Transcript Predictors of Academic Success at a Historically Black

The Institutional Review Board
(IRB) and its functions
Anthony K. Wutoh, Ph.D., R.Ph.
Professor
School of Pharmacy
College of Pharmacy, Nursing and Allied
Health Sciences
Co-Chairman, Institutional Review Board
Howard University IRB
What is your image of the
IRB?
Why were/are IRBs
needed?
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Tuskegee Syphilis Study (Alabama, 19321972)
Nazi Experiments (1930s-1940s)
Stanley Milgram's experiment ."Obedience
and Individual Responsibility" (Yale, 19611963)
Willowbrook Study (New York, 1963-1966)
Tearoom sex (Washington Univ., 1960s)
Research conducted in prisoners, children
and other vulnerable populations
Recent Violations
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In a totally unprecedented flurry of enforcement activity, the
National Institutes of Health (NIH) Office for Protection from
Research Risks (OPRR) stopped research at Rush-PresbyterianSt. Luke's Medical Center (AP 1998), the West Los Angeles
Veterans Affairs Medical Center (Monmaney 1999; Hilts 1999a),
Duke University (Stout 1999; Weiss 1999), the University of
Illinois at Chicago (Guerrero and Herguth 1999; Grahnke and
Ritter 1999), the University of Colorado (Hubler 1999), Virginia
Commonwealth University (Mathews 2000), and most recently,
the University of Alabama at Birmingham (Hansen and Spencer
2000; Hilts 2000).
While there have been some substantive concerns relating to
subject enrollment and informed consent, most of these
sanctions have been levied because of sloppy and inadequate
operation of institutional review boards (IRBs) and slow or
inadequate response to OPRR's concerns.
Violations
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Researchers at Stanford University were permitted by the state in
1997 to test the use of Depakote in incarcerated adolescent males
to see if the drug would reduce aggressive behavior (Weber
1999).
Researchers at the New York State Psychiatric Institute, the Mount
Sinai School of Medicine, and the Research Foundation of the City
University of New York came under fire for giving fenfluramine to
young children, many of whom were Hispanic or African American.
The children were at-risk younger siblings of child offenders
identified by the researchers through court records (Hilts 1998a;
Waldman 1999; Bernstein 1999).
In the early 1990s, plastic surgeons at the Manhattan Eye, Ear,
and Throat Hospital performed a study in which different surgical
face-lift techniques were used on the opposite sides of patients'
faces without securing IRB approval and without express patient
consent (Hilts 1998b).
Jesse Gelsinger and Gene
Therapy (U. of Penn.)
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In 1999-2000 the Food and Drug Administration stopped all gene
therapy trials at the University of Pennsylvania, because of alleged
shortcomings and violations of protocols, revealed in an audit
.prompted by the death of Jesse Gelsinger
Gelsinger suffered from Ornithine transcarbamylase (OTC)
deficiency, a rare metabolic disorder.
Gelsinger's death also prompted a revelation of at least six deaths
in other gene therapy trials that had not been reported to the
NIH, in violation of the law, because the investigators determined
the deaths were caused by the subjects' disease and not the
experimental therapy.
Several institutions and foundations sponsoring genetic therapy
research halted trials because of concerns about patient safety.
The public hearings also spurred the reporting to NIH of 652
adverse events in trials using modified adenoviruses (as used in
the Penn trial), compared to only 39 that had been reported
promptly as required by law.
Issues - Conflict of interest, did not meet the inclusion criteria,
consent forms did not adequately discuss risks.
Research Regulations
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In 1979, the federal government developed regulations of
ethical principals underlying the current regulations and
standards that are contained in the Belmont Report.
It was the capstone of the National Commission for the
Protection of Human participants of Biomedical and Behavioral
Research. It outlines the ethical principals upon which the
ethics of a research study are evaluated in the United States.
The Belmont Report embodies the moral consensus upon which
stand our present US Federal regulations governing the ethics
of human participants research conduct with Federal funds
from the majority of Federal agencies.
Our present regulations formulize The Belmont Report's
requirements for informed consent and establish another
Commission recommendation that formalized and extended the
existing peer review system of that time, which has matured
into the Institutional Review Board (IRB) system that we have
today.
Historical Overview
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The protection of the rights and privacy of human
participants involved in research activities is mandated
by federal law.
The National Research Act Public Law 99-158, The
Health Research Extension Act of 1985, and the
National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research
provide guidelines for research with human participants
to ensure their protection in the design and conduct of
research.
