Establishing Precompetitive Collaborations to Stimulate Genomics-Driven Product Development: Workshop Summary (2011)

Many patients are comfortable with the sharing of their personal biomedical data because they trust the institution asking them to participate, observed Ellen Wright Clayton, professor of genetics and health policy and director of the Center for Biomedical Ethics and Society at Vanderbilt University. When more than 4,000 Vanderbilt faculty and staff were asked whether sending deidentified genetic information to a national database would affect their willingness to participate in a biobank, 69 percent said it would not affect their willingness to participate, 12 percent said they would be less willing, and 18 percent said that they would be more willing. “In general, they don’t mind, they think it’s a pretty good idea,” said Clayton.

Nevertheless, there are serious ethical considerations associated with

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

whether it is appropriate to use them for identification. For example, will the federal government be able to access databases within the government, in academia, or in companies, and if so what will the government be able to do with that information? The question, according to Clayton, “is not whether something is identifiable or not, but who gets access to it and for what purpose?”

Tools are being developed to assess the risks of identification, but investigators and biobanks also will have to decide explicitly about the level of identifiability they will maintain in the specimens and data they use, stated Clayton. Should the collector of data be able to link data or a specimen with an individual? Should a repository? How can good privacy practices be maintained in all institutions? Data use agreements may often be necessary, said Clayton, especially when sharing identifiable data and samples.

The bottom line, said Clayton, is “that the use of data and biospecimens for research entails significant ethical obligations to the individuals from whom they were obtained.” Researchers and institutions have to consider carefully what they are asking of participants. They need to figure out how to address participants’ concerns. Said Clayton, “we have to think about what we’re going to do to protect privacy and identity, and we have to do this going forward in an environment [in which] sharing data and sharing samples are absolutely essential to getting to the kinds of advances in science to promote [the] health care that we need.”

In response to a question about increasing the diversity of the population represented in biorepositories and how to address the fears of nonwhite participants about the potential misuse of biological samples, Clayton said that “some of their distrust is well earned.” Overcoming these fears will mean earning their trust. “It is community engagement, it is responsiveness, it is including individuals, and [it is] sharing with them why it makes a difference to be involved in this kind of research and doing so in ways that are sufficiently transparent to gain their trust.” A necessary step for including African-American, Hispanic, and other non-white populations is to figure out what their concerns are and to address them with transparent policies that hold the system accountable.

Carolyn Compton observed that some patients seem willing to voluntarily give up privacy by placing their information in public places in order to benefit a disease area. Clayton noted that a cultural change is needed to make it safer to put this type of information out there because otherwise patients may take it back. “We should seek to create a society where [such contributors] will not be penalized. [That is an area] where we, as a society, have a capacity to do better,” said Clayton.

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