Human Subjects Protection Committee
at
Cal Poly Pomona
The Institutional Review Board
Bruce W. Kennedy, MS RLATG CMAR
Compliance Associate
IRB Administrator
Office of Research and Graduate Studies
September 21, 2007
Basics of the IRB
- Agenda
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Purpose of the IRB
Development of Research Ethics
Scope of Authority
Regulations re Human Subjects Review
Elements of Informed Consent
Forms and Procedures
Human Subjects Training and Education
Wrap-up
Basics of the IRB
- Purpose
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Protect the welfare of human research subjects
(or participants).
Assure compliance with both federal law and
ethical standards for the conduct of human
subjects research.
Review protocols
Establish policy for the campus
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a medical school IRB would be different than a
program of behavioral sciences
Respond to non-compliance
Basics of the IRB
- Purpose
The Cal Poly Pomona IRB
 The committee
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faculty representing various disciplines
outside, unaffiliated members
administrator
Meets once per month generally
Chair is Dr. David Adams, a professor of
philosophy and ethics
Basics of the IRB
Respect for Persons
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- the IRB Principles
Voluntary participation
Informed consent
Privacy and confidentiality
Beneficence
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Risks must be justified by benefits to the research subject or to
the community.
Risks must be minimized.
Data gathering must be monitored to ensure safety of subjects.
Justice
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Subjects must be selected equitably.
Avoid exploitation of vulnerable groups or populations of
convenience.
Those likely to benefit are not systematically excluded.
Basics of the IRB
- Development of Research Ethics
Milestones:
 1940s - Nuremberg Code
 1950s-60s - Controversial studies
 1964 - Declaration of Helsinki
 1970s - “Common Rule”
 1970s - Belmont Report
 1990s - 2000s - IRBs and protections
Basics of the IRB
- Research Ethics
Nuremberg Code …
At the end of World War II, 23 Nazi doctors and
scientists were put on trial for the murder of
concentration camp inmates who were used as
research subjects. That led to:
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Informed consent is essential.
Risks must be justified by anticipated benefits.
Research must be conducted by qualified researchers.
Physical and mental suffering must be minimized.
Basics of the IRB
- Research Ethics
Controversial studies, examples,
historical perspective…
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Milgram study, ‘60s
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The purpose of this study was to determine response to authority in
normal humans. The researchers told recruited volunteers that the
purpose was to study learning and memory. Each subject was told to
teach a "student" and to punish the students' errors by administering
increasing levels of electric shocks. The "student" was a confederate
of the researcher who pretended to be a poor learner and mimicked
pain and even unconsciousness as the subject increased the levels
of electric shock. 63% of the subjects administered lethal shocks;
some even after the "student" claimed to have heart disease. Some
of the subjects, after being "debriefed" from the study experienced
serious emotional crises.
Basics of the IRB
- Research Ethics
Controversial studies, examples
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Tuskegee syphilis study, 1932-1971
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Initiated by the Public Health Service, this
study was designed to document the natural
history of syphilis in African-American men.
Willowbrook study, 1956
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In 1956, at an institution for mentally retarded children in Staten
Island, New York, a study was initiated to determine the natural
history of viral hepatitis and to test the effectiveness of gamma
globulin as an agent for inoculating against hepatitis. Children
were deliberately infected with a mild form of hepatitis.
Basics of the IRB
- Research Ethics
Declaration of Helsinki ...
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The World Medical Association has developed the Declaration of
Helsinki as a statement of ethical principles to provide guidance
to physicians and other participants in medical research
involving human subjects. Medical research involving human
subjects includes research on identifiable human material or
identifiable data.
Medical progress is based on research which ultimately must
rest in part on experimentation involving human subjects. In the
field of biomedical research a fundamental distinction must be
recognized between medical research in which the aim is
essentially diagnostic or therapeutic for a patient, and medical
research the essential object of which is purely scientific and
without implying direct diagnostic or therapeutic value to the
person subjected to the research.
Biomedical research involving human subjects must conform to
generally accepted scientific principles and should be based on
adequately performed laboratory and animal experimentation
and on a thorough knowledge of the scientific literature.
Basics of the IRB
- Research Ethics
Common Rule ...
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The National Research Act was passed in 1974 which
established:
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a national commission for the Protection of Human Subjects
of Biomedical and Behavioral Research.
the requirement for establishment of IRBs at institutions
receiving federal monies.
the various regulatory standards known collectively as the
“Common Rule.”
effective since 1991
adopted by 19 federal agencies
based upon subpart A 45 CFR 46
this, a set of basic regulatory standards
Basics of the IRB
- Research Ethics
Belmont Report ...
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published in 1979
included the Belmont Principles
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respect for persons
beneficence and
justice
Basics of the IRB
- Research Ethics
Risks ...
 Evaluated according to the probability and
magnitude of any harm that might occur
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Will the risk occur in almost all subjects or in only one
of 10,000 subjects?
Quantify risk according to the magnitude of harm
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minor itchiness
could some subjects die?
social, legal, economic, or psychological risks
risks may apply to the individual subject or may apply
to a broader segment of the society.
