Research Administration Office

University of California

Memo Operating Guidance

No. 90-1

January 16, 1990

Subject: Integrity in Research: NSF and PHS Regulations and Proposed University Policy

This memorandum does three things:

Provides information about Senior Vice President Frazer's proposed University Policy on Integrity in Research and provides copies of material referenced in Senior Vice President Frazer's draft policy and transmittal letter dated December 18, 1989;

II. Alerts that an Assurance for the Public Health Service is required as of January 1, 1990; and

III. Begins the discussion about how to implement the policy with respect to subgrantees.

Each of the above subjects is discussed in the following paragraphs.

I. Proposed University Policy

A. PHS and NSF Misconduct in Science Regulations

The Public Health Service regulations on Responsibilities of Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science, effective November 8, 1989 require each institution receiving PHS support to have procedures for reviewing, investigating, and reporting allegations of misconduct in science in connection with PHS sponsored biomedical and behavioral research. The PHS regulations also require each institution to submit an annual assurance certifying that the institution has established and will comply with the policies and procedures required by PHS.

II. The National Science Foundation regulations on. Misconduct in Science and Engineering Research, effective July 1, 1987, specify what NSF staff should do if they learn of possible misconduct under an NSF award and set out responsibilities of awardee institutions.

B. Senior Vice President Frazer's Proposed Policy

Since the NSF and PHS regulations bear on academic policy, Senior Vice President Frazer issued a draft proposed policy dated December 18, 1989 for comment. See Enclosure 1. Senior Vice President Frazer's transmittal letter provides a background discussion of past efforts made within the University and University Associations on the current issue, as well as copies of the PHS and NSF regulations. The letter also references existing University policies which are not enclosed in the letter. These policies are included in this memo for your reference as Enclosure 2.

The transmittal letter states that the University has policy in place regarding the conduct of research; that the purpose of the proposed policy is to reaffirm the University's commitment to integrity in research and to ask campuses and laboratories to ensure that guidelines and procedures are in place to address allegations of misconduct; and affirms that the University must comply with the NSF and PHS regulation to be eligible for awards from these sponsors.

Assurances

The PHS regulations require each institution to submit an annual assurance certifying that the institution has established and will comply with the PHS regulation.

Enclosure 3 is a copy of the PHS 6315, Initial Assurance

Regarding Procedures for Dealing with and Reporting Possible

III. Misconduct in Science. Each campus and Laboratory received their own copy of this form from PHS preprinted with the PHS institutional cede assigned to the location. The Initial Assurance must be completed and returned no later than January 1, 1990.

Annual updates of the initial assurance will be required, along with aggregate information on allegations, inquiries, and investigations. PHS has not yet developed the form for the annual update or aggregate information that will be required.

Based on existing policies and procedures and the transmittal letter from Senior Vice President Frazer, the University of California can state that we have an existing system for responding to allegations of misconduct and that we will also comply with the PHS final regulations on the subject whenever there is an allegation concerning a PHS-sponsored project.

Unlike standard assurances which are signed by the Contract and Grant Officer, it is a local option regarding which campus official should sign the PHS Form 6315, Initial Assurance. Contract and Grant Officers should determine whether the Assurance has been submitted for their campus or Laboratory, and who the designated signatory is.

Implementation of the Integrity In Research Policy to non-University Performers

The PHS Instructions for completing the assurance state that the University will be responsible for compliance with the PHS regulations of any organization that receives PHS support through the University. At this point in time we would like to discuss internally the University's responsibility under the regulations and how the University can effectively implement the PHS regulation without assuming a direct compliance and oversight role for subgrantees. A Reply Requested letter will be issued for your review under separate cover. Until an implementation has been developed, we recommend that you do not obtain copies of the PHS 6315 Assurance for consortia members.

For further information about the proposed University policy, the contacts in the Office of the President are Ellen Switkes at (415) 643-6512 or Belle Cole at (415) 642-4301.

