Adil E. Shamoo, Ph.D. Pengarang

1. Clarifying the concept of the “ Social” in risk assessments for human subjects research Sara R. Jordan, Ph.D.a and Phillip W. Gray, Ph.D.b aVirginia Polytechnic Institute and State University, Center for Public Administration and Policy, Blacksburg, Virginia, USA; bTexas A&M University at Qatar, Liberal Arts Program, Texas A&M Engineering Building, Doha, Qatar ABSTRACT International guidelines for the conduct of research with human participants, such as those put forth by the Council for International Organizations of Medical Sciences (CIOMS, 2002), recommend that research review committees account for social risk and benefits to society in their review of proposed research. What do the concepts of the “social” and “society” mean in the context of the review of human participants research? Here we analyze concepts of social and society to define the terms: social harm, social risk, social benefit, and benefits to society. We argue that use of these terms invite more questions than answers and beg for difficult empirical research to determine the nature, likelihood, and magnitude of this category of risk and benefit. Until more research is done and these questions are answered, we advise reviewers to adopt an attitude of provisionalism and caution in their review of specifically “social” risks and benefits and “benefits to society.” KEYWORDS Research risks; social science research; research benefits; social; society 2. Grave fraudulence in medical device research: a narrative review of the PIN seeding study for the Pinnacle hip system Joan E. Steffen, B.A.a, Ella A. Fassler, B.S.b, Kevin J. Reardon, M.A.a, and David S. Egilman, M.D., M.P.H.c aNever Again Consulting, Attleboro, Massachusetts, USA; bAgainst Method Consulting, Brooklyn, New York, USA; cDepartment of Family Medicine, Brown University Attleboro, Massachusetts, USA ABSTRACT In 2001, DePuy, a wholly-owned subsidiary of Johnson Johnson (J&J/DePuy), initiated a seeding study called the “Multi-center, Prospective, Clinical Evaluation of Pinnacle Acetabular Implants in Total Hip Arthroplasty” (PIN Study). J&J/DePuy designed this study to develop new business opportunities during the launch of their Pinnacle Hip System (PHS) and generate survivorship data for marketing. This article, the first review of a seeding trial for a medical device, examines internal company documents relating to the PIN Study; the analysis herein focuses on the integrity of J&J/ DePuy’s research practices in conception, implementation, and analysis. J&J/DePuy violated the study protocol and manipulated data; consented participants in violation of standards protecting human subjects; and did not secure Institutional Review Board approval for all study sites. J&J/ DePuy used PIN Study results as the “fundamental selling point” for the PHS. Medical device seeding trials are distinct from previously-documented pharmaceutical seeding trials because companies can profit directly from device sales and because these studies may be the first clinical evaluation of the device (as was the case for the PIN Study). Seeding trials are malleable marketing projects, not rigorous scientific studies. Regulatory bodies, physicians, and others should be vigilant for persuasive marketing accounts disguised as science. KEYWORDS DePuy; FDA; Johnson & Johnson; Pinnacle hip system; medical ethics; research ethics; seeding trial; total hip arthroplasty 3. The protection of unrepresented patients in emergency care research Linus Broström, Ph.D. and Mats Johansson, Ph.D. Department of Clinical Sciences, Lund, Lund University, Lund, Sweden ABSTRACT In emergency care research, it may be the case that neither informed consent nor surrogate consent is possible. In order to nonetheless allow for such research, codes and regulations of research ethics have increasingly incorporated provisions regarding this specific situation. The protection that those provisions offer need to be better understood. This article addresses in what ways they protect individuals, and especially the extent to which the suggested protection compensates for the loss of surrogate consent. The Declaration of Helsinki, the Additional Protocol to the Convention on Human Rights and Biomedicine, and the EU Clinical Trials Regulation serve as the main illustrations. KEYWORDS Emergency research; human subjects ethics; human subjects regulation and oversight; research ethics; vulnerable populations; informed consent; surrogate consent; proxy consent