These federal regulations require that any institution
requesting and receiving funds from a federal
department or agency for research involving human
participants must assure that such research is reviewed
and approved by the institution's institutional review
board (IRB).
IRB Review Process
Purpose of the IRB at
Howard University
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Review research proposals, projects, and
activities that involve human participants;
Determine for each activity or proposed
activity if human participants will be placed
at risk;
if risk is involved, determine if the
importance of the knowledge to be gained
warrants allowing the participant to accept
the risks;
Oversee protection of rights and welfare of
participants.
Assess whether the researcher(s) is/are
qualified to conduct research involving
human participants.
In General
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Applies to funded and unfunded research
Submission of a protocol and approval by
the IRB is mandatory for any faculty, staff
or student who will interact with a human
being for purposes of conducting research
Research may not begin before approval
from the IRB is given
IRB Membership
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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.
Each IRB shall include at least one member whose primary concerns
are in the scientific area and at least one member whose primary
concerns are in nonscientific areas.
Each IRB shall include at least one member who is not otherwise
affiliated with the institution and who is not part of the immediate
family of a person who is affiliated with the institution.
No IRB may have a member participate in the IRB's initial or
continuing review of any project in which the member has a
conflicting interest, except to provide information requested by the
IRB.
Every nondiscriminatory effort will be made to ensure that no IRB
consists entirely of men or entirely of women, including the
institution's consideration of qualified persons of both sexes, so long
as no selection is made to the IRB on the basis of gender. No IRB
may consist entirely of members of one profession.
Howard University IRB
Membership
Frank Bolden
Education
Vernon Bond, Ed.D
Exercise Physiology
Alfonso Campbell, Ph.D.
Co-Chair
Psychology
Vincent Hollis, Jr., Ph.D.
Biology
Alicia Horton, JD,MPH
Education, Legal
Leslie Jones, MD
Ophthalmology
Charles Mouton, MD,
Chairman
Medicine
Jacqueline Smith, Ph.D.
Social Work
Anthony Wutoh, Ph.D.
Pharmacy Administration
Henry Ferry, Ph.D.
Religion
Robert Taylor, MD
Medicine
Non-affiliated
Non-affiliated
Leave of absence
What type of research
requires review?
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Research which involves the administration of drugs or other
substances to participants
Research involving pregnant women and/or fetuses in utero
Research involving participants with life-threatening physical
conditions
Research involving physically intrusive procedures
Research which previous experience (by the particular
investigator or other investigators) has shown to create a
potential of risk to participants
Research which potentially could put the participant at risk for
legal or civil liability or invade a participant's privacy in regard
to sensitive aspects of his/her behavior (e.g., illegal conduct,
drug use, sexual behavior, alcohol use).
What about survey research
or questionnaires?
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Research which involves the interviewing of participants
requires review by the IRB for several reasons;
– The IRB must insure the risks do not outweigh the
benefits of this research
– The IRB must review potential questionnaires and
items for inappropriate or potentially harmful items
– Certain populations may be at risk for psychological
harm (for example; crime/rape victims, Post traumatic
stress disorder (PTSD), etc.
– The investigator must be qualified to administer these
items.
– Potential risk of disclosure of identity/confidentiality
What types of Research
could possibly be exempted?
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Research in which the risks of harm reasonably anticipated are not
greater than those ordinarily encountered in daily life or during the
performance of routine procedures in education and/or in the
practice of psychology and medicine
Research on the effectiveness of educational, classroom, and/or
instructional strategies, provided that these strategies are familiar,
and nonintrusive in their implementation
Research using educational tests (cognitive, diagnostic, aptitude,
achievement) if participants' identities are thoroughly protected
Research using survey procedures or interview procedures where
participants' identities are thoroughly protected and their answers
do not participant them to criminal and civil liability
Research involving the collection or study of existing data,
documents, records, specimens, or other products, if these sources
are publicly available or the information is recorded by the
investigator in such a manner that the participants cannot be
identified directly or indirectly.
Remember – The IRB, not the investigator, decides upon
the exemption status of a protocol
Some research can not be
exempted!!!!
Socio-behavioral
research?
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Regarding Laud Humphreys Tea Room Sex Research….
