Institutional Review Board, Human Subjects Research, and by a3yruG

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									Institutional Review Board,
 Human Subjects Research,
                 and Ethics:
   The Responsible Conduct
                 of Research




             The University of Texas at El Paso
                 General Compliance Training
         Institutional Review Board (IRB)
          and Human Subjects Research
The following topics will be covered in this section:
   •   What are the basic ethical principles of the Belmont Report?
   •   What is the Institutional Review Board?
   •   What authority does the IRB have?
   •   What is a good definition for “research” and “human subject”?
   •   Can identifiable private data be taken from research that can be
       linked to the subjects?
   •   How do I know if I need to submit a protocol form for IRB
       approval?
   •   What are the elements needed in an informed consent document?
   •   When can I begin data collection from human subjects?
   •   Who is responsible for reporting any problems/injuries with
       research subjects?
   •   Where can I find out more information?
     What are the Basic Ethical Principles
           of the Belmont Report?
The Belmont Report, which was issued April 18, 1979 after a
conference held in February 1976 at the Smithsonian Institution‟s
Belmont Conference Center in Maryland, identified three basic
ethical principles that should govern human subject research.
These three principles are:
   • respect for persons,
   • beneficence and
   • justice.
     What are the Basic Ethical Principles
      of the Belmont Report? (continued)
Respect for Persons
Each research subject is an individual capable of making up his or her
own mind about whether to participate in a research study. Research
subjects that have a diminished capability (whether they are immature,
incarcerated or incapacitated) are vulnerable. They receive special
protection under federal law (45 Code of Federal Regulations Part 46).
     What are the Basic Ethical Principles
      of the Belmont Report? (continued)
Beneficence
Comes from the Hippocratic maxim “do not harm.” Subjects in a
research study should be protected from research risks, have their
decisions respected and their well-being assured. Researchers need
to maximize possible benefits and minimize possible risks to subjects.
An informed consent document is usually required to communicate the
risk/benefit ratio and other relevant information to subjects.
     What are the Basic Ethical Principles
      of the Belmont Report? (continued)
Justice
Implies that subjects should be selected equitably. No one group of
subjects, such as the economically disadvantaged or the
institutionalized, should continually bear the burden of research.
                    What is the IRB?
 The Institutional Review Board (IRB) at The University of Texas
  at El Paso (UTEP) is a committee representing various research
  disciplines.
 It was established by federal law (45 Code of Federal
  Regulations Part 46) and the Multiple Project Assurance
  document signed by UTEP and federal officials at the Office for
  Human Research Protections (OHRP).
 The IRB oversees all research involving human subjects
  conducted by faculty, students, or staff; or the usage of any
  University property or non-public information to contact human
  research subjects.
 IRB members are of varied professions and genders. Members
  may be scientists or nonscientists, and some members have no
  affiliation with UTEP.
     What Authority Does the IRB Have?
 The IRB has the authority to approve, disapprove or modify
  research protocols. The committee can also suspend or
  terminate its approval of a research activity.
 The committee uses a deliberative process to review protocols.
  Protocols can either be exempt from IRB review; reviewed by
  expedited (review by members); or full committee review
  (review by a quorum of members).
    What is a Good Definition for “Research”
             and “Human Subject”?
    45 Code of Federal Regulations Part 46.102 (d) defines
     “research” as “a systematic investigation, including research
     development, testing and evaluation, designed to develop or
     contribute to generalizable knowledge.”
    45 CFR 46.102 (f) lists a “human subject” as “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.”
Could Private Data be Taken from Research
   that Can be Linked to the Subjects?
 It is important that you determine the nature of your
  research data; i.e., does it include documents, records,
  pathological specimens, or diagnostic specimens.
  Determine whether the data is public or non-public; the
  information that you collect can be linked directly or
  indirectly back to the research subjects; or if it is entirely
  anonymous.
 Research protocols may be exempt if the data you are
  collecting:
   1. Existed before your research begins
   2. Is publicly available, and
   3. Is anonymous.
     How Do I Know if I Need to Submit a
      Protocol Form for IRB Approval?
If you are engaged in a research project where there is an
intervention or interaction with a living person from whom
data/information/specimens (identifiable or unidentifiable) will be
collected using public or non-public sources, you are required to
submit a protocol form, informed consent, questionnaires, and any
approval letter (from school districts, clinics, hospitals, etc.)
needed in your particular project.

