Findings from Legal Research
Our legal research focused on pertinent case law relevant to government contracts with universities that fall under FAR, FAR provisions and amendments, approximately 40 RFPs governed by FAR from publicly available Web sites, along with actual contracts and data use agreements (DUAs) provided to us by interviewees.4

Government Contracting and the FAR
Government contracting is a highly regulated aspect of contract law that follows uniform policies and procedures. The acquisition of supplies and services by all government agencies is governed by the FAR.5 The FAR provisions were developed to assist the government in contracting for timely, high value products and services, while maintaining the public’s trust and fulfilling public policy objectives.

The FAR govern all government contracts, which are used when the agency’s purpose is to acquire goods or services for the direct benefit or use of the Federal government. Government contracts are distinguishable from grants and cooperative agreements, which are broader agreements that are used either to transfer a thing of value to a state or local government or to promote a broader national interest. The government agency is generally involved in a more “hands-on” manner in the case of contracts than in grants or cooperative agreements and FAR governed contracts encompass “work-for-hire” agreements that use private contractors do carry out government activities. Some agencies have created supplements to the FAR. For example, the Department of Defense has promulgated the “DFARS,” the Defense Federal Acquisition Regulation Supplement. Health and Human Services (HHS) also supplements FAR.

It has been recommended that FAR be required for all healthcare organizations given the large volume of money spent on the industry; government grants to healthcare industries have exceeded $1 trillion/year. Currently, however, the FAR only apply to government contracts and not to research grants or cooperative agreements in the healthcare industry. Other regulations, such as Office of Management and Budget (OMB) circulars, apply to grants and cooperative agreements.

First Amendment Jurisprudence, Universities & Academic Freedom
The First Amendment provides for broad protections against government intrusion upon free speech, imposing a high standard of proof on official efforts to limit free speech and restrict what can enter the “marketplace of ideas.” In particular, any attempt to place a prior restraint on speech, that is, to restrict an idea before it has had a chance to enter a public forum, is presumptively unconstitutional.

In situations in which government provides funds aimed at achieving a specific policy goal or message, the Supreme Court has afforded the government broad leeway to show preference for specific policies and to subsidize favored viewpoints. In the controlling case on this issue, Rust v. Sullivan, the Supreme Court upheld an HHS regulation (known as the Gag rule) that prohibited recipients of Title X family planning funds from engaging in abortion counseling activities with federal funding.6 The Rust holding reaches broadly, stating that “The Government can, without violating the Constitution, selectively fund a program to encourage certain activities it believes to be in the public interest, without at the same time funding an alternative program which seeks to deal with the problem in another way.”7 Thus the government enjoys the power to make decisions on how to allocate federal resources, regardless of whether the allocation decisions include viewpoint regulations.

At the same time, in upholding the restriction at issue in Rust, the Court explicitly found that the government was not restricting speech in traditionally open forums, and specifically mentioned universities as one such open forum. Significantly, the Court stated, “we have recognized that the university is a traditional sphere of free expression so fundamental to the functioning of our society that the Government’s ability to control speech within that sphere by means of conditions attached to the expenditure of Government funds is restricted by vagueness and overbreadth doctrines of the First Amendment.”8

While Rust is the controlling Supreme Court precedent on this topic, a federal district (trial) court in the influential Federal Circuit had occasion in 1991 to rule on a specific case of attempted prior restraint against a university. In Board of Trustees of Leland Stanford Junior University v. Sullivan, the court struck down application of certain provisions of the HHS/FAR (“HHSAR”) to university research as unconstitutional under the First Amendment.9 A copy of the Stanford decision is included in Appendix B.

Although a federal trial level court normally would not be controlling case law, in 2005, HHS revised the HHSAR to acquiesce to the Stanford decision, meaning that its principal holding striking down prior restraint in a university research context was explicitly to be honored. Although Stanford focused on a contract between the government and a university, the government presumably could not condition a university’s subcontracting rights on its willingness to forego freedom of speech. The thrust of the decision therefore would carry over to situations where a university is a subcontractor to another entity who holds the prime contract.

The HHSAR revision was published in the Federal Register on January 3, 2005.10 The relevant pages of the federal register from January 3, 2005 can be found in Appendix C.

