Clinical research is increasingly conducted in settings that include private physicians’ offices, clinics, community hospitals, local institutes, and independent research centers. The migration of such research into this new, non–academic environment has brought new cadres of researchers into the clinical research enterprise and also broadened the pool of potential research participants. Regulatory approaches for protecting human subjects who participate in research have also evolved. Some institutions retain their own Institutional Review Boards (IRBs), but Independent IRBs, community hospital IRBs and community–based (...) IRBs also fulfill oversight responsibilities. This article sheds light on this evolving world by discussing the findings gleaned from two studies: a study of the decision making processes used by members who serve on different kinds of IRBs and a study of the decision making processes employed by research participants. The article then discusses how the key findings may inform proposed revisions to the Common Rule. (shrink)

There is a good deal of biomedical research that does not produce scientifically useful data because it fails to recruit a sufficient number of subjects. This fact is typically not disclosed to prospective subjects. In general, the guidance about consent concerns the information required to make intelligent self-interested decisions and ignores some of the information required for intelligent altruistic decisions. Bioethics has worried about the ‘therapeutic misconception’, but has ignored the ‘completion misconception’. This article argues that, other things being equal, (...) prospective subjects should be informed about the possibility of non-completion as part of the standard consent process if it is or should be anticipatable that there is a non-trivial possibility of non-completion and that information is likely to be relevant to a prospective subject's decision to consent. The article then considers several objections to the argument, including the objection that disclosing non-completion information would make recruitment even more difficult. (shrink)

Background Ethically, informed consent regarding randomised controlled trials (RCTs) should be understandable to patients. The patients can then give free consent or decline to participate in a RCT. Little is known about what patients really understand in consultations about RCTs. Methods Cancer patients who were asked to participate in a randomised trial were surveyed using a semi-standardised interview developed by the authors. The interview addresses understanding, satisfaction and needs of the patients. The sample included eight patients who participated in a (...) trial and two who declined. The data were analysed on the basis of Mayring's qualitative analysis. Results Patients' understanding of informed consent was less developed than anticipated, especially concerning key elements such as randomisation, content and procedure of RCTs. Analysing the result about satisfaction of the patients, most of the patients described their consultations as hectic and without advance notice. Health limitations due to cancer played a decisive role. However, most of the patients perceived their physician to be sympathetic. Analysing the needs of patients, they ask for a clear informed consent consultation with enough time and adequate advance notice. Conclusion This study fills an important empirical research gap of what is ethically demanded in an RCT consultation and what is really understood by patients. The qualitative approach enabled us to obtain new results about cancer patients' understanding of informed consent, to clarify patients' needs and to develop new ideas to optimise the informed consent. (shrink)

Scientists in earlier times considered personal research participation an essential component of their work. Exposing themselves to untested interventions was seen as the most ethical way to gauge the human response to those interventions. The practice was also educational, for it generated useful information that helped researchers plan subsequent human studies. Self-experimentation was eventually replaced by more comprehensive ethical codes governing human research. But it is time to bring back the practice of self-experimentation, albeit in modified form. Through serving as (...) a study subject, investigators and other research professionals can obtain valuable information about their work. (shrink)

Laura Odwazny and Benjamin Berkman have raised several challenges regarding the new reasonable person standard in the revised Common Rule, which states that in‐ formed consent requires potential research subjects be provided with information a reasonable person would want to know to make an informed decision on whether to participate in a study. Our aim is to offer a response to the challenges Odwazny and Berkman raise, which include the need for a reasonable person standard that can be applied consistently (...) across institutional review boards and that does not stigmatize marginal groups. In response, we argue that the standard ought to be based in an ordinary rather than ideal person conception of reasonable person and that the standard ought to employ what we call a liberal constraint: the reasonability standard must be malleable enough such that a wide variety of individuals with different, unique value systems would endorse it. We conclude by suggesting some of the likely consequences our view would have, if adopted. (shrink)