Program for applied research on fertility regulation (PARFR)

Evaluation covers the period 5/72-12/80 and serves as a basis for a new FY81-85 project phase; no methodology is specified. PARFR"s greatest strength is its competent and dedicated staff. Of the 137, mostly preliminary studies, which have been funded, 34 of the projects -- 80% of which are unique to PARFR and unsupported by other agencies -- are promising enough to allow planning of final preclinical or early clinical trials. PARFR projects employ a broad range of approaches and a sound balance of contraceptive methods, although it has not been possible to develop projects on contraception which emphasize specific methods of delivery or use. The staffing, laboratory facilities, research designs and plans, and principal investigators for the two subcontracted projects are adequate. PARFR has inititated 21 projects in l0 countries in an attempt to conduct as much clinical and laboratory research as possible in LDC"s. Difficulties have arisen in some countries due to A.I.D. restrictions, political problems, and investigators" commitments to other donors. The only cause for concern is the composition, tenure, and decisionmaking mechanisms of PARFR"s Scientific Advisory Committee (SAC). SAC has a disproportionate number of ob/gyn clinicians and a lack of expertise in other areas (e.g., epidemiology and experience performing clinical trials of drugs). There is also an apparent conflict of interest, as several SAC members are involved in PARFR activities. PARFR projects are well monitored, the ethical aspects of proposals are fully covered, informed consent is included in all proposals involving human subjects, and each project is approved both by its own institutional review board (IRB) and by the IRB of Northwestern University. PARFR"s relationships with its funding agencies, including A.I.D., are good; and its projects seldom duplicate those of other agencies. Despite its small staff, PARFR has made a monumental effort to publish information on the development and status of methods of fertility regulation. PARFR can effectively use the funds requested for the next 5 years. If the funding is curtailed, some worthwhile projects would have to be cut. A project review and site visit should be conducted in 12/82.