No items for Senate action are included in this report.

During the academic year 2001-02, the Committee on Research (C-Res) met nine times, including one public meeting, to address issues related to University research policy and its implementation. The Committee took the following actions during the 2001-02 academic year:

1. Revised the format and content of the annual faculty disclosure and certification of compliance with the Faculty Policy on Conflict of Commitment and Interest. This revision was completed in advance of the conversion of that disclosure and certification to a campus-wide web-based application.
   
   
2. Approved a revision to the University's policy on Scientific Misconduct, clarifying the applicability of the policy.
   
   
3. Asked for and received clarification from the Provost regarding the combination of leave of absence and sabbatical leave for the faculty.
   
   

In addition, the Committee discussed the following subjects and determined that, in these areas, current policy and requirements are adequate:

1. Possible regulatory requirements related to educational programs related to the "Responsible Conduct of Research," and the current status of such programs at Stanford.
   
   
2. Policy requiring a waiver for delays of more than 90 days in the publication of research results.
   
   

Each of these is discussed in greater detail in the following sections of this report.

1. ANNUAL DISCLOSURE AND CERTIFICATION OF COMPLIANCE WITH THE FACULTY POLICY ON CONFLICT OF COMMITMENT AND INTEREST
   
   The Committee was asked by the School of Medicine to consider whether or not the faculty should be required to disclose ALL financial relationships with outside companies, eliminating financial thresholds for such disclosures. The question concerned financial interests in companies when those interests relate, either directly or indirectly, to research involving human subjects or laboratory animals. The question also addressed the difficulty of assessing the value of a financial interest in a privately-held, e.g., a "start-up" company. Because of the difficulty in estimating assets in such companies, the School suggested requiring an annual disclosure of any outside financial interests with no financial threshold, whenever those interests related to a faculty member's university activities
   
   Acknowledging cultural and other differences across schools and departments, University policy allows individual schools to require additional information on the annual faculty disclosure and certification. The Committee therefore concluded that the School of Medicine could modify its requirements in this regard without further review or approval by the University. The analysis of this and other questions related to the annual faculty disclosure and certification led to an in-depth discussion and analysis of the requirements of the faculty policy and of the disclosure process.
   
   Independently of Committee action, the School of Medicine had developed and now uses a web-based application for the submission of the annual disclosure and certification required by this policy. With support from the Dean of Research Office, an application is being developed for campus-wide use. The Committee therefore devoted considerable attention in the year 2001-02 to the format and content of the annual disclosure and certification, in advance of the conversion of this form to a campus-wide web-based application.
   
   In an iterative process carried out through a series of meetings, the Committee reviewed the content and format of the annual disclosure and approved a revised series of questions to accommodate electronic filing and review. The application will present background information on the policy itself, as well as explanations of situations and cases involving potential conflicts of commitment and interest. Based on the organization and content of the Faculty Policy on Conflict of Commitment and Interest, the application would walk the faculty member through a series of "yes/no" questions concerning their activities for the previous year. The application would request additional clarification only where the faculty member indicated an activity or outside interest requiring explanation.
   
   At the Committee's public meeting on May 20, 2002, the proposed content and format of the online application were demonstrated and discussed.
   
   During these discussions, the Committee clarified and refined the following components of the annual disclosure and certification required by policy:
   
   
   1. No outside financial interest needs to be disclosed unless the outside entity is related in some way to the faculty member's teaching, research or administrative work on behalf of the University. Therefore, the annual disclosure form first asks the faculty member to review his/her activities where companies or other outside entities are involved, then to identify their financial interests (of those of an immediate family member), if any, in those companies.
      
      With regard to relevant financial interests, the new disclosure form eliminates financial thresholds for equity in privately-held companies (generally "start-up" companies). Equity in publicly-traded companies and other financial interests would be categorized as one of the following:
           under $10,000;
           between $10,000 - $50,000;
           between $50,000 - $100,000;
           over $100,000.
      
      
   2. Conflicts of commitment may arise and are addressed in the policy in the following areas:
      
      1. Outside consulting
      2. Holding a management position at an outside company
      3. PIship through an outside entity different from Stanford University
      4. Other professional activities that might detract from a faculty member's ability to carry out University responsibilities
         
         
      The revised disclosure form asks specifically about each of these circumstances.
      
