FROM:   Acting Deputy Assistant Secretary for Minority Health

SUBJECT:   Comments on Draft OMB Circular A-110

Thank you for providing the opportunity to comment on the draft OMB Circular for "Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations." Office of Minority Health's (OMH) comments center on applicability of the Circular; legislative intent; maintenance of confidentiality and privacy; research participation, definition of "data," "publication" and "policy;" and costs of providing the information.

Although the OMH does not fund research grants, it does have several grant programs for which client data are collected to enable the provision of services. OMH's grantees do not now provide data to OMH except in summaries for progress reports and renewal applications. It is not clear whether the draft OMB Circular applies to OMH's grants programs since there is a conflict between the third sentence under Supplementary Information which states that Federal awarding agencies are required to ensure that all data produced under an award will be made available to the public, and the actual clause in the proposed notice which states that Federal awarding agencies shall respond to an FOIA request for "data relating to published research findings produced under an award that were used by the Federal Government in developing policy."

OMH is concerned that the draft Circular A-110 is contrary to the legislative intent behind the FOIA. FOIA was not intended to be a method of unrestricted data acquisition and is an inappropriate media to share research data. Requesters may seek an unrestricted range of sensitive data on the basis that it is requisite to understand the Government's underlying rational for a policy or rule. For example, the proposed rule change could make available patient information obtained in a clinical trial, video taped data, and early research observations jotted down in an investigator's notebook. The proposed revision of Circular A-110 may have a chilling effect on creativity, intellectual property rights (patent law), and public-private partnerships and create a disincentive to report and publish research findings.

A controversial issue with the draft revision is confidentiality and privacy as well as the volunteer participation of human subjects in research studies. Although personal identifiers may be removed from data sets in a clinical trial, the identity of participants may be ascertained using demographic data such as race/ethnicity that may set the stage for harassment and discrimination.

In addition, many subjects take the word "confidential" literally. The new revision would

require the Informed Consent and the principal investigator to inform the subjects of the possibility that the data will be released if requested and approved. This is similar to the issues surrounding access to results of genetic testing. Many states have enacted privacy and confidentiality codes regarding to whom and/or under what circumstances an individual's genetic testing results can be released. In the case with the new revision, the subjects may be told and assume that the release of the data records will be exempt from the FOIA due to the invasion of personal privacy; however, that will not be determined until after the agency has obtained the data. This, in the near future, may interfere with recruiting an adequate sample size to implement and complete a study.

OMH endorses the explicit mention of FOIA exemption 6 in the "Supplementary Information." Given the policy to encourage the involvement of racial and ethnic minorities in HHS funded research, it is critical to the OMH that the HHS be required to shield "personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy." It is not clear from the draft revision whether medical information on the fitness and suitability of the participants in clinical trials funded by NIH is exempted.

According to the proposed revision of Circular A-110, Congressional proponents have stated that the amended Circular shall apply to all Federally funded research, regardless of "whether the award recipient is also using non-Federal funds." OMH recommends that the Office of General Counsel be consulted regarding the legal ramifications of this statement, particularly with regards to confidentiality agreements made by researchers with their non-Federal funding organization.

OMH endorses the data definition approach used by the OMB, i.e., to define research data as that pertaining to "published research findings produced under an award that were used by the Federal Government in developing policy or rules." This approach could provide the protections sufficient to deter undue/untimely intrusion into research or harassment of researchers. This is important since the "person" requesting research data includes corporations.

The revision does not state whether the specifics of the variables and methodology to define and accurately analyze the data are to be included in a response to a FOIA request for grant data. It appears that a requester would need such information to accurately use the data, primarily if the requester is using the data to oppose a policy or regulation or is using the information in a competitive market affecting a large pool of individuals, i.e., insurers.

It is not clear what constitutes a "publication" or a "policy." These two terms are vague/ambiguous and lend themselves to overly broad interpretations. For example, if clinical trials are conducted and it is determined that the therapeutic intervention is a great success and should be universally utilized, it is unclear whether this proclamation constitutes a policy or a publication. In addition, it is not clear whether FOIA applies when only part of the data are released.

There needs to be a more precise understanding of what it means for data to be "used by the Government in developing policy or rules." One use may be very explicit, such as specific data cited in proposing a policy while in another case, there might be a body of literature that was

cited. It is unclear whether the entire of body of literature is available to the public or whether only the specific data that were "used by the Government" would be covered by the FOIA. This issue must be explicitly resolved because requesters of information under the amended FOIA may successfully argue that the entire body of literature (including unpublished results) constitutes "underlying data" or that all of the literature is necessary to understand the reasoning for the Government's policy.

It is not clear what is meant by the "The Federal Government has the right to (1) obtain, reproduce, publish or otherwise use the data first produced under an award; and (2) authorize others to receive, reproduce, publish, or otherwise use such data for Federal purposes." Does the Federal Government then own such data, to the total exclusion of the investigators performing the conceptualization, planning and implementation of the investigation? It is unclear who the "others" may be, apart from the Federal Government. What does "Federal purposes" mean?

Although the draft Notice itself makes clear that data has to first be published before it is FOIA discoverable, the supplemental information section has sentences that do not clearly state this stipulation. They could/should accordingly be qualified. Please note that the three year time limit on the retention of data by grantees may not allow researchers to complete the analysis or publication that has been started.

Circular A-110 presents agencies and grantees with potentially large bureaucratic and administrative burdens that may not be compensable. Data gathered in response to a FOIA request, but not obtained solely in response to a FOIA request, also imposes a financial burden on the recipient and applicable subrecipients. Presumably, such production costs are covered under the "fees that the agency may assess under the FOIA (5 U.S.C. 552(a)(4)(A))." However, direct production costs do not include a myriad of costs such as the compromised efficiency of an office that has been burdened with numerous FOIA requests. Circular A-110 has not adequately considered the administrative costs/burdens placed on grantees and Federal agencies. OMH recommends that Agency Officials be allowed to determine guidelines and appropriate charges.

If you have any questions regarding these comments, please call Olivia Carter-Pokras, Ph.D. at (301) 443-9923.

Nathan Stinson, Jr., PhD, MD, MPH