Improving ethical review of research involving incentives for health promotion.

Alex London and colleagues propose new ethical frameworks for evaluating the risks associated with research in which financial or other incentives are used to promote healthy behavior.

Informed consent: an international researchers' perspective.

We reported 164 researchers' recommendations for information that should be included in the informed consent process. These recommendations were obtained during training workshops conducted in Africa, Europe, and the United States. The 8 elements of informed consent of the US Code of Federal Regulations were used to identify 95 items of information ("points"), most related to benefits and research description. Limited consensus was found among the 3 workshops: of the 95 points, only 27 (28%) were identified as useful by all groups. These points serve as a springboard for identifying information applicable in different geographic areas and indicate the need for involving a variety of individuals and stakeholders, with different research and cultural perspectives, in the development of informed consent, particularly for research undertaken in international settings.

Challenges in the Ethical Review of Research Involving Complementary and Integrative Medicine.

Complementary and integrative medicine (CIM) involves using practices outside mainstream Western medicine, often derived from Eastern traditional medicine, and combining those practices with Western medicine. Conducting CIM research that is necessary to determine whether particular interventions are beneficial and safe will involve a set of ethical challenges. Institutional review boards (IRBs), also known as research ethics committees or research ethics boards, are responsible for determining that research studies involving human subjects appropriately address ethical and regulatory concerns inherent to the research. Like other research with human subjects, research involving CIM is subject to ethical review and ongoing oversight by an IRB. IRBs are often challenged by the review of CIM. These challenges include accounting for cultural differences and the interests of competing stakeholders. In this report, we describe these issues that were the focus of a workshop that was part of an international conference held in Seoul, Korea, on April 4, 2015.

Parent ratings of ability to consent for clinical trials in fragile X syndrome.

Advances in understanding neurobiology and intellectual disabilities have led to clinical trials testing new medications. This study assessed parents' perceptions of the ability of their son or daughter with fragile X syndrome (FXS), an inherited form of intellectual disability, to participate in the consent process for clinical trials. Four hundred twenty-two families participated in a survey that included six items assessing various aspects of the ability to provide consent. A rank ordering of decisional tasks was found. The easiest task was to understand that the medication was different from his or her medical treatment; the most difficult was the ability to understand and weigh the potential benefits and risks of study participation. Factor analysis suggested that despite the range in difficulty, the six items were best summarized by a single decisional ability score. Parents of 29% of males reported that their son was not at all capable of participating, but the remainder exhibited a range of decisional skills. Factors associated with this variability include age and parents' willingness to enroll their child in clinical trials. We conclude that many individuals with FXS appear to be able to participate at some level in the consent or assent process, but will likely need individualized support to maximize effective participation.

Many worlds, one ethic: design and development of a global research ethics training curriculum.

The demand for basic research ethics training has grown considerably in the past few years. Research and education organizations face the challenge of providing this training with limited resources and training tools available. To meet this need, Family Health International (FHI), a U.S.-based international research organization, recently developed a Research Ethics Training Curriculum (RETC). It was designed as a practical, user-friendly tool that provides basic, up-to-date, standardized training on the ethics of human research. The curriculum can easily be adapted to different audiences and training requirements. The RETC was reviewed by a group of international experts and field tested in five countries. It is available in English, French, and Spanish as a three-ring binder and CD-ROM, as well as on the Web. It may be used as either an interactive self-study program or for group training.