Readability and Understanding of Informed Consent Among Participants With Low Incomes: A Preliminary Report.

With passage and implementation of the Affordable Health Care Act, more vulnerable segments of the U.S. population will now have access to regular health care and increased opportunities to participate in biomedical research. Yet, access to new groups brings with it new responsibilities for investigators, most importantly, reducing burdens for participants. Data collected through this small pilot study suggest several preliminary but potentially important findings when working with adults from low-income populations: First, while all participants read some parts of the consent forms (55%), only a minority reported reading the entire form (45%); second, 73% of participants reported understanding the study very well whereas only 27% reported understanding the study "a little"; third, there was a slight reported advantage of the simplified form over the regular form; however, this difference varied by section. Relatedly, other research has shown a high incidence of persons reading none of the consent form, but signing a statement that they have read and understood the study. Why does this occur? What are we teaching people when we request that they sign a consent form they have chosen not to read? What are the ethical and regulatory implications? Embedded ethics studies such as this one, although pilot and preliminary in nature, offer a number of advantages, such as stimulating additional scientific inquiry as well as challenging established institutional practices.

Witnesses to research wrongdoing.

Research wrongdoing undermines scientific integrity, occurs widely, and takes many forms. We interviewed 135 NIH principal investigators who reported witnessing and responding to research wrongdoing. They reported taking a variety of actions, including formal notification of institutional officials, peer shaming, and one-on-one discussions with their peers to address wrongdoing that ranged from improper attribution of authorship to falsification, fabrication, and plagiarism. Unexpectedly, administrative mismanagement in handling allegations appeared more prevalent than any of the other forms of wrongdoing reported. Institutions may lack effective or efficient processes for managing even the most egregious cases of research wrongdoing. To assist institutions in designing effective, nimble programs, we suggest resources from which institutional officials may draw.

Ethical issues in mental health research: the case for community engagement.

PURPOSE OF REVIEW: To describe community-engaged research (CEnR) and how it may improve the quality of a research study while addressing ethical concerns that communities may have with mental health and substance abuse research. This article includes a review of the literature as well as recommendations from an expert panel convened with funding from the US National Institute of Mental Health. RECENT FINDINGS: CEnR represents a broad spectrum of practices, including representation on institutional ethics committees, attitude research with individuals from the study population, engaging community advisory boards, forming research partnerships with community organizations, and including community members as co-investigators. SUMMARY: CEnR poses some challenges; for example, it requires funding and training for researchers and community members. However, it offers many benefits to researchers and communities, and some form of CEnR is appropriate and feasible in nearly every study involving human participants.

Evidence-Based Ethical Problem Solving (EBEPS).

Although there is usually agreement about the ethical principles that should govern human research, there may be little agreement on how those principles should be interpreted into research procedures in some instances. Empirical research on ethical issues can often elucidate ways to improve on existing research practices and resolve debates with one's institutional review board.

What is the Value of a Timely Empirical Question?

ETHICAL ANALYSIS IN THE HUMAN research enterprise often proceeds on the assumption that conceptual ethical analysis alone will suffice. Investigators, ethics committees and others usually agree on the relevant ethical principles, but may argue about what action should follow from those principles. Typically, the debate does not lead to the formulation of empirical questions that could result in elucidation of the problem and, perhaps, yield a solution agreeable to all. Without common ground for resolving these differences with an evidence-based solution, a discouraged investigator and a compromised research method may be the outcome. JERHRE has sought to remedy this situation through publication of empirical solutions, research agendas, editorials calling for various courses of empirical research, and through the first of many conferences seeking to promote evidence-based ethical problem solving. This special issue of JERHRE is devoted, in part, to the results of that first conference.

Introduction: data sharing and disclosure limitation techniques.

THIS SPECIAL SECTION OF JERHRE is in response to the needs of institutions to develop advanced data sharing capabilities. On October 1, 2003, the National Institutes of Health (NIH) initiated a requirement that investigator-initiated proposals for grants with direct costs over $500,000 in any year incorporate plans to accommodate sharing research data. The requirement stipulates that such plans describe the procedures through which shared data would be rendered "free of identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects." (http://grants2.nih.gov/grants/policy/data_sharing). We expect that many researchers who deal with human research data are unfamiliar with the procedures presented in the ensuing articles. These sophisticated procedures have been developed to help protect confidentiality of subjects' data in files that are shared, while simultaneously preserving the analytic value of data for secondary users. Among these are procedures developed by government statisticians that include innovative methods to prevent deductive disclosure of identities. More recently, academic researchers and data experts have adapted or extended these methods. Together, these methods aim to achieve both disclosure limitation and retention of key analytic usefulness of the shared data.

The evolution of best ethical practices in human research.

Ideally, best practices in human research would evolve quickly in the wake of new ethical challenges, but in reality such challenges sometimes evoke Procrustean new oversight requirements that benefit neither human subjects nor science. The rapid advance of new topics, methods and ethical challenges in human research inevitably raises questions about the appropriateness of time-honored research practices, and about the most intelligent application of ethical principles to these new contexts. Such questions typically call for an insightful and nuanced understanding of the new context, rather than debate based on older conceptions. JERHRE serves as a forum to promote and publish meritorious empirical research on ethical issues, designed to enable us to learn from these challenges, and thereby hasten the evolution of best ethical practices in human research.