Discussion
This study focused on federal limits applied to research conducted by Universities working under contract. It is not possible, without significant funding, to review all forms of restriction by both public and private funders to all types of entities at all levels of government. We examined university research and federal contractual restrictions because judicial policy —explicitly recognized by at least one federal cabinet department—suggests that there are real limits to what conditions the government can attach to its funded research. Where a contract involves the acquisition of data by academic researchers, rather than funding of the research itself, the case for broadly recognized rights would appear to be even stronger.

Our recommendations to the exploratory committee are as follows:

1. Applying the 2005 Federal Register intent to all restrictive clauses: The problems with rights in data clause negotiations suggest that the spirit of the Federal Register notice should go beyond confidentiality clauses and should be applied to all clauses in contracts, whether DUAs or funded research. The government can properly claim the right, in our view, to take steps to ensure that prior to publication, confidentiality and privacy restrictions have been honored. This right though needs to be bounded by strict timelines in order to keep from degenerating into a prior restraint de facto.

2. Encouraging review and comment rights: The federal government may wish to encourage review and comment rights, particularly where it considers data SBU, and researchers might be wise to honor such requests, if properly time-bounded. Federal officials’ comments can be exceedingly valuable if obtained in a timely fashion prior to publication.

3. Eliminating SBU from the health services research lexicon: No one really knows what this means and the federal government continues to use a subjective (and thus potentially unconstitutional) test. HSR data simply are not the type of data that are sensitive in our view. They might sometimes be embarrassing, but cost, quality, safety, and access issues in health care simply are not “sensitive.”

4. Drafting sample clauses: AcademyHealth should consider the development of sample clauses applicable to privacy, confidentiality, and rights in data, that would meet government needs without crossing the boundaries of legality.

5. Facilitating discussion among federal contract officers and University officers: Everyone we spoke with asked for clarification. AcademyHealth might consider training university officers on this topic at the ARM and sponsoring a daylong special session with the government to explore the issues as they apply to health services research.

6. Exploring the issue at the state level: It is evident from our discussions that state government conduct in a prior restraint context poses an equally important matter of concern.

7. Privately funded Research: The legal situation for publication restrictions in work funded by not-for-profit and for profit entities differs from that for government. From the perspective of users of research findings, these differences may be less clear, yet such restrictions may differentially affect how research is interpreted and evaluated. If the goal of our efforts with respect to publicly supported research is to achieve an “influence free” standard, we should offer a mechanism whereby private funders can write contracts and grants that meet such a standard. Model language and expectations would also be helpful.

During the special session held at the ARM (see Appendix A), participants also made suggestions for additional action AcademyHealth might consider taking in support of publication freedom:

Educational Primer
While some universities have developed an in-house expertise at negotiating federal contracts, other universities and other non-university-based settings, which negotiate fewer contracts, are less adept at this process. These organizations would benefit from an educational primer which outlines common pitfalls that are encountered during a contract negotiation, including processes to reach a satisfactory agreement. The primer could also address challenges that may arise during the course of the research project and at the point of publication. The primer might be structured for a variety of users (researcher, university, funder, prime contractor, subcontractor). The primer should include restrictions that can also appear in DUAs.

Policy
AcademyHealth might consider adopting a policy statement supporting a set of best practices in contract negotiation. The policy might also support a set forth best practices related to the review and comment process for draft manuscripts and DUAs.

Model Language
Participants at the AcademyHealth ARM suggested that AcademyHealth develop model contract language based on language which has proven successful in ensuring publication freedom.

We have not tested what the response to model language would be from federal agencies. Some policymakers may reject it, while others might find it to be a helpful platform from which to negotiate. Similarly, while universities competing for federal dollars may not want to adopt uniform contract language, they too might find model language to be helpful in the negotiation process.

Finally, we might further explore the following:

Collaborations
During the course of our interviews, we learned of two entities which may serve as natural partners in our effort to address publication restrictions.

• Federal Demonstration Partnership (FDP) - The FDP is a cooperative initiative among 10 federal agencies and 98 institutional recipients of federal funds that meets 3 times each year. The purpose of FDP is to reduce the administrative burdens associated with research grants and contracts. For more information on this initiative, see http://thefdp.org.
  
• Council on Government Relations (COGR) - COGR is an association of research universities. Its primary function is to provide advice and information to its membership and to make certain that federal agencies understand academic operations and the impact of proposed regulations on colleges and universities. COGR helps to develop policies and practices that fairly reflect the mutual interests and separate obligations of federal agencies and universities in research and graduate education. For more information, see http://www.cogr.edu.

Legislation
AcademyHealth could work with its advocacy arm, the Coalition for Health Services Research, and others interested in scientific research, to reach out to policymakers in an effort to clarify relevant authorizing and appropriations statutes. The Coalition might develop strategies to encourage more broad-ranging changes in governmental practice and custom where control of research output is concerned.

AcademyHealth and/or the Coalition might consider how it could support two relevant pieces of legislation:

• Federal Research Public Access Act of 2006, S. 2695—On May 2, 2006, Senators Cornyn and Lieberman introduced the “Federal Research Public Access Act of 2006,” S. 2695. The purpose of this Act is, “To provide for Federal agencies to develop public access policies relating to research conducted by employees of that agency or from funds administered by that agency.” The Congressional Record reveals that the impetus of this bill is to provide better value to American taxpayers by increasing their access to federally-funded research. The bill requires all agencies to develop public access policies and to deposit articles that result from federally-funded research in free, publicly-accessible archives within six months of publication.15 In this way, the Congress can ensure that Americans do not have to pay twice to see the results of the research funded with tax dollars. At least 48 universities have expressed their support for the legislation.16
  
• Bill to Protect Scientific Integrity in Federal Research and Policymaking, S. 1358—In June 2005, Senator Dick Durbin (D-IL) introduced a “Bill to Protect Scientific Integrity in Federal Research and Policymaking,” S. 1358. This bill prohibits federal employees: (1) from tampering with the conduct of federally-funded scientific research or analysis, (2) from censoring findings of such research or analysis, or (3) from directing the dissemination of scientific information known by the directing employee to be false or misleading. Representative Henry Waxman (D-CA) introduced a similar bill, H.R. 839, in February 2005. The bill is currently under consideration by the Senate Committee on Homeland Security and Governmental Affairs.