    This policy applies to all research involving human
              subjects, regardless of funding.
  What Happens Once I Submit the Form?
 Principal Investigators (PIs) submit the protocol form and all
  other documents to the Office of Research and Sponsored
  Projects (ORSP) Institutional Review Board (IRB) via IRBNet
  (www.irbnet.org).
 The ORSP reviews the protocol for completeness and makes a
  preliminary determination of the review status as exempt,
  expedited or requiring full committee review.
 PIs are generally required to have an IRB protocol in “pending
  status” before submission of a grant application.
  What Happens Once I Submit the Form?
                                                      (continued)

 IRB approval can take two weeks or more to complete,
  depending upon the research project involved.
 The protocol must be approved by the IRB before any research
  data collection may begin.
 You will receive an email notification from ORSP via IRBNet
  when the protocol has been approved.
 In your study documents at www.irbnet.org, your memo of
  determination will be available to you and your collaborators to
  be used as needed.
  What Happens Once I Submit the Form?
                                                      (continued)

 Protocols are usually approved for a one year period.
 PIs must submit their protocols for review at least two weeks
  before the expiration date, and is to be reviewed annually until
  the research has concluded.
 ORSP will send a notice of renewal to the PI prior to the
  protocol‟s expiration.
 All changes to the protocols, once approved, must be submitted
  for subsequent review prior to implementing any changes.
     What Are the Elements Needed in an
       Informed Consent Document?
These 10 basic parts should be included in your statement of
informed consent to research subjects:
   1. Purpose of the research, time or costs the subject will spend to
      participate, and a full description of all the procedures to be
      used with the subject (in simple terms).
   2. Risks to the subject.
   3. Benefits of participating in the research project.
   4. Alternative procedures or treatments.
   5. Procedures for safeguarding confidentiality of records.
   6. Compensation or medical treatment available for injury, if
      applicable.
  What Are the Elements Needed in an
 Informed Consent Document? (continued)
7. Contact the ORSP for any questions, injuries or for the names
   and phone numbers of PIs and Institutional Coordinator for
   Research Review.
8. Participation is voluntary, and the subject may end his/her
   participation at any time without any penalty
9. Space for signature & date by participant (and parent or
   guardian, if needed) and PI unless a waiver of signed consent
   has been granted by the IRB.
10. A Spanish (or other subjects‟ languages) translation of the
    English version of the informed consent (depending upon the
    subjects to be included in the research) at the level of language
    appropriate for those particular subjects.
        When Can I Begin Data Collection
            from Human Subjects?
The involvement of human subjects in research, including faculty
or staff projects, surveys, theses, dissertations and all student
human subject research projects, may not begin until the IRB has
reviewed and approved the research protocol, informed consent,
and testing instruments. Approval letters for off campus research
performance sites (such as school districts, clinics, hospitals, etc.)
must be on file with this office before the study data collection may
begin.
       When Can I Begin Data Collection
        from Human Subjects? (continued)
The PI will receive an email notification confirming approval of the
protocol. In the study documents at www.irbnet.org, your memo
of determination will be available to you and your collaborators to
be used as needed. Once IRB approval has been obtained, the
PI must obtain appropriate informed consent from each subject
prior to collecting research information.
   Who is Responsible for Reporting any
 Problems/Injuries with Research Subjects?
 PIs will promptly report to the IRB any injuries or other
  unanticipated problems encountered during the course of the
  research study.
 PIs should call the Office of Research and Sponsored
  Projects (ORSP) at 915-747-8841 to report research-related
  injuries or problems.
Ethics: The Responsible Conduct of Research
The following topics will be covered in this section:
   •   What is misconduct in science?
   •   What constitutes fabrication of research data?
   •   Describe falsification in reporting on research findings.
   •   Plagiarism: How do I know if I have pirated someone‟s ideas?
   •   How can I avoid conflict of interest situations?
   •   How do I renew or make changes to an approved IRB protocol?
   •   When do I cease research on an approved IRB protocol?
   •   How do I file an amendment to my approved protocol?
   •   What do I do if problems/injuries occur with my subjects after IRB
       approval of my research?
         What is Misconduct in Science?
According to the Office of Research Integrity, DHHS, “Misconduct
will be limited to „fabrication, falsification, or plagiarism in
proposing, performing or reviewing research or in reporting
research results.‟” (From ORI Annual Report, 1999)
         What Constitutes Fabrication of
               Research Data?
 Fabrication of data means that a scientist manufactures a fake
  set of research results, makes up data or distorts the truth of
  the experiment.
 An example would be a researcher who concocts fake data to
  plot a graph, thus inventing false research conclusions.
        Describe Falsification in Reporting
              on Research Findings
 Falsification implies an alteration of data, or distortion of
  experimental results.
 For example, a scientist might falsify the scoring of taped
  interviews with subjects. The data exists, but has been
  manipulated and misrepresented.
     Plagiarism: How Do I Know if I Have
           Pirated Someone’s Ideas?
When a researcher lifts another person‟s text, pictures, cartoons,
quotations, surveys, graphs, or other ideas into his/her own
research paper, without clearly stating who is really responsible
