COMMENT BY: Council of State and Territorial Epidemiologists
SUBJECT:Against proposed revision to OMB Circular A-110
DATE: April 5, 1999

Dear Mr. Charney

The Council of State and Territorial Epidemiologists, an association of 450 state and local public health epidemiologists, is pleased to provide its comments on the proposed amendment to Section .36(c) of OMB Circular A-110, addressing public access to research data under the Freedom of Information Act (FOIA), pursuant to P.L. 105-277.

CSTE believes the proposed amendment language has significant, unintended consequences that will cause serious disruption of public health practice and the research upon which it depends. Specifically, CSTE concerns are that under the proposed amendment, the current waiver federal agencies may employ regarding access to the original research data of its awardees, will be eliminated. This means any request for research data under FOIA will require awardees to forward all data to the awarding federal agency, including sensitive individually identifiable data. While the latter will be protected from release to the public under FOIA, release to the federal agency itself may violate many current confidentiality agreements between research subjects and researchers. This could have a profound impact on the collection of data related, for instance, to clinical trials, epidemiologic studies, and other areas of medical research. The use of patient medical records, public health data sets, and other data sources is governed by strict confidentiality agreements that require researchers to stringently observe and control the uses to which these data are subjected. The entire structure of current agreements may need to be reassessed to account for the loss of the federal waiver option.

There is additional concern in the research community about the lack of protection under FOIA for the anonymity of entities that may be providing sensitive original data, such as those facilities treating individuals with sexually transmitted diseases, mental illness, or substance abuse. Public access to original data from these identifiable sources, even though individuals themselves may be protected, may have a serious chilling effect on the willingness of individuals to participate in clinical research, or to authorize research uses of their medical records.

Other issues impacting, and potentially harming the research endeavor, under the proposed amendment to OMB Circular A-110, involve the very broad description of data, that the data must be linked to federal policy, and that no cost recovery for providing potentially massive amounts of original data is provided to federal awardees. Data is not defined and therefore could pertain to a vast amount of possible materials such as meeting notes, laboratory samples, secondary sources, etc. It is frequently virtually impossible to specifically link the myriad federal policies developed to any particular study or data within that study. This degree of ambiguity could result in numerous unspecific requests for original data that causes a massive undertaking of information recovery for which there is no financial compensation. A fee may be charged to an entity making a FOIA request if the research that results is solely in response to the FOIA request, but not otherwise. This could be a tremendous, unremunerated burden for many entities conducting federally supported research and could make it impossible for many to continue a research program.

The potential negative impact on the progress of research generally also impacts the practice of public health which provides essential, and legally proscribed under state law, safeguards for the public’s health. Diminished access to research subjects in the broader research community, and reduced research activity generally, impairs the advance of knowledge. This will ultimately hurt public health’s ability to improve its assessment and response to health problems such as food safety, emerging infectious diseases, chronic diseases, and environmental hazards.

CSTE is also concerned that, under the proposed amendment to OMB Circular A-110, state health departments receiving federal funds to carry out basic public health activities such as surveillance for emerging infectious diseases, will be directly subject to the FOIA requirements. Again, legally based confidentiality agreements that may have to be redrawn and the lack of protections for facilities providing information both may have serious chilling effects upon the ability of public health departments to conduct these basic safeguard activities. Sweeping, undefined issues such as what constitutes data, the relationship of research to federal policy, and the lack of reimbursement for data recovery would seriously impact chronically understaffed, and underfunded state health departments and their ability to carry out their essential functions.

In closing, CSTE is very concerned about the proposed amendment to OMB Circular A-110 and believes it warrants considerably more review that the 60-day public comment period affords. The implications are so extensive and so serious that CSTE recommends that both the Administration and the Congress, with guidance provided by an outside body of recognized scientists and public health professionals assembled, perhaps, by the National Academy of Sciences, carefully weigh the appropriate process for sharing federally supported research information. This may require either repeal or suspension of the relevant provision under P.L. 105-277, but that action should be considered.

Sincerely

Patricia Quinlisk MD, MPH President Council of State and Territorial Epidemiologists