Blanket Consent to Biobanking:
Whose Choice is it Anyway?

Kathi E. Hanna, M.S., Ph.D.

Senior Vice President, Section Head
Scientific Reports and Proceedings
Styllus, LLC

The information contained in a single human cell is so vast it is difficult to appreciate, given its size. The entire complement of DNA is contained within, as are the secrets of how cells grow, differentiate into tissues and organs, communicate with each other, become diseased, and die. Although scientists have long studied human cells to understand, diagnose, and treat disease, technological breakthroughs and powerful new molecular techniques allow cellular information to be mined in ways never before possible. Thus, human biological materials—whether cells, tissues, organs, or subcellular structures such as DNA—have become one of the most valuable research resources available to science. At the same time, their use raises ethical issues deserving careful consideration because such material also contains information that is unique to the individual from whom it came, for example, the existence of tiny mutations that affect health and predict future disease.

The most common source of human biological materials for research is the clinical setting, where blood or tissue is removed for diagnostic or therapeutic purposes and excess materials can be used in research or banked for future use. Healthy volunteers also can donate blood or other material for research purposes. Most specimens can be stored for long periods of time, or indefinitely. Increasingly, it is useful for the material to be stored with identifiers to enable researchers to retrieve relevant medical information about the person over time. Often, samples are coded, so scientists can obtain that information without ever knowing the identity of the individual. In some cases, identifying information is completely stripped from the material.

According to federal regulations for the protection of research subjects, if an investigator can identify or readily ascertain—either directly or indirectly through coding systems—the identity of the living individuals from whom the specimens came, then the research involves human subjects. And, as with any other type of research involving human subjects, protections must be in place to safeguard the best interests of those who consent to the research use of their material. One measure is to ensure that the materials are stored in a secure way so as to protect the confidentiality of those who have donated samples.

Another essential safeguard is to ensure that the donors provide informed consent to the research use of their specimens. Unfortunately, that simple sounding fix is far more complicated in practice, with wide ranging opinion on what constitutes consent. Much of the complexity arises from the fact that specimens are often collected and stored before a specific research study has been identified. For example, a cancer patient consents to collection and storage of excessive tumor tissue for future unspecified research studies.

On the extreme protectionist side are those who believe that such material should not be used until the donor is fully informed of the exact nature of the study to be undertaken. Thus, the donor must be located and asked to provide consent for the now known study. They assert that consent cannot be fully informed if donors do not know the exact nature of the study, its risks and benefits, and who is conducting it.

A more moderate view is that “blanket consent” to all future research should be sufficient; that people are wise enough to understand that their tissue might be useful in future studies, whether in cancer or heart disease, and are capable of consenting to all such potential uses, with the assurance that information obtained through the research will remain confidential. Individuals who are not comfortable with providing such blanket consent should withhold it and should not donate their specimens under such uncertain conditions. Losing this fraction of potential donors will not negatively affect the research enterprise.

Those who believe that people are capable of understanding and providing blanket consent, including me, believe that it is impracticable and even intrusive to track people down years after a biopsy to ask if their stored tissue can now be used in a new study. Such actions offer little if any additional protection in an area of research where risks tend to be minimal. In addition, the only way to avoid such a requirement is to seek a waiver of the informed consent requirement by a convened Institutional Review Board, an option available under HHS but not FDA regulations.

Focus groups conducted in the late 1990s by the now defunct National Bioethics Advisory Commission and more recent surveys demonstrate that most Americans are willing to donate material to future unspecified research as long as they are asked in advance and are comfortable that research results will not be shared with third parties who might not have their best interests at heart, for example, employers or insurers.

In sum, if concerns about breaches of privacy or confidentiality are the primary deterrent to streamlining and simplifying the consent process for biobanking, it seems that science and the public health would be far better served by removing the potential for such harms occurring. Sophisticated encryption systems and public policies that outlaw medical discrimination are preferable to slowing or restricting critical research efforts through unnecessarily restrictive interpretations of what constitutes informed consent. Consent is a voluntary process. We should not be striving for policies that aim to ensure that everyone will provide consent. Rather we should be seeking a policy that allows potential donors to consider whether blanket consent is sufficient for their decision making purposes, and if so, to autonomously make the choice to bank their specimens for future research.