There was considerable public outrage as well. Journalist
Nicholas von Hoffman, who was given some details of the
case by one of the angered members of the Sociology
Department, wrote an article about Humphreys' research
and offered the following condemnation of social scientists:
"We're so preoccupied with defending our privacy against
insurance investigators, dope sleuths, counterespionage
men, divorce detectives and credit checkers, that we
overlook the social scientists behind the hunting blinds
who're also peeping into what we thought were our most
private and secret lives. But there they are, studying us,
taking notes, getting to know us, as indifferent as
everybody else to the feeling that to be a complete human
involves having an aspect of ourselves that's unknown."
Considerations
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Confidentiality of Information - The confidentiality of the human
participants is typically the most important factor in determining
whether a research proposal is exempt from further review.
One University states that “…an investigator must not maintain any
form of linkage in order to go back and review the record at a later
time. If linkage between the data and the participant must be
maintained, the protocol should be submitted for review.”
Due to the nature of much social science research, the possibility
of physical harm to human participants is typically minimal or nonexistent. However, human participants could suffer financial or
emotional harm in some circumstances if their individual responses
to sensitive questions became public knowledge.
As an example, if a participant describes various faults in the
management practices of their organization as part of a research
survey and if their identifying information is later associated with
their responses then they may face retribution by their
managers. To avoid any possibility of this type of problem the
confidentiality of the participant’s responses must be maintained
and the measures taken by the researcher to protect this
confidentiality must be fully delineated in the IRB Research
Protocol.
Examples of confidentiality
statements…
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“Strict confidentiality will be maintained at all
times. New employees and their project managers will
be given numbers for tracking purposes. Contact
records used for linking the names of the new
employees and their project managers to their tracking
numbers will be deleted at the conclusion of the
study. During the study, the contact records will be
maintained in one computer location protected by
password and one disk backup stored in a governmentclassified safe. All reporting will be in the aggregate;
names or colleges will not be used to identify
individuals.”
Example…
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“Information obtained in this study will be strictly confidential
unless disclosure is required by law. Participants will be
assigned a study number, and this number, rather than the
participants’ names, will be recorded at the time of
interviews. Only the study investigator will have a record of
which person has been assigned what number and this
information will be secured in a locked filing
cabinet. Participant names will not be used in the reporting
of information in publications or conference
presentations. The results of the study will be reported in
terms of the various treatment groups, not in terms of
individuals. Thus anonymity and confidentiality will be
protected.”
Informed Consent
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Use of Informed Consent Forms
The participation by human participants in any
research project must be consensual.
“…no investigator may involve a human being as a
participant in research, as defined in this policy and
procedure manual, unless the investigator has
obtained the participant's informed consent. The
process of informed consent is constituted by two
essential elements: (1) the participant has the
information he or she requires to make an effective
decision, and (2) the participant's participation is not
coerced, i.e. his or her consent is voluntary.”
Informed Consent Process
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While this requirement usually results in the use of an Informed
Consent Form in the proposed research, the requirement for
human participants to provide their informed consent does not
necessarily require the participant to execute a document as
proof of their consent. The IRB may approve a consent
procedure which does not include, or which alters, some or all
or the elements of informed consent, or waive the requirement
to obtain informed consent provided the IRB finds and
documents:
– The research involves no more than minimal risks
– The rights and welfare of participants will not be adversely
affected
– The research could not practicably be carried out without
the waiver or alteration
– Whenever appropriate, the participants will be provided with
additional pertinent information after participation
IRB Process
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Review the IRB website and submit a signed application
(including your faculty mentor)
http://www.huirb.howard.edu/apps.htm
Dissertations and Theses require submission of committee
approval
The IRB will review at the next scheduled meeting (every
other week) and provide one of the following
recommendations;
– Approve
– Amend
– Reject
– Table
Conduct your research project and meet the requirements for
responsible conduct of research
Submit required reports and documentation
Summary…Take home
message
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The IRB is a key element in the conduct of
human participant research at the
University.
But, it is the primary responsibility of the
IRB to safeguard the rights and safety of
human participants. It is not necessarily
the role of the IRB to expedite research at
the University at the expense of safety
and human rights.
References
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http://muse.jhu.edu/journals/journal_of_he
alth_politics_policy_and_law/v025/25.5merz
.html
desu.edu/research/osp/forms/IRBpresentati
on.ppt
education.ua.edu/ncate/documents/IRB%2
0Fall%202005%20update.ppt
http://web.missouri.edu/~bondesonw/Laud.
html
Isn’t the IRB Great?!?!?
I love the IRB