Field Notes

Implications.

Much of my scholarly work focuses on the ethical, legal, and social implications of research with human biological materials. Collections of these materials—tissue samples, blood, and DNA, for example—combined with health information obtained from surveys and medical records are commonly called biobanks. Some biobanking initiatives, like the Autism Tissue Program, were created to support disease-specific research. Others, like the Genetic Alliance Biobank, were created to provide biological materials for a wide range of genetic research.

It's been over a decade since researchers, patient advocates, bioethicists, and other stakeholders began discussing the ethical, legal, and social implications of research with human biological materials, but several key issues are still debated. At workshops, meetings, and other sessions I've attended over the last eight months, several common themes emerged:

Consent. An ongoing challenge for biobanking initiatives is how to develop consent policies for research with biological materials and associated data that are ethically robust yet do not create unnecessary barriers to research. Policies vary. Some initiatives, like the U.K. Biobank, require participants to give consent for broad future use of their biological materials and health information. Others use a tiered consent approach, which gives people the opportunity to designate the type of research that can and cannot be conducted.

Privacy and confidentiality. Researchers have always been obligated to protect the confidentiality of research participants' personal information. Yet obtaining genetic information from participants raises new challenges, especially when genetic data are stored and shared electronically. Congress passed the Genetic Information Nondiscrimination Act (GINA) last year in response to public fear that insurance companies and employers would use genetic information to deny health insurance or employment. Yet biobanking initiatives must still establish strong electronic data security policies to prevent unauthorized access to research participants' genetic information and other health data.

Return of research results. Surveys of public attitudes reveal support for research with biological materials and a general willingness to provide them for research. Yet some respondents say their willingness to participate in biobanking initiatives depends on whether researchers will provide participants with research results, and there are substantial concerns about providing individual genetic research results when genetic research is currently exploratory and has limited analytic validity and clinical utility.

As research with biological materials identifies key factors in disease formation, the societal challenge will be to ensure that all Americans have affordable access to the diagnostic, preventive, and treatment interventions that emerge from such research. That will likely be the implication that is most difficult to deal with.