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Interactive Public Docket

COMMENT BY: American Lung Association
SUBJECT:Against proposed revision to OMB Circular A-110
DATE:MArch 24, 1999

Mr. Charney:

On behalf of the American Lung Association (ALA), I am contacting your to express our strong concern with proposed changes to OMB A-110 published in the Thursday, February 4 edition of the Federal Register (Vol. 64, No. 23, p. 5684). The proposed rule will have a severe negative impact on the development of public health policy and will ultimately harm our nationís health.

The ALA does recognize the steps OMB took to narrow the scope of changes to OMB Circular A-110. The underlying legislation enacted by Congress was extremely broad and damaging. The narrow interpretation proposed by OMB is a small positive step. Despite the good intent of OMB, the proposed rule is fatally flawed and cannot be fixed within the regulatory process.

POLICY CONCERNS

The ALA strongly urges policy makers to repeal the underlying legislative provision amending OMB Circular A-110. While we recognize repeal of the underlying legislation is not within the power of the OMB and is not an option in the regulatory process, the ALA felt it important to take this opportunity to express our strong opposition to the underlying legislation. The ALA recognizes there are legitimate issues that need to be resolved regarding public access to federally funded research information. However we strongly believe that the FOIA is not the appropriate vehicle to address these concerns.

Again, while we recognize this is not within the scope of OMB authority, the ALA is extremely concerned that the underlying provision was inserted into the FY99 Omnibus Appropriations bill without public input. We strongly recommend policy makers engage in a public hearing process to solicit input from the many different communities involved in the collection, dissemination, consumption and use of research data. It is only through this public process that a workable solution to the real issues surrounding public access to federally funded research information can be achieved.

The ALA recommends a 90 day extension in the open public comment period. As our following comments will demonstrate, the implications of the proposed OMB Circular A-110 are very complicated and will have pronounced impacts on the U.S. research enterprise. Sorting out complexities regarding what constitutes, "data", when information is "published" and when a federal agency is using research data to set "policy" is a difficult process. To reach a common understanding of these key terms will take an extensive, iterative public discussion. Reaching an agreement of these terms cannot be accomplished in the 60 day comment period.

Additionally, understanding the legal implications of the proposed rule will take more time. We are especially concerned with impacts the proposed rule will have on the Bayh-Dole provision dealing with patenting of research findings supported by public funds. Developing an informed legal understanding of the Bayh-Dole implications will take time. Providing thoughtful comments on how best to coordinate the impacts of the proposed OMB Circular A-110 with the Bayh Dole provision will take even more time. We strongly urge a 90 day extension of the public comment period to accomplish these tasks.

The ALA is gravely concerned that the proposed changes in the OMB Circular A-110 will be used a tool to harass researchers engaged in research with public policy implications. American Lung Association volunteers are engaged in a wide range of research pursuits, including studies of the health effects of air pollution, tobacco use and work place safety. Recent research findings in all three of these areas have prompted state and federal governments to take active legislative and regulatory actions to protect the health of the American people in these three areas. Many of the legislative and regulatory actions, though needed and fully appropriate, were not welcomed by certain industries that wanted to maintain the status quo. Additional research into the health effects of air pollution, tobacco use and work place safety may support further government protections.

Under the proposed amendments, industries that have a financial interest in opposing additional government protections on clean air, tobacco control and work place safety will be able to use the Freedom of Information Act (FOIA) to harass federally funded researchers who are doing work in these areas. If research data becomes subject to FOIA requests, impacted industries can easily tie up researchers time and energy by filing endless requests for data. Additionally, once these vested interests have the data in hand, they may try to unfairly discredit the data, forcing researchers to spend additional time, energy and resources to defend the validity of their data.

The ALA believes this is an inevitable outcome of the proposed OMB Circular A-110 amendments. As currently drafted, there are no protections to prevent this type of harassment activity. Similarly, the exception clauses in FOIA would not prevent harassment activity either. We are concerned the current mechanisms of OMB Circular A-110 and FOIA cannot be altered to ensure harassment of individual researchers does not become common place.

Furthermore, should the proposed changes to OMB Circular A-110 occur, research harassment or the threat of research harassment will dramatically reduce the flow of valid scientific data that is needed to establish public health standards on issues like clean air, clean water, work place safety and other public health issues. The proposed rule will effectively deter the development of valid data that supports the development of needed public health standards. At a time when the scientific community is gaining valuable information on how environmental exposures impact our nationís health, the policy proposed in OMB Circular A-110 is ill-considered.

