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Historical Analysis of Ownership & Publication Rights in Government Contracts for Health Services Research

Interview Results: Key Themes

1. Culture/Custom

The general consensus of those we spoke with is that less federal funding is being awarded through grants and more is being awarded though contracts, which allows government agencies to impose greater restraints. Researchers who became accustomed to greater freedoms in a grant environment are resistant to contract-based limitations.

There is a general sense that government agencies are becoming increasingly inflexible regarding a researcher’s publication rights. With more limited research funds available, this places the universities in a difficult negotiating position.

We heard that “every funder has an answer they want” and funding agencies want contractors to be discreet. Yet, researchers question the validity of federal agencies acting more like corporate funders in what is becoming a more prescriptive environment. The increased politicization of federal agencies seems to be shaping the research environment and fostering a contract-heavy procurement process.

2. Misinterpretation of authorizing legislation

University contracting officers pointed out that in its aggressive use of contracting powers, some government counterparts misinterpret the Public Health Service Act. Some government contracting officers contend that in order to comply with their authorizing legislation, they must review and approve products produced with federal funding to ensure quality. The scientific community would argue that quality is maintained through the peer-review process and through timely publication.

3. Misapplication of FAR provisions

Some government contracts contain blanket prohibitions for limited needs. Government contracting officers often insert boilerplate clauses without fully understanding the purpose behind the research. For example, restrictive language on publishing may be included when the real intent of the agency is to protect human subjects. University contracting officers find that confusion can arise when their government counterparts are unfamiliar with the “science” behind a project.

During the negotiation process, these misapplications of FAR provisions may be identified, but are only corrected if the government contracting officer is open to examining the underlying purpose behind the contract clauses and the appropriateness of their use vis-à-vis the specific project. When contracting “by the book” is not appropriate for the underlying project, the contracting officer may need input from the Principal Investigator to clarify the structure of the research study.

4. Lack of knowledge of revisions to HHSAR, lack of institutional knowledge by contracting officers

The contract provisions originating with an HHS-based agency that are associated with the release of information are largely governed by HHSAR, the agency’s supplement to the FAR. HHSAR 352.224-70, created in 1984, addresses Confidentiality of Information. This provision has been particularly problematic for university contracting officers because of its prohibition on the release of a researcher’s findings if the results are of such a nature that premature release would cause injury to the public health. University contracting officers were able to temper this broad prohibition by invoking an additional section of the regulation, which provided that parties to the contract could specify the subject matter covered by the prohibitions. Therefore, if the government agency refused to delete the clause, the university could specify the subject matter that would fall within its parameters. In 2005, universities received even more relief when HHSAR 352.224-70 was revised to eliminate the prohibition dealing with threats to public safety.

The challenge for university contracting officers is negotiating with government counterparts who do not have historical knowledge of applicable regulations, or revisions to HHSAR.

5. Sensitive But Unclassified (SBU)

Another means to restrict disclosure and publication rights for federally-funded research is use of “sensitive but unclassified” (“SBU”) secrecy clauses. SBU is not well-defined in federal regulations, and the phrase is made more vague by the fact that not all agencies use this exact term. Some agencies will use phrases such as “for official use only” instead. The result of this label is a limitation or restriction on the disclosure and publication of the results of research.

Scientists in the mid-1980s opposed the use of SBU secrecy clauses. “The presidents of Stanford, Caltech, and MIT jointly informed the White House in early April 1984 that their universities would refuse to conduct certain kinds of sensitive, but unclassified, scientific research for the Pentagon if DOD reviewers were given the power to restrict the publication of findings.”13 In addition to infringing on academic freedom, inclusion of SBU clauses is at odds with the national security policy which calls for an open policy for unclassified fundamental research.14

Our literature review indicated that SBU is a category that appears in research for the Department of Defense or other research related to national security. Our interviews, however, revealed that SBU is also used within HHS. One interviewee’s agency recently revamped its process for awarding IDIQ contracts. The interviewee explained that in response to complaints about the contracting process, and specifically in response to complaints about publication restrictions and lengthy notice and comment periods, the agency had developed a classification process. The new IDIQ’s classify task orders into “policy sensitive” and “not policy sensitive,” with separate review processes for each. Any task orders involving research that the agency deems “policy sensitive” must undergo agency approval prior to publication and disclosure, but task orders that are not policy sensitive can be published after a reasonable period of notice and comment. The interviewee indicated that the agency had received positive feedback on this revised process, although only a handful of contracts have been awarded under this new process. The interviewee indicated that the agency had worked with its general counsel’s office to develop and implement this new process. Significantly, the determination as to what is policy sensitive is an ad-hoc determination, made at the program level.

   

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