinent information
                          following participation in the research?
                                  Yes              No        Not Applicable




SCPMG Research Application 01/13/09                                                                                    Page 8
         14. Are you requesting a waiver of the requirement to have participants sign a written informed
         consent document for this study?
             If YES, describe how the research involves no more than minimal risk to participants and
             involves no procedures for which signed consent is normally required outside of the research
             context OR, explain how the signed consent document would be the only record linking the
             participants to the research, and the principal risk to the participants would be potential harm
             resulting from a breach of confidentiality.

              YES, this study research involves no more than minimal risk to participants and involves no
         procedures.


         IF THIS IS A RETROSPECTIVE CHART REVIEW STUDY AND THERE WILL BE NO
         DIRECT CONTACT, SKIP TO THE CONFLICT OF INTEREST POLICY STATEMENT FOR
         RESEARCH.
         14a. Is this study FDA regulated?
                     Yes            No

         15. Will an investigational drug(s) or biologic(s) be used in this study?
                     Yes               No
                  If yes, please list name of investigational agent(s) and IND filing number:

         16. Will an approved drug(s) be used in this study for a non-approved purpose, delivery, or dosage?
                    Yes            No If No, skip to question 17
                If yes, is an IND required? Yes                      No
                If No, did the FDA provide you a notification that an IND is not required?
                   Yes             No
         If FDA did not provide you a notification, please justify why an IND is not required.


         17. Will an investigational device(s) be used in this study?
                     Yes               No
                  If yes, please list name of device, manufacturer and IDE number:

                  If yes, the sponsor has determined that this is a:
                       Significant Risk Device, or     Non-significant Risk Device

         18. Will genetic testing be a part of this study?
                     Yes               No If No, skip to question 19
                  If yes, identify the procedures/tests, the organizational affiliation of those who will conduct
                  the genetic testing and the storage and disposal protocol for the genetic material.


         19. Will Gene therapy/Gene transfer/rDNA/Biohazardous agents be a part of this study?
                     Yes              No If No, skip to question 20
                  If yes, has the protocol been submitted to the Institutional Biosafety Committee (See SOP
                  KP-200, Researh Involving Biohazardous Agents, Select Agents and Toxins, Recombinant
                  DNA, Gene Transfer or Gene Therapy).         Yes                     No


         20. Will any research participant be exposed to more than the standard level of ionizing radiation?
                 Yes                   No

SCPMG Research Application 01/13/09                                                                           Page 9
              If different from standard of care, has the protocol been submitted to the Research Radiation
              Safety Committee (See SOP KP-201, Radiation Exposure)?
                 Yes                   No



         21. Check any of the following procedures that will be conducted:
                       HIV testing
                       Cell-line creation
                       None




SCPMG Research Application 01/13/09                                                                      Page 10
                                      Conflict of Interest Policy Statement for Research




It is the policy of KPSC, as well as of the Food and Drug Administration and the U.S. Public Health Service, to require
those who conduct research to avoid actions or situations which may appear to conflict with their independence and
objectivity.

A conflict of interest exists when a financial interest could directly and significantly influence the design, conduct, or
reporting of research. A financial interest consists of anything of monetary value from a sponsoring business, including
consulting fees, honoraria, equity interests and intellectual property rights.

A significant financial interest exists when the value of financial interests from the sponsoring business, in aggregate,
exceeds $10,000 or, if monetary value cannot be ascertained, 5% ownership in the business. KPSC does not permit
persons with significant financial interests to serve as investigators on research projects conducted at KPSC because of
the possibility of a real or perceived conflict of interest. All investigators are required to disclose significant financial
interests at the time the project is reviewed by KPSC.

I understand the KPSC policy on conflict of interest and attest to the fact that I do not have a significant financial
interest in the sponsoring business. I agree to resign as an investigator on this study and to abstain from further
participation in it if a significant financial interest develops.


