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Élodie Hérault, Gina Bravo, Lise Trottier
Surrogates' decisions and advance directives currently offer the best opportunities for people to participate in research at times of decisional incapacity. We investigated which of these options better reflects an older adult's willingness to engage in research should he or she be solicited to enroll in a study after losing the capacity to consent. Data were drawn from a recently completed trial in which older adults were invited to record their research advance directives in a booklet designed for that purpose...
September 2018: IRB
Sarah R Lieber, Thomas D Schiano, Rosamond Rhodes
Given the numerous questions related to patient selection, surgical technique, and posttransplant care requiring evidence-based answers, transplantation programs should be conducting research with patients waiting to receive an organ and those who have undergone organ transplantation. Yet, there continues to be a dearth of human subjects research in the field of transplantation medicine. Here, we discuss challenges that may deter transplantation programs from engaging in transplant-related research. Taking liver transplantation as our illustrative example, we explain the vulnerabilities of patients with end-stage organ failure and the complex ethical issues of decisional capacity, coercion, and the timing of study enrollment...
September 2018: IRB
Bryan A Sisk, Eric Kodish
Appropriate enrollment in early-phase clinical trials demands that potential research participants understand and appreciate critical study-related information, because discrepancies in understanding or appreciation can potentially invalidate informed consent to participate in research. Four terms were previously developed to categorize these discrepancies: therapeutic "misconception," "therapeutic misestimation," "therapeutic optimism," and "unrealistic optimism." In this article, we propose a continuous framework of therapeutic misperceptions, rather than discrete categorical concepts...
July 2018: IRB
Brandon Brown, Jerome T Galea, Karine Dubé, Peter Davidson, Kaveh Khoshnood, Lisa Holtzman, Logan Marg, Jeff Taylor
Providing incentives is an accepted and common practice in human subjects research, including clinical HIV research. While we know that financial incentives among similar studies can greatly vary, surprisingly little research exists on how to determine when such incentives are excessive or constitute an "undue inducement." Multiple factors, such as risks and benefits, study procedures, study budget, historical precedent, recommendations from institutional review boards, advice from other investigators, and local regulations may influence decisions about appropriate incentives, but little empirical data exist about what incentives are offered to potential research participants...
July 2018: IRB
Minisha Lohani, Kristopher A Hendershot, Wendy Pelletier, Kristin Stegenga, Margie Dixon, Pamela S Hinds, Melissa A Alderfer, Rebecca D Pentz
Previous research has focused on the risks of research participation but has rarely considered possible benefits. For a study of family decision-making during pediatric bone marrow transplant, we conducted qualitative interviews with 132 family members across 36 families up to three times over the course of a year, before and after transplant. We concluded the study with qualitative interviews of 70 family members from 21 of the original families one year after the transplants, focusing on benefits and concerns regarding their research participation...
July 2018: IRB
Emily A Largent, Joel S Weissman, Avni Gupta, Melissa Abraham, Ronen Rozenblum, Holly Fernandez Lynch, I Glenn Cohen
No abstract text is available yet for this article.
January 2018: IRB
Donna L Snyder, Robert M Nelson
No abstract text is available yet for this article.
January 2018: IRB
Barbara E Bierer
The revised Common Rule, published in January 2017, was the result of an arduous and lengthy process and of missed opportunities to rebalance foundational ethical principles and thereby to invigorate engagement in clinical research. The revision's shortcomings include a failure to substantively amend the definition of research even though generalizable knowledge is not the appropriate criterion by which to distinguish research from clinical care. The revised Common Rule does little to advance the oversight and governance of the continuum between research and clinical care, in which a central question is the balance between research in the service of public health and individual autonomy and privacy...
November 2017: IRB
Carl H Coleman
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...
November 2017: IRB
Karen J Maschke
For this theme issue, "Reflections on the Revised Common Rule," we invited leading experts and scholars in research ethics to identify and comment on some of the important changes that the U.S. Department of Health and Human Services made to the Common Rule in a final regulation the agency released in January 2017. The authors draw on their experience as institutional leaders, members of national research ethics advisory bodies and institutional review boards, and scholars with deep knowledge of the ethical issues that human biomedical and behavioral research raises...
November 2017: IRB
Holly Fernandez Lynch, Emily A Largent, Deborah A Zarin
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 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...
November 2017: IRB
Suzanne M Rivera
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...
September 2017: IRB
Rose Mwangi, Paul Ndebele, Ann Mongoven
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...
September 2017: IRB
Holly A Masset, Michelle Hiser, Nancy L Atkinson, Christine Brittle, Robert Bailey, Jeanne Adler, Grace E Mishkin, Andrea M Denicoff, Nancy Roach, Marjorie Good, Danielle Burgess, Lorna Patrick, Margaret Mooney, Jeffrey S Abrams
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...
September 2017: IRB
Stephanie A Kraft, Kathryn M Porter, Diane M Korngiebel, Cyan James, Melissa Constantine, Maureen Kelley, Alexander M Capron, Douglas Diekema, Sandra Soo-Jin Lee, Mildred K Cho, David Magnus, Benjamin S Wilfond
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...
July 2017: IRB
Kyle A McGregor, Devon J Hensel, Amy C Waltz, Elizabeth Molnar, Mary A Ott
No abstract text is available yet for this article.
July 2017: IRB
Emily A Largent, Holly Fernandez Lynch
No abstract text is available yet for this article.
July 2017: IRB
Amy Corneli, Jeremy Sugarman
No abstract text is available yet for this article.
March 2017: IRB
Marilyn C Morris, Susan L Rosenthal
No abstract text is available yet for this article.
March 2017: IRB
Carl Elliott
No abstract text is available yet for this article.
March 2017: IRB
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