Refer: Barbara Yoder (415) 642-2886 ATSS 8-582-2886

Subject Index: 01, 02

Organization Index: F-375, F-711

Enclosures

cc:

AVP Moore

Director Cole

Director Switkes

David F. Mears

Director

Research Administration Office


December 18, 1989

CHANCELLORS

LABORATORY DIRECTORS

MEMBERS, PRESIDENT'S CABINET

ACADEMIC COUNCIL CHAIR SPIESS

Dear Colleagues:

Attached for your review and comment is a proposed Policy on Integrity in Research (Attachment A). The purpose of the proposed Policy is to reaffirm the University's commitment to integrity in research and to ask the campuses and the Laboratories to ensure that-guidelines and procedures are in place to address allegations of misconduct in research and to consider other aspects of integrity in research, as appropriate. Some campuses and Laboratories are already involved in this process.

Background

As you might know, during the decade of the 1980's, there has been much public attention and interest on reports of misconduct in research at some academic institutions. In the national arena questions have been raised about the ability or willingness of educational institutions to investigate vigorously and address possible incidences of misconduct in research.

That period also has been a time of self-examination for the academic community and recommitment to ethical standards. The Association of American Universities (AAU) and the Association of American Medical Colleges (AAMC) appointed committees to consider issues of integrity in research. The AAMC report, "The Maintenance of High Ethical Standards in the Conduct of Research," was issued in 1982, and the AAU "Report of the AAU Committee on the Integrity of Research" appeared in 1983. The final section of the AAU report recommends that all academic institutions develop policies which state explicitly the expectations for high standards of ethical behavior in research, the procedures for dealing with alleged misconduct, and the sanctions that apply.

In 1987, the National Science Foundation (NSF) issued a set of regulations entitled "Misconduct in Science and Engineering Research" (Attachment B). The NSF regulations require that awardee institutions "...should maintain and effectively communicate to their staffs appropriate policies and procedures relating to misconduct..." The Public Health Service (PHS) regulations on "Responsibilities of Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science" (Attachment C) were issued on August 8, 1989, and effective November 8, 1989. These regulations require each institution receiving PHS support to have procedures for reviewing, investigating, and reporting allegations of misconduct in science in connection with PHS sponsored biomedical and behavioral research. The PHS regulations also require each institution to submit an annual assurance certifying that the institution has established and will comply with the policies required by PHS.

During 1988, a group representing several higher education and professional associations, including AAMC and AAU, developed a document entitled "Framework for Institutional Policies and Procedures to Deal with Fraud and Misconduct in Research," published November 4, 1988. That document is attached to assist campuses and Laboratories with their local procedures (Attachment D).

Context for a University Policy

In the context of these events, many academic institutions, including the University of California, have been undertaking their own reviews of policies and procedures relating to investigating allegations of misconduct.

The University has a long-standing tradition of policies and procedures that regulate the conduct of research for faculty and students and provide procedures for addressing allegations of misconduct in research. These policies and procedures are set forth in the Academic Senate Bylaws, the University Policy on Faculty Conduct and the Administration of Discipline, and University Policies Applying to Campus Activities, Organizations, and Students--Part A, Student Conduct and Discipline. Other pertinent University policies pertaining to integrity in research are listed in Attachment E. Procedures for administration of discipline also exist for other academic and staff employees in accordance with applicable personnel policies and collective bargaining agreements.

Compliance with Federal Sponsor Requirements

As previously noted, the Public Health Service has issued final regulations on "Responsibilities of PHS Awardee and Applicant Institutions for Dealing with and Reporting Possible Misconduct in Science" and the National Science Foundation has issued regulations on "Misconduct in Science and Engineering Research." As a condition of award, effective immediately, the University must comply with the provisions of those Federal regulations, including provisions on confidentiality and specific reporting requirements to the sponsoring agency, for dealing with and reporting possible misconduct in science under extramural awards sponsored by these agencies.

This is a formal review of proposed policy, and appropriate notice should be provided to employees and employee organizations. If you have any questions, please call Director Ellen Switkes at (415) 643-6512 or Director Belle Cole at (415) 642-4301. Please forward your comments to Associate Vice President Moore by February 15, 1990.

