A qualitative study on acceptable levels of risk for pregnant women in clinical research

BMC Medical Ethics 18 (1):35 (2017)

Abstract
There is ambiguity with regard to what counts as an acceptable level of risk in clinical research in pregnant women and there is no input from stakeholders relative to such research risks. The aim of our paper was to explore what stakeholders who are actively involved in the conduct of clinical research in pregnant women deem an acceptable level of risk for pregnant women in clinical research. Accordingly, we used the APOSTEL VI study, a low-risk obstetrical randomised controlled trial, as a case-study. We conducted a prospective qualitative study using 35 in-depth semi-structured interviews and one focus group. We interviewed healthcare professionals, Research Ethics Committee members and regulators who are actively involved in the conduct of clinical research in pregnant women, in addition to pregnant women recruited for the APOSTEL VI case-study in the Netherlands. Three themes characterise the way stakeholders view risks in clinical research in pregnant women in general. Additionally, one theme characterises the way healthcare professionals and pregnant women view risks with respect to the case-study specifically. First, ideas on what constitutes an acceptable level of risk in general ranged from a preference for zero risk for the foetus up to minimal risk. Second, the desirability of clinical research in pregnant women in general was questioned altogether. Third, stakeholders proposed to establish an upper limit of risk in potentially beneficial clinical research in pregnant women in order to protect the foetus and the pregnant woman from harm. Fourth and finally, the case-study illustrates that healthcare professionals’ individual perception of risk may influence recruitment. Healthcare professionals, RECs, regulators and pregnant women are all risk adverse in practice, possibly explaining the continuing underrepresentation of pregnant women in clinical research. Determining the acceptable levels of risk on a universal level alone is insufficient, because the individual perception of risk also influences behaviour towards pregnant women in clinical research. Therefore, bioethicists and researchers might be interested in changing the perception of risk, which could be achieved by education and awareness about the actual benefits and harms of inclusion and exclusion of pregnant women.
Keywords No keywords specified (fix it)
Categories (categorize this paper)
DOI 10.1186/s12910-017-0194-9
Options
Edit this record
Mark as duplicate
Export citation
Find it on Scholar
Request removal from index
Translate to english
Revision history

Download options

Our Archive


Upload a copy of this paper     Check publisher's policy     Papers currently archived: 42,156
Through your library

References found in this work BETA

Add more references

Citations of this work BETA

No citations found.

Add more citations

Similar books and articles

Minimal Risk in Research Involving Pregnant Women and Fetuses.Carson Strong - 2011 - Journal of Law, Medicine and Ethics 39 (3):529-538.
The Perils of Protection: Vulnerability and Women in Clinical Research.Toby Schonfeld - 2013 - Theoretical Medicine and Bioethics 34 (3):189-206.
Minimal Risk in Research Involving Pregnant Women and Fetuses.Carson Strong - 2011 - Journal of Law, Medicine and Ethics 39 (3):529-538.
Abortion, Relationship, and Property in Labor: A Clinical Case Study.Donna Dickenson & Susan Bewley - 1999 - Cambridge Quarterly of Healthcare Ethics 8 (4):440-448.

Analytics

Added to PP index
2017-05-16

Total views
17 ( #482,325 of 2,253,657 )

Recent downloads (6 months)
2 ( #795,528 of 2,253,657 )

How can I increase my downloads?

Downloads

My notes

Sign in to use this feature