Comment on "Multidimensional results reporting to participants in genomic studies: getting it right".

Bookman et al. write to correct the impression given in the Commentary by Kohane and Taylor that the recommendations of the National Heart, Lung, and Blood Institute (NHLBI) Working Group "Reporting Genetic Results in Research Studies" included advice to return genetic information to research subjects only in cases where there is a proven or preventative intervention for the identified disorder. In fact, the report does recommend that genetic information be returned to subjects when there is an intervention available, but it does not recommend against giving this kind of information to subjects if there is no available intervention.

The research imperative revisited: considerations for advancing the debate surrounding medical research as moral imperative.

Medical research is frequently regarded as not only laudable, but even obligatory. However, the moral foundation for such an obligation is far from clear. Lively debate concerning the viability of an obligation to conduct and support medical research is transpiring among a small number of scholars speaking from a variety of backgrounds, yet the current discussion is predominantly situated within several discrete academic and professional circles, allowing only sporadic engagement within and between scholarly disciplines and the medical realm.

Rethinking risk in pediatric research.

This article reviews four areas of pediatric research in which we have identified questionable levels of allowable risk, exceeding those foreseen by the Commission. They are the following: (1) the categorization of increasingly risky interventions as minimal risk in a variety of protocols; (2) the increasing number of applications for federal panel review of research not otherwise approvable because of higher projected risk levels; (3) research on asymptomatic at risk children; and (4) the inclusion of children and adolescents in placebo-controlled trials for participants of all ages without performing subgroup analysis. While embracing the imperative to include children in research is an encouraging step towards providing the pediatric population with effective medical care and finally eradicating the therapeutic orphan, we must ensure that this research does not become overly permissive.

Research Ethics Review and Aboriginal Community Values: Can the Two be Reconciled?

CONTEMPORARY RESEARCH ETHICS REVIEW COMMITTEES (RECs) are heavily influenced by the established academic or health care institutional frameworks in which they operate, sharing a cultural, methodological and ethical perspective on the conduct of research involving humans. The principle of autonomous choice carries great weight in what is a highly individualistic decision-making process in medical practice and research. This assumes that the best protection lies in the ability of patients or research participants to make competent, voluntary, informed choices, evaluating the risks and benefits from a personal perspective.

Reporting genetic results in research studies: summary and recommendations of an NHLBI working group.

Prospective epidemiologic studies aid in identifying genetic variants associated with diseases, health risks, and physiologic traits. These genetic variants may eventually be measured clinically for purposes of diagnosis, prognosis, and treatment. As evidence of the potential clinical value of such information accrues, research studies face growing pressure to report these results to study participants or their physicians, even before sufficient evidence is available to support widespread screening of asymptomatic persons.

Randomized controlled trials of aprotinin in cardiac surgery: could clinical equipoise have stopped the bleeding?

Background: Aprotinin is a serine protease inhibitor used to limit perioperative bleeding and reduce the need for donated blood transfusions during cardiac surgery. Randomized controlled trials of aprotinin evaluating its effect on the outcome of perioperative transfusion have been published since 1987, and systematic reviews were conducted in 1992 and 1997.

Methods: A systematic search was conducted for all RCTs of aprotinin that used placebo controls or were open-label with no active control treatment.

Learning from the experience of others: ethical issues surrounding the use of clinical data for teaching and other professional activities.

Effective education in medicine and other health sciences commonly relies on the use of clinical cases. This enables learners to advance their understanding of complex clinical problems. It also allows experienced clinicians to impart their knowledge of unusual problems or innovative approaches.

Turning a blind eye: the success of blinding reported in a random sample of randomised, placebo controlled trials.

Objective: To examine the reporting and success of double blinding in a sample of randomised, placebo controlled trials from leading general medicine and psychiatry journals.

Methods: Identification of placebo controlled, randomised controlled trials from prespecified general medical and psychiatric journals indexed on Medline between 1 January 1998 and 1 October 2001, from which a random sample of 200 randomised clinical trials was chosen, of which 191 trials were evaluated.

Results: Only seven of the 97 (7%) general medicine trials provided evidence on the success of blinding, with five reporting that the success of blinding was imperfect.

Science and society: children and incompetent adults in genetic research: consent and safeguards.

Recent changes to the legal and ethical criteria that govern the inclusion of children and incompetent adults in genetic research are likely to lead to advances in research, but might leave the rights of the participants in this research in need of additional safeguards. Here, we discuss why this might be and propose policy considerations that could help to protect the rights of these particularly vulnerable groups of research participants.

Ethical issues in neonatal intensive care: perspectives for the neurologist.

Intensive medical care for neonates may present medically complex and ethically challenging issues affecting not only patients but also their families and the professionals caring for them. The consulting neurologist working with these infants and their families is frequently a key figure in determining diagnoses and prognoses. This places the neurology specialist at the center of the process by which the treating team provides parents with appropriate information, collaborates with them in making medical and ethical decisions, and supports them through immeasurably difficult times.