      
   3. The Faculty Policy on Conflict of Commitment and Interest also includes specific requirements in the following areas, and a related question has therefore been included on the disclosure form:
      
      1. Presence on campus
      2. Free and open exchange of research results
      3. Use of university resources
      4. Ownership of intellectual property.
         
         
   In addition, the committee developed several recommendations related to the online application by which faculty members would file their disclosures:
   
   
   1. A "home page" should first explain the following important points related to University policy:
      
      
      1. The existence of outside financial interests or activities is not in itself a violation of any rule. Some appearances of conflicts of commitment and interest frequently occur. Stanford's policy seeks to manage potential risk through disclosure.
         
         
      2. This policy exists, and these disclosures are required, in order to protect individual faculty members and students. Appropriate disclosures can avoid serious difficulties for the individual and for Stanford University.
         
         
      3. Disclosures are confidential and will be viewed within Stanford only by those who have the appropriate authorization, i.e., school deans and those whom they name for this purpose, and individuals named by the Vice Provost and Dean of Research for this purpose.
         
         On this last point, the Committee recognized that the University must assure the security of the information disclosed by faculty members, while also recognizing that such information may be subject to subpoena by authorized government agencies or sponsors. For that reason, the wording of the annual certification was modified to say: "I supply this information for confidential review by Stanford University and for such other limited purposes as are required by law, contract or regulation. I do not authorize release of any of it for any other purpose."
         
         
   2. Different schools and departments may have differing expectations regarding the University responsibilities of its faculty members. For that reason, the annual disclosure asks broad rather then limited questions. The Committee suggested that each question be linked directly to the explanation of that particular issue within the policy. They also suggested that illustrations and examples be provided in the context of circumstances and situations that might arise in different schools. These should be made available as links within the application.
      
      
   Provided with this annual report are two attachments related to this activity:
   
   

   Attachment A, Faculty Policy on Conflict of Commitment and Interest
   
   Attachment B, Final draft of the annual disclosure format.

   NOTE: Work on the conversion of this disclosure and certification to a web-based application began during the summer of 2002. It is expected to be implemented in the fall of 2003, with the annual disclosures related to activities during the 2002-03 academic year.
   
   
   
   
2. SCIENTIFIC MISCONDUCT
   
   The Committee reviewed and approved a revision to the University's Scientific Misconduct Policy. The policy, as revised, is provided as Attachment C to these minutes.
   
   The revision incorporates a new discussion of applicability, specifying that defined procedures for allegations, inquiries and investigations of scientific misconduct will be applicable to:
   
   
   1. research conducted at Stanford University by Stanford personnel,
      
      
   2. research conducted elsewhere by Stanford personnel as part of their Stanford University responsibilities, and
      
      
   3. at Stanford's discretion, to research where there is a claim that the work was done at Stanford or by someone claiming a Stanford affiliation.
      
      
   The revised policy also clarifies that other alleged misconduct, including serious academic deficiencies which are not defined as scientific misconduct, are to be addressed by the cognizant dean, or by initiating the appropriate disciplinary procedure. The policy does not change the definition of scientific misconduct, nor does it change requirements related to allegations, investigations and reporting of alleged scientific misconduct.
   
   
   
   
3. FACULTY LEAVE AND SABBATICAL ABSENCE
   
   At the request of the School of Engineering, the Committee directed a request to the University Provost for clarification of the limits on faculty absence from campus, specifically whether leaves of absence can be combined with sabbatical leave for extended absence.
   
   The Provost responded that University policy, as defined in the Faculty Handbook, allows for the possibility that a faculty member, with the approval of a department chair and school dean, could, in a seven-year period, have two years of leave other than sabbatical and sabbatical leaves of more than one year distributed over the same time. Thus, absences of more than three years within a seven-year period are possible. The Provost, however, made the comment that this was unlikely because of the time that it takes to accrue sabbatical eligibility. He also indicated that he would consider setting an upper bound on combined absence, and would seek input on this question from school deans.
   