for the work, this is plagiarism. Edward E. David, Jr. in Ethics
and Values in Science, from a presentation at the February 25-
26, 1993 Sigma Xi forum on Ethics, Values and the Promise of
Science, defines “Plagiarism - appropriating without proper credit
not only others‟ words, but also their ideas.”
      How Do I Avoid Conflict of Interest
                Situations?
UTEP‟s policies/procedures for Management of Conflict of Interest
in Sponsored Research states: “A potential conflict of interest
occurs when an individual‟s private interests compete with his/her
professional obligations to the University to a degree that an
independent observer might reasonably question whether the
individual‟s professional actions or decisions are determined by
considerations of personal gain, financial or otherwise. Federal
regulations address such conflicts when a significant financial
interest could affect or may be reasonably expected to bias the
design, conduct or reporting of NSF and/or HHS sponsored
research.”
      How Do I Avoid Conflict of Interest
             Situations? (continued)
A researcher (including his spouse and dependent children) has a
significant financial interest in a company if his/her salary
(consulting fees or honoraria), equity interests (stocks), or
intellectual property rights (royalties) exceed $10,000 or are more
than five percent ownership interest. “Could any of my or my
immediate family‟s financial interests potentially be affected in any
way by my current or proposed grant/contract supported
research?” At UTEP, if a researcher answers “yes” to this question,
he/she should disclose this financial interest to the ORSP as a
potential conflict of interest.
      How Do I Avoid Conflict of Interest
             Situations? (continued)
An example of a conflict of interest situation would be a physician
working at a University laboratory who has a significant financial
interest (stock) in a large pharmaceutical company. He also
benefits from research dollars coming back to fuel his drug testing
from that company. He stands to gain from the increased value of
his stock in the pharmaceutical firm, when the drugs do well on the
market.
  How Do I Renew or Make Changes to an
        Approved IRB Protocol?
Continuing (annual) IRB review of an approved IRB protocol must
be handled in a substantive and meaningful manner by the IRB
before the protocol expiration date (see last approval memo for
expiration date). The researcher (PI) will be reminded via email
that his/her protocol is expiring. Researchers need to submit a
renewal request via www.irbnet.org at least two weeks before
protocol‟s expiration date. The progress report questions are
located in the online document library and this must be included
with the request along with current consent documents and any
changes they wish to make in their protocol and other documents
related to the study. Researchers may elect to terminate their
protocol if the study is no longer active.
        When Do I Cease Research on an
           Approved IRB Protocol?
A protocol is considered expired at the end of its protocol
period. All research related to this study must cease unless a
renewal request has been approved by the IRB. This renewal
request must be submitted via www.irbnet.org at least two weeks
before the study expiration date. The IRB office will process the
renewal through IRB review. You will be notified by email when
   the
review process is complete. The determination letter will be
available with other study documents at www.irbnet.org.
         How do I File an Amendment to
            My Approved Protocol?
An approved IRB protocol may be modified during its protocol
period by submitting a revision package via www.irbnet.org.
This package must include informed consents, procedures,
research sites, subjects, testing instruments, a change in PI,
etc. The PI needs to identify the nature of the changes in the
amendment request; i.e., additional questions in a survey
instrument, change in data collection method, etc. All amended
documents need to be included in the revised package submitted
on www.irbnet.org. If a research site is being added, an approval
letter from that site is required in order to receive IRB approval.
         How do I File an Amendment to
         My Approved Protocol? (continued)
When an amendment is approved by the IRB, the original
protocol period (from the date the protocol was first approved or
the last renewal approval) will stay in force for the amendment
approval. Example: If a protocol was initially approved for a
protocol period of January 1, 2007 through December 31, 2007,
and an amendment to that protocol is presented in June, 2007, the
date of the amendment approval will reflect the date the IRB
approved the protocol amendment, but the protocol period listed on
the amendment approval will remain January 1, 2007 through
December 31, 2007.
What Do I Do if Problems/Injuries Occur With My
 Subjects after IRB Approval of My Research?
The PI of a research project has the responsibility to protect
the rights and welfare of human research subjects. This includes
requirements to provide each subject with an IRB-approved
informed consent document, and to promptly report to the IRB
office via phone or email any injuries, adverse events, unexpected
problems, or additional risks of harm or discomfort previously
unrecognized if encountered during the course of the study.
          Where Can I Find Out More?
 Office of Research and Sponsored Projects (ORSP)
  Administration Building, Room 209
  915-747-5680 or irb.orsp@utep.edu
 Institutional Review Board Administrator
  Administration Building, Room 209
  915-747-5680 or irb.orsp@utep.edu
 Office of Research and Sponsored Projects
  Institutional Review Board
  http://research.utep.edu/Default.aspx?tabid=47162
 Office for Human Research Protections (OHRP)
   http://www.hhs.gov/ohrp/
               Thank You…
If you are a UTEP employee, a copy of the
 completion certificate for this training module
 needs to be included when submitting a
 protocol to the ORSP Office, unless you have
 submitted one to that office within the past
 three years.

								
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