Response to OMB Circular A-110

IGES Response to OMB Circular A-110

 

March 31, 1999

 

 

Dr. F. James Charney, Policy Analyst

Office of Management and Budget

Room 6025

New Executive Office Building

Washington, DC 20403

 

Dear Dr. Charney,

 

I am writing on behalf of the International Genetic Epidemiology Society (IGES) to comment on OMB Circular A-110 regarding the proposal to extend the Freedom of Information Act (FOIA) to cover recipients of federally funded research grants.  Access to the source data for studies used in making government policy is an important goal that is widely supported by the academic community, but needs to be done in a way that protects individual rights and does not discourage collaborative research.  Many issues are addressed in a thoughtful statement posted by the NIH on their website (www.nih.gov/grants/policy/a110implications.htm) and will not be repeated here.  We confine these remarks to the specific implications for research in our field of genetic epidemiology.

 

IGES has several concerns we wish to bring to your attention, relating to issues of protection of confidentiality for participants in family studies, the willingness of families to participate in such research, the willingness of investigators to embark on collaborative research arrangements, and intellectual property rights of the investigators.

 

Genetic epidemiology is the study of the genetic and environmental causes of disease in human populations and relies heavily on family-based study designs for investigating such factors.  We have found that families are often highly motivated to participate in such research concerning medical conditions that affect them or their loved ones.  To foster this cooperation, genetic epidemiologists have gone to great lengths to protect the interests of their study subjects, particularly with regard to issues of informed consent and nondisclosure of potentially sensitive information to other family members and outside parties.  The potential for misuse of such information by insurance carriers, employers, or even other family members is too serious to be ignored.  There has been a vigorous discussion of these issues in the genetics and bioethics communities, as I am sure you are well aware.  We understand that FOIA provides some exemptions to protect data that could reasonably be used to identify individuals and would thus constitute a violation of privacy.  However, IGES is concerned that these protections have not been adequately tested in the context of family studies, which typically contain a great deal of information to establish family linkages that might be difficult to obscure without compromising the usefulness of the data.  For example, the pedigree structure itself could, in some instances, be sufficiently informative to allow the family or members of the family to be identified, even if all individual identifiers were removed. Furthermore, some genetic data, such as genotypes at a large number of genetic loci, are themselves unique and can be used as personal identifiers if these data are released.  Genotype data of this sort are currently used as personal identifiers in forensic investigations and release of such data to the general public would be a definite violation of the agreements made by investigators to protect the privacy of research subjects, as mandated by federal law and federal Institutional Review Board regulations. Restrictions on the ability of investigators to collect such identifying information for fear of possibly having to make them available to outsiders could seriously jeopardize the conduct of research in our field. NIH has issued “Certificates of Confidentiality” for certain research projects for just this reason, but their ability to withstand a court challenge has never been adequately tested.

 

Secondly, we rely heavily on the willingness of families to participate in such studies, and have provided rigorous guarantees of confidentiality and nondisclosure in the informed consent process.  We are concerned that this proposal might make it difficult to offer these same guarantees in the future.  For example, informed consent documents frequently tell the potential subjects that their data will be used only for very specific research purposes, but we would not be able to provide any assurances about uses others who obtained them under FOIA might put these data to in the future.

 

Third, genetic epidemiology is a highly interdisciplinary and collaborative field.  Obtaining the requisite breadth of expertise among the investigative team and recruiting the requisite number of families often entails collaborative arrangements with investigators at several different institutions, even in different countries sometimes.  It is not uncommon for all the world’s investigators to pool their data for re-analyses aimed at greater precision or to answer questions that no single group could address.  Such collaborations are part of what makes IGES an international society and are very much in the spirit of what this proposed amendment aims to accomplish.  We have therefore had to deal with these issues of confidentiality in data sharing for a long time and believe it can be accomplished with the appropriate controls.  It would be very unfortunate, however, if the implementing regulations had the effect of discouraging such collaborations.  Ultimately, it is the responsibility of the original investigators to ensure that any collaborative arrangements they may enter into will not violate the promises they have made to their study subjects or harm them in any way.  Such arrangements are possible in the collegial atmosphere of collaborative research, voluntarily entered into by the investigators themselves, but it is not so obvious that this would be possible if data were demanded by outsiders with no such collaborative intent in mind, or even with the intention of using the data for purposes other than what they were collected for.  These issues could become particularly complex in the case of international collaborations, where a FOIA request might conceivably extend to data collected in foreign countries, but as part of a partially US-funded collaboration.  It would be important that the cultural and legal sensibilities of our foreign collaborators be respected in such circumstances.

 

Finally, we are concerned about protection of the intellectual property rights of the original investigators and of the effects on U.S. taxpayers of failing to protect these rights of original investigators. There is the possibility that expensively obtained data would be released to private companies in such a way that they can leapfrog publicly funded researchers and patent results that would have remained in the public domain if the data had remained privately held by the original researchers long enough for them to make the same discoveries. We will be faced with the possibility that large corporations will be poised to pounce on the profitable data as soon as the federal government has spent large amounts of money to generate these data, and then these companies will take the final results out of the public domain, thus maximizing their individual profits at the taxpayers’ expense.  Private patenting of genes has been opposed by the National Institutes of Health and by most of the genetic professional societies.  However, we believe that the proposed FOIA application to certain kinds of genetic research data will actively promote patenting of genes by private companies using data obtained with federal dollars, thus eventually increasing health care costs for the American public over what they would have been if the data had remained confidential and the genes had been placed in the public domain upon discovery.  The restriction of access to data only after publication provides some protection of the investigators’ rights, but many studies take years to complete and result in many publications along the way.  We are concerned that a narrow interpretation of “publication” could force investigators to turn over a rich database long before they have analyzed it to their satisfaction. This will have a chilling effect on research at universities and research institutions, where promotion and tenure require scientific publications, because no scientist will be able to spend years collecting data only to have others, who have made no such investment of time and effort, have the ability to publish or patent the results of analysis of these data before them.

 

In conclusion, the International Genetic Epidemiology Society supports the principle that publicly funded research data should only be made available to the public if it is certain that this can be done in a manner that protects the rights of the study subjects and the investigators.  We further believe that certain genetic data are themselves personal identifiers and as such cannot be released to the public under the freedom of information act, without violation of the privacy of research subjects currently guaranteed by Institutional Review Board policy as dictated by federal law.

 

Time constraints have not allowed us to put these comments to a vote of the entire membership, but this letter has been drafted with the help of all the officers of the Society.  The undersigned have read and approved the final draft on behalf of all members, who we believe would broadly support these views.

 

 

Sincerely,

 

 

 

Duncan C. Thomas, President

University of Southern California, Los Angeles, CA, USA

 

Francoise Clerget-Darpoux, Past President

INSERM, Paris, France

 

Lynn R. Goldin, President Elect

National Cancer Institute, Bethesda, MD, USA

 

Roger M. Siervogel, Secretary-Treasurer

Wright State University, Yellow Springs, OH, USA

 

Members of the Board of Directors:

 

Laurent Abel, INSERM, Paris, France

Christopher I. Amos, University of Texas, Houston, TX, USA

Joan Bailey-Wilson, Baltimore, MD, USA

Partha Majumder, Indian Statistical Institute, Calcutta, India

Kenneth Morgan, McGill University Health Center, Montreal, Canada

Daniel J. Schaid, Mayo Clinic/Foundation, Rochester, MN, USA

 

Former Presidents:

            D.C. Rao, Washington University, St Louis, MO, USA

            Robert Elston, Case Western Reserve University, Cleveland, OH, USA