Sustaining Public Trust: Falling Short in the Protection of Human Research Participants

Abstract

Sustaining Public Trust: Falling Short in the Protection of Human Research Participants Anna C. Mastroianni (bio) An aura of complacency surrounds the protection of human research participants in the United States. From investigators to policy-makers, many involved in research are exhibiting bureaucratic resignation, allowing paperwork compliance and checkboxes to protect the rights and interests of participants. The routinizing of ethics gives some tangible assurance that a system is in place, but it also undermines deliberate attention to ethical issues. Meanwhile, there is a disconnect between oversight practices and public perceptions. In a March 2008 survey conducted jointly by USA Today, the Kaiser Family Foundation, and the Harvard School of Public Health, 28 percent of respondents believed that most pharmaceutical companies acted unethically when testing new drugs on people.1 Since the line between public and private sector research has blurred, this perception could readily affect attitudes toward public sector drug development as well. Maintaining public trust is absolutely crucial to the research enterprise. Without trust, volunteers will be impossible to recruit, and the public will be unwilling to fund research. Here I venture some preliminary thoughts on some of the central marks of public trust in the research enterprise: creating accountability in research, instilling confidence in the integrity of process, ensuring fairness and transparency in the research enterprise, and affirming a commitment to the protection of human participants by all involved in research. To create accountability, the public needs to be assured that processes are in place to protect research participants. We have those systems in the form of regulations and oversight bodies, such as institutional review boards, the Office of Human Research Protections, the Food and Drug Administration, and Congress. Although the system has been subject to legitimate criticism, some level of standardization (and bureaucracy) is required to ensure a common approach to research protections. In the USA Today survey, 44 percent said that government regulation was insufficient to ensure that prescription drugs are safe.2 Perhaps the movement toward voluntary accreditation of human research protection programs through the Association for the Accreditation of Human Research Protection Programs offers a way to certify public accountability by establishing performance standards above federal and state requirements. Accreditation may become more desirable in an increasingly competitive research environment. Indeed, public, private, and international entities are paying attention, and nearly one hundred and twenty institutions have received accreditation to date.3 The public also needs to be confident that the system is working as intended and is being maintained. Are we falling short in instilling public confidence in research? Although infrastructure deficiencies in research approval and oversight have been heavily scrutinized in the scholarly literature, they rarely attract public attention until something goes wrong. A surge in litigation for research injuries and declining confidence in the FDA show that the public is indeed paying attention—and that its confidence is shaken. Over the years, the volume of research has grown tremendously, and research has come to involve more complex and invasive technologies. Given the litigious climate in health care, it is no surprise that litigation for research injuries is on the rise.4 Every death and injury (preventable or not) can have a negative impact on the public’s perception of the research enterprise. Participants surely expect that if they are injured while providing benefit to society, they will receive prompt treatment and be reimbursed at least for the real costs imposed on them (such as medical expenses and loss of work), if not also for “pain and suffering.” Yet the regulations require only that participants be informed about whether compensation and medical treatment for research injury is available, not that researchers or sponsors actually provide compensation or treatment. More than twenty-five years after the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research articulated ethical justifications for no-fault compensation for research injuries (reinforced by similar recommendations by a number of blue ribbon committees5), only a relatively few research institutions have policies in place to compensate injured research participants, and these pay only for medical expenses.6 No wonder litigation looks attractive. In the medical malpractice context, there is some evidence that...