The Institutional Review Board
M. Jeffery Mador, M.D.Chair-Buffalo VAMC IRBAssociate Professor of
Medicine
Outline
What is an IRB? Why does it exist What do we do
How does the IRB impact your research HIPAA
Should it affect research? (no) What you need to know about its impact
on your research
What is an Institutional Review Board?
An administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities
Independent of other committees and independent of the needs of the institution
Research involving human subjects (or their records) must be reviewed by an IRB
Why do IRBs exist? Historical context
Nuremburg trials Atrocious trials done in the name of science
Tuskegee syphilis trial 1932 -1972 study designed to look at the natural
history of untreated syphilis Willowbrook Hepatitis study
Retarded children were deliberately fed a solution including the feces of children with hepatitis
Rules governing IRB activity
After the Tuskegee studies were reported in The NY Times and The Washington Post, Congress acted
National Research Act of 1974 Established IRBs
Code of Federal regulations contains broad outlines of what an IRB should do
New rules are written, generally in response to bad events, such as those occurring in 1999-2000
Major research problems occurred between 1999-2001
Death of a research participant in a gene therapy trial at the University of Pennsylvania First suit against a University for clinical research
Death of a normal volunteer At JHH Closed research activities at the Medical School
with the largest federal research budget Investigations of ‘research misconduct’ closed
research at 10 major research universities The approved informed consent for a study
involving subjects with melanoma contained mis-information
First suit against members of an IRB
Death of a normal subject at Johns Hopkins An investigator was studying the physiology of
asthma and reactive airways He asked normal volunteers to inhale a drug
formerly used for ↑BP, but taken off the market when better drugs were available
He made the drug in his lab, and didn’t include that information in the protocol
He was unaware that the drug had been associated with rare pulmonary problems
The subject, a regular volunteer in research studies, developed respiratory distress about 24 hours post participation and died
Problems discovered with IRB activities
Insufficient project review by the IRBs Casual review of research projects Lack of attention to regulations
Lack of knowledge about research regulations by those doing research
Financial conflicts of interest by those doing research
IRB changes since 2001
Requirement for each researcher to complete an educational program Available on the web
Increased educational requirements for IRB members
Potential for audits by the Office of Human Research Protection
HIPAA rules
Types of IRB Review Full review
More than minimal risk Requires review and approval (by vote) of a
full IRB committee Expedited
No more than minimal risk Approved by IRB chair and designated
representatives Usually approved relatively rapidly
‘Exempt’
Continuing review All studies are re-reviewed at least yearly
(except for those that are exempt) The IRB sends a reminder Information desired
Number enrolled Problems encountered Is the study still appropriate (literature
review) If the investigator does not respond to our
reminder, the study will be suspended and may be closed
Categories of expedited review Clinical studies on drugs and devices as
long as the study does not increase the risk
Blood tests, within limits From healthy adults >110 pounds The amount drawn may not exceed 550 mls
over an 8 week period and less than 2Xs/week
Different rules for children Biologic specimens collected by non-
invasive means (scaling of teeth, nail clippings, sputum etc.)
Categories of Expedited Review (2)
Collection of data through non-invasive procedures routinely employed in clinical practice (excludes x-ray and microwaves)
Study of materials collected for non-research purposes Medical record information (confidentiality
important) Collection of data by voice recordings, etc.
IRB must assure that confidentiality is assured
Some studies are exempt from IRB continuing review
Exempt studies are reviewed by the IRB chair, designated as exempt and a letter is sent indicating that and the applicable federal Regulation
Exempt studies do not require continuing review Six exempt categories
Surveys, publicly available tissues or samples, food evaluations, educational tests
Note that any study done in minors, prisoners or other special populations cannot be exempt
How should this be reviewed?
The PI is a physical therapist who wants to investigate the effect of a controlled exercise program on osteoarthritis of the knee
Eligible subjects have osteoarthritis and will be randomized to their usual activities or a program which requires supervised exercise 3 Xs/ week
All subjects have permission from their MD to participate. All will have an x-ray of their knee as part of the study and will answer weekly questionnaires about quality of life
Can this be expedited?
