IRB最新文献

Public access to clinical trial consent forms, beyond those individuals involved in reviewing, conducting, or participating in a trial, has been notoriously poor, resulting in missed opportunities for empirical analysis and improvement, among other benefits. However, recent changes to the Common Rule and policies governing ClinicalTrials.gov promise to make trial consent forms more accessible to the public, including prospective trial participants, other trialists and IRBs, and those seeking to study research consent. Analysis of publicly available consent forms can facilitate development of best practices, make the process of drafting consent forms more efficient, and provide insight into how well consent forms are satisfying their mission of protecting and promoting the autonomy of trial participants. Gaps in public access will remain even under the new policies, but we are on the cusp of an exciting new dataset that can contribute to addressing a perpetual challenge in research ethics: optimal informed consent.

The revised Common Rule contains several changes designed to reduce the time institutional review boards (IRBs) spend on overseeing low-risk studies, including an expansion of the categories of research that are exempt from the regulations and a list of specific activities that do not satisfy the regulatory definition of "research." While these changes go a long way toward the goal of reducing unnecessarily regulatory burden, they leave several important questions about IRB jurisdiction unresolved.  The most significant omission is the failure to address when IRB review is necessary for quality assurance activities.  In addition, the revised Common Rule's distinction between "research" and "public health surveillance" may prove to be unworkable as applied to some types of public health activities.  Many of these interpretive questions stem from the inherent ambiguities in the regulatory definition of research, which turns on whether an activity is "designed to develop or contribute to generalizable knowledge." Because the revised Common Rule does not alter this basic definition, difficult questions about the circumstances in which IRB review is required are likely to remain.

On January 19, 2017, the Office for Human Research Protections, released an updated "Common Rule" that was the product of a six-year administrative odyssey to modernize and improve the regulations that had been in place for more than thirty years.  Although the impulse to update the regulatory landscape for human research is laudable, some of the changes proposed appear reactive and focused on making misconduct more difficult, rather than facilitating important science with reasonable safeguards. Instead of making research more difficult for all scientists across the board, a more sensible approach would involve better education of the public about the ways their specimens and data may be used to advance important scientific discoveries coupled with a legitimate method for holding bad actors accountable for deliberate violations of the rules. Regardless of what happens with the Common Rule, we need a reframing of research as a social good that requires reasonable oversight, not reactive rule making.

Since 1998, the National Cancer Institute (NCI) has mandated that researchers use its consent form template in developing consent forms for their NCI-funded clinical trials. The template was substantially revised in 2013 to aid in the development of simpler, more concise consent forms. The NCI conducted a randomized controlled trial with cancer survivors (N = 153) to assess the revised template's effect on individuals' knowledge, satisfaction, clarity, and likelihood of joining a trial in the future. We found that the revised template resulted in equally high knowledge and satisfaction scores as the original template, but with fewer words and pages. The likelihood that an individual would participate in a trial diminished after he or she reviewed either the original or revised consent form, yet having knowledge about trials before reviewing the consent forms resulted in increased satisfaction. To ensure an informed decision-making process, we recommend using the revised NCI consent form template along with using educational interventions aimed at increasing the understanding potential participants have of a trial before they receive a consent form.

This study entailed conducting extensive qualitative interviews of mothers who had been invited to have their infants participate in the Kilimanjaro Intermittent Preventive Treatment of Malaria in Infants (Kili IPTi) trial, designed to assess the efficacy of intermittent preventive malaria chemoprophylaxis for infants. Our study sought to explore whether there was a relationship between the mothers' understanding of the research and the decision to enroll their infants or to decline. Such empirical data is necessary to address widely voiced concerns that limited understanding of research or exploitive inducement may undermine informed consent among clinical trial recruits in developing countries. The most striking result of the study was that, in general, those who declined to have their children participate in the trial had a better understanding of the trial than those who agreed to have their children participate. Decliners were more likely to understand the experimental nature of the trial and were less likely to confuse research with treatment, the conceptual error often labeled "therapeutic misconception." Notably, in the context of the Kili IPTi trial, perception of clinical benefit may have been an accurate perception rather than therapeutic misconception because ancillary clinical benefits were provided to research participants. Neither participants nor decliners cited "altruistic" reasons for their decisions, despite presumptions among some scholars that such reasons are ethically the most appropriate motivations for participation in clinical research.

Understanding how patients decide whether to enroll in research can help improve educational materials, protocols, and recruitment rates. However, little is known about patients' willingness to participate in research on medical practices (ROMP), or studies comparing interventions within usual care. We assessed willingness to consider participating in ROMP by surveying 1095 adults in the United States, of whom 834 answered at least one open-ended question about their reasons for being willing or unwilling to consider participating in two scenarios involving ROMP. Most respondents were willing to consider participating in the research scenarios. The most commonly cited reasons for being willing to consider participating included benefit to others and oneself; the top reasons for being unwilling to consider participating included belief that the research was unsafe and an unfavorable view of experimentation. Responses also revealed misconceptions about ROMP among both those who were willing and unwilling to consider participating. Because these misconceptions may present an obstacle to recruiting participants in ROMP, there may be a need for educational initiatives to clarify the nature of these types of studies.