_________________________________                          ____________________________
Signature                                                  Date

_________________________________
Printed Name




SCPMG Research Application 01/13/09                                                                        Page 11
                                      Policies and Regulations Agreement Form



KPSC investigators are subject to organizational and public policies and regulations designed to protect KPSC members,
the KPSC organization, and the investigators For further information about these policies and regulations, summarized
below, contact the IRB Administrator, at 8/ 335-3665 or (626) 405-3665. An original signed copy of this form must be
sent to the IRB administrative office by all KPSC principal investigators. A new form does not need to be signed for
each new project.

Human Subjects Protection: As required by federal law, Kaiser Foundation Hospitals (KFH) maintains a Federalwide
Assurance (FWA) with the Office for Human Research Protections (OHRP) in which KPSC assures that it will comply
with federal regulations applicable to the protection of human subjects. This agreement requires all KPSC investigators
(and non-KPSC investigators who conduct research at KPSC or involving KPSC members) to have their research
reviewed by the KPSC IRB and to comply with all IRB requirements. Copies of this agreement and related documents
are available from the IRB administrative office.

Human Subjects Education Requirement: To ensure that research of the highest quality is performed at KPSC, all
investigators and personnel involved in research are required to obtain certification of education in the protection of
human subjects. This certification must be renewed every three years. Investigators will not be allowed to participate in
human subjects research unless they are certified. Please attach a copy of your certificate if you have not done so
previously.
HIPAA Privacy Rule Education Requirement: Read the 22 Page Power Point Presentation and submit the
documentation of completion (page 22) to the IRB administrative offices, attention James Doyle. This is a one time
requirement; the documentation will be kept on file.

Conflict of Interest: KPSC physicians and employees are required to avoid activities that could adversely affect the
independence and objectivity of their judgment, interfere with the timely performance of their duties, discredit the
organization, conflict with the organization’s best interests, give the appearance of creating a conflict of interest, or
disclose proprietary or confidential information without appropriate authorization. Investigators are required to disclose
and avoid any significant financial interests that would reasonably appear to affect the research.

Scientific Misconduct: Investigators must avoid scientific misconduct which means fabrication, falsification,
plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific
community for proposing, conducting, or reporting research. Scientific misconduct has serious consequences for the
investigator and the organization. KPSC is required to investigate allegations of scientific misconduct in KPSC and to
report on investigations and findings to the Office of Research Integrity (ORI), Department of Health and Human
Services (DHHS).

Intellectual Property & Inventions: Anything of value developed within or as a result of a research study conducted
at KPSC, whether or not subject to patent or copyright, will be owned by Kaiser Foundation Health Plan (KFHP), KFH,
and KPSC unless otherwise agreed to in writing.

I understand and agree to abide by these policies and regulations:


_____________________________ _____________________________ ________________
      Investigator’s Name               Signature                   Date




SCPMG Research Application 01/13/09                                                                      Page 12
                                               HIPAA Privacy Rule Questionnaire

        Study Evaluation of Safety and Effectiveness of Mesh Implantation in Surgical Interventions for
        Title: the Treatment of Pelvic Floor Disorders


    Instructions: If you do not complete this form, your application will not be processed. The information
    requested in this form will be used to determine whether your study requires a Privacy Rule Authorization
    section in the consent form, disclosure tracking, and/or legal agreements.
    Italicized words in this questionnaire are terms specific to the Health Insurance Portability and Accountability Act
    (HIPAA) Privacy Rule. The HIPAA Research Glossary provides you with definitions of Privacy Rule terms as
    they relate to research. You may obtain a copy of the HIPAA Research Glossary by contacting your KPSC IRB
    Administrator or on the KPSC website (http://researchweb.lsrs.ca.kp.org/). You may also look on the Kaiser
    Foundation Research Institute (KFRI) website (http://kpnet.kp.org/kfri/).
    This questionnaire was designed with a skip pattern. Please make sure you follow the bolded skip instructions.
    If there is not a skip instruction, proceed to the next question.


