Post-Menopausal Women at Risk
A scenario meant to stimulate discussion about the ethical issues that arise in randomized research trials studying the effects of hormones on thwarting Alzheimer's disease in women who are particularly susceptible to the disease.
The estimated lifetime risk rises from 20% to 40% for people who have first-degree relatives (a parent or sibling) with Alzheimer's disease (AD). This study involves the first randomized double-blind controlled study of hormonal replacement in post-menopausal women at higher risk for AD because of first-degree relatives.
The informed consent form indicates that the protective value of hormonal replacement has not yet been firmly established. It is, however, widely known that hormonal replacement has other benefits for women, including the preservation of bone density. Furthermore, the protective benefits with respect to the onset of dementia have been widely asserted based on retrospective observational studies.
- Why might a placebo control study be considered unethical in this context?
- How should the risks and benefits of entering such a study be explained?
Caroline Whitbeck introduced methods and modules for discussing numerous issues in responsible conduct of research at a Sigma Xi Forum in 2000. Partial funding for the development of this material came from an NIH grant.
You can find the entire sequence on the OEC at Scenarios for Ethics Modules in the Responsible Conduct of Research. Some information in these historical modules may be out-of-date; for instance, there may be a new edition of the professional society's code that is referred to in an item. If you have suggestions for updates, please contact the OEC.