8th Postgraduate Course for Training in Reproductive Medicine and Reproductive Biology

  The Americas Annual Technical Report 1997

J. Villar and E. Ezcurra
HRP - UNDP/UNFPA/WHO/World Bank Special Programme

INTRODUCTION

• Implementation of regional and national plans for reproductive health research and participation in the global research effort;
• Strengthening of regional and national research networks in basic reproductive biology, clinical/epidemiological investigations and social sciences research relevant to reproductive health;
• Increased linkage between institutional strengthening support and implementation of specific research initiatives, be they regional or national; and
• Establishment of a strict scientific and ethical peer-review process to further enhance the quality of research being undertaken.

The main activities implemented under these strategies are described in the following section.

REGIONAL STRATEGIES AND ACTIVITIES

Implementation of regional and national plans for reproductive health research and participation in the global research effort

Launching research initiatives in topics of relevance to regional needs in reproductive health was one of the main goals of the present biennium. During 1997, several important activities were carried out within this context.

Three centres from Brazil, Chile and Mexico are implementing the multicentred research project "Acceptability of emergency contraception in Latin America" which is funded by the Mellon Foundation; data collection is expected to be completed by June 1998. Institutions from Argentina, Bolivia, Cuba and Peru elaborated a multicentre social science research proposal on "Reality and beliefs in the sexual and reproductive decision-making process: men’s perceptions and behaviour". This proposal was approved in principle by the Regional Advisory Panel for the Americas in October 1997 and is expected to complete the scientific and ethical review process by mid-1998. The proposal resulted from a Technical Cooperation among Developing Countries (TCDC) project which made possible preliminary activities such as meetings and communication between the investigators to elaborate the research proposal. The study is planned to be supported with TCDC funds, jointly awarded by the Programme and the Rockefeller Foundation. Several hospitals from Argentina, Brazil, Cuba, Guatemala and Mexico will take part in a multicentre study developed by the centres that will address the problem of the increasing rate of caesarean sections in Latin America. This proposal was approved and will be funded with a grant from the European Community. Women’s perceptions on the quality of antenatal care will be evaluated in a multicentre trial that will include two centres from Argentina and Cuba as well as two centres from other regions (Saudi Arabia and Thailand). Funds for this project have been secured from the Programme, The Population Council and the National Institutes of Health, USA.

Four centres involved in basic reproductive biology research have recently identified a common topic for a regional research initiative—the study of the mechanisms of action of hormonal methods used for emergency contraception (EC). Preliminary work was undertaken in 1997 to prepare a detailed plan of activities to be initiated in 1998.

All these projects are based on the concept of regional networking and are focused on topics which are relevant to regional research needs in reproductive health. It is important to highlight that the vast majority of funds required for these studies have been raised from external sources.

In addition to these regional research initiatives, the centres are involved in projects which address national priorities. During 1996, from the overall number of 216 reported studies, 33 projects (15%) were implemented with support from capacity building grants (Long-term Institutional Development, Resource Maintenance and Re-entry Grants). Eighty-two projects (38%) were carried out at the centres with support from national sources. These projects employ methodologies ranging from molecular biology techniques to focus group discussions and cover the full spectrum of reproductive health issues. The participation of the regional centres in the global research effort is exemplified by the 25 projects (12%) conducted in our collaborating institutions with support from other Strategic Programme Components. Likewise, the institutional strengthening efforts deployed by the Programme in our regional centres have contributed to facilitate their capacities for fund-raising from other international agencies to address topics of global or local relevance. During 1996, 76 projects (35%) were carried out in our regional centres with support from international agencies other than WHO.

Table 1 summarizes the research activities of the centres in 1996 and illustrates the holistic coverage of reproductive health issues.

A more detailed discussion of the linkages between institutional strengthening grants and specific research projects will be given in another section of this report.

Strengthening of regional and national research networks in basic reproductive biology, clinical/epidemiological investigations, and social sciences research relevant to reproductive health

In the Region, there are three research networks in operation: basic reproductive biology, clinical/epidemiology research and social sciences research. The regional network of clinical/epidemiological research is made up of centres from Argentina, Brazil, Cuba, Guatemala and Mexico, and activities include both research and training programmes in reproductive epidemiology. The network is instrumental in the implementation of the multicentre studies on caesarean section and/or quality of antenatal care. Twelve students from various countries have successfully completed the Master’s Degree course in Reproductive Epidemiology that began in Mexico in March 1991 at the National Institute of Public Health in Cuernavaca. This institute continues to attract foreign students to its course; it is expected that the 1998 course will be taken by eight students, three of whom will be supported by WHO Research Training Grants (RTGs).