            1.    In the conduct of this study, will you have access to subjects’ Protected Health Information (PHI)? PHI
                  is individual-level health information plus any information that could be used to link the identity of
                  an individual with his/her health information.
                               Yes
                               No You do not need to answer questions 2 – 20 of the HIPAA Privacy Rule
                                   Questionnaire.

            2.    Who within the Kaiser Permanente entities (e.g., KFHP, KFH, PMG) within your Region will use
                  (i.e., have access to – see HIPAA Research Glossary) the Protected Health Information in the
                  context of this research?
                                Principal Investigator                  Co- or Sub-investigator(s)
                                Research nurse(s)                       Pharmacist(s)
                                Research assistant(s)                   Statistician(s)/Analyst(s)
                                Programmer(s)/IT                        Others (specify):

            3.    Will anyone not on Kaiser Permanente’s workforce have access to Protected Health Information in
                  the conduct of this study?
                               Yes                       No

            4.    Does the data being used or created for this study qualify as a Limited Data Set?
                  A Limited Data Set is health information that can include dates (e.g., admission, discharge, service
                  dates, birth/death dates and age) and geographic descriptors (e.g. zip codes, state, county, city and
                  precinct, but not street addresses) but must exclude other identifiers. See the HIPAA Research
                  Glossary.
                               Yes  Skip to question 17
                               No




SCPMG Research Application 01/13/09                                                                          Page 13
           5.    What Protected Health Information (PHI) will be used in the conduct of this study?
                               Medical record (paper or electronic), including laboratory, pharmacy, radiology, etc.
                               Disease registry or any database maintained within Kaiser Permanente (specify):
                               Research record (shadow file)
                               Research or non-routine laboratory, radiology, or other reports (specify): CT scan or
                               Ultrasound pre and/or post-op.
                               Sensitive patient data, e.g., STD tests, HIV tests, genetic marker tests, etc.
                               (specify):
                               Other (list all):

           6.    Do you anticipate that your study will have a consent form including a Privacy Rule Authorization
                    section for participants to sign?
                               Yes, participants will sign a consent form
                               No, a consent form will not be used  Skip to question 8

           7.    When will the participants’ authorization to use or disclose PHI expire?
                                At the end of the study  Skip to question 18
                                At a specified date after the Institutional Review Board (IRB) has accepted the final
                               report
                               (specify the date and justification for extending the authorization beyond the end
                               of the study):            Skip to question 18
                               The authorization will never expire (provide justification for having the
                               authorization never expire):              Skip to question 18

           8.    Are you requesting a waiver of the requirement for a signed authorization to use or disclose PHI
                 either for the entire study or any portion of it (e.g., recruitment portion of a clinical trial)?
                               Yes
                               No
           9.    Does the use or disclosure of PHI for this study present no more than a minimal risk to the privacy of
                 the individuals whose PHI will be accessed?
                               Yes             No

           10. Describe your plan to protect any identifiable information from use or disclosure not approved by the
               IRB.
               PHI will be used to indentify interested groups but will not be disclosed as aggregate data.

           11. Describe your plan to destroy any identifiers at the earliest opportunity or provide a rationale for
               retaining the identifiers.
               All PHI date will be detroyed by a secured confidential shredder after data collection phase
               competed.

           12. Describe why the research could not be done if you were required to obtain authorization from each
               individual whose PHI you intend to use.
               There will be difficult to contact all individuals to obtain authorization. In addition, this study
               presents no more than a minimal risk to the privacy of the individuals whose PHI will be accessed.

           13. Describe why the research could not be done without access to the PHI.
               PHI will be used to identify the patients who be included in interested groups.