Requests for Proposals
Our review of over 40 RFPs available on public and government websites (such as agency websites and www.fedbizopps.gov), revealed that most RFPs did not expressly restrict publication or disclosure of data. Several recent RFPs, however, indicate that one or more HHS agencies have started to include restrictive language in RFPs. Appendix E contains a sample of the restrictive language found in these recent RFPs.

Contracts
Some of our interviewees from universities allowed us to examine their contracts. A number contain problematic clauses in light of Stanford. Some of the more problematic clauses in HHS contracts include the “confidentiality of information” clause (HHSAR 352.224-70), and the “rights in data – special works clause” (FAR clause 52.227-14). The confidentiality of information clause was modified in 2005 in response to the Stanford decision, as discussed above. The modifications to this clause are reflected in Appendix D. The “rights in data – special works” clause grants to the government the right to control data generated by contractors. The text of this clause, which is not addressed in the 2005 Federal Register rule, is included in Appendix D as well. It creates an absolute restriction on the publication or dissemination of this data. Interviews with contracting officers revealed that this clause has been used more frequently in contracts for basic science and research over the past few years, and some university contracting officers believe it has been inappropriately applied. University contracting officers generally attempt to have this clause removed or modified if it appears in a contract for health services research.11

In addition to these FAR/HHSAR provisions, some university contracting officers have noted the appearance of unique clauses in contracts with HHS agencies. For example, some HHS agencies have crafted special clauses restricting the use and publication of data and analyses generated by contractors. Other clauses restrict the use of the agency logo or other information identifying the agency as the source of funding for the research if information is published without the agency’s review and approval.

Data Use Agreements
During the roundtable discussion in Seattle, members addressed concerns that clauses restricting publication and disclosure of data might be contained in data use agreements. Accordingly, after the June meeting in Seattle, we reviewed several data use agreements provided to us by some of the university contracting officers we interviewed for this effort. We were able to review three such agreements. In addition, one of the authors of this analysis had occasion to negotiate a DUA with an HHS agency during the preparation of this report. Her experiences are described here.

One of the agreements examined contains clauses guarding the confidentiality of the information contained in the data set, including agency review and approval in order to ensure that no breach of confidentiality has occurred. The DUA contains no prior restraint on content.

Another DUA includes FAR clause 52.227-14, “Rights in Data – Special Works,” one of the problematic clauses that has appeared in other government contracts for health services research. This DUA includes a provision requiring the contractor to provide proposed publications using the data for review and comment. Although the clause does not require agency approval of the draft, it allows the agency two months to comment and suggest changes. It also requires written notification to the agency that the publication maintains privacy and confidentiality of the individuals whose information is supplied by the DUA, ensures the quality of statistical and analytical work, and ensures that the information was used expressly for the purposes for which it was supplied. This notice is required prior to publication. If the agency and the researcher do not agree prior to publication, the researcher must include a statement disclaiming agency endorsement of the work.

The third DUA that we reviewed does not contain specific FAR or HHSAR references, but contains numerous provisions establishing the right of the government to review and approve the content of research using the data, apart from review rights relating to matters of privacy, security, and confidentiality. These broadly stated provisions would appear to amount to a prior restraint, thereby running afoul of Stanford and the underlying intent to the revisions of HHSAR.

Over the course of this study, one of the three authors negotiated a DUA that was replete with “review and approve” restrictions unrelated to the need to ensure compliance with privacy and confidentiality requirements. When questions were first raised, the agency responded by sending a special DUA marked for University research. This alternate DUA substituted review and comment rights for review and approve rights and set comment time periods. Nonetheless, in order to secure access to the data at all the author has had to provide exhaustive information regarding the type and content of the research to be conducted, the source of the funding, and detailed explanations of the need for individual-level data. Although some of this information might be justifiable to ensure that no individually identifiable information is made available unless absolutely necessary, the level of detail demanded, particularly questions regarding the content of research and source of support, would appear to skirt the edges of Stanford and certainly appear to step over the edges of the decision’s intent. Preventing access to the data at all until the content of future speech is disclosed appears to be simply a point along the same continuum.