The Programme provides support to the Centre for Population Studies (CENEP) in Buenos Aires, Argentina to establish and coordinate the regional social sciences network. Its purpose is two-fold. Firstly, the Centre disseminates information on social sciences research relevant to reproductive health, on training opportunities, scientific meetings, etc. The network has already published six bulletins and 12 newsletters; the latter are circulated via e-mail to more than 250 scientists from the Americas and other parts of the world. The second main task of the Centre is to coordinate the regional, multicentre research project which includes social scientists from Argentina, Bolivia, Cuba and Peru. As mentioned before, the elaboration of the proposal ("Reality and beliefs in the sexual and reproductive decision-making process: men’s perceptions and behaviour") was completed in June 1997 and project implementation is expected to begin in mid-1998.

With respect to the basic sciences network, centres from Argentina, Chile and Mexico have identified, as mentioned in the previous section, a topic for a new regional research initiative focused on the study of the mechanisms of action of hormonal preparations used for emergency contraception. Given the expertise and special facilities available in these centres, studies at the cellular and molecular levels of the effects of hormonal steroids (both naturally occurring and synthetic) in target organs are quite feasible. In addition, the availability of non-human primates would make possible the implementation of studies that for ethical reasons cannot be done in humans. The combination of studies in women and in a subhuman primate model, and the expertise at the cellular and molecular levels, provide a unique opportunity to explore the mechanisms of action of hormonal, emergency contraception preparations.

In coordination with the Programme’s Laboratory Methods Group (LMG), the regional reagent programmes from Argentina, Cuba and Mexico are integrated in the overall plan of activities of Programme-supported immuno-assay reagent production and quality control. During 1997, these institutions continued to carry out activities related to the development and testing of primary reagents for enzymeimmunoassay (EIA) technology, mainly focused on the testosterone EIA. This work complements that undertaken at the central laboratory in London and facilitates technology transfer from a developed centre (London) to institutions from the region. The network of regional centres involved in this activity was instrumental in the organization of the Symposium held in Cusco, Peru in April 1997 to celebrate the 20th Anniversary of the Matched Reagents Programme.

The Programme continued to support the Latin American Programme of Cooperation and Research in Human Reproduction (PLACIRH), a unique regional research and research training organization active in the field of reproductive health. During the 1996–1997 biennium, PLACIRH evaluated 77 research projects, nine of which have been approved and funded. Ninety per cent of these dealt with general aspects of reproductive biology and basic sciences; sixteen short-term fellowships were also granted—most of these were for the transfer of laboratory methodology. The Rockefeller Foundation (PLACIRH’s main sponsor) approved US$ 500 000 for up to three years to allow PLACIRH to support research projects in molecular and cellular biology, reproductive biology, contraceptive biology and STDs. Steps are being taken by PLACIRH to improve its links with industry and also to form links with developed countries.

PLACIRH is also participating in the Americas Reproductive Sciences Network which is a collaborative effort to identify priority areas for research. Argentina, Brazil, Canada, Chile, Mexico, and the USA are involved, as well as the NIH and the Fogarty Fellowship Fund.

Increased linkage between institutional strengthening support and implementation of specific research initiatives, regional or national

At its 1995 meeting held in Atlanta (GA, USA), the Regional Subcommittee recommended that "resources for new Long-term Institutional Development (LID) and Resource Maintenance Grants (RMG) should be linked to specific research projects and all budget lines such as salaries, equipment, reagents, etc., should correspond to contributions to well defined research activities". Enforcement of this strategy began with the review of new applications for institutional strengthening submitted during the 1996–1997 biennium.

Six institutions from Argentina, Brazil, Chile, Guatemala and Panama had LID Grant support during this period, while five others from Chile, Cuba, Mexico, Peru and Venezuela received funding through Resource Maintenance Grants. Given that both these types of grants are for five-year periods, most of these centres initiated their activities during the previous biennium.

