Electronic Thesis and Dissertation Repository

Degree

Doctor of Philosophy

Program

Health and Rehabilitation Sciences

Supervisor

Marilyn Evans

2nd Supervisor

Jeff Nisker

Joint Supervisor

Abstract

This thesis addressed a cluster of issues related to risk and the pregnant woman’s decision making in clinical practice and research. In terms of clinical practice, the minimal risk concept - a low risk standard codified in research ethics regulations - was applied to clinicians’ information provision to the patient. As clinicians must discuss a variety of health risks, minimal risk standards may be useful as a threshold to demarcate risks that clinicians should discuss with the patient. Application of minimal risk standards to risk factors in pregnancy showed the usefulness and limitations of these standards. In terms of pregnant women’s clinical research participation, analyses of national and international research ethics regulations suggested that regulations could potentially be overprotective. A grounded theory study revealed that pregnant women were protective of themselves and their fetus in considering clinical research participation. In determining whether a clinical research project involving pregnant women would be acceptable, obstetric healthcare providers emphasized the adherence to regulatory requirements while researchers in reproduction areas focused on scrutinizing the scientific quality and interpretation of prerequisite studies. These three populations shared safety concerns. While minimal risk standards may be useful in identifying risks to be discussed with the patient, determining permissible risk during pregnancy may be more complex, including consideration on the risk benefit ratio in the pregnant woman’s context. This thesis has implications on risk communication in clinical practice and research, policies on clinical research with pregnant women, and education for healthcare providers, clinical investigators, and the general public.

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