April 5, 1999

F. James Charney
Policy Analyst
Office of Management and Budget
New Executive Office Building, Room 6025
Washington. D.C. 20503

Dear Mr. Charney:

The Association for Health Services Research (AHSR) appreciates the opportunity to respond to the Notice of Proposed -Revision to OMB Circular A-110, "Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals and Other Non-profit Organizations" (Federal Register, February 4, 1999). AHSR is the national professional association devoted to Improving the field of health services research. AHSR represents more then 2,800 individuals and 130 organizational members, including universities, insurers, providers, major employers, and health plans that both use and produce health services research Information.

AHSR commends OMS for Its efforts to provide needed classification to the legislative language amending Circular A-110. The Association is most concerned about the effects the proposed revision would have on stifling public and private health services research. As a result, AHSR will be recommending Congress repeal, or, at a minimum, suspend the statute to allow for further deliberation and consideration of Its consequences.

The proposed notice presents a quagmire of administrative and confidentiality issues for health services researchers that will significantly affect both current and future research efforts. In particular, AHSR Is concerned that the notice prevents federal agencies from waiving their. right to obtain data produced under federal awards and requires health services researchers to submit data to federal agencies without regard to the confidential or sensitive nature of the information. Agency waiver of access to data is essential to the conduct of certain sensitive types of research, such as drug and substance abuse and mental health research,

While AHSR believes every effort would be made by federal agencies to fully apply the protections of the Freedom of Information Act (FOIA) to research data, It is alarming that privacy protections such as the removal of patient identifiable information will occur only after the information has been turned over to the agency. These provisions will require researchers to reassess their current research confidentiality agreements, policies, and procedures, as they no longer will be able to assure patients or other research subjects that their data will be hold in strictest confidence. These provisions threaten the confidentiality of research data and are certain to have a negative impact on the willingness of individuals to allow the use of their medical records for research purposes.

While the proposed notice is an improvement over the legislative language, several serious questions remain, including:

1. The proposed. notice poorly defines several critical terms needed to fully assess and determine the compliance requirements of the law. Further clarification of the terms 'data", 'publication", and 'policy' are needed to provide researchers with a clear understanding of how to comply with any revised Circular A-1 1 0.
2. What data is required to be released (observer notes, laboratory samples)?
3. When is data considered published?
4. Do the requirements apply only to studies that are directly attributable to federal policy?
5. Is federal policy and rulemaking limited to notices published in the Federal Register or does the definition extend to Congressional legislation, federal manuals, public health Initiatives, etc?
6. Will this revision apply only to specific research findings cited in federal rulemaking, or Will -It apply to the broad array of health services research which may have influenced federal decisionmaking on a particular issue?

AHSR also is concerned that the law unfairly places the burden of Implementation costs on the researcher and research institution. Compliance with FOIA requests for research data will be particularly burdensome for health services researchers who often rely upon extensive databases of information to conduct research studies, Researchers and research institutions will need to take compliance costs into account when determining their direct and Indirect ' research costs, just as the federal agencies will surely need to expand their own FOIA staff, Without an Increase In either the federal cap on indirect administrative cost reimbursement for grant awards or a change in the law to provide some mechanism for remuneration, these costs will serve to diminish the resources available for research.

AHSR believes that the questions and concerns raised by the proposed revision to Circular A-110 must be more fully assessed and the full Implications of these provisions appropriately addressed to ensure that they do not Impede health research. Indeed, without further clarification, these provisions have burdensome requests and litigation at a level that could be utilized to hot only Intimidate researchers and their institutions, but to seriously undermine the research and information our nation needs to answer pressing health policy issues. We appreciate your consideration of our comments and urge you to address these critical concerns prior to finalizing any revisions to Circular A-110.

Sincerely,

W. David Helms
Chief Executive Officer