In 1997, 13 research projects linked to institutional strengthening grants were still in progress and 12 were completed; in addition, eight Research Training Grant recipients were carrying out their Re-entry Grant projects (see Table 1 for topics covered by these 33 studies supported by nine capacity building grants).

Five new applications for capacity building grants were reviewed in the 1996–1997 biennium, all of which were linked to specific research proposals. Four (from Argentina, Brazil, Mexico and Venezuela) were approved by the Regional Advisory Panel and the same number of projects underwent the full technical and ethical review process which led to approval by the Programme’s Scientific and Ethical Review Group (SERG). These projects are in the areas of fertility regulation, male reproductive health, and maternal health; two of these studies are basic science investigations, one is a clinical project and the fourth is a social sciences study.

At the same time, centres taking part in the regional research initiatives are being strengthened through their participation in these multicentre studies which are all based on proposals approved after extensive ethical and scientific review. Three institutions from Bolivia, Mexico and Peru, not formerly receiving institutional strengthening grants, are now being supported with funds from these projects and benefit from the technical and scientific know-how of their more developed counterpart institutions which are part of the networks. This practical application of the concepts of "strengthening through research" and "networking" is critical to an optimal use of the limited capacity-building resources centrally available, promotes intraregional cooperation, and amplifies the impact of the efforts and resources that the Programme has deployed in building up research capacities in the region over the last 20 years.

Establishment of a strict scientific and ethical peer-review process to further enhance the quality of research being undertaken

One of the main concerns linked to regional and national reproductive health research has been that, in the past, projects undertaken by regional centres may, in some instances, lack a sound scientific basis. If the new policy of strengthening research capacities by means of relevant, well-designed research projects is to be enforced, the establishment of a strict review mechanism for individual projects was considered essential.

The first step of this process involves the Regional Advisory Panel which determines whether or not a research proposal submitted as part of an institutional development grant addresses a topic relevant to the needs and priorities of the region or the country. Once the proposal is approved in principle by the Panel, it undergoes a full scientific and ethical review process that ends with its submission to SERG.

In the Region of the Americas, the review process is initiated by a literature search conducted by Secretariat to identify potential external reviewers, who must be scientists active in the particular topic addressed by each proposal. In 1997, 18 grant-linked projects were sent to 94 external reviewers, from whom a high response rate was obtained (68/94, or 72%). In most cases, detailed reviews were obtained which contained valuable methodological and technical recommendations to improve the quality of the proposal. The principal investigator is then requested to produce a revised proposal which is sent again to the same external reviewers for a final assessment before submitting the project to SERG. From the 51 external reviewers participating in the second round of the review process in 1997, an even higher response rate was obtained (42/51, 83%).

The overall results of the review process show that, in 1997, 4/18 projects (22%) were disapproved by external reviewers, two were withdrawn by the principal investigators, four of the five submitted to SERG were approved and eight are still undergoing review.

The main drawback of the system is the length of the review process, which in most cases takes from 12–18 months. Targeting "interested" reviewers has allowed a slight decrease of the time lapse between the submission of the original proposal and its final approval by SERG. On the other hand, many of the proposals have been considerably improved in methodological, technical and ethical aspects by this active exchange between the re-viewers and principal investigators, and in a few cases external reviewers have even volunteered to provide technical resources (guidelines, software, special reagents, etc.) to further enhance the quality of the projects.

We consider that this activity is an important component of institutional strengthening because it not only assists institutions to acquire the necessary capacities to undertake research of relevance to their countries, but also helps to bridge the gap between the technical and ethical values of global and national reproductive health research.

COUNTRY REPORTS

During 1997, the Programme collaborated with 23 institutions (11 of these received major institutional strengthening support, 11 received small grants and one a TCDC grant) in 12 countries of Latin America. The collaboration occurred in Argentina, Bolivia, Brazil, Chile, Colombia, Cuba, Guatemala, Mexico, Panama, Paraguay, Peru, and Venezuela. A description of the main developments at country level follows.

