Feature

A flurry of reports and recommendations could change the face of human subjects research. Several projects are aimed at reworking the current system by rewriting the regulations, better educating researchers and institutional review boards (IRBs), and standardizing the system. Below is a summary of some of the major projects under way:

  • IRB accreditation. Two organizations are moving to begin to accredit IRBs using a process much like the one that accredits university and college departments. The Institute of Medicine has endorsed standards created by the National Committee for Quality Assurance (http://www.ncqa.org/Programs/QSG/VAHRPAP/vahrpap.htm) to accredit Department of Veterans Affairs human subjects research. Meanwhile, the Association for the Accreditation of Human Research Protection Programs (AAHRPP) has drawn up accreditation standards and hopes to begin pilot accreditation soon (http://www.aahrpp.org). APA, through its Board of Scientific Affairs, is monitoring AAHRPP's effort with an eye toward ensuring that special provisions are made for reviewing behavioral research, and that AAHRPP does not create an added layer of bureaucratic hoops that would delay the timely approval of research protocols even further.

  • National Bioethics Advisory Committee (NBAC) report. NBAC released its report on "Ethical and Policy Issues in Research Involving Human Participants" last October to positive reviews. One of its main recommendations is that there be a single set of regulations for human subjects research regardless of whether the research is publicly or privately funded. In addition, the report emphasized the need for IRBs to better distinguish "minimal risk" research. In terms of informed consent, the report emphasizes that IRBs should be more concerned with how well prospective study participants understand what they're agreeing to than with the form of documentation used to obtain consent. However, NBAC was a committee created under President Clinton, and President Bush has shown little interest in pursuing the committee's recommendations (to view the report see http://bioethics.georgetown.edu/nbac/).

  • "Human Research Subject Protections Act." Rep. Diana DeGette (D-Colo.) and several colleagues have penned a bill that would implement a series of changes in large part based on the NBAC report. In particular, the bill includes better matching of regulations to the level of research risk, tightening the monitoring of ongoing research and strengthening IRBs. They introduced the bill in 2000, but it went nowhere. They planned to reintroduce it this session, but at press time that had not happened.

  • Educating IRBs and researchers. APA's Board of Scientific Affairs is creating an educational packet for IRBs, university administrators and researchers that discusses how regulations on human subjects research pertain to behavioral research, the special issues that arise when reviewing such research compared with biomedical research and "best practices" for how researchers and IRBs can work together to facilitate the research review process.

--B. AZAR