The role and responsibilities of witnesses in the informed consent process

Various mechanisms to ensure the protection of subjects in human research have been suggested, including the presence of witnesses during the informed consent process. For our commentary on the use of witnesses and their potential role and responsibility during the consent process, we start by addressing current guidelines for human subjects research in four Latin American countries. By using examples from public health research, we highlight some of the practical difficulties of using witnessed consent, from becoming a meaningless ritual at one end of the spectrum to the research subject feeling intimidated or coerced to participate at the other. Apart from these practical difficulties, it is unclear what responsibility the witness could and should have. We argue that there are important ethical questions about the role of witnesses that have not been adequately addressed in national and international regulations. This work addresses these gaps and argues that more debate is required to define the role and responsibilities of witnesses in the consent process, their training requirements and whether a universal legal requirement for witnessed consent, regardless of the type of research, is desirable.     

Assessment of a decision aid to assist genetic testing research participants in the informed consent process

Limited attention has been given to applying decision-making theories from psychology to the content and process of informed consent in genetic testing research. Data are presented from a study that developed and assessed a psychological theory-based decision aid as part of the informed consent process. This innovative approach assisted at-risk women in assessing the consequences of participating in a research project that offered them free hemophilia A genetic carrier testing. Results suggest: (1) the decision aid can be incorporated into the consent process with few problems; (2) women of varying educational backgrounds can complete the decision aid; (3) while women consider many consequences of genetic testing, their primary focus is on the implications for their family; and (4) this is in marked contrast to the typical benefit-harm statements prepared by researchers for genetic testing.     

Altruistic surrogacy and informed consent

A crucial premise in many recent arguments against the moral permissibility of surrogate motherhood arrangements is the claim that a woman cannot autonomously consent to gestating and relinquishing a child to another couple, because she cannot be fully informed about what her future emotional responses will be to the foetus developing within her, and to the giving up of the newborn infant to its social parents. When conjoined with some moral principle about the justifiable limits on the ways others can be expected to exercise their autonomy on our behalf, this claim is often taken to establish that various forms of surrogate motherhood arrangements are morally wrong. In this paper I want to show that there is a serious non sequitur in this kind of argument. That is, I want to show that even if women cannot in fact have this kind of information about what their future emotional responses to pregnancy and relinquishment will be, nothing follows about the wrongness or otherwise of surrogacy. For, when we consider what counts as informed consent in the context of other important ventures with uncertain consequences, it becomes clear that informed consent does not require having this kind of information about one's future emotional states. In putting these arguments, I also hope to clarify some of the connections which might be thought to hold between informed consent and autonomous decision-making generally.     

DNA sampling and informed consent.

Standard consent forms for blood and tissue sampling are inadequate for DNA sampling. However, creating new and separate forms for each type of activity associated with DNA analysis (banking, linkage analysis and genetic diagnosis) tends to dissociate the participant from what is essentially a medical continuum. Furthermore, DNA sampling involves the sharing of samples and data among centres. To ensure patient control throughout this multifaceted process, we have developed an integrated approach to obtaining consent for DNA sampling at each level of participation. Movement from one level to another is reflected in the choices offered to participants. This inclusive approach is based on the underlying principle of informed consent, namely the respect for individuality, confidentiality and freedom of choice. This approach should help practitioners of medical genetics recognize the medical context of DNA sampling.     

Ethical issues in implementation research: a discussion of the problems in achieving informed consent

Background

Implementation of research into practice in health care systems is a challenging and often unsuccessful endeavor. The United States Department of Veterans Affairs (VA) Quality Enhancement Research Initiative (QUERI) research teams include formative evaluations (FE) in their action-oriented VA implementation projects to identify critical information about the processes of implementation that can guide adjustments to project activities, in order to better meet project goals. This article describes the development and use of FE in an action-oriented implementation research project.

Methods

This two-year action-oriented implementation research project was conducted at 23 VA Spinal Cord Injury (SCI) Centers, and targeted patients, staff and the system of care, such as administration and information technology. Data for FE were collected by electronic and paper surveys, semi-structured and open-ended interviews, notes during conference calls, and exchange of e-mail messages. Specific questions were developed for each intervention (designed to improve vaccination rates for influenza in veterans with spinal cord injury and disorder); informants were selected for their knowledge of interventions and their use in SCI Centers.

Results

Data from FE were compiled separately for each intervention to describe barriers to progress and guide adjustments to implementation activities. These data addressed the processes of implementing the interventions, problem-solving activities and the status of interventions at SCI Centers.

Conclusion

Formative evaluations provided the project team with a broad view of the processes of implementing multi-targeted interventions as well as the evolving status of the related best practice. Using FE was useful, although the challenges of conducting FE for non-field researchers should be addressed. Work is needed to develop methods for conducting FE across multiple sites, as well as acknowledging variations in local contexts that affect implementation of interventions.