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.


The 50th Anniversary of the Declaration of Helsinki: Progress but Many Remaining Challenges

Joseph Millum, David Wendler, Ezekiel J. Emanuel

JAMA. Published online October 19, 2013.

Since 1964, through 7 revisions, the World Medical Association’s (WMA’s) Declaration of Helsinki has stood as an important statement regarding the ethical principles guiding medical research with human participants. The declaration is consulted by ethics review committees, funders, researchers, and research participants; has been incorporated into national legislation; and is routinely invoked to ascertain the ethical appropriateness of clinical trials.

There is much to praise about the revision process and the latest revision, which coincides with the declaration’s 50th anniversary. The Working Group extensively consulted stakeholders and justified the proposed revisions. The result is a declaration that is better organized into clear sections, more precise, and likely to be more effective at protecting research participants.

Research participation by low-income and racial/ethnic minority groups: how payment may change the balance

Jennifer K. Walter with James F. Burke, Matthew M. Davis 

Minorities are underenrolled in clinical research trials, and one-third of trials are underenrolled overall. The role of payment has not been studied at the national level as an explanation for enrollment patterns. Our objective was to examine the distribution of self-reported previous research participation across different sociodemographic groups; to assess the public's perception of fair payment for a low-risk medicine trial and the association between requested payment and sociodemographic characteristics; to estimate the amount of payment for a medication trial to achieve proportional representation of minorities and different socioeconomic groups. This was a cross-sectional study with nationally representative data collected in 2011 by the C.S. Mott Children's Hospital National Poll on Children's Health. To determine the relationship between perceived fair payment and individual-level characteristics, we used multivariable linear regression. With 60% participation rate, in a sample of 2,150 respondents 11% (n = 221) of the sample had previously participated in medical research. Requested payment differed significantly by racial/ethnic group with Hispanics requesting more payment than non-Hispanic whites (0.37 [95%CI 0.02, 0.72]) In contrast to payment at $49, $149, and $249, payment at $349 yielded proportional representation of racial/ethnic minority groups. Hispanics requested higher payment for research participation, suggesting a possible explanation for their underenrollment.

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.