It is widely assumed that informing prospective subjects about the risks and possible benefits of research not only protects their rights as autonomous decisionmakers, but also empowers them to protect their own interests. Yet interviews with patient‐subjects conducted under the auspices of the Advisory Committee on Human Radiation Experiments suggest this is not always the case. Patient‐subjects often trust their physician to guide them through decisions on research participation. Clinicians, investigators, and IRBs must assure that such trust is not misplaced.

When may a physician enroll a patient in clinical research? An adequate answer to this question requires clarification of trust-based obligations of the state and the physician-researcher respectively to the patient-subject. The state relies on the voluntarism of patient-subjects to advance the public interest in science. Accordingly, it is obligated to protect the agent-neutral interests of patient-subjects through promulgating standards that secure these interests. Component analysis is the only comprehensive and systematic specification of regulatory standards for benefit-harm evaluation by research (...) ethics committees (RECs). Clinical equipoise, a standard in component analysis, ensures the treatment arms of a randomised control trial are consistent with competent medical care. It thus serves to protect agent-neutral welfare interests of the patient-subject. But REC review occurs prior to enrolment, highlighting the independent responsibility of the physician-researcher to protect the agent-relative welfare interests of the patient-subject. In a novel interpretation of the duty of care, we argue for a “clinical judgment principle” which requires the physician-researcher to exercise judgment in the interests of the patient-subject taking into account evidence on treatments and the patient-subject‘s circumstances. (shrink)

Scientific research and ethics -- Ethical theory and decision making -- Data acquisition and management -- Mentoring and professional relationship -- Collaboration in research -- Authorship -- Publication and peer review -- Misconduct in research -- Intellectual property -- Conflicts of interest and scientific objectivity -- The use of animals in research -- The use of human subjects in research -- The use of vulnerable subjects in research -- Genetics, cloning, and stem cell research -- International research.

We have recently reached a watershed in the research community’s consideration of the ethics of research. The way is now open for a more nuanced discussion than the one of the last decade in which attention to legal and quasi-legal procedures for handling misconduct dominated. The new discussion of ethical issues focused on trustworthiness takes us beyond consideration of conduct that is straightforwardly permitted, forbidden or required, to consideration of criteria for responsible behavior. This paper develops an overview of the (...) subject of trustworthiness among researchers. It illustrates and discusses various types of betrayal and defections in research conduct, and locates these in relation to many of the situations discussed elsewhere in this issue. (shrink)

In Playing Politics with Science, David B. Resnik explores the philosophical, political, and ethical issues related to the politicalization of science and ...

Background: The advent of AIDS brought about a group of patients unwilling to accept crucial aspects of the methodological standards for clinical research investigating Phase 1 drugs, surgeries or devices. Their arguments against placebo controls in trials, which depended-at the time-on the terminal status of patient volunteers led to a renewed discussion of the ethics of denying patients with catastrophic illnesses access to last-chance experimental drugs, surgeries or devices. Sources of data: Existing ethics and health policy literature on the topic (...) of access to experimental drugs. Areas of agreement: The positions of those arguing for or against free access to experimental drugs for terminally ill patients are irreconcilable. Areas of controversy: At stake are questions about the kinds of personal sacrifices society can reasonably expect patients in clinical trials to make to ensure statistically predictive results. These would benefit by necessity a much larger number of current and future patients-the conflict is about individual versus public interests. It is also about the question of whether or not the state can legitimately prevent patients with terminal illnesses from unfettered access to experimental drugs, surgeries or devices in order to motivate them to participate in clinical trials. We review the ethical arguments for and against the provision of access to Phase 1 agents for terminally ill patients. Growing points: Finding a compromise between providing free or no access to Phase 1 drugs for terminally ill patients. Areas timely for developing research: We ought to investigate means to increase access to experimental drugs for terminally ill patients without sacrificing necessary clinical trials' sounds scientific methods. (shrink)