Objectives To determine whether parachutes are effective in preventing major trauma related to gravitational challenge. Design Systematic review of randomised controlled trials. Data sources: Medline, Web of Science, Embase, and the Cochrane Library databases; appropriate internet sites and citation lists. Study selection: Studies showing the effects of using a parachute during free fall. Main outcome measure Death or major trauma, defined as an injury severity score > 15. Results We were unable to identify any randomised controlled trials of parachute intervention. (...) Conclusions As with many interventions intended to prevent ill health, the effectiveness of parachutes has not been subjected to rigorous evaluation by using randomised controlled trials. Advocates of evidence based medicine have criticised the adoption of interventions evaluated by using only observational data. We think that everyone might benefit if the most radical protagonists of evidence based medicine organised and participated in a double blind, randomised, placebo controlled, crossover trial of the parachute. (shrink)

Classifying research proposals by risk of harm is fundamental to the approval process and the most pivotal risk category in most regulations is that of “minimal risk.” If studies have no more than a minimal risk, for example, a nearly worldwide consensus exists that review boards may sometimes: (1) expedite review, (2) waive or modify some or all elements of informed consent, or (3) enroll vulnerable subjects including healthy children, incapacitated persons and prisoners even if studies do not hold out (...) direct benefits to them. The moral and social purposes behind this threshold are discussed along with relevant views from the National Commission, NBAC, NHRPAC, Grimes v. Kennedy Krieger Institute, The Nuremberg Code, and The WMA's Declaration of Helsinki. Representative policies from Australia, Canada, South Africa, the U.S., and CIOMS are reviewed revealing different understandings of this sorting threshold. Six of nine frequently cited interpretations of “minimal risk” are untenable. The “absolute” interpretation of the “routine examination” standard is defended as best. (shrink)

Researchers have frequently complained that the NHS ethical review system stifles good research. At last measures are being put in place to address this criticism, but will they undermine the protection of research participants? The Declaration of Helsinki recognizes that medicine will not progress without good quality research, but also demands that the well-being of research participants takes precedence over the interests of science and society. This article examines the implications of the ongoing reform of the NHS research ethics review (...) system for researchers, ethics committees and research participants. (shrink)

Concepts that refer to trends like globalization and medicalization have, of late, become a hallmark of public debates. The logic of such concepts is that the same word can refer both to good and bad developments, partly depending on the chosen viewpoint. Hardly anyone opposes the global enforcement of human rights, but the global liberation of trade is sometimes viewed with suspicion. In a similar vein, advances in medicine are seldom seen as a bad thing, but medical solutions to social (...) issues can be seen as problematic. (shrink)