The Ethics of including women in clinical trials
On International Women’s Day 2017, the EIWH wishes to congratulate CIOMS’s on its carefully deliberated and bold step to revise their International Ethical Guidelines on health-related research to include vulnerable population groups. The new guidelines emphasise the scientific and social value of research and that research must be sensitive to justice and fairness.1 The CIOMS Guidelines also tackle the ethical dilemma that “vulnerability” of certain population groups has led to a higher risk in real life.
Ever since the Thalidomide tragedy of the 1950’s women of childbearing age have been largely excluded from clinical trials. This has led to a lack of information about the safe use of medicines in women, especially during pregnancy and lactation. The US Centers of Disease Control and Prevention estimate that 9 in 10 women use some form of medication during pregnancy and about 7 out of 10 take at least one prescription medicine.2
Adapting their Guidelines to a rapidly changing reality, CIOMS has introduced guidance for including, vulnerable population groups such as women, pregnant women, children etc in health-related research and given guidance on how to analyse “vulnerability”. Guideline 18 states that “a general policy of excluding from clinical studies women who are biologically capable of becoming pregnant is unjust in that it deprives them of the benefits of new knowledge derived from these studies.” For women of child bearing potential, the Guideline adds that “they must be informed in advance of the possibility of risks to the fetus, should they become pregnant during their research participation.” “Women must be included in health-related research unless a good scientific reason justifies their exclusion.”
CIOMS Guideline 19 addresses the health needs of pregnant or breastfeeding women. It states that “research designed to obtain knowledge relevant to the health needs of pregnant and breastfeeding women must be promoted. However, “this research must be initiated only after careful consideration of the best available relevant data.”
The EIWH very much hopes that these Guidelines will help to tackle the current lack of robust evidence and information about the safe use of medicines during pregnancy and lactation for both women and their healthcare professionals. To highlight this gap in pubic health, the EIWH has produced a Policy Brief on the Safe Use of Medicines in Pregnancy and Lactation3.
For further reading:
CIOMS: The Council for International Organizations of Medical Sciences (CIOMS) is an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949. http://www.cioms.ch/
CIOMS Ethical Guidelines: http://cioms.ch/ethical-guidelines-2016/WEB-CIOMS-EthicalGuidelines.pdf
EIWH Policy Brief on Safe Medicines Use during Pregnancy and lactation
1 The Council for International Organizations of Medical Sciences (CIOMS) was established jointly by the World Health Organization (WHO) and the United Nations Educational, Scientific and Cultural Organization (UNESCO) in 1949 as an international, nongovernmental, nonprofit organization and now includes 45 international, national, and associate member organizations, representing many of the biomedical disciplines, national academies of sciences, and medical research councils.
3 EIWH Policy Brief on Safe Medicines Use during Pregnancy and lactation https://eurohealth.ie/safe-use-of-medicines-during-pregnancy-lactation/