the use of biospecimens or data from individuals, according to Clayton. Many of these considerations are related to the idea of informed consent, which rests on the concept of autonomy—that patients should be allowed to decide what to do. However, other issues are also at stake, including control, respect, and expectations. Some research participants, said Clayton, believe that they should not only have control over the uses of their samples and data but also have some stake in the intellectual property that emerges from that use. Questions also surround whether research participants should receive information back from researchers about their samples and whether they should be contacted in the future to give additional samples or information.
Given the wide array of issues, it is important to clarify what is at risk. A tremendous amount of epidemiological research and other types of investigations have been done in the United States for decades without any informed consent or notification whatsoever, according to Clayton. She said that the research community has moved to the point of recognizing that people and communities need to know more about what is being done in the research environment and with their information. This is “an evolution in our ethical thinking that’s tremendously important.” In situations where people are going to receive information about their samples or be recontacted to serve in future studies, said Clayton, consent needs to be more robust. “You have to look at what’s actually at stake,” she added. “You can’t say ‘autonomy’ and end the discussion.”
As more samples and data are shared, the scope of consent needs to be addressed. Broad consent can never be truly informed, said Clayton. As a consequence, issues of governance become central. The organizations that collect and use research data, according to Clayton, need to decide what they are going to tell research participants; they also need “to realize that informed consent cannot bear the whole weight in this area.” People generally want to know what kinds of research will be conducted with their samples and who will be doing the research. For example, research participants are generally more comfortable with academic institutions than they are with commercial entities. “We can agree that this may be misguided, but it’s something that we have to consider going forward.”
Identifiability is another key issue in the use of biospecimens and biological data. Samples are more useful scientifically when there is more information linked to them. Additionally, linkages create the opportunity to return research results to individuals. However, as more data are linked, the risks to privacy become greater.
An important step, said Clayton, is to eliminate the word “anonymous” from discussions of biomedical research. “All [you] can talk about is more or less identifiable,” she said, and as data become more identifiable because of more extensive and robust databases, the important question will be