ARGENTINA

Support has continued to the Centre for Perinatal Studies (CREP) in Rosario and to the Department of Obstetrics and Gynaecology of the Centre for Medical Education and Clinical Investigation (CEMIC) in Buenos Aires. CREP conducts research in the areas of maternal and infant health, adolescent health and reproductive health epidemiology, and it serves as a training and research methodology referral centre for the country and the region. With respect to research, it is one of the four sites of the Antenatal Care project and it will also participate in the misoprostol trial and in the regional caesarean section study, both ready for initiation in 1998. CEMIC is part of a regional reagent programme for the development of reproductive hormone assay kits.

The Centre for Population Studies (CENEP) in Buenos Aires is the coordinator and one of the study sites of the regional multicountry social science study on men’s perceptions and behaviour with respect to decision-making processes affecting sexual and reproductive health.

In 1997, the Institute for Experimental Biology and Medicine in Buenos Aires was awarded a LID Grant to further develop basic sciences research in the field of male fertility. Research in reproductive epidemiology and endocrinology was supported through Small Grants to the Center for Endocrinology Research of the Children’s Hospital in Buenos Aires, the Laboratory of Growth and Development Research at the National Pediatric Hospital in Buenos Aires, and the Centre for Applied and Experimental Endocrinology in La Plata.

BOLIVIA

Bolivian investigators participated in the preparatory activities of the four-country, regional social science research initiative on men’s perceptions and behaviour in respect of decision-making processes affecting sexual and reproductive health. The study is to start in 1998.

BRAZIL

The Campinas Centre for Research and Control of Maternal and Infant Disease (CEMICAMP) of the University of Campinas is the main recipient of Programme support in the country. Grants cover work undertaken on training in research methodology, and on research dealing with clinical epidemiology and social science issues relevant to contraceptive introduction and other aspects of women’s reproductive health. CEMICAMP is one of the three study sites implementing the regional multi-centre study on acceptability of emergency contraception; it also conducts one of the three projects being carried out to explore the process of informed consent.

CEMICAMP serves as the regional coordinating centre for introductory trials of Cyclofem in Latin America. In this role, the Centre assists in the development of national capabilities for conducting such trials and related data management.

The Programme also provides a Small Grant to the Centre of Reproductive Biology (CBR) in Juiz de Fora; this centre is mainly involved in basic reproductive biology studies using non-human primates.

CHILE

Chile has the widest range of collaborative projects in the Region of the Americas. Three institutions, all located in Santiago, continued to receive support: the Chilean Institute of Reproductive Medicine (ICMER), the Unit of Reproductive Biology and Development at the Catholic University of Chile, and the Institute for Maternal and Child Health Research (IDIMI). These centres also participate in Programme-supported institutional development activities and act as regional training centres.

In addition to institution-initiated research focused on the biology and physiology of reproduction of the New World monkey Cebus apella, the Unit of Reproductive Biology and Development has taken the lead in establishing and coordinating the regional basic sciences network that will explore the mechanism of action of hormonal preparations used for emergency contraception. Collaboration among research institutions is supported also through the LID Grant awarded to the research network of ICMER. Research is focused on projects which integrate biomedical and social science approaches and methodologies and whose aim is to improve contraceptive use and family planning services. The ICMER is likewise coordinating and participating in the regional multicentre study on acceptability of emergency contraception, initiated in January 1997.

COLOMBIA

The University of Valle in Cali has collaborated with the Programme since 1980 in implementing the national programme in human reproduction and is currently receiving a Small Grant from the Programme. The Centre is involved in plans to reduce maternal mortality in the country, the main objectives being: (i) to develop operational research to improve delivery of maternal health services; (ii) to support epidemiological studies on the development of risk models for the primary causes of maternal morbidity and mortality in Colombia; and (iii) to improve the network of maternal care research.

CUBA

Cuba’s research in reproductive health is conducted within the well-established national strategic plan by the National Coordinating Network for Research in Human Reproduction (comprised of the National Institute of Endocrinology, the Hospital Americas Arias, and the Ramon Gonzalez Coro Hospital) and in concert with the other public health programmes in the country. Extensive collaboration in multicentre trials is ongoing with various Strategic Programme Components.

The Institute of Endocrinology continues to conduct basic sciences research in the area of reproductive immunology and is also involved in activities of the Reagent Production Programme conducted in coordination with the Institute of Nutrition in Mexico City and CEMIC in Buenos Aires. The Institute’s Social Sciences Unit will implement the four-country regional research initiative on men’s perceptions and behaviour in respect of decision-making processes affecting sexual and reproductive health.

