Research Grant Recipient, Judy Friedland
Examining the Roles and Responsibilities of Research Assistants in Their Interactions with Research Participants in Vulnerable Circumstances: A Focus Group Study
By Judy Friedland
All research studies that involve human participants must undergo an ethics review. The purpose of the review is to ensure that participants are protected: that their dignity is respected, that concern is shown for their welfare, and that any decisions about participating are fully informed and autonomous (TCPS2, 2014). Concern about protecting participants is heightened when studies involve people considered to be in vulnerable circumstances.
