FREEDOM OF INFORMATION ACT COMMENTARY 
COMMENTS ON PROPOSED REVISIONS ON ACCESS TO RESEARCH DATA

September 8, 1999 

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

RE: [64 FR 43786] Request for Comments in Clarifying Changes to Proposed Revision on Access to Research Data 

Dear Mr. Charney: 

The American Society for Pharmacology and Experimental Therapeutics (ASPET) appreciates this opportunity to respond to OMB’s request for clarification to the proposed revisions of Circular A-110 [64 FR 43786], that would make all federally funded research data available under the Freedom of Information Act (FOIA). ASPET is a 4,500 member scientific society comprised of biomedical researchers in academia, industry, and government.  Implementation of the statute (PL 105-277) has great implications for the future conduct of pharmacological research and the discovery and development of new and improved therapeutic agents. 

The proposed revisions indicate OMB has made an exceptional effort to minimize the burden and threat that the statutory language of P.L 105-277 would place upon scientific researchers. Many of these concerns were raised in our letter of March 23 during the first comment period. These include threats to future research collaboration among scientists, research institutions, and private industry that would undermine the transfer of technology; maintaining privacy of research subjects; and avoiding release of preliminary research data. 

However some serious issues remain. ASPET offers the following comments requested to help to clarify and define changes in the latest OMB proposed revision. 

Clarification of “Data”: 

ASPET supports the narrowing of the definition of “research data” to include “factual material commonly accepted in the scientific community as necessary to validate research findings…” By defining what is not considered data, OMB strengthens protections for researchers intellectual property and mitigates possible unwarranted intrusion of patient privacy. However, deleting names of research subjects are just one means of protecting research subjects privacy. Given the complex data sets and methodology involved in many clinical trials, it could still be possible to identify research subjects. Thus, there are no real assurances that complete privacy is possible. Without such assurance the ability to recruit research subjects remains
jeopardized. 

Clarification of “Published”: 

ASPET supports OMB’s restricted definition of published research material to peer- reviewed journals or when a Federal agency publicly cites to the research findings in support of agency action. We believe this will help prevent the premature release of data before a study is completed, protect a researcher’s patent rights, and encourage industry to continue to support partnerships with universities since propriety data would be protected. 

Clarification of “Used by the Federal Government in Developing Policy or Rules”: 

ASPET supports OMB’s restricted definition that data accessed under FOIA should occur only when an agency promulgates regulations and not extend to agency actions such as guidance, surveys, assessments, and reports. 

ASPET supports OMB’s recommendation that the public’s interest in having access to research data is likely to be greatest in the case of those regulations that “have a substantial impact on society.” OMB suggests and ASPET supports a $100 million impact threshold for identifying those regulations that have a substantial impact on society. A $100 million threshold will minimize undue harassment from certain entities opposed to specific types of research. ASPET is unable to identify any current or past regulatory actions that do not meet this threshold and where the public would benefit from access to the underlying data that would justify burdens or risks to science. 

Clarification of “Cost Reimbursement”: 

ASPET believes that universities would have to establish new mechanisms for implementation and compliance to the proposed FOIA revisions. It is not clear to ASPET if these will add to the indirect administrative costs of federally funded research or if these new costs would be recovered as direct costs of the research. ASPET believes the costs of implementation should not be taken from the researchers direct costs of the research. 

In conclusion, ASPET believes that in spite of OMB’s narrowing of the application of the underlying statute, the statutory language still has potential to create undue burdens on researchers, threatening the pace of biomedical discovery. Furthermore, ASPET questions whether implementation of this proposal is workable and would allow legal challenges from entities interpreting the statute in different ways. This threat would intimidate and adversely impact the pace of research conducted by individual scientists and research institutions. 

Sincerely, 

Jerry R. Mitchell 
President 
American Society for Pharmacology and 
 Experimental Therapeutics