Publication Highlights
Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary
Edited by Ezekiel J. Emanuel, Robert A. Crouch, John D. Arras, Jonathan D. Moreno, & Christine Grady. The Johns Hopkins University Press, 2003.
What Makes Clinical Research Ethical?
Since obtaining informed consent does not ensure ethical research, it is imperative to have a systematic and coherent framework for evaluating clinical studies that incorporates all relevant ethical considerations. Ezekiel Emanuel, David Wendler (NIH), and Christine Grady (NIH) delineated 7 requirements that provide such a framework by synthesizing traditional codes, declarations, and relevant literature on the ethics of research with human subjects. This framework should help guide the ethical development and evaluation of clinical studies by investigators, IRB members, funders, and others. [JAMA. 2000;283(20):2701-2711]
A Consent Form Template for Phase I Oncology Trials
We reviewed 272 phase I oncology trial consent forms and then created an improved informed consent template in both English and Spanish by redesigning and rewording the consent form to be specific to phase I trials, to avoid repetition, and to use simplified language, identifiable sections framed by first-person questions, and tables to present information. The resulting consent form template is shorter than average and considerably easier to read (the Flesch-Kincaid Reading Ease score for the English version was 68.3 vs. 52.6 for the average consent form, and the Spanish translation had a Fernandez-Huerta reading ease score of 64). The template also meets the recommended eighth-grade maximum reading level for consent forms. Use of this template should help improve the informed consent process. [Koyfman, McCabe, Emanuel, Grady. IRB: Ethics & Human Research 31, no. 4 (2009): 1-8.]
Toward a Framework for Policy Analysis of Microbiome Research
Pamela Sankar directs this NIH-Common Fund project. Its goal is to devise a new approach to integrating consideration of ELSI issues into ongoing scientific research. Working with researchers funded through the Human Microbiome Project, the research seeks to examine how researchers understand the influence of social values on their work and to devise ways to enhance their ability to reflect critically on how normative assumptions shape research design and research practice.
IRB Forum
Jon Merz moderates IRB Forum, a website that promotes the discussion of ethical, regulatory and policy concerns with human subjects research. The IRB Forum strives to create an atmosphere for open and respectful conversation about issues of mutual interest to the members. The IRB Forum is open to past and current members of Institutional Review Boards (IRB) or Research Ethics Committees (REC) , IRB/REC administrators, individuals involved in IRB/REC oversight, and others with professional involvement in IRB/REC and/or research activities. Others will be admitted if their involvement in human subjects research will contribute to the discussion of issues pertinent to The IRB Forum. International participants are welcome.
Race & Genetics Research
Race and ethnicity have become increasingly prominent variables in genetic research despite the claim by the Human Genome Project that its results prove that there is no genetic basis for race. This NIH-NHGRI funded project, directed by Pamela Sankar, examines this contradiction through an analysis of scientific literature that uses race or ethnicity as a variable and through interviews with scientists conducting this research.
