Women and Health Research

Ethical and Legal Issues of Including Women in Clinical Studies: Volume 2: Workshop and Commissioned Papers

Author: Federman, Daniel; Faden, Ruth; Mastroianni, Anna C.
Publisher: National Academies Press
ISBN: 9780309050401
eISBN Pdf: 9780309586504
eISBN Epub: 9780309176866
Place of publication: United States
Year of digital publication: 1994
Month: January
Pages: 262
Language: English

Caption

There is a growing perception that biomedical research has focused more on the health problems of men relative to those of women and that women have been denied access to advances in medical diagnosis and therapy as a result of being excluded from clinical studies.

Women and Health Research, Volume 2, addresses issues connected with women's participation in clinical studies: ethical issues related to recruitment, retention, and the inclusion of pregnant women and other women of childbearing age; legal issues such as liability, compensation for injury, constitutional concerns, and federal regulations; and health consequences associated with exclusion or underrepresentation.

The commissioned papers focus on the research participation of women from specific racial and ethnic groups and on whether women have been underrepresented in biomedical research, based on a systematic survey of clinical studies reported in a prominent medical journal.

WOMEN AND HEALTH RESEARCH
Copyright
Preface
Contents
Women's Participation in Clinical Research: From Protectionism to Access
- CURRENT FEDERAL POLICY
- PROTECTIONIST POLICIES
- ADVENT OF INCLUSIONARY POLICIES
- CONCLUSION
- NOTES
Women in Clinical Studies: A Feminist View
- NOTES
Ethical Issues Related to the Inclusion of Pregnant Women in Clinical Trials (I)
- THE PREGNANT WOMAN AS SUBJECT
  - Therapeutic: To Meet the Health Needs of the Mother
  - Nontherapeutic Research: Not Meeting the Health Needs of the Pregnant Woman
- THE FETUS AS SUBJECT
  - Therapeutic: To Meet the Health Needs of the Fetus
  - Nontherapeutic Fetal Research: Not to Meet the Fetus's Health Needs
- NOTES
Ethical Issues Related to the Inclusion of Pregnant Women in Clinical Trials (II)
- REFERENCES
Ethical Issues Related to the Inclusion of Women of Childbearing Age in Clinical Trials
- NOTES
Health Consequences of Exclusion or Underrepresentation of Women in Clinical Studies (I)
- TYPES OF INFORMATION DEFICITS
- TYPES OF CONSEQUENCES
  - Morbidity and Mortality
  - Diagnosis and Treatment Patterns
  - Treatment Outcomes
  - Provider Perceptions
- CONCLUSIONS
- NOTES
Health Consequences of Exclusion or Underrepresentation of Women in Clinical Studies (II)
Recruitment and Retention of Women in Clinical Studies: Theoretical Perspectives and Methodological Considerations
- THE DYNAMICS OF RECRUITMENT AND RETENTION
- CROSS-CULTURAL DIFFERENCES: MEN VS. WOMEN
- GENDER DIFFERENCES: IMPLICATIONS FOR RESEARCH
- METHODOLOGICAL CONSIDERATIONS FOR RESEARCHERS
- REFERENCES
Recruitment and Retention of Women of Color in Clinical Studies
- NOTES
Recruitment and Retention of Women in Clinical Studies: Ethical Considerations
- INCENTIVES TO ENROLL AND TO CONTINUE PARTICIPATION
- FREE ABORTION AS AN INCENTIVE
- DEALING WITH DROPOUTS
- COSTS OF INVOLVING WOMEN AS RESEARCH SUBJECTS
- TWO SEPARATE AGENDAS ON THE INCLUSION OF WOMEN
- WOMEN IN (SOME) DEVELOPING COUNTRIES
- REFERENCES
Impact of Current Federal Regulations on the Inclusion of Female Subjects in Clinical Studies
- THE IMPACT OF PRESENT LAW
  - Regulations that Appear to Limit Women's Participation in Clinical Research
    - FDA Definition of "Childbearing Potential" and Required Prior Reproductive Studies
    - DHHS Limitations on Research with Pregnant Women
  - Federal Requirements that Support the Inclusion of Women in Clinical Research
    - FDA Premarketing Testing
    - DHHS Regulations on Research with Children
- RECOMMENDED CHANGES IN THE FEDERAL LAW
