Over the past three decades, the Special Programme for Research, Development and Research Training in Human Reproduction (the Programme) has built up an extensive international network of centres with which it collaborates in the design and implementation of research projects in various aspects of human reproduction. Ethical guidelines and practices established by the Programme require that all proposals for research projects involving human subjects that are submitted to the Programme for support are approved first by an appropriately constituted local institutional or national ethics review body. Each proposal is also reviewed by the Programme's Scientific and Ethical Review Group (SERG) and by the WHO Secretariat Committee on Research Involving Human Subjects (SCRIHS) by both of which approval must be given before a project can be supported.
In 1992, a report on Quality assurance for ethics in research involving human subjects was discussed by SERG. The report highlighted the problem that, while ethical guidelines exist, it is not clear to what extent ethical issues are uniformly understood or debated across centres, nor in what way institutional ethical review is carried out. A survey carried out at the request of SERG among the Programme's collaborating centres indicated that a wide variety of concepts and standards was being used by these institutions in their ethics review procedures. This led to the recommendation by SERG that the Programme should institute regional workshops devoted to the principles of ethics in research on human subjects in the field of human reproduction. The proposal to hold such workshops was reinforced at a subsequent meeting on Ethical aspects of research, development and introduction of fertility regulation methods held in June 1994, which included members of SERG and representatives of women's health advocacy groups.
In response to these various recommendations and to SERG's endorsement of the Programme's role in fostering awareness of, and adherence to, ethical standards and practices in reproductive health research, a series of Regional Workshops on Ethical Issues in Research in Reproductive Health was initiated. The first of these was held in Bangkok, Thailand in March-April 1997, the second in Viña del Mar, Chile in November 1998, the third in Kadoma, Zimbabwe in November-December 2000 and the fourth in Cairo, Egypt in November 2001.
The overall objective of the Workshops is to stimulate discussion on, and encourage ethical practices in, reproductive health research among scientists and clinicians and other individuals who may be current or potential future members of ethics review committees. Reproductive health research in this context includes biomedical, social science and epidemiological research involving human subjects, covering such areas as fertility regulation, infertility, sexually transmitted diseases and HIV infection.
The specific objectives of the Workshops are to:
- enable participants to be aware of and address ethical concerns in deciding on research needs and priorities, in preparing research proposals, and in the process of review of research proposals and monitoring the conduct of research;
- review and discuss ethical principles governing research involving human subjects;
- identify sustainable mechanisms for ensuring that ethical requirements are adhered to at the local and national levels, including the development of institutional ethical review committees, procedures to deal with failures to comply with ethical requirements;
- foster the convening of flocal and national follow-up workshops.
Working, background and reference documentation
The working documentation consists of extracts from research proposals that have been submitted to the Programme for funding and a number of scenarios based on situations which present one or more ethical issues specific to the topic of the particular session in which they are presented.
Copies of internationally-accepted guidelines on biomedical research and epidemiological research, and guidelines developed by the Programme that address specific topics or issues in reproductive health research are provided as background and reference documents.
Structure, content and format
Although the Workshops focus on participant problem solving, with guidance and assistance from the faculty members, the process is expected to be fully interactive with open and free discussions and exchange of information and experience. Topics covered include:
- the need for ethical review of research proposals;
- informed decision-making (informed consent and informed dissent);
- risks and benefits;
- special ethical issues pertaining to reproductive health research in the social sciences;
- special ethical issues pertaining to reproductive health research in epidemiology;
- general ethical issues, such as reproductive health research involving adolescents, and partner notification/consent in connection with taking part in reproductive health research; and
- the constitution, operation and responsibilities of ethics review committees.
The Workshops are run according to a format of alternating plenary sessions and working groups. Working groups are constituted in advance to provide a mix of nationalities and professional backgrounds and, if possible, a gender balance. The membership of the working groups is maintained throughout the Workshop to aid the development of beneficial group dynamics. However, the tasks of chairing and acting as rapporteur are rotated for each session so that everyone in the group has a chance to do one of these tasks. The groups are responsible for appointing the chairs and rapporteurs. The faculty members disperse themselves among the groups, and rotate through the different groups, acting as resource people and providing clarification if problems or misunderstandings arise.
Each topic is introduced and presented in plenary session by a member of the faculty. Participants then break into their working groups in order to work through either a protocol or a scenario presenting one or more ethical issues or problems related to the topic in question. A number of specific questions are presented in connection with each scenario. In these working group sessions, participants constitute themselves as a "mock" ethics review committee to identify problem areas and ethical issues arising from the protocols or scenarios and try to reach consensus on such issues, including suggestions for the revision of consent forms and associated information. The groups' discussions are reported back in a subsequent plenary session in which the outcome of the deliberations of the five groups is discussed.