Consortium to Examine Clinical Research Ethics (CECRE) - this project was funded by the Doris Duke Charitable Foundation and investigated human subjects research protections and IRB review. CECRE analyzed the concept of “vulnerability” in HSR protections (Pubmed) and proposed a targeted form of research protocol review (full-text), identified problems in the oversight of human participant research and made recommendations for reform (full-text), and examined the costs of IRB review (full-text). Consortium members included Jeremy Sugarman and Ruth Faden.
Recent Publications Kass, N. Early phase clinical trials: Communicating the uncertainties of ‘magnitude of benefit’ and ‘likelihood of benefit’. Commentary, Clin Trials 2008; 5: 627-629.
Henderson GE, Churchill LR, Davis AM, Easter MM, Grady C, Joffe S, Kass N, King N, Lidz CW, Miller FG, Nelson DK, Peppercorn J, Rothschild BB, Sankar P, Wilfond BS, Zimmer CR. Clinical trials and medical care: Defining the therapeutic misconception. PLoS Medicine 2007; 4: e324 doi:10.1371/journal.pmed.0040324.
Taylor H, Sugarman J, Pisetsky D, Bathon J. Formative research in clinical trial development: Attitudes of patients with arthritis in enhancing prevention trials. Ann Rheum Dis 2007; 66: 542-4. Taylor H, Johnson S. Ethics of population based research. J Law Med Ethics, 2007; 35: 295-99. Taylor H. Implementation of NIH inclusion guidelines: Survey of NIH study section members. Clin Trials 2008; 5: 140-6.
Abdoler E, Taylor H, Wendler D. The ethics of Phase 0 oncology trials. Clin Cancer Res 2008; 14: 3692-7.
Older…
Pentz RD, Flamm AL, Sugarman J, Cohen MZ, Xu Z, Herbst RS, Abbruzzese JL. Who should go first in trials with scarce agents? The views of potential participants. IRB 2007; 29; 1-6.
Tilburt J, Ford JG, Howerton MW, Gary TL, Lai GY, Bolen S, Baffi C, Wilson RF, Tanpitukpongse TP, Powe NR, Bass EB, Sugarman J. Applying justice in clinical trials for diverse populations. ClinTrials 2007; 4: 264-269.
Speckman JL, Byrne MM, Gerson J, Getz K, Wangsmo G, Muse CT, Sugarman J for the Consortium to Examine Clinical Research Ethics. Determining the costs of institutional review boards. IRB; March-April 2007; 7-13.
Simon AE, Wu AW, Lavori PW, Sugarman J. Preventive misconception: its nature, presence, and ethical implications for research. Am J Prevent Med 2007; 32:370-374.
DeBruin DA, Scholder SL, Kahn J, Mastroianni AC, Marshall MF, Lantos J, Sugarman J. Educational approaches to the responsible conduct of clinical research: an exploratory study. AcademMed 2007; 82: 32-39.
Merritt M, Moral Conflict in Clinical Trials, Ethics 2005; 115:306-330
Levine C, Faden R, Grady C, Hammerschmidt D, Eckenwiler L, Sugarman J, on behalf of the Consortium to Examine Clinical Research Ethics. “Special Scrutiny”: A targeted form of research protocol review. Ann Intern Med 2004; 140: 220-223.
Sugarman J. Using empirical data to inform the ethical evaluation of placebo controlled trials. SciEngineer Ethics 2004; 10: 29-35.
DeCamp M, Sugarman J. Ethics in population-based genetic research. Accountability in Research 2004; 11: 1-26.
DeCamp M, Sugarman J. Ethics in behavioral genetics research. Accountability in Research 2004; 11: 27-47
