Research Administration Office

University of California

Memo Operating Guidance

No. 87-26

August 6, 1987

Subject: Public Health Service Grant Application Form PHS 398, Assurance on Scientific Fraud (Misconduct)

The May 15, 1987 Contracts and Grants Information Letter transmitted copies of the revised Public Health Service Grant Application Form PHS 398, a summary of the major changes, and a summary of recent revisions to the PHS Grants Policy Statement.

We have conferred with staff of the Vice President for Academic Affairs and General Counsel and have determined that the revised PHS 398 Checklist, Assurances, Item d. regarding Scientific Fraud (Misconduct) Assurance, can be checked affirmatively.

Box 1 of the assurance states: "Administrative review process has been established." Based upon review of the current policies of the University on integrity in research recently completed by staff of the Vice President for Academic Affairs, it is correct to provide assurance that administrative review processes have been established. For more information on this subject, see Enclosure i which is a copy of the Academic Personnel Manual Section 015, "University Policy on Faculty Conduct-and the Administration of Discipline," (reprinted from the 1986 Faculty Handbook, p. 57-60).

Box 2 of the assurance states: "Reporting requirements of the published scientific misconduct regulations will be followed." Based upon the PHS statements on page 7 of the PHS 398 Application package that "development of these regulations will be publicized by communication with applicant organizations both directly and through the Federal Register and the NIH Guide for Grants and Contracts," the University is assured that we will be allowed the opportunity to comment upon the regulations prior to their implementation. Further, the statutory language of P.L. 99-158 which requires the assurance states that each entity which applies for a grant "will report to the Secretary any investigation of alleged scientific fraud which appears substantial." (See Enclosure 2 for a copy of the relevant section of P.L. 99-158.) Therefore, the published regulations should not compromise due process principles or academic discipline procedures. However, to insure that our agreement to the Assurance, Box 2, is not perceived as a "blank check" to follow any and all future regulations, we have sent a letter to the Public Health Service indicating that the University is not Waiving any rights to assert a claim that the regulations, when promulgated, are invalid and/or inconsistent with the statute. (See Enclosure 3 for a copy of the letter to PHS.)

When the regulations are published for comment, staff in the Office of Research and Public Policy in the Office of the Vice President for Academic Affairs will be reviewing the regulations and soliciting campus comments in preparation of the University's response. Until the regulations are finalized, you may follow the interim guidance provided in this memoranda regarding the Scientific Fraud (Misconduct) Assurance.

Refer: Barbara Yoder

ATSS 8-582-2886

(415) 642-2886

Subject Index: 01, 02

Organization Index: U-115, F-350

Acting University Contracts and Grants Coordinator

Enclosures

cc:

Associate Vice President Moore

Director Cole

University Counsel Dorinson


Enclosure 3

August 6, 1987

Robert E. Windom

Assistant Secretary for Health

Public Health Service

716G, Hubert Humphrey Building

200 Independence Avenue, S.W.

Washington, D.C. 20201

Dear Assistant Secretary Windom:

The University of California has advised our campuses that the recently revised Public Health Service grant application Form 398, Checklist, Assurances, Item d., Scientific Fraud (Misconduct) Assurance can be affirmatively completed pending issuance for comment and finalization of the regulations to be promulgated pursuant to Section 493 of P.L. 99-158, "Health Research Extension Act of 1985."

Please be advised that by so stating, the University is not waiving any rights to assert that the regulations, when promulgated, are invalid and/or inconsistent with Section 493 of the scope of P.L. 99-158.

I know you can appreciate our difficulty in making an assurance that we will follow a regulation that has not yet been promulgated. Therefore, at this time, we could only make such an assurance based upon a presumption that the regulations, when published, will be consistent with P.L. 99-158.

Sincerely,

David F. Mears

University Contracts and Grants Coordinator

cc:

Director Cole

University Counsel Dorinson

University Contract & Grant Officers