Identity is in the details

April 12, 2010 • Posted in Genomic & Genetics Issues

D. Joy Riley, M.D., M.A.

Executive Director

June 2009

Privacy and research are two major concerns in discussions of biobanks.  They are important in another arena as well.  Whenever we are patients in a medical office or a hospital, medical records are created.  Whenever we have blood, other body fluids, or tissue taken, the remnants after testing are usually stored.   Neither of these facts constitutes news.   Novel uses of such information and samples, however, is a newsworthy subject, even if it is seldom read in the popular press.

In 1996, the US Congress made a law, the goal of which was to protect the privacy of “personally identifiable health information” (see definition of HIPAA below).  Little more than a decade later, the Institute of Medicine (see definitions below) charged a committee with these tasks:

1)  Assess whether the HIPAA Privacy Rule is having an impact on the

conduct of health research

2)  Propose recommendations to facilitate health research while

maintaining or strengthening the privacy protections of personally

identifiable health information.

The findings could only be a surprise to one who has but recently come to these shores.  The IOM’s Committee on Health Research and the Privacy of Health Information found the privacy protections of HIPAA inadequate, and that the HIPAA Privacy Rule “impedes important health research.” There are several recommended remedies.   Here are two.

Remedy 1:  Develop a new framework of oversight through the Department of Health and Human Services (HHS) and “other relevant federal agencies”.  This oversight would apply to all health research in the US — regardless of the entity funding it.

Remedy 2:  Separate “information-based research” from “interventional clinical research”.  The former includes medical records or stored biological materials (read “biobank”); the latter, people participating in treatments deemed experimental.

Some may laud the centralization (and hopefully, the loss of redundancy) of research efforts in the United States.  Standardization is important, certainly.  To trust our federal government to make something “standard” is not unreasonable; to trust the same government to make something simpler is an act of faith.  Politics in any lab is a reality.  With federal control of all research, that political system is simply larger; the leadership, more powerful.

Separating “information-based research” from “interventional clinical research” means that the level of consent can differ between the two.  It may mean that no one will have to ask you to use your stored information — whether that information comprises words on a page or a DNA sample stored in a lab.   Given that our identity is in the details of our records, either physical specimens or written reports, these are not small changes the IOM is advocating.

No one is saying much publicly about this right now, but that does not mean that plans are not being laid for using medical records and biological samples in ways that are new and without the informed consent that Americans are accustomed to yielding.  It is important — nay, imperative — that we stay informed.  The Tennessee Center for Bioethics & Culture is here to help.



The German National Ethics Council defines a biobank as a “collection of samples of human bodily substances (e.g., cells, tissue, blood or DNA as the physical medium of genetic information) that are or can be associated with personal data and information on their donors.”

Source:  Simon, Jürgen, Rainer Paslack, et. all., “A Legal Framework for Biobanking: the German Experience.” European Journal of Human Genetics. May 2007, Vol. 15 Issue 5, 529.

HIPAA (Health Insurance Portability and Accountability Act)

Enacted by the US Congress in 1996, this law “called for a set of federal standards, now known as the HIPAA Privacy Rule, for protecting the privacy of personally identifiable health information.”

Source:  Institute of Medicine Report Brief, “Beyond the HIPAA Privacy Rule:  Enhancing Privacy, Improving Health Through Research.”  February 2009.

Institute of Medicine

The Institute of Medicine serves as adviser to the nation to improve health.

Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public.  The mission of the Institute of Medicine embraces the health of people everywhere.