Nearly every day we hear of a new wonder drug or medical
treatment for an age-old problem. These new medicines and
treatments have greatly enhanced our health and quality of life.
Moreover, we stand at the threshold of research advances that to
many of us are frankly inconceivable. However, recent reports of
major research projects being suspended give reason to question what
safeguards are in place to protect from harm those who are so
desperate for a cure, they will try anything.
In the United States, clinical research is under not one or two
but three different legislated review processes. This triple-
review process has evolved over the last 40 years as a check and
balance of protections.
First, federal law and regulation require all research in the
United States to be under the supervision of a local review board
commonly called an institutional review board, or IRB. In addition,
there are two separate and distinct federal agencies, which share
responsibility for research and IRB oversight: the Office for
Protection from Research Risks (OPRR) and the Food and Drug
Administration. While the OPRR's main tool for oversight has been a
documentation process, on-site visits are also used. The FDA's main
mechanism for local board oversight is the inspection process. The
FDA also inspects drug companies, which sponsor much of the research
and the clinical research investigators, who are often practicing
Local board review
The responsibilities of local boards fall into two main
categories: initial review and continuing review. The initial
review of all human research focuses primarily on the research
protocol, the informed consent form to be signed by participants and
any advertisements to be used in recruiting participants. In
carrying out this review, the boards seek focus in four major areas.
First, they look to see that any risks that participants may
incur are warranted in relation to the anticipated benefits of the
study treatment. Then they look to see if the informed consent
clearly conveys the risks and the true nature of the research. They
also look to see that advertisements are not misleading. Finally,
they check to see that the selection of participants is equitable
and justified. The most in-depth focus of this review is on the
informed consent document as it is the vehicle for providing
accurate understandable information to potential research
The continuing review process requires reviews at regular
intervals throughout the study. In addition to this continuing
review, changes in the research procedures and reports of unexpected
adverse reactions are received periodically and reviewed to ensure
that the anticipated benefits continue to outweigh the risks
associated with the treatment being studied.
It is estimated that there are 3,000 to 5,000 local review boards
across the country. They are most commonly associated with hospitals
and academic centers. Boards also exist in managed care
organizations and government agencies (such as the National
Institutes of Health, the Centers for Disease Control, and state
governments). In addition, there are for-profit review boards.
These boards are totally independent of the institutions and clinics
in which the research takes place.
Federal regulations require that boards have at least five
members with varying backgrounds. At least one member must have
primarily scientific interests, one must have primarily
nonscientific interests, and one must be otherwise unaffiliated with
the institution in which the IRB resides. A quorum for approval of
any study must include at least one member whose interests are
primarily nonscientific. Nonscientific and unaffiliated members
play a crucial role in assuring protections necessary for
participant understanding and informed consent.
While local review is the mainstay of public protection,
governmental oversight is deemed necessary to prevent scientific
fervor from running roughshod over local board efforts to protect
vulnerable participants. …