A Preferred Path Forward for Regulating Research Using De-Identified Data and Biospecimens

Contributed by Kristen Rosati, J.D., Partner, Coppersmith Brockelman, PLC, Phoenix Arizona.

The tension between private rights and the public good is apparent in many recent public policy debates.   Will we allow parents to choose not to vaccinate their children, when that decision can decrease the “herd immunity” necessary to protect other children?   Will we allow public funds to be committed to charter schools, which will provide better education for individual kids, but decrease the funding available for improving public schools?  Will we allow individuals to control the use of their de-identified data and biospecimens for research, when doing so will hinder the development of improvement in health outcomes and life-saving treatments for the public as a whole?   With today’s polarized politics, these policy discussions are increasingly challenging.  Thankfully, there is a path forward for the use of de-identified data and biospecimens that both protects the individual and achieves the public good.

The Office for Human Research Protections Notice of Proposed Rulemaking:  On September 28, 2015, the Department of Health and Human Services Office for Human Research Protections (the OHRP) issued a Notice of Proposed Rulemaking (the NPRM) to modify the Common Rule. The NPRM proposed sweeping changes to increase protection for human subjects participating in research, but also to reduce the burden, delay, and ambiguity for investigators.

In at least one respect, the OHRP missed the mark by a wide margin.  The OHRP proposed to require consent from individuals to use their de-identified biospecimens for future research, with an exception only for research that will generate information already known about an individual for validation testing and development of diagnostic tests.  In making this proposal, the OHRP clearly focused only on the issue of private rights:

In 2013, scientists demonstrated that the identity of individual research subjects could be ascertained by collating and analyzing certain types of genomic data, including genomic data from publicly available information sources.  Thus, the possibility of fully identifying biospecimens and some types of data from which direct identifiers had been stripped or did not originally include direct identifiers has grown, requiring vigilance to ensure that such research be subject to appropriate oversight. Most importantly, people want to be asked for their permission. A growing body of survey data show that many prospective participants want to be asked for their consent before their biospecimens are used in research.  [Citations omitted]

Criticisms of the NPRM:   Not surprisingly, the research community overwhelmingly opposed this aspect of the NPRM.  Most recently, the National Academies of Science issued a publication entitled Optimizing the Nation’s Investment in Academic Research:  A New Regulatory Framework for the 21st Century.  The National Academies recommended withdrawing the NPRM and withholding additional regulations until a national commission (to be constituted) has issued a report on a way to regulate research across federal agencies —with input from the regulated community.   As described by the National Academies:

The review [of responses to the NPRM] “suggested that the NPRM is overly complex, poorly written, and not supported by data.”

[T]he Presidential Commission for the Study of Bioethical Issues “suggested that the primary proposal to expand the definition of ‘human subject’ to include all non-identified biospecimens is inconsistent with the ethical rationale described in the NPRM and will stall certain kinds of research using deidentified biospecimens that pose no risk to human subjects and are unlikely to impact participants’ autonomy interests.” Further, the HHS Secretary’s Advisory Committee for Human Research Protections (SACHRP) “concluded that, ‘To the extent that the NPRM’s core proposal is meant to ensure that subjects provide meaningful consent to future research with biospecimens and to prevent biospecimen re-identification, the NPRM would do nothing of the sort.’”  … 94 –100% of patients and members of the research community, including researchers, universities, medical centers and industry, opposed the changes.” [Citations omitted]

A Path Forward:  The OHRP legitimately is concerned with protecting the privacy of individuals whose biospecimens are used for research.  Our biospecimens carry an enormous amounts of information about us.  They include information about our genetic predisposition to disease and our familial history.  Federal law does not prohibit the use of genetic information to make decisions about life insurance and disability insurance; the Genetic Information Nondiscrimination Act protects against discrimination in health insurance and employment decisions, but has the glaring omission of not preventing discrimination in other contexts.  As sources of genomic information associated with identity increase, such as electronic health records and publicly available genealogy databases, there is an increasing risk of “triangulating” individual identity in research databases.

However, to address that risk, the answer is not requiring individual consent to use de-identified biospecimens for future research.  There is substantial academic work showing that consent does not provide sufficient protection for people.  That is especially true when the consent is the “broad consent” proposed by the OHRP, which will not need to describe the particular type of research that will be conducted with an individual’s biospecimens.

Rather, the answer is to prohibit re-identification of individuals in data and biospecimens used for research (with limited, thoughtful exceptions, such as research conducted on re-identifiability).  Federal law and the vast majority of state laws presently do not contain any prohibition against the re-identification of individuals, unless the data are held by HIPAA covered entities.  Prohibiting re-identification of individuals whose biospecimens are used for research (with or without consent) would address the acute need to procure biospecimens for research and at the same time honor individual rights.  In this particular public policy debate, there need not be tension between the public good and private rights.


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