The Americas Arias Hospital is participating in the multicentre Antenatal Care project and will participate in the regional caesarean section study planned to begin in 1998.

GUATEMALA

The Guatemalan Research Group in Reproductive Health receives support to develop a reproductive health research unit for epidemiological and health service studies focused on the country’s research priorities. Its Epidemiologic Research Centre received official recognition from the Ministry of Health and Social Welfare and provides consultant assistance to institutions in the Central American subregion. Research is focused on a large follow-up study of women and their offspring of the index pregnancy that occurred approximately 10 years ago. It is aimed at evaluating the reproductive health experience of women from urban areas as related to different socio-cultural characteristics. Two other important activities include: the development of specific Spanish-language software for perinatal and maternal mortality surveillance programmes, and the implementation of new technology to evaluate quality of care within the urban maternal and child health system in Guatemala.

MEXICO

The Department of Reproductive Biology in the National Institute of Nutrition, Mexico City, is the main recipient of Programme support in the country. The Institute and its collaborating centres receive major support from national authorities including the Ministry of Health, which has extensive national programmes for the improvement of reproductive health. The Institute is also actively involved with the various Strategic Programme Components and other international funding agencies. The Institute maintains a very high level of research productivity and continues to play an important role in collaboration with the Programme and other research centres in the region. In 1997, the Institute continued to receive Resource Maintenance and Basic Resources for Training Grants, which have facilitated its extensive participation in research and training. The Institute also participates in the regional programme for the production of assay reagents for reproductive hormones in coordination with the Institute of Endocrinology in Havana, Cuba and CEMIC, Buenos Aires, Argentina. The Institute is one of the four centres constituting the regional basic sciences network, the aim of which is to explore the mechanism of action of hormonal preparations used for emergency contraception.

The Programme supports activities in three other Mexican centres. One is the Reproductive Biology Department of the University of Coahuila at Torreon, which is developing programmes in the area of postpartum contraceptive methods and the relationship between reproductive health and environmental contamination. Support to this centre is focused on a study that explores the influence of adverse environmental conditions on male reproductive health.

The second grant is to the two-year M.Sc. Degree programme in Reproductive Epidemiology organized by the National Institute of Public Health at its centre in Cuernavaca. Twelve students have graduated over the past six years from Programme-supported centres in Argentina, Chile, Cuba, Guatemala, Mexico, Panama, Peru and Venezuela.

The Institute for Scientific Research of the University of Durango is the third Mexican centre involved in Programme-supported activities. In conjunction with ICMER (Chile) and CEMICAMP (Brazil), Durango is implementing the regional multicentre study on acceptability of emergency contraception, initiated in January 1997.

PANAMA

The Centre for Research in Human Reproduction completed research projects in priority areas such as sickle cell anaemia and the use of contraceptives, adolescent reproductive health, and infertility. Since 1997, it receives Small Grant support and continues collaborating with the Programme’s Research Group on Post-ovulatory Methods of Fertility Regulation in the implementation of a project on the safety and efficacy of emergency contraception methods.

PARAGUAY

A TCDC project allowed the continuation of collaborative activities with Paraguay; a centre in that country (CERI) is involved in a "twinning" programme with CENEP, Buenos Aires, to conduct social science research relevant to reproductive health.

PERU

The Programme supported the Peru University Cayetano Heredia which completed a second five-year LID Grant in 1996 and is presently receiving a Resource Maintenance Grant. Research carried out by the Institute of Research on Altitude, the Institute of Population Studies and the Department of Gynaecology and Obstetrics includes studies in the areas of reproductive health of adolescents, reproduction at high altitude, reproductive immunology, and population and demography. The University also serves as a resource and training centre in reproductive health. There is collaboration with research groups in Argentina, Australia, Brazil, Chile, and Mexico, as well as with regional and international agencies such as PLACIRH, the Rockefeller Foundation and UNFPA.

The Institute for Population Studies will be one of the sites of the four-country, regional social science research initiative on men’s perceptions and behaviour in respect of decision-making processes affecting sexual and reproductive health.

