Academic journal article The Hastings Center Report

Trust: The Fragile Foundation of Contemporary Biomedical Research

Academic journal article The Hastings Center Report

Trust: The Fragile Foundation of Contemporary Biomedical Research

Article excerpt

In addition to its investigation of research conducted in the past, the Advisory Committee on Human Radiation Experiments also examined the current status of research with human subjects to ensure that research today and in the future be conducted in accord with the highest ethical standards. To that end, the Advisory Committee conducted three projects that examined contemporary human subjects research. Among these was the Subject Interview Study, a project that enrolled almost 1,900 outpatients nationwide to determine their experiences with and attitudes about research.[1] Approximately one hundred of the patients who enrolled in this study and reported having personal experience in medical research were interviewed a second time and in greater depth to gain further insight into their reasons for participating and their understanding of the research enterprise. This paper describes the findings from these interviews and their implications for conducting ethically sound research with human subjects.

These in-depth interviews were conducted at fourteen institutions across the country, including academic research institutions, Veterans' Affairs hospitals, community hospitals, and federal government hospitals. Patients were recruited from the waiting rooms of medical oncology, radiation oncology, and cardiology out-patient clinics at each of the participating institutions. During interviews, which averaged forty-five minutes, patients were asked to describe the research project in which they were enrolled, how they had learned about it, how they had decided to participate, consent procedures, how they felt about the experience, and how they felt about research more broadly. Interviewers encouraged respondents to speak freely about each topic and also to raise additional topics that were of relevance to their experience in medical research.[2]

Of the 103 patients who were interviewed, there were almost equal numbers of women and men. Patients tended to be Caucasian (74%), to be high school but not college graduates (52%), and to have private health insurance (65%). Participants also were significantly more likely to be in research evaluating a therapy (65%), than in survey research or studies evaluating a diagnostic test. In this report, we will focus predominantly on the experiences of patients enrolled in therapeutic research.

Why Patients Become Subjects

Many factors influenced patients, decisions to participate in research. And as one might expect, those in therapeutic research cited different reasons for participating than did those in other types of research. Among the more prominent motivations for subjects enrolled in therapeutic research was a sense that the experimental intervention was better than any existing alternative, and indeed offered some hope of personal benefit.[3] Patients made comments such as, "If there's something new on the market that might be better than the traditional program they've been using, why not try it?" (Subject 333208-7), or "I was more interested in something more advanced and potentially better" (44327-2).

The theme of hope was often wedded to despair. For many patients, research came after they had tried other standard or experimental interventions and either had exhausted those treatments, effectiveness or had experienced little benefit at all. Often, they viewed the investigational "treatment, as a last hope for improvement or amelioration of their conditions. As one respondent said, "Well, what was driving me to say `yes' was the hope that this drug would work ... When you reach that stage ... and somebody offered that something that could probably save you, you sort of make a grab of it, and that's what I did" (332250-0) Less typical were the comments of one respondent who said, thoughtfully, "You don't know what that cancer's gonna do. God, I don't ... think anybody can guarantee you any benefits" (552126-5). Clearly, many patient-subjects hope for personal benefit when they enroll in research, hope that this intervention might offer them longer life, less pain, or fewer symptoms. …

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