Safeguards in Clinical Research

Article excerpt

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 physicians.

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 participants.

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.

Government oversight

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. …