TheCRE.com
CRE Homepage About The CRE Advisory Board Newsletter Search Links Representation Comments/Ideas
Reg Week Archives
Data Access
Data Quality
Regulation by Litigation
Regulation by Information
Regulation by Appropriation
Special Projects
CRE Watch List
Emerging Regulatory Issues
Litigation
OMB Papers
Guest Column
Voluntary Standards Program
CRE Report Card
Public Docket Preparation
Interactive Public Docket
Electronic Regulatory Reform
Consumer Response Service
Site Search

Enter keyword(s) to search TheCre.com:

Interactive Public Docket

COMMENT BY: The Mayo Foundation
SUBJECT: Against proposed revision to OMB Circular A-110
DATE: March 29, 1999

Dear Mr. Charney:

We are writing to express our serious concerns about the FY 1999 Omnibus Appropriations Bill containing a provision directing OMB to amend Circular A-110 and "require Federal awarding agencies to ensure that all data produced under an award will be available to the public under the FOIA." This will be a substantial change from current law which states that data in the files of a federal grant recipient is not subject to the Freedom of Information Act (FOIA), only those data at the awarding agency. Our concern is that the proposed rule would make all data subject to FOIA, particularly the concept that "research results and underlying data would be available to the public in accordance with the FOIA."

We believe the proposed policy will create many difficulties for the conduct of critically important research into the causes, prevention and treatment of disease, and further, that the proposed policy will not benefit the public. There are several specific issues we would like to bring to your attention:

• Recognizing patient issues first, we have grave concerns about patient privacy. The proposal endangers the confidentiality of human subjects participating in clinical trials. There are many situations where patients might well elect not to participate in trials if their personal data were at risk for public release. The assurance of patient privacy is a bedrock component of all clinical trials, many of which directly advance the quality of patient care and successful treatment of disease.

• The Federal government has developed a number of policies to strengthen the relationships between the academic (Federally-funded) medical research community and industry, including Small Business Innovation Research Grants, Bayh-Dole Agreements and the Cooperative Research and Development Agreements or CRADAs. The proposed policy will jeopardize these relationships since proprietary data - not only the technical data but also strategies and areas of emphasis - would be in the public domain. Not only will this diminish the success of the Federal government in promoting industry-academia collaborations, it will retard progress of medical science in the most critical areas where there is the greatest interest and need. Future interactions would also be threatened since the policy applies to all Federal grantees, regardless of the level of funding.

• The proposed policy is broadly written, without definition of many key terms. For example, "data" is not clearly defined. Does data include patient records, laboratory notebooks, drafts of manuscripts, and preliminary data not yet properly analyzed? Depending upon definition, the effort to comply with the rule as written could literally overwhelm individual investigators, immediate staff and academic institutions. There is no discussion of how this effort would be funded. Investigators and institutions are under rigorous fiscal challenges currently, and imposing these additional burdens could make it impossible to continue important clinical research in many settings.

• There is a temporal issue with regard to the proposed policy. There is no language addressing how far back such requests could extend for studies. There are a number of research areas requiring studies over prolonged periods of time, and analyses over, in some cases, decades before data can be appropriately interpreted by the investigators. Data are often blinded or sealed until completion of these studies to assure that early results, which lack statistical significance, cannot compromise continuing conduct of the study. Release of these data could readily derail important longitudinal studies.

Mayo Foundation would urge reconsideration of this proposed rule. We do not believe this policy would be in the best interest of the public, of subjects participating in research studies, or of investigators and institutions dedicated to furthering biomedical science and patient care.

Sincerely,

Michael B. Wood, M.D.
President and Chief Executive Officer Mayo Foundation

Matthew M. Ames, Ph.D.
Director for Research
Mayo Clinic Rochester

John A. McDonald, M.D., Ph.D.
Director for Research
Mayo Clinic Scottsdale

Steven G. Younkin, M.D., Ph.D.
Director for Research
Mayo Clinic Jacksonville