The ethical requirements to respect the autonomy and values of individuals and protect them from serious risks are consistent with several approaches to consent for research on biological samples. For example, respect for autonomy does not determine whether people should provide one-time general consent or should specify which diseases may be studied using their samples. In this context, data on the views of individuals can help identify a best approach among the available options.
Current data provide consistent and strong evidence that people want to control whether their samples are used for research and that most are willing to contribute samples. The data also show that most people prefer one-time general consent, on the understanding that an ethics committee will review and approve future projects. These data provide compelling evidence that one-time general consent is the best option (see appendix 2 on bmj.com
One-time general consent respects the wishes of people to control the use of their samples without mandating that they decide the specific projects for which the samples are used. Widespread support for this approach indicates that it would be socially acceptable and should lead to high rates of donation.
The data also show that one-time general consent is supported by the “reasonable person” standard. This standard directs investigators to offer participants the choices that reasonable people want to make, given their interests, concerns, and goals. The finding that most people endorse one-time general consent is consistent across more than a decade, for thousands of people living in countries around the world. These data are also consistent across many different groups, including religious leaders, participants in past and present research, and the general public. This consistent and widespread support indicates that onetime general consent offers people the choice(s) reasonable people want to make when deciding whether to donate samples for research.
Individual opinions, even when widely held, sometimes reflect confusion and bias, not the views of reasonable people. Granting this possibility, the preference for one-time general consent, in addition to being consistent with relevant values and principles, seems reasonable. One-time general consent allows people to control whether their samples are used for research. Although it does not allow people to control the projects for which their samples are used, there is no reason to think that they want to make such decisions. One-time general consent protects people from serious risks, provided an ethics committee finds that future projects are acceptable and pose no more than minimal risks.
Finally, one-time general consent has practical advantages. It increases the scientific and social value of donated samples and lowers the costs of conducting research on them, eliminating the need to track the choices for each sample. One-time consent also allows people to avoid being repeatedly contacted and asked for consent, possibly for decades.
Survey research can be affected by many aspects of a given study, including framing effects and the possibility that individuals did not understand some questions. Nevertheless, these data are consistent across many studies, which surveyed various groups in different countries over a decade, using different questions and different methodologies. Secondly, one-time general consent may not be consistent with the values of some groups. Future research should evaluate its acceptability for groups, such as Native Americans, and areas of the world, such as Latin America, that are not included in the present data. Thirdly, the existing studies focus on blood samples; people may have different views on research with other types of samples, such as semen and placenta.
The consistency of these data suggests the default option of one-time general consent should be modified in compelling cases only. To implement onetime general consent, the consent form and process should contain at least the following six elements: request to obtain samples for future research; risks, if any; absence of direct benefits; information, if any, to be provided by individuals; reliance on ethics committees to review and approve future research provided it finds the research is ethical and poses no greater than minimal risk; solicitation of individual questions. Additional elements should be included as appropriate for individual studies (see appendix 2 on bmj.com
It is now recognised that people should give informed consent for the use of their biological samples in research
The types of consent needed and when consent should be obtained have not been defined
Studies have collected data on the views of more than 33 000 people on this issue
These data support one-time general consent
The data do not indicate whether people want information on the research goals of future studies, pooled results, individual results, or a combination of these types of information. The data also do not address the possibility that some information might cause anxiety or that retaining identifiers precludes anonymising samples. Hence, recommendations for a uniform approach to providing information on future studies must await further research. To help investigators and ethics committees determine when personal identifiers should be retained, research should assess how people balance being able to receive future information against the added protection that comes with anonymising samples.