Basics of the IRB
- Scope of Authority
Any research undertaken at Cal Poly
Pomona, or involving Cal Poly faculty,
staff, or students either as investigators or
subjects.
Basics of the IRB
- Regulations
DHHS
has these components
FDA
NIH
OHRP
and the research is overseen by the
IRB
Code of Federal Regulations …
Title 21, CFR Part 50 and CFR Part 56
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Title 45, Public welfare, CFR Part 46 (45 CFR 46)
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Food and Drug Administration (FDA)
Focused on clinical, medical, therapeutic studies
Department of Health and Human Services (DHHS)
Protection of human subjects in general
Miscellaneous others at the federal, state, and
institutional levels
Basics of the IRB
- Regulations
Definition of subject …
A human subject is a “living individual about
whom an investigator (whether professional or
student) conducting research obtains:
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(a) data through intervention or interaction with the
individual or
(b) identifiable private information.”
Vulnerable subjects
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prisoners, children, pregnant women, fetus,
medically-afflicted, plus others
Basics of the IRB
- Regulations
Definition of research ...
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Covered research is any “systematic
investigation including research development,
testing and evaluation, designed to develop or
contribute to generalizable knowledge.”
Basics of the IRB
- Regulations
Is it research? ...
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Collecting data for the purpose of publication,
professional presentation at a conference or
seminar, dissemination to colleagues on the
Internet, or inclusion in a dissertation does
count as research.
For teachers, gathering data from students to:
(a) improve your teaching, (b) assess your
course or program, or (c) collect student input
for employment actions does not constitute
research.
Basics of the IRB
- Regulations
Are you doing research?
Assess your role ...
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Conducting “typical” research as a principal
investigator, abbreviated as PI.
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student, graduate student, clinician, investigator
Acting in the capacity of a teacher with the
intention of assisting your students to learn.
Acting in the capacity of a researcher with the
intention of studying the process of teaching and
learning. Publication of results is not a
necessary condition.
Basics of the IRB
- Regulations
What are data?
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Examples
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Privacy and de-identification
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Survey sheets and questionnaires, biological samples, audio and video
tapes, transcripts of verbal communication, photographs, paper and
electronic records, and more
Existing (archived) data or samples
Observation of public behavior
Collection of new data though human intervention
Storage and retention
Protected
Medical records and HIPAA
Confidential vs. anonymous collection
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Definitions
Can the collected data be traced back?
Can the data identify one or more persons?
Basics of the IRB
- Regulations
Means of protocol review ...
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Exempt
 Research using existing data or samples.
 Observation of public behavior.
 Research involving surveys or questionnaires where no personally
identifying information is gathered or retained.
 Eligibility for exemption must be determined by the IRB, not the
investigator.
Expedited
 Poses no more than “minimal risk” to the subject, i.e., “no more than
those ordinarily encountered in daily life or during the performance of
routine physical or psychological examinations or tests."
 Approvable by review of two members of the Board.
 Doesn’t necessarily mean quick or fast review.
Full board
 Research that is neither exempt nor expeditable must receive review
by the full committee.
 Means a convened meeting of the IRB for face-to-face discussion.
Basics of the IRB
- Informed consent
Elements of informed consent include …
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Explanation of the purpose(s) of the research.
Description of the procedure(s) to be followed.
Summary of the data to be collected.
Description of any foreseeable risks or discomforts to the
subject.
Description of the benefits to the subject or to others,
including compensation.
Explanation of how the investigator (PI) will maintain
confidentiality of records.
Contact information of all PIs.
A statement that participation is voluntary, that refusal to
participate involves no penalty or loss of benefits, and
that the subject may discontinue at any time.
Anything else that will help the subject to understand.
Basics of the IRB
- Forms and Procedures
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Protocol
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Informed consent form
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purpose, methodology, recruitment and description
of subjects, risk evaluation, anonymity and
confidentiality, benefits, compensation, etc.
consent for adults
assent for minors
Surveys and questionnaires
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paper
electronic (Zoomerang)
Basics of the IRB
- Forms and Procedures
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Submit protocol electronically as a MS Word file
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Provide evidence of training
Allow IRB time to review
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send attachments like consent form or surveys
send front page by regular mail with signatures
comments are summarized by chair and sent to PI
response by PI is evaluated by the chair
could be 1 week or 1 month
Approval memo is sent
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approval is granted for up to one year
renewals and amendments are permitted
Basics of the IRB
- Training and education
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IRB adopted www.citiprogram.org in early 2006
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30+ modules, various groups, completion reports
required of all researchers with human subjects
To demonstrate experience and appreciation for
human subjects protection.
IRB approval
- aspects
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A memo is issued
Protection for many
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Compliance
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the investigator(s)
the subjects
the institution
we live in a regulated world
with federal regulations and institutional policies
Perspectives from peers
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IRB members can contribute to the study
suggestions to the methodology
Basics of the IRB
- Wrap-up
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These are the basics
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Federalwide Assurance
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every protocol is unique
a document submitted to the federal government
Cal Poly Pomona will comply with the regulations
More info?
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www.csupomona.edu/~research/irb/
www.hhs.gov/ohrp/
members of the IRB
Thank you for your interest in the IRB and its practices!