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Responsible Research: A Systems Approach To Protecting Research Participants

by Daniel D. Federman

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From the New England Journal of Medicine, November 13, 2003
Today's medical research enterprise was born in the early 1950s with the trial of streptomycin -- the first clinical trial in the modern sense. Even in the late 1970s, "the typical study was conducted at a single research institution by a single investigator or a small team of investigators," according to Responsible Research. "Today, however, some research involves scores or even hundreds of centers and tens of thousands of participants, with multiple investigators, review boards, and institutions possibly involved." The stated goal of this report from the Institute of Medicine is "to improve the system of protections [of research participants] as a whole, as it has not adequately adapted to the vast growth in the scale and complexity of research." The report is focused on research conducted in the United States, but its principles and approaches are relevant to the research enterprises in many countries. It deals only with research that involves competent adults, not vulnerable populations such as children or other persons who are unable to consent for themselves. This is a wise limitation in view of the complex and often difficult additional considerations involved in the protection of such persons. It will be important to explore those considerations fully in later reports. The central goal of this report is the protection of research participants, and the central message is that we cannot simply assume that protective measures are effective. An integrated, properly structured, responsibly administered system is needed to ensure that protection. Such a multifaceted, interconnected system of protections must include the comprehensive review of protocols (scientific review, review of potential financial conflicts of interest, and review of ethical aspects), ethically sound participant-investigator interactions, ongoing and risk-appropriate safety monitoring, and quality-improvement and compliance activities. It must also include adequate resources for all aspects of the system of protections; comprehensive, compulsory ethics-education programs; accountability at all levels; explicit lines of authority and responsibility; leaders who establish an institutional culture of excellence in ethics and science; transparency and open communication; compensation for persons who are injured in research; and review of every research project involving human participants, regardless of the source of funding or other factors. In short, the responsibilities engendered by an adequate protection program go far beyond a review of ethics, important as such a review is. The report recognizes that the nature of the relationships among the partners in the research enterprise -- industry, academia, and government -- challenges the ability to protect human research subjects. But it is assumed that the structure of the enterprise is basically acceptable and that its ethical functioning simply requires proper governance -- in particular, with respect to potential conflicts of interest. Some people would challenge this assumption and call for a radical uncoupling of those partners as the only way to ensure the ethics of the enterprise. The ethical pillars undergirding the report's recommendations are respect for all research participants, whose interests must always come first; fulfilling obligations of trust to the research participants and, in so doing, maintaining the public's trust and support; being honest and open in relation to all information and data, including the facilitation of public access to the data; and acting with the utmost integrity and exercising good ethical judgment. As the report makes clear, putting these principles into practice requires enormous attention to detail. Other important points can be deduced from the report. Responsibility for research is like a cake, in that everyone can have a slice, but not like a football game, in which one person can get rid of the football by having another catch it. Everyone in the research enterprise has continuing responsibilities to all research participants. Form is no mere formality. The structures and processes used to govern research will determine how effectively participants will be protected. It is not enough to know what the ethical requirements are; we must design systems to implement them. Language is not neutral. For example, the report recommends the use of the term "research ethics review boards," not "institutional review boards," to place the emphasis on ethics review, rather than on the protection of the institution. Similarly, the report recommends the use of "research participant," not "research subject," to avoid suggesting passivity on the part of the participant and to recognize the participant's contribution, and "consent forms," not "informed consent forms," because consent is a process and whether or not it is informed is an ongoing question of fact, not a matter of signing a form. Furthermore, good facts are essential for good ethics, and we are seriously lacking many of the facts needed to ensure good ethics in medical research. Data with respect to the scope and scale of protection activities and their effectiveness and with respect to current gaps and deficiencies in the protection system are urgently needed. Ethics come from the top of an organization; its leaders set an organization's ethical tone and must be accountable for any breaches of ethics. Not all research should be treated equally. For example, low-risk research does not require the same degree of scrutiny as high-risk research. Indeed, treating all research equally can mean that high-risk research is not as well reviewed and monitored as it should be. Fulfilling ethical responsibilities requires the provision of education in ethics for everyone who is involved in the research enterprise. Resources must be provided for this education, as well as for ethics reviews, the accreditation of ethics programs and activities, and the sharing of best practices for ethical action. There will be new issues -- for instance, that of the ethics of research designed to counter bioterrorism. In this area, the normal rules and protections for the marketing of new drugs or biologic agents may have to be sidestepped. We may have to move directly from research evidence of effectiveness in animals to the use of new drugs in humans, if human studies are not ethical or feasible because they would involve the administration of potentially lethal or disabling toxic substances to healthy human volunteers. The report recognizes that the only effective way to protect research participants is to embed ethics in every aspect of the research enterprise, and this is a complex, daunting, and essential task. The report is a valuable road map, providing wise advice and red-flagging the common ways in which breaches of ethics occur in research. It will not be the final word, but it merits serious attention. Margaret A. Somerville, LL.D.
Copyright © 2003 Massachusetts Medical Society. All rights reserved. The New England Journal of Medicine is a registered trademark of the MMS.

Book Info
Harvard Univ., Boston, MA. Text outlines an approach to ensure the protection of research participants through the establishment of effective Research Participant Protection Programs (HRPPPs). Includes such issues as the need for in-depth, complementary reviews of science, ethics conflicts of interest, informed consent, and accreditation. DNLM: Clinical Protocols.



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