SCPMG Research Application 01/13/09                                                                         Page 14
           14. Is the Protected Health Information (PHI) that you are requesting to use or disclose the minimum
               necessary to conduct this study?
                               Yes            No


           15. How many individuals’ Protected Health Information (PHI) will be disclosed?
                               No Protected Health Information will be disclosed.  Skip to question 20
                               Fewer than 50 individuals  Skip to question 17
                               50 or more individuals

           16. What type of Protected Health Information (PHI) will be disclosed?
                               Clinical/Diagnostic
                               Health Care
                               Demographic




SCPMG Research Application 01/13/09                                                                     Page 15
           17. Will you disclose Protected Health Information (PHI) only as a Limited Data Set?
                               Yes  Complete 17A – 17H
                               No  Skip to question 18

                 17A.     Name of the recipient (individual or entity) receiving the Limited Data Set, including contact
                          name and telephone number:
                          Cara Krulewitch, CNM PhD
                 17B.     What service will the recipient provide?
                          statiscal programming and analazing data.
                 17C.     Name of individuals or class of individuals (e.g., data analysts, etc.) permitted to use the
                          Limited Data Set:
                          Cara Krulewitch, CNM PhD
                 17D.     What information will be included in the Limited Data Set?
                          ages, dates of services, pre-op diagnosis, procedures, obstetric history, medical history,
                                    adverse events.
                 17E.     How will the recipient use the Limited Data Set (e.g., analyze data, produce report)?
                          Cara Krulewitch will analyze data and assist in writing the report.
                 17F.     Will the recipient be permitted to re-disclose the information to a third party and if so, to
                          whom (names of the individuals or entities)?
                          No
                 17G.     Will the recipient use subcontractors with access to the Limited Data Set (specify names)?
                          No
                 17H.     In addition to disclosing Protected Health Information (PHI) as a Limited Data Set, will you
                          also be disclosing Protected Health Information which does not meet the criteria of a Limited
                          Data Set?
                                        Yes  Skip to question 18
                                        No  Skip to question 19

           18. To whom will you disclose Protected Health Information (PHI)?
                               Protected Health Information (PHI) will not be disclosed
                               Sponsor or pass through entity (specify):
                               Sponsor’s agent(s) e.g., CRO, central laboratory, etc. (specify):
                               Collaborating investigator in another Kaiser Permanente Region (specify):
                               Outside collaborating investigator or research institution (specify):
                               Data coordinating center (specify):
                               Service vendors contracting with Kaiser Permanente to support this research, such as
                               mailing, survey, web hosting, data/specimen storage, laboratory services, and radiology
                               services  Answer questions 18A – 18F for each vendor
                               Other (specify):




SCPMG Research Application 01/13/09                                                                         Page 16
                 If service vendors will receive or create Protected Health Information (PHI), provide the following
                 information for each vendor (attach a separate page if necessary).
                 18A.     Name of the vendor, including contact name and telephone number.

                 18B.      What service will the vendor provide?

                 18C.     What is the permitted use of the Protected Health Information (PHI) by the vendor (e.g.,
                          only for this research study)?

                 18D.     Will the vendor be permitted to disclose the information to a third party and if so, what
                          is/are the name(s) of the individuals or entities?

                 18E.     Will the service vendor use subcontractors (specify names)?

                 18F.     Should Kaiser Permanente impose additional restrictions on the use of this data?


           19. If the study is a clinical trial, will participants be required to waive their right to access their
               Protected Health Information (PHI) collected during their participation in the clinical trial?
                           The study is not a clinical trial.
                           Yes, participants will be required to waive their right to access their study records
                           during the clinical trial.
                           No.
           20. Do you assure that you will only use and disclose Protected Health Information (PHI) as described in
               this Application (i.e., the Protected Health Information (PHI) will not be reused or re-disclosed to
               any other person or entity), except as required by law (any changes in use or disclosure will be
               approved by the Institutional Review Board (IRB) prior to implementation)?
                               Yes             No




SCPMG Research Application 01/13/09                                                                              Page 17

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:50
posted:8/7/2011
language:English
pages:17