   

1. "RESPONSIBLE CONDUCT OF RESEARCH"
   
   On December 1, 2000, the Office of Research Integrity (ORI) of the US Department of Health and Human Services adopted and published the final Public Health Service (PHS) Policy on Instruction in the Responsible Conduct of Research. The proposed policy would have required instruction for all research staff (defined as "staff at the institution who have direct and substantive involvement in proposing, performing, reviewing, or reporting research, or who receive research training supported by PHS funds or who otherwise work on the PHS-supported research project even if the individual does not receive PHS support") in the following nine "core instructional areas:"
   
   
   1. Data acquisition, management, sharing, and ownership
   2. Mentor/trainee responsibilities
   3. Publication practices and responsible authorship
   4. Peer review
   5. Collaborative science
   6. Human subjects protection
   7. Research involving animals
   8. Research misconduct
   9. Conflict of interest and commitment
      
      
   In considering a possible response to this requirement, the Committee engaged in a conversation with Professor Ernle Young, co-Director of the Stanford Center for Biomedical Ethics, and the creator of Stanford's Responsible Conduct of Research Course (Med 255). This course is offered annually as part of the PRECEPT Program, completion of which is a requirement for any "trainees," including postdoctoral scholars, supported by the National Institutes of Health (NIH).
   
   The Committee considered the content and format of existing programs at Stanford and elsewhere and discussed several issues including curriculum, methods, campus-wide applicability, and particular content areas. The Committee did not formulate any specific recommendations for additional requirements or programs at Stanford, but did reinforce the fundamental importance of trust and confidence to the research enterprise - trust by researchers and by the general public in the integrity of work done by others.
   
   On February 5, 2001, the ORI received a Congressional inquiry raising concerns about the rule-making process used in this case. In its response, the ORI announced that new requirements in this regard would be suspended while the regulation was under review. New requirements were not promulgated during the remainder of the academic year.
   
   
   
   
2. PUBLICATION DELAYS
   
   The Committee was asked to consider a revision to the policy related to publication waivers. Stanford's Openness in Research Policy allows for a delay of up to 90 days for publication of results, particularly in the case of multi-site studies for which a publication committee receives data from participating sites and make decisions about joint publications. In these cases, the Dean of Research has the authority to approve a waiver for a longer delay in publication. In practice, such waivers have been approved for periods of up to two years.
   
   The Committee was asked to consider a blanket waiver whereby such requests could be automatically approved in the case of multi-center clinical trials, where all other requirements of the policy have been met. The Committee concluded that case-by-case review was appropriate in these situations and therefore no policy change was needed.
   
   
   
   

The annual public meeting of the Committee on Research was held on May 20, 2002 in Room 101 of the Packard Electrical Engineering Building. In addition to Committee members, approximately 30 other guests attended.

The agenda for this meeting centered on the Faculty Policy for Conflict of Commitment and Interest, and on the Committee's work on the content and format of the annual disclosure and certification. Ann Arvin, Associate Dean of Research, presented issues that often come up in the context of conflict reviews. Ann George, staff to the Committee, demonstrated a model of how the electronic disclosure would work. Those in attendance asked general questions about the policy and the disclosure format, but raised no objections to the proposed disclosure model.

Elisabeth Paté-Cornell (Chair)
   Management Science and Engineering, Chair
Tareq Al-Naffouri
   Graduate student member, Electrical Engineering
Brian Cantwell
   Aeronautical/Astronautical Engineering
Mildred Cho
   Academic Staff, Center for Biomedical Ethics
Ronojoy Ghosh
   Graduate student member, Aero/Astro Engineering
Paul Goldstein
   Law School
James Harris
   Electrical Engineering
Baljeet Kaur
   Postdoctoral Scholar, Medicine/Gastroenterology
Shawn Kerrigan
   Graduate student member,Civil/Env'l Engineering
Margaret Neale
   Graduate School of Business
John Perry
   Philosophy/CSLI
Mary Lake Polan
   Gynecology & Obstetrics

Ex Officio:

Charles Kruger,
   Vice Provost and Dean of Research and Graduate Policy
Ann Arvin 
   Associate Dean of Research

School representatives:

John Brauman
   School of Humanities and Sciences
James Nelson 
   School of Medicine
Jeff Koseff
   School of Engineering

Other regularly-invited guests:

Tom Fenner
   General Counsel Office
Katharine Ku
   Office of Technology Licensing
Geoff Grant
   Office of Research Administration

Staff:

Ann George
   Assistant Dean of Research

1. Faculty Policy on Conflict of Commitment and Interest
   
   
2. Model for a web-based disclosure and certification of compliance with the Faculty Conflict of Commitment and Interest policy
   
   
3. Scientific Misconduct: Policy on Allegations, Investigations, and Reporting