VENEZUELA

The Programme is associated with three research institutions in Venezuela. In 1997, it provided support in the form of a Resource Maintenance Grant to the Foundation for the Study of Mother and Child (FUNDAMATIN), a private non-profit organization associated with the Maternity Concepción Palacios in Caracas and with the Venezuelan Institute of Scientific Research (IVIC). The grant is focused on a basic sciences research study approved by SERG in 1997 and being implemented at the IVIC. The study explores basic science issues related to the pathophysiology of eclampsia. FUNDAMATIN also has research units in infertility, family planning, endocrinology and reproductive biology which are associated with the corresponding departments of the Maternity. In collaboration with IVIC, FUNDAMATIN organizes an M.Sc. postgraduate programme in human reproductive biology.

The Department of Biology at the Simón Bolívar University in Caracas continues to receive Small Grant support. This Department conducts research in several areas of reproductive biology.

Table 1. Research projects in reproductive health by field and funding source

Annex 1

REGIONAL ADVISORY PANEL FOR THE AMERICAS IN 1997

Members

• *C. Hogue (Chairman), Emory School of Public Health, Atlanta, GA, USA
• *E. Taucher, Institute of Nutrition and Food Technology, Santiago, Chile

Co-opted Members

• *S. Campo, Hospital de Niños, Buenos Aires, Argentina
• R. Ferriani, University of Sao Paulo, Sao Paulo, Brazil
• *Z. Palma, Women’s Centre, Buenos Aires, Argentina

Collaborating agency scientists

• J. Belizán, Latin American Centre for Perinatology, Montevideo, Uruguay
• *A. Langer, The Population Council, Mexico City, Mexico
• R. Rivera, Family Health International, Research Triangle Park, NC, USA
• J. Tolosa, International Clinical Epidemiology Network, Pennsylvania, PA, USA

*Denotes woman

Annex 2

REGIONAL SCIENTISTS

Principal investigators of centres in 1997

• A. Andrade, Centre for Reproductive Biology (CBR), Juiz de Fora, Brazil
• K. Austin, Centre for Research in Human Reproduction, Panama City, Panama
• *S. Bassol, University of Coahuila, Torreon, Mexico
• *S. Campo, Endocrinology Research Centre (CEDIE), Buenos Aires, Argentina
• G. Carroli, Centre for Perinatal Studies (CREP), Rosario, Argentina
• R. Deis, Reproduction and Lactation Laboratory (LARLAC), Mendoza, Argentina
• L. Devoto, Institute for Maternal and Child Health Research (IDIMI), Santiago, Chile
• *G. Etchegoyen, Centre for Applied and Experimental Endocrinology (CENEXA), La Plata, Argentina
• F. Febres, Foundation for the Study of Mother and Child, Caracas, Venezuela
• R. Fogel, Centre for Interdisciplinary Studies (CERI), Asunción, Paraguay
• G. Gonzales, Peru University Cayetano Heredia, Lima, Peru
• *E. Hardy, Centre for Research and Control of Maternal and Infant Disease (CEMICAMP), Campinas, Brazil
• E. Kestler, Epidemiologic Research Centre, Guatemala City, Guatemala
• F. Larrea, National Institute of Nutrition, Mexico City, Mexico
• O. Mateo de Acosta, National Institute of Endocrinology, Havana, Cuba
• *G. Muñoz, Simon Bolivar University, Caracas, Venezuela
• *E. Pantelides, Centre for Population Studies (CENEP), Buenos Aires, Argentina
• *S. Quiroga, Centre for Medical Education and Clinical Investigation (CEMIC), Buenos Aires, Argentina
• M. Rivarola, Growth and Development Research Laboratory, Garrahan Pediatric Hospital, Buenos Aires, Argentina
• J. Rivera, National Institute of Public Health, Cuernavaca, Mexico
• O. Rojas, University of Valle, Cali, Colombia
• *C. Romero, Hospital J.J. Aguirre, Santiago, Chile
• *M. Serrón-Ferré, Pontifical Catholic University, Santiago, Chile
• F. Zegers-Hochschild, Chilean Institute of Reproductive Medicine (ICMER), Santiago, Chile

*Denotes woman

Print this page

Edited by Aldo Campana,