The Institutional Review Board

Monica B. Spaulding, M.D.Chair-Health Sciences IRB

Professor of Medicine

Outline What is an IRB?

Why does it exist What do we do

IRB Reviews Full Expedited

HIPAA Its impact on your research

What is an Institutional Review Board?

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? 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 can be written or rules can be modified 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 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) An investigator was studying the physiology of

asthma and reactive airways

He recruited normal volunteers to inhale a drug formerly used for ↑BP

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)

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

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 We use CITI, a web-based program

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

< minimal risk Approved by IRB chair and designated

representatives Usually approved relatively rapidly

Expedited projects Most residents will be doing expedited projects Non invasive studies include:

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 Clinical studies on drugs and devices as

long as the study does not increase 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

The phenomenon of continuing review All studies must be re-reviewed at least

yearly 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 will be closed

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

Full review projects

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? 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 Are HIPAA requirements met

Informed consent 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 This is very hard!

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 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

IRB decisions

Approval without any changes Approval pending minor changes

Most common For expedited projects those revisions are

usually handled by e-mail 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

IRB Committees at UB Social and Behavioral

Studies which are not invasive Usually cover studies done on the Amherst campus

Womens and Childrens Hospital For those <18 unless emancipated adults All studies on pregnancy come to HS-IRB

Health Sciences IRB Invasive studies Medical records Studies which may have HIPAA issues

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

Waiver from an authorization Retrospective medical record review

If possible, consents 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 You indicate why obtaining a consent is impossible

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: IRB office Website:

www.research.buffalo.edu/humansubjects/IRB/

healthsciences