(This volume was gifted to the Forum by Dr. Ruth Macklin.)
The book is a report by a committee consisting of leading experts in ethics, research, medicine, industry and law. It deals with the ethical, scientific and legal issues relating to the inclusion of women in clinical studies.
These concerns have come into focus because of increasing attention both from the public and from women’s health activists who perceive that biomedical research has not given the same attention to the health problems of women as has been given to those of men. They also feel that women have not benefited from advances in medical diagnosis and therapy as seen from their lower participation in clinical studies.
Key questions are raised: Have women been truly equally represented in clinical research? How do social biases influence research agendas? What about liability for harm ensuing as a consequence of research studies? Do pregnant women and those of child- bearing age need special consideration?
Although the Congress of the United States of America passed an act (National Institutes of Health Revitalisation Act 1993) aimed at providing equal representation to women in clinical research, the committee is of the opinion that this goal is far from attainment. Among the reasons provided by it are the great cost of implementing the provisions of the Act and practical issues such as legal liability.
The book begins by addressing matters that form the crux of the report such as the role clinical trials play in the development of knowledge and the current status of women as regards their active participation in medical research.
Subsequent chapters are devoted to the ethical, social and legal dilemmas that must be resolved before women be provided genuine equality representation in clinical studies.
The concluding chapter gives committee’s recommendations for effective implementation of the NIH Revitalisation Act 1993. These pertain to the investigators, institutional review boards, initial review groups and technical evaluation groups.
The Appendices cover forty abstracts of papers dealing with women’s participation in clinical studies between 1977 and 1993 , the diethylstilbestrol case study, an excerpt from the NIH Revitalisation Act 1993, information regarding compensation systems for injuries related to research and short biographies of members of the committee.
In essence it is a book for all those who believe in the critical importance of justice in clinical research.