Vulnerable participants in health research : Methodological and ethical challenges

Abstract

Ethical guidelines for conducting research are embedded in the Helsinki Declaration of 1964. We contend that these abstract and intentionally universal guidelines need to be appropriated for social and health care research, in which purpose and methods often deviate from medical research. The guidelines appear to be instrumental and over simplistic representations of the often “messy” realities surrounding the research process that is often guided by relational and local negotiations of ethical solutions. Vulnerable participants, for instance, challenge both professional and research ethics, leaving both professionals and researchers in ethical and moral dilemmas. In this article, we specifically focus on the methodological challenges of obtaining informed consent from drug users and terminally ill cancer patients in our PhD research. The question is how you can illuminate the needs and problems of vulnerable patients and - at the same time - respect their integrity without exposing them unnecessarily. The article illuminates the interactional construction of roles and relationships and how they affect the contextual construction of vulnerability. In this respect, we demonstrate that both patients and researchers are at risk of being vulnerable. In conclusion, we outline and advocate for a more contextualized approach and empirically-informed ethics to informed consent in research with potentially vulnerable participants.

Ethical guidelines for conducting research are embedded in the Helsinki declaration of 1964. We contend that these abstract and intentionally universal guidelines need to be appropriated for social and health care research in which purpose and methods often deviate from medical research. The guidelines appear to be instrumental and over simplistic representations of the often ´messy´ realities surrounding the research process which is often guided by relational and local negotiations of ethical solutions. Vulnerable participants, for instance, challenge both professional and research ethics and leave both professionals and researchers in ethical and moral dilemmas. In the article we specifically focus on the methodological challenges of obtaining informed consent from drug users and terminally ill cancer patients in our PhD-research. The question is how you can illuminate the needs and problems of vulnerable patients and - at the same time - respect their integrity without exposing them unnecessarily? The article illuminates the interactional construction of roles and relationships and how they affect the contextual construction of vulnerability. In this respect we demonstrate that not only patients but also researchers are at risk of being vulnerable. In conclusion, we outline and advocate for a more contextualized approach and empirically informed ethics to informed consent in research with potentially vulnerable participants.