Sincerely,

William R. Frazer

Attachments

cc:

President Gardner

Associate Vice President Moore

Assistant Vice President Cox

Assistant Vice President Justus

Assistant Vice President Levin

Director Rogin

Deputy General Counsel Morrison

bcc: Director Cole, Director Mears, Director Phillips, Director Switkes, Assistant Director Spitz, Coordinator Lee, Coordinator Okada, Coordinator Rader


Attachment A

DRAFT

University of California

Office of the President

December 15, 1989

PROPOSED UNIVERSITY POLICY ON INTEGRITY IN RESEARCH

Policy

It is long-standing policy of the University of California to encourage and maintain the highest ethical standards in research. This Policy reaffirms the University's commitment to integrity in research.

Integrity in research includes not just the avoidance of wrongdoing, but also the rigor, carefulness, and accountability that are hallmarks of good scholarship. All persons engaged in research at the University are responsible for adhering to the highest standards of intellectual honesty and integrity in research. Faculty and other supervisors of research activities have a responsibility to create an environment which encourages those high standards and integrity in research. Open publication and discussion, emphasis on quality of research, appropriate supervision, maintenance of accurate and detailed research procedures and results, and suitable assignment of credit and responsibility for research and publications are essential for fostering intellectual honesty and integrity in research.

University policies set forth expectations for high standards of ethical behavior for faculty and students involved in research and provide procedures for addressing allegations of misconduct in research. These-policies and procedures are set forth in the Academic Senate Bylaws, the University Policy on Faculty Conduct and the Administration of Discipline, and University Policies Applying to Campus Activities, Organizations, and Students--Part A, Student Conduct and Discipline. Procedures for administration of discipline also exist for other academic and staff employees in accordance with applicable personnel policies and collective bargaining agreements.

Misconduct means fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. Misconduct does not include honest error or honest differences in interpretations or Judgments of data./1

The University will continue to take prompt and vigorous action to investigate and address allegations of misconduct in research, based on the following principles:

Institutional and academic responsibility for self-regulation;

Mechanisms to protect to the greatest extent possible, the due process rights of the accused, the interests of those making allegations, and the public interest;

The highest degree of confidentiality compatible with an effective response and applicable sponsor reporting requirements; and

Precautions against real or apparent conflict of interest.

Campus and Laboratory Implementation

Campuses and Laboratories shall have necessary guidelines and procedures to provide appropriate response to allegations of misconduct in research. Such guidelines and procedures should specify how pertinent University policies and procedures will be used to address allegations of misconduct in research by faculty, students, and staff. Whenever extramural funds are involved, local guidelines and procedures also shall require compliance with conditions of the award, including applicable regulations issued by the sponsor of the research. Such regulations include, but are not limited to, the Responsibilities of PHS Awardee and Applicant Institutions for Dealing with and Reporting Possible Misconduct in Science (42 CFR, Part 50, Subpart A) and the National Science Foundation regulation on Misconduct in Science and Engineering Research (45 CFR, Part 689). Among their requirements, these regulations require specific reports to the sponsoring agency.

Chancellors and Laboratory Directors shall designate an official responsible for implementation of this Policy, which may include the consideration of initial reports of misconduct and, when necessary, the referral or initiation of formal investigations. Local guidelines and procedures should clarify available mechanisms for imposing appropriate sanctions or discipline on individuals when the allegation of misconduct has been substantiated.

Local guidelines or procedures may also address issues such as the responsibilities of research supervisors, assignment of credit for publications, training of research apprentices, education on research ethics, requirements for recordkeeping of experimental procedures, and data storage. Chancellors and Laboratory Directors may also designate ombudspersons to provide confidential advice to researchers, staff, and students with questions or problems related to research ethics.

Copies of local guidelines and procedures shall be sent to the Senior Vice President--Academic Affairs for review as to compliance with this Policy.

Note 1/The definition of misconduct is from the Public Health Service, Department of Health and Human Services (42 CFR Part 50, Subpart A, Responsibilities of PHS Awardee and Applicant Institutions for Dealing with and Reporting Possible Misconduct in Science), and it is consistent with the ethical principles and types of unacceptable conduct regarding scholarship listed in the Faculty Code of Conduct and with the types of misconduct specified in the University Policy on Student Conduct and Discipline.