Abstract
In this chapter we examine ways in which research ethics committees can appropriately conduct ethics review of clinically important trials pertaining to the management of medical conditions of pregnant women. Given the well-documented variability of research ethics committees’ decision-making, it is reasonable to predict variability among committees regarding their reviews and decisions of research involving pregnant women. At least some of this variability is due to a lack of sufficient guidance on the part of national and international research guidelines, which results in a reluctance to approve clinical research involving pregnant women. After summarising the problems inherent in the relevant guidelines, we propose additional considerations and recommendations to guide research ethics committees, researchers, trial sponsors, and funding agencies in the review and oversight of such research.
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- 1.
This is the term commonly used in Europe and elsewhere. It is equivalent to Institutional Review Board (IRB) and Research Ethics Board (REB) used in the United States and Canada, respectively.
- 2.
In Canada, the TCPS2 is the most widely applicable policy guidance for research ethics review. It allows for, and uses the language of, greater or lesser ‘scrutiny’ (in accordance with the degree of foreseeable risks) in its proportionate approach to research ethics review (see, for example, Chapter 1C).
- 3.
TCPS2; Code of Federal Regulations; Directive 2001/20/EC of the European Parliament and of the Council; Additional Protocol to the Convention on Human Rights and Medicine, concerning Biomedical Research (Council of Europe); Declaration of Helsinki (WMA); Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants (WHO); General Considerations for Clinical Trials (ICH); Guideline for Good Clinical Practice (ICH); and International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS).
- 4.
We present this as a problem of justice, but note that disproportionately greater enrolment of participants with a lower socioeconomic status may also introduce a variable that biases or complicates the analysis (of investigational drugs on managing important medical conditions during pregnancy) and thereby diminish the generalizability of results.
- 5.
This is not a uniquely North American attitude: when asked whether the exclusion of pregnant women from German clinical trials was appropriate, leading reproductive toxicologists in the country responded that their inclusion was neither necessary nor desirable (Wild 2012, 85).
- 6.
For example Canada’s TCPS2 Article 6.5 and its Application provide guidance on parameters for involving ad hoc advisors.
- 7.
Françoise Baylis and Scott A. Halperin (2012) have explored additional options within clinical trials methodologies for research involving pregnant women .
- 8.
See Zwarenstein et. al. (2008) to distinguish between explanatory and pragmatic clinical trial study designs.
- 9.
Alternatively, it may justify a sub-analysis of data from pregnancy participants, or gathering additional data from these participants to contribute to understanding the effect of the investigational drug on the health of pregnant women and their foetuses (both during the study and in a follow up period).
- 10.
Anecdotally, it is the authors’ experience serving on research ethics committees that much of the post-pregnancy follow-up involves only collecting information as to the outcome of the pregnancy (i.e., a live birth, the presence or not of any obvious congenital anomalies at birth).
- 11.
Applicable laws in the jurisdiction in question will take precedence.
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Acknowledgements
The authors gratefully acknowledge Angela Ballantyne, Françoise Baylis, Annette Rid, and Verina Wild for their helpful comments on a previous draft of this chapter.
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Ells, C., Lyster, C. (2016). Research Ethics Review of Drug Trials Targeting Medical Conditions of Pregnant Women. In: Baylis, F., Ballantyne, A. (eds) Clinical Research Involving Pregnant Women. Research Ethics Forum, vol 3. Springer, Cham. https://doi.org/10.1007/978-3-319-26512-4_6
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