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.