How should this study be reviewed?
A dentist is interested in why students chose to have oral piercings
He develops a survey in which high school students will be asked a variety of questions incl.
Do you have any oral piercings? Have you ever considered having one? Did you have any hesitation about a piercing. If so, what
were your concerns? The survey is anonymous, without an IC What kind of review should this be?
What happens to full review projects?
The full protocol is reviewed by two IRB members The primary reviewer generally has knowledge of the
subject (if not available on the committee, an outside reviewer is used)
These reviewers must not have a personal interest in the study
The abstract and informed consent are sent to all other members
Each reviewer completes an evaluation form which the IRB keeps as part of the file
What do we review? Research design
Are the objectives clear with sufficient background information to justify the study?
Is there a reasonable statistical plan? Does it require more subjects than can
reasonably be enrolled Are risks minimized and reasonable in
relationship to any potential benefit The informed consent HIPAA requirements
What should be in the IC? Clear indication that this is research Description of what will be done Description of risks and benefits Indicate that participation is ‘voluntary’ alternatives to participation and what these
are? A statement about compensation for potential
injury is needed. Usually the statement says that there is no
compensation (UB policy)
When is an informed consent needed?
Any direct intervention Any study requiring a review by the Full
IRB committee Any project in which the risk is greater
than that occurring in an ‘ordinary’ day What about chart reviews?
That becomes a HIPAA issue AUTHORIZATION VS. WAIVER
IRB decisions
Full approval Approval pending minor changes
Most common
Tabled Major questions have been raised about the
study design, but the study is believed to be worthwhile
Disapproved (rare)
Other IRB communication
Once approved, the study must be done as described Changes to the study or to the
informed consent need to be approved by the IRB
Ads must be approved Deviations from the proposal need
to be sent to the IRB
Interventions in “normal” subjects What does the IRB think about?
What is the risk? Is the risk reasonable, since there is
no benefit to the subject? The benefit is to the researcher who
plans to publish the study Since there is risk and no benefit,
many studies offer compensation. But what distinguishes re-imbursement from
inducement?
Is this study likely to be approved?
The investigator is interested in the breathing mechanics of ‘deep sea’ divers
Subjects who dive without breathing apparatus can go to great depths and apparently survive low oxygen tension
Subjects, competitive deep sea divers, will be asked to wear monitors of oxygen tension, cardiac monitors and do their usual dive
There is no benefit to the diver, only to science, and the dive is associated with some risk
There are deaths associated with this competitive diving
HIPAA – Health Insurance Portability and Accountability
The law was written to protect individuals from losing insurance with a job change
Congress was supposed to define and establish guidelines for medical privacy but didn’t get around to it
Thus the law was written by the Department of Health and Human Services
Clearly it has far reaching effects, particularly in research
HIPAA authorization
Researchers can create PHI, access and receive PHI by reviewing records
If this is being done prospectively, the patient must authorize the release of information
The authorization may be included in the whole informed consent or be a separate document
Waivers Retrospective medical record review
If possible, signatures from the involved individuals are needed
This is impossible in many cases Subject has died or has moved
A waiver allows you to access that information, providing that
There is a plan to protect the information It is coded or somehow secured Statement that the research cannot be done
without it
De-identified data
Data that is de-identified, according to 18 identifiers, is not subject to HIPAA rules
But the investigator must get the data when it has been de-identified Removing identifiers and storing data under
a secure code doesn’t fulfill the letter of the law
Conclusion Institutional Review Boards exist to
protect participants in research IRBs also protect researchers
Second opinion about research quality Is the question worth asking? Is the study being done in the safest way? Can the question be answered? Can it be statistically justified?
HIPAA concerns are so far manageable, although an added burden for many
Questions Health sciences IRB
150 Parker Hall Phone 829-2752 Contact: Darlene Campanella
[email protected] Website:
www.research.buffalo.edu/humansubjects/IRB/healthsciencesB Buffalo VAMC _Phone: 716-862-6525 Janine,[email protected] http:\\www1.va.gov/visns/visnO2/research/buf/
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