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

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


1
Institutional Review Board,Human Subjects
Research,and Ethics The Responsible Conduct
of Research
The University of Texas at El Paso General
Compliance Training
2
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?

3
What are the Basic Ethical Principlesof the
Belmont Report?
  • The Belmont Report, which was issued April 18,
    1979 after a
  • conference held in February 1976 at the
    Smithsonian Institutions
  • 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.

4
What are the Basic Ethical Principlesof 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).
5
What are the Basic Ethical Principlesof 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.
6
What are the Basic Ethical Principlesof 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.
7
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.

8
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).

9
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
  • Data through intervention or interaction with the
    individual, or
  • Identifiable private information.

10
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
  • Existed before your research begins
  • Is publicly available, and
  • Is anonymous.

11
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.

12
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.


13
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.


14
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 protocols expiration.
  • All changes to the protocols, once approved, must
    be submitted for subsequent review prior to
    implementing any changes.


15
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
  • 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).
  • Risks to the subject.
  • Benefits of participating in the research
    project.
  • Alternative procedures or treatments.
  • Procedures for safeguarding confidentiality of
    records.
  • Compensation or medical treatment available for
    injury, if applicable.


16
What Are the Elements Needed in an Informed
Consent Document? (continued)
  • Contact the ORSP for any questions, injuries or
    for the names and phone numbers of PIs and
    Institutional Coordinator for Research Review.
  • Participation is voluntary, and the subject may
    end his/her participation at any time without any
    penalty
  • 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.
  • 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.

17
When Can I Begin Data Collectionfrom 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.

18
When Can I Begin Data Collectionfrom 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.

19
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.

20
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
    someones 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?

21
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)
22
What Constitutes Fabrication ofResearch 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.

23
Describe Falsification in Reportingon 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.

24
Plagiarism How Do I Know if I Have Pirated
Someones Ideas?
When a researcher lifts another persons 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.
25
How Do I Avoid Conflict of Interest Situations?
UTEPs policies/procedures for Management of
Conflict of Interest in Sponsored Research
states A potential conflict of interest occurs
when an individuals private interests compete
with his/her professional obligations to the
University to a degree that an independent
observer might reasonably question whether the
individuals 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.
26
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
familys 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.
27
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.
28
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
  • protocols 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.

29
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.

30
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.

31
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.

32
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.

33
Where Can I Find Out More?
  • Office of Research and Sponsored Projects (ORSP)
  • Administration Building, Room 209
  • 915-747-5680 or irb.orsp_at_utep.edu
  • Institutional Review Board Administrator
  • Administration Building, Room 209
  • 915-747-5680 or irb.orsp_at_utep.edu
  • Office of Research and Sponsored Projects
  • Institutional Review Board
  • http//research.utep.edu/Default.aspx?tabid47162
  • Office for Human Research Protections (OHRP)
  • http//www.hhs.gov/ohrp/


34
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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