  - Amendment of FDA Regulations
  - Amendment of DHHS Regulations
  - National Institutes of Health Policy
- CONCLUSION
- NOTES
Brief Overview of Constitutional Issues Raised by the Exclusion of Women from Research Trials
- DISPARATE TREATMENT, DISPARATE BENEFITS, AND EQUAL OPPORTUNITY
- CONCLUSION
- REFERENCES
Liability Exposure for Exclusion and Inclusion of Women as Subjects in Clinical Studies
- TORT LIABILITY DOCTRINES
- LIABILITY FOR EXCLUDING WOMEN FROM CLINICAL STUDIES
- LIABILITY FOR INCLUDING WOMEN IN CLINICAL STUDIES
- CONCLUSION
- NOTES
Liability Exposure When Offspring are Injured Because of Their Parents' Participation in Clinical Trials
- Does the desire of the federal government to include women in clinical trials preempt claims alleging the children were…
  - Identifying potential claimants and their claims.
  - Children's claims against their parents.
  - Impact of one parent's negligence on the other parent's claims.
  - Claims against third parties.
  - Does it matter whether the researcher works for the government?
  - May children sue the federal government if they were injured before birth by their parent's participation in research while…
  - The risk of liability for injuries incurred during research is low.
  - The potential for liability is much greater if efforts are not made to detect fetotoxic effects.
  - Finding out about fetotoxicity averts harm to children.
- NOTES
Compensation for Research Injuries
- REASONS FOR COMPENSATION
  - Economic Reasons
  - Ethical Reasons
  - Political Reasons
- TYPES OF COMPENSATION SYSTEMS
  - Tort Liability
  - Mandatory Compensation Systems
  - Voluntary and Contractual Systems
- CONCLUSIONS
- NOTES
Justice and the Inclusion of Women in Clinical Studies: A Conceptual Framework
- THE INJUSTICE OF OUR PRACTICES
- REMEDIES
- NOTES
Women's Representation as Subjects in Clinical Studies: A Pilot Study of Research Published in JAMA in 1990 and 1992
- METHODS
  - Sample
  - Data Collection
  - Measures and Rules for Coding
- ANALYSIS
- RESULTS
- SUMMARY AND DISCUSSION
- APPENDIX: REASONS FOR EXCLUDING ARTICLES FROM THE ANALYSES
  - Unit of Analysis
  - Topic
  - Method of Analysis
- REFERENCES
- NOTES
Racial Differentials in Medical Care: Implications for Research on Women
- THE CONSTRUCTION OF RACE: AN HISTORICAL PERSPECTIVE
- THE DANGERS OF DIFFERENCE IN MEDICAL RESEARCH
- A LEGACY OF DISTRUST: A RESEARCH OBSTACLE
- RECOMMENDATIONS
- NOTES
Health Status of American Indian and Alaska Native Women
- HISTORICAL FACTORS
- EARLY IMPACT OF DISEASE AND A LEGACY OF DISTRUST
- RESERVATION LIVING CONDITIONS
- CONTEMPORARY HEALTH PROBLEMS AND ASSESSMENT OF NEEDS
  - Cigarette Smoking
  - Obesity
  - Diabetes
  - Reproductive Health
  - Infant Mortality
  - Cancer, Cardiovascular Disease, and Tuberculosis
  - Mental Health
  - Alcohol Consumption
  - Biological Alcohol Susceptibility and Stereotyping
- CURRENT HEALTH CARE NEEDS AND URGENT RECOMMENDATIONS
- NOTES
Ethical and Legal Issues Relating to the Inclusion of Asian/Pacific Islanders in Clinical Studies
- DESCRIPTION OF THE POPULATION
  - Unique Characteristics of the APIA Population
- SOURCES OF EPIDEMIOLOGIC AND HEALTH DATA
  - Historical Factors and Manpower Development
  - Factors Affecting Data Interpretation in Clinical Trials
    - Definition of the Study Population
    - The Myth of a Healthy Minority
    - Lack of Baseline Epidemiologic Data on Ethnic Subgroups
    - Dissemination of Information from Existing Studies
    - The Issue of Informed Consent
- DISCUSSION
- REFERENCES
Inclusion of Latino Women in Clinical and Research Studies: Scientific Suggestions for Assuring Legal and Ethical Integrity
- LATINO HEALTH: A BRIEF OVERVIEW
  - Existing Data Sets
- LIMITATIONS OF EXISTING RESEARCH APPROACHES
- HUMAN PROTECTION PROCEDURES AND INFORMED CONSENT
- RECOMMENDATIONS
- REFERENCES
Appendix Author Biographies