Research Administration Office

University of California

Memo Operating Requirement

86 -7

April 14, 1986

Subject: World Health Organization General Award Conditions

BACKGROUND

The current version (undated) of the World Health Organization (WHO) Technical Service Agreement contains two clauses which are unacceptable to the University of California. These clauses are numbered 6 and 7 on Enclosure I and concern patent rights and human subjects, respectively.

Problems connected with WHO award terms have been the subject of Contract and Grant Memo No. 26-78 (June 28, 1978) and an Information Letter dated June 19, 1984.

This memo updates operating requirements for dealing with award conditions attached to WHO awards. C& G Memo No. 26-78 dated June 28, 1978, on this subject is hereby canceled.

HUMAN SUBJECTS

Negotiations concerning Clause 7, "Research Involving Human Subjects", have resulted in an agreement with WHO which calls for Contracts and Grants Officers to line out the first two sentences of paragraph 7.3 and write in the margin, "As amended by agreement between WHO and the University dated October 30, 1985".

The language agreed to as a substitute for the deleted sentences is set forth in Enclosure 2. Enclosure 2 also shows how paragraph 7.3 should be altered before accepting any WHO award containing this clause.

PATENT RIGHTS AND PUBLICATION

Negotiations concerning Clause 6, "Use of Results, Exploitation of Rights, and Publication", are still in progress. In the meantime, Contracts and Grants Officers should delete the entire clause and write in the margin, "As amended by agreement between WHO and the University of California dated July 30, 1980."

The language agreed to as a temporary substitute for the deleted Clause 6 is set forth in Enclosure 3. Enclosure 3 also shows how the clause should be altered before accepting any WHO award containing this clause.

We will inform you as soon as a final agreement with WHO on the patent/publication issue has been reached.

Refer: Bill Sellers ATSS 8-582-3045 (415) 642-3045

Subject Index: 11, 18

Organization Index: X-950

Cancel: C& G Memo No. 26-78

David F. Mears

University Contracts and Grants Coordinator

Enclosures

cc:

Laboratory Contracts and Grants Officers

Trice Dietrick, PTCO


Enclosure 2 to C& G Memo 86-7

7. RESEARCH INVOLVING HUMAN SUBJECTS

Substitute:

(a) The Institution agrees to provide medical care to human subjects any injury or illness suffered as a result of participation in an authorized University activity coveted by University policy on the protection of human subjects in research or to reimburse the subject for the costs of such treatment in accordance with the conditions and exceptions as discussed in the "University Policy for Medical Treatment of Human Subjects for Injuries Resulting from Participation in Research" dared January 10, 1979.

(b) The Institution shall obtain insurance or have a self-insurance programme to cover its liability under statute or the law of tort for death, injury or illness suffered by any subject arising out of the research under this Agreement.

The University of California has agreed to pay for medical costs and for any legal liability incurred (7.3 a and b). In response to WHO's concern we would not foreclose the possibility of providing additional compensation in cases of extraordinary. hardship. However, it must be recognized that this must be accomplished at the complete discretion of the University and in light of all relevant factors rather than through a contractual provision which provides for unlimited coverage, and a standard whose meaning and scope is subject to the vagaries of judicial interpretation.


Enclosure 3 to C& G Memo 86- 7

SUBSTITUTE: Any discovery conceived and reduced to practice in the course of' research carried out under this Agreement shall be the property of the University, provided, however, that the University shall seek patent protection thereon and make such discovery available for commercial licensing upon reasonable terms and conditions. For distribution to the public sector in developing countries, the University shall on request make available to WHO for distribution to Governments of WHO Member States any technical publications as well as non-exclusive licenses to make, use and sell the subject matter covered by patents taken out by the University as a result of WHO assisted research. Such licenses shall be for governmental purposes only and shall be royalty-free or at preferential rates, taking into account WHO's contribution to the research. In the event the University elects not to seek patent protection on such discovery, and to the extent that the University has the legal right to do so, the University agrees to assign all rights to such discovery to the World Health Organization.

The Institution and the Principal Investigator shall have the right to publish research results. The responsibility for the direction of the work shall not be ascribed to WHO. All publications shall include a notice, unless otherwise instructed by WHO, indicating that the underlying investigation enjoyed financial support from the WHO unit involved. In the event of independent publication, two off-prints of copies shall be sent to WHO unless another number is stipulated. WHO funds my not be used publication costs unless specifically authorized. WHO assumes no obligation to publish documents submitted to or contracted for by WHO.