. "6 Improving Human Research Participant Protection Program Performance and Clarifying Roles." Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: The National Academies Press, 2002.
The following HTML text is provided to enhance online
readability. Many aspects of typography translate only awkwardly to HTML.
Please use the page image
as the authoritative form to ensure accuracy.
Responsible Research: A Systems Approach to Protecting Research Participants
(1977). Although this information is the most comprehensive available, it has a number of serious limitations23 and is severely outdated.
The University of Washington is one of the few organizations, to this committee’s knowledge, that offers long-term compensation for research injuries.24 When the system was first established in the 1970s, few formal claims for compensation were processed, but officials at the university attributed this to a lack of knowledge about the program among participants (President’s Commission, 1982a). In 1998, University of Washington officials estimated that the School of Medicine enrolled about 100,000 people per year in clinical studies with potential for adverse effects and that the compensation program for those injured paid $2,300 to $5,000 total annually (Marwick, 1998). At the University of Washington, the investigator is responsible for reporting whether an adverse effect was the result of research, at which point the plan goes into effect. The school pays for medical care and related expenses, such as travel.
The DHEW report and the more recent University of Washington examples appear to provide the most relevant information about the number and cost of injuries, but, obviously, this information is both sketchy and inconsistent. However, based on the media attention given to adverse research events in recent years,25 the increased attention given by regulatory agencies to institutional noncompliance and financial conflicts of interest, and the growing pressures on the research system, the potential for diminished public trust in the research community is real (Marwick, 2002).
To ensure credibility, it is critical to have data about the number, severity, and costs of research injuries, and it is not acceptable for society to continue to leave unaddressed a fundamental ethical obligation for the simple want of basic information. Some pertinent information could be abstracted from FDA and research institutions’ adverse event reports or experiences at institutions such as the University of Washington that already offer self-funded no-fault compensation. Similarly, such analysis can make use of the international experience (Box 6.8).
In its telephone interviews, the Task Force relied on data provided by investigators using their own judgment; the interviewers suggested nontherapeutic research if the determination of the type of research was vague; the Task Force had to make assumptions about the length of participation by subjects; and the definition of therapeutic injury did not include the word “unanticipated.” Also, in 1977, the Common Rule was not in effect, and the research landscape was very different from that found today.
Some recent articles on the topic include Blumenstyk, 2002; DeYoung and Nelson, 2000a,b; Flaherty, et al., 2000; Flaherty and Struck, 2000; LaFraniere, et al., 2000; Lemonick and Goldstein, 2002; Nelson, 2000; Shaywitz and Ausiello, 2001; Stephens, 2000; Stolberg, 2002; Wilson and Heath, 2001a,b,c,d,e,f,g.