Transcript The role of the Institutional Review Board

The Institutional Review Board
Monica B. Spaulding, M.D.
Chair-Health Sciences IRB
Professor of Medicine
Outline
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What is an IRB?
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Why does it exist
What do we do
IRB Reviews
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Full
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Expedited
HIPAA
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Its impact on your research
What is an
Institutional Review Board?
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An administrative body established to protect
the rights of welfare of human research subjects
recruited to participate in research activities
Independent of other committees and
independent of the needs of the institution
All research involving human subjects (or their
records) must be reviewed by an IRB
Why do IRBs exist?
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Historical context
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Nuremburg trials
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Tuskegee syphilis trial
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Atrocious trials done in the name of science
1932 -1972 study designed to look at the natural history
of untreated syphilis
Willowbrook Hepatitis study
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Retarded children were deliberately fed a solution
including the feces of children with hepatitis
Rules governing IRB activity
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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
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New rules can be written or rules can be modified generally
in response to bad events, such as those occurring in 19992000
Major research problems
occurred between 1999-2001
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Death of a research participant in a gene
therapy trial at the University of Pennsylvania
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Death of a normal volunteer At JHH
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First suit against a University for clinical research
Closed research activities at Johns Hopkins, the
medical school with the largest federal research
budget at the time
Investigations of research conduct closed
research at 10 major research universities
because of misconduct
Death of a normal subject at
Johns Hopkins (1)
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An investigator was studying the physiology of
asthma and reactive airways
He recruited normal volunteers to inhale a drug
formerly used for ↑BP
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The drug had been taken off the market when better drugs
were available
Since it could no longer be purchased, he made the
drug in his lab
Death of a normal subject at
Johns Hopkins (2)
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The subject, a regular volunteer in research studies, developed
respiratory distress about 24 hours post participation and
subsequently died
Massive literature searches turned out rare reports of pulmonary
problems from the drug when it was being used clinically
The FDA investigated, denied all responsibility, although they
had reviewed the project
The Office for Human Research Protection investigated, found
fault with the IRB and shut down all research
OHRP then reviewed the IRB activities at other institutions and
faulted the system
Problems discovered with IRB
activities across the country
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Insufficient project review by the IRBs
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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
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Requirement for each researcher to
complete an educational program
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We use CITI, a web-based program
Potential for audits by the Office of
Human Research Protection
HIPAA rules
Types of IRB Review
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Full review
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More than minimal risk
Requires review and approval (by vote) of a full
IRB committee
Expedited
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< minimal risk
Approved by IRB chair and designated
representatives
Usually approved relatively rapidly
Expedited projects
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Most residents will be doing expedited projects
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Non invasive studies include:
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Review of charts, old x-rays or other imaging studies,
lab values
Or invasive studies which use simple blood draws
Approval is generally rapid
If changes are needed, we usually communicate
them by e-mail
Nevertheless, give your self enough time to deal
with the IRB minutiae
Categories of expedited review
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Clinical studies on drugs and devices as long
as the study does not increase risk
Blood tests, within limits
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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)
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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
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Medical record information (confidentiality important)
Collection of data by voice recordings, etc.
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IRB must assure that confidentiality is assured
The phenomenon of
continuing review
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All studies must be re-reviewed at least yearly
The IRB sends a reminder
Information desired
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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
will be closed
Some studies are exempt from
IRB continuing review
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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
Full review projects
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These are generally invasive studies or utilize a new
drug or drugs.
In most cases, residents are not involved as a PI in such
a study
Such studies are reviewed monthly, but by the
committee
The studies are reviewed closely by at least three
committee members and are discussed by the full
committee.
Approval takes much longer, just because of the
processes involved
What do we review for both
fulll and expedited projects?
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Research design
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Are the objectives clear with sufficient background
information to justify the study?
Is there a reasonable statistical plan?
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Does it require more subjects than can reasonably be
enrolled
Are risks minimized and reasonable in relationship
to any potential benefit
The informed consent
Are HIPAA requirements met
Informed consent
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If a consent is required, there are a
number of required elements
The IRB provides a template at their
web site which includes the required
elements
The informed consent must be written
so that a 10th grader can understand it
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This is very hard!
How should this be reviewed?
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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?
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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.
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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 should be in the IC?
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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
IRB decisions
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Approval without any changes
Approval pending minor changes
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Tabled
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Most common
For expedited projects those revisions are usually
handled by e-mail
Major questions have been raised about the study
design, but the study is believed to be worthwhile
Disapproved (rare)
Other IRB communication
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Once approved, the study must be done
as described
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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
IRB Committees at UB
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Social and Behavioral
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Womens and Childrens Hospital
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Studies which are not invasive
Usually cover studies done on the Amherst campus
For those <18 unless emancipated adults
All studies on pregnancy come to HS-IRB
Health Sciences IRB
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Invasive studies
Medical records
Studies which may have HIPAA issues
HIPAA – Health Insurance
Portability and Accountability
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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
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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
Waiver from an authorization
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Retrospective medical record review
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If possible, consents from the involved individuals
are needed
This is impossible in many cases
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Subject has died or has moved
A waiver allows you to access that information,
providing that
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There is a plan to protect the information
It is coded or somehow secured
Statement that the research cannot be done without it
You indicate why obtaining a consent is impossible
De-identified data
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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
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Removing identifiers and storing data under a
secure code doesn’t fulfill the letter of the law
Conclusion
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Institutional Review Boards exist to protect
participants in research
IRBs also protect researchers
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Second opinion about research quality
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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
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Health sciences IRB
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150 Parker Hall
Phone 829-2752
Contact: IRB office
Website:
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www.research.buffalo.edu/humansubjects/IRB/healthsciences