Accreditation Urged to Help Protect Study Participants

WASHINGTON—Medicine and other sciences need to move beyond institutional review boards (IRBs) and adapt a broader focus for protecting participants in human research studies, according to a new Institute of Medicine (IOM) report. It recommends a vigorous accreditation system to oversee what it terms "human research participant protection programs," or HRPPPs.

"The need to improve protections has become more apparent as report after report has highlighted mounting concerns about the ability of the participant protection system to keep up with the evolving research enterprise," the report stated.

HRPPPs exist in the nation today in many forms, although not generally under that name and not as a single recognized entity, the committee that wrote the IOM report concluded. Essentially, four principal functions comprise an HRPPP, it said:

To ensure a sound study design and to ensure that its potential for advancing knowledge justifies the use of human participants.

To provide an assessment of a study’s risks and benefits independent of the researchers involved.

To ensure that a person’s participation is voluntary and informed.

To ensure that participants are recruited equitably, and that risks and benefits are distributed fairly.

These four basic responsibilities need to be considered as a whole and subject to accreditation procedures, the report argued.

Committee chair Daniel D. Federman, MD, professor of medicine and medical education, Harvard University, said that "accreditation does, indeed, possess strong potential as a mechanism to strengthen the participant protection system." He said that this approach should be pursued as soon as possible and called pilot testing of any accreditation program critical to the eventual success of the effort.

Accreditation, when viewed as a mark of excellence, might offer "a competitive advantage over nonaccredited competitors in seeking support from sponsors or access to participants, researchers, or students," the report suggested.

Incidents Raise Concerns

The IOM committee began a two-part study of participant protection issues in human trials last year at the request of the Department of Health and Human Services, after several incidents in 1999 raised concerns about the adequacy of measures to ensure protection of study participants.

First, the former federal Office of Protection from Research Risks and the Food and Drug Administration suspended human research programs at several major universities for noncompliance with federal regulations.

Second, an 18-year-old volunteer in a University of Pennsylvania gene therapy experiment died as the result of his treatment. A follow-up investigation found "that the system intended to protect him from unacceptable research risks instead failed him," the IOM report noted.

The new report, Preserving the Public Trust: Accreditation and Human Research Participant Protection Programs, is focused solely on accreditation issues.

The committee is continuing with a more comprehensive assessment of the overall system for protecting human research volunteers, which it will issue next year. That study will examine ways to improve the informed consent process, ease the burdens on IRBs, and ensure that investigators are educated about the ethics and practices of conducting research.

In its review, the panel examined two draft standards and accepted one developed by the private National Committee for Quality Assurance (NCQA) for the Department of Veterans Affairs as a framework for other groups wanting to initiate accreditation programs.

The report cited the NCQA standards because they "include specific attention to quality improvement, provide flexibility in achieving performance goals (eg, increased protection of research participants), and are explicit in their grounding in current regulations."

In expanding the draft NCQA standards for use beyond VA facilities, the committee recommends that the standards be strengthened in several specific ways, including how investigators will be reviewed (beyond the review of protocols by IRBs); how sponsors will be assessed; how participants will be involved in setting performance standards; and how oversight mechanisms can ensure participants’ safety.

"Any set of standards must be flexible enough to be applicable to a variety of institutions yet rigorous enough to ensure that their enactment enhances protection of participants in human research," the committee said.

The committee further recommended that research participants should be included in the formulation of accreditation standards, the accreditation process, and all HRPPP operations.

It also advised that the accreditation process "should accommodate organizations involved in research beyond the traditional research organization models involved in academic health centers and VA facilities." And it recommended that accreditation standards be developed for all research programs involving humans, including behavioral and social science studies.

"Whether it is a demographic survey used to develop marketing ads or a clinical trial testing the efficacy of a new therapy, research involving humans is touching all of our lives with increasing frequency," Dr. Federman said.

He indicated that the cornerstone of this research is trust: "Trust between the individual participating in a research study and the investigator, the university, the hospital, or the private company conducting the research."

To preserve this trust, he said, the research system and the specific mechanisms for protecting human research participants "must be credible and accountable to the public."