Arquiene

University of Massachusetts Medical School
Department of Psychiatry,
Center for Mental Health Services Research

An Observational Descriptive Study of IRB Decision Making
Charles W. Lidz, PhD, Philip J. Candilis, MD, Paul Appelbaum, MD, Robert Arnold, MD, Suzanne Garverich, BA, Christopher Jackson, MA, & Theresa Roach, MA

Why Study IRBs?

Institutional review boards (IRBs) are theprinciple way that society has for assuring

ethical conduct of research. We rely on IRBs

to protect subjects from harm, to assure
adequate informed consent and to help

assure the quality of the research process.
Yet there has been little, if any, investigation

of their decision-making processes. IRBs
are almost universally seen as over-

worked and under-staffed but they bear

thebrunt of criticism in government

a nd media reports for ethical lapses in
clinical research. Many reforms have been

proposed. However, before attempting
to make structural changes in IRBs or to

Transcripts of audio recordings

Data Collection

u

u

of a single meeting

of each of twenty IRB panels.
Interviews with:
1. Panel Chairs
2. Protocol reviewers
3. IRBadministrators
4. IRB staff

strengthen their oversight capacity, it
nature of the decision-making process,

a. What issues about applications are the focus of IRB
attention; e.g., the scientific validity of a protocol, or issues of risk or
informed consent?
b. How, if at all, do the occupants of different roles (chair, community
member, attorney, scientific expert, etc.) differ in theirassessments and
discussions of applications?
c. How do IRB members identify problems in applications? What information
resources do they use and how do they use them?
d. How do IRBs organize the work of application review through
the use of staff, pre-meeting review and formal meetings?

quantitative and qualitative analysis on the same data. We

they make decisions regarding research
protocols.We need to understand the

the essential features of that process, the

organizational context in which it occurs
a nd its strengths and weaknesses.

For this reason, this study is undertaking
a general description of IRB decision-making

processes. We are looking at how decisions
are made about new applications that
are presented to IRBs. By applying both

quantitative andqualitative research

techniques to IRB deliberations, and to
semi-structured interviews with IRB

reviewers and staff, we are beginning
the complex process of describing IRB
decision-making.

Contact Information
Charles W. Lidz, PhD, Psychiatry
Phone:
508-856-8716
E-mail:
charles.lidz@umassmed.edu
Suzanne Garverich, BA, Psychiatry
Phone:
508-334-0548
E-mail:suzanne.garverich@umassmed.edu

Attorney, Committee Member: “I’m neither a statistician
nor a physician, or a nurse or anybody who would be able to
make reasonable sense out of the medical side of things. So I
figure my main goal there as a lay person is to look at what
the hell they’re doing and see whether the consent form…
fairly decides what’s going on and most particularly fairly
decides whatever risks they’reasking you to undergo.”

Study Questions

Our data consists of transcripts of meetings and open-ended

is important to understand exactly how

Reviewer: I read the consent form and I sort of have like a little
um, game that I play. I imagine that its my mother who’s being
presented with this consent form, could she understand it? Um,
you know would I feel like she knew what she wasgetting into,
would I feel like she had a good sense of what her risks were, um,
you know somebody who’s not necessarily educated like us.

Physician Committee Member: I just try and make sure that
there’s some scientific basis behind what they’re proposing to do…..
and then I try and make sure the safety parameter that they’re
proposing they follow, are appropriate and adequate, and then
I...