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

campanella@research.buffalo.edu Website:

www.research.buffalo.edu/humansubjects/IRB/healthsciencesB Buffalo VAMC _Phone: 716-862-6525 Janine,Hilliard@va.gov http:\\www1.va.gov/visns/visnO2/research/buf/

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