CAE

Centring the Human Subject in Health Research: Understanding the Meaning and Experience of Research Participation

Research Team:
UBC - Susan Cox (PI), Michael McDonald (Co-PI), Cathy Schuppli (Postdoc), Kim Taylor (RA) & Natasha Damiano (RA).
University of Manitoba - Patricia Kaufert (Co-I), Joseph Kaufert (Co-I), & Lisa LaBine (RA).

Visit Centring the Human Subject in Health Research website.

Funded by CIHR & Michael Smith Foundation for Health Research

The purpose of our study is to explore the meanings and experiences of being a human subject in various types of health research. We will do so within the context of understanding the relationship between human subjects, health researchers and research ethics boards (REBs) but always with an emphasis on the perspectives of human subjects. Our study will determine what issues are relevant to human subjects, researchers and members of REBs and how these differ. The study will also explore how the topic, design, structure and organization of different types of health research gives rise to new or overlooked ethical issues. This will inform the development of new understandings of the experience of being a research subject and new methods of implementing these understandings in research design, the process of ethical review and the governance of research involving humans.

The project adopts a qualitative research design. In each of the 3 phases, we will be guided by an international advisory board of experts in research involving humans.

Phase I includes an intensive literature review. This will assist in categorization of different types of health research design and the issues that each raises for research ethics and governance. We will also conduct in-depth interviews with research participants, members of REBs, clinical and social science health researchers, and scholars and other key informants in research ethics.

Phase II involves the selection of 4 health research projects with a design reflecting significant issues identified during Phase I. For each case we will examine documents (i.e., proposal, consent forms, revisions requested by the REB) and carry out in-depth interviews and focus groups with researchers, research participants and others.

Phase III involves presenting the findings to experts in ethics and human subject research. Feedback will inform a series of focus groups, consultation workshops and public forums to which we will invite REB members, researchers and other participants in human subject research. A final report will describe our findings and offer recommendations on the process of ethical review and governance of research ethics.

Current activity: Carrying out interviews for Phase I.