The proposed rule will breach patient confidentiality protections necessary to conduct clinical research.

One of tenants underlying clinical research ó research conducted with human subjects ó is confidentiality. Participants in clinical trials feel protected in knowing that information regarding their medical history and participation in clinical trials is held in strict confidence between participant, the researcher and hosting research institution. Without this assurance, recruitment for clinical research becomes nearly impossible.

The proposed amendment to OMB Circular A-110 greatly impinges on this necessary confidentiality. While the ALA recognizes that FOIA exemptions protect data that could reasonably be used to identify individuals, merely removing unique identifiers from data will not completely ensure privacy of clinical trial participants. Even if reasonable confidentiality protections could be ensured, responsible researchers would have to inform study participants that data regarding them could become publicly available. Potential participants will have a legitimate concern that their "confidential data" would not truly be confidential. This would have a chilling effect on clinical trial recruitment. Additionally, FOIA exemptions provides confidentiality for individuals, not institutions. The confidentiality of research conducted on organizations or institutions would not be protected.

The proposed rule will dramatically increase research administration costs in the U.S. Prior to the proposed change in OMB Circular A-110, data was "owned" by institutions hosting the research. It was the responsibility of the researcher and the hosting research institution to "house" the data. The proposed change in Circular A-110 would essentially say the federal government owns the data. Federal research institutions would now be responsible for collecting and storing research data. Federal granting agencies would also be responsible for receiving, administering and judging the validity of FOIA requests. The collection, storage of data, and the administration of FOIA requests is a function most federal granting agencies are not equipped to do. To meet this new responsibilities would require significant dedication of new funds to support these activities. While we recognize the proposed OMB Circular A-110 allows agencies to charge for FOIA requests, the rule does not appear to allow grantees to recoup costs for complying with FOIA requests. We are concerned that much of the burden related to FOIA requests will be passed on to grantees, who have no ability to recoup the costs.

The proposed rule will reduce incentives for public/private research initiatives. The present legislative language applies to data funded in whole or in part by the federal government. This raises concerns for researchers with some federal support who have collaborative studies supported by private entities. Requiring full public access to data for which the federal government may have made minimal contribution to is a strong disincentive and will lead to less public/private research collaboration.

PROPOSED DEFINITIONS

The ALA strongly believes the proposed changes to OMB Circular A-110 will lead to harassment of researchers, increased research costs, less public/private research cooperation, and will compromise patient confidentiality. These inevitable implications of amending OMB Circular A-110 are unacceptable. With these concerns noted, the ALA has the following concerns with the proposed OMB A-110 as drafted.

The term "data" is not defined. Data is not defined in the regulation or in legislation. The term "data" can be vastly expansive and can be used differently by various individuals, institutions and agencies. For example, what types of records would be considered "data" under the OMB proposed change: tissue samples, patient records, x-ray ../images?

The term "policy" is not defined. Policy can cover a broad range of federal activities including proposed legislation, rule promulgation, executive orders, agency internal policy and other federal activities. Written federal policies rarely specify the published research findings that support them. For example, federal public health measures addressing tobacco-related illnesses are literally supported by thousands of studies from many avenues of epidemiological, clinical, behavioral and basic research. Would all of this vast body of research be subject to requests under the amended OMB Circular A-110?

The term "publication" is not defined. Is "publication" limited only to articles found in scientific peer-reviewed journals? Does "publication" include other forms of data presentation such as meetings and workshops, abstracts, communications, and press reports? If a researcher is legally compelled to provide data related to a "published" finding, should only data related to that finding be released? Should all data collected in the course of a lengthy study be released? Should only data, that in retrospect supports the published findings of the specific paper be released?

Without well constructed answers to the above questions, we feel the draft amendment of the OMB Circular A-110 is unworkable.

The American Lung Association appreciates the opportunity to share our grave concerns with the proposed OMB Circular A-110. The ALA strongly believes the proposed changes to Circular A-110 represents bad public policy. While it is not difficult to predict the inevitable negative consequences of the amended OMB Circular A-110, it will take considerably more time to develop effective policies to limit the negative impacts the rule will have on the research community and the American public.

Sincerely,

Fran DuMelle
Deputy Managing Director,
American Lung Association