Medicine and Medical Science in the Age of Bioethics
Grant Number: 1G13LM008781-01A2
Researchers(s): Raymond DeVries
Abstract: Four decades ago the profession of bioethics did not exist. Today, bioethics is a part of the landscape of the life sciences: ethics committees are now mandatory in American hospitals; all federally funded research that involves human beings or animals must be reviewed by a board constituted to protect the subjects of research; a plethora of seminars offer training in bioethics for those who need, or wish, to offer ethical advice; bioethics courses are now a regular part of the curriculum at universities, colleges and medical schools. Given the growing importance of bioethics for the practice of medicine and medical research, it is imperative that those who provide, and those who use, medical services have a clear picture of how this new profession is influencing the art and science of healing...
Democratic Deliberation and Surrogate Consent for Dementia Research
Funding: R01-AG029550 and The Greenwall Foundation
Researcher(s): Scott Kim, Raymond DeVries, P.S. Appelbaum, D. Knopman, Laura Damschroder, Aimee Stanczyk, Ian Wall
Abstract: Enrolling adults with decisional incapacity in dementia research based on surrogate permission (surrogate-based research, or SBR) lacks widely accepted policy guidelines, despite decades of controversy. This project assesses the views of caregivers and the general public regarding SBR. It uses an innovate method called democratic deliberation to obtain the educated, deliberative opinions regarding the appropriateness and limits of SBR. The results will inform the work of research ethics policymakers, policy-implementers (such as IRBs), researchers in their recruitment of incapacitated subjects, and family members who may act as surrogates for research consent.
Therapeutic Misconception and Neurosurgical Trials with Sham Controls
Funding: R01-NS062770 and The Michael J. Fox Foundation for Parkinson's Research
Researcher(s): Scott Kim, Raymond DeVries, K. Kieburtz, R. Wilson, S. Frank, H.M. Kim
Abstract: Ethicists have raised concerns that elderly patients with a progressively debilitating disease such as Parkinson’s disease (PD) may be too vulnerable for research that involves novel, invasive interventions (such as gene transfer and cell transplants) that use a controversial masking design, i.e., sham neurosurgical controls. Are these subjects laboring under a therapeutic misconception (TM), a phenomenon in which subjects erroneously believe that research, rather than being an experimental procedure for the sake of creating knowledge to help future patients, is actually a novel form of treatment intended to help them? This project will study enrollees and decliners of four actual PD neurosurgical clinical trials that involve a sham surgery control. A semi-structured interview method (Conditional Probe Interview) has been developed to provide an in depth account of the subjects’ motivations, expectations, understanding, and decision-making process. This project will provide insights for optimizing informed consent practices for future sham surgery controlled trials and clarify the key controversial aspects, and the complex contours of, TM and related phenomena.
Institutional Review Board (IRB) Reform
Researcher(s): Scott Kim, Peter Ubel, Raymond DeVries
Abstract: Although everyone agrees that IRB oversight of human subjects research is necessary and important, many suggestions have been made to improve the system. We are exploring the idea that the current system may be devoting inordinate amount of resources (well over 50%) to closely oversee research protocols with little potential for harm, resulting in a very low benefit to cost ratio. We are proposing alternative models to correct this, thereby shifting needed resources to better regulate more problematic research protocols.