The Institutional Review Board

M. Jeffery Mador, M.D.

Chair-Buffalo VAMC IRB Associate 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

IRB continuing review from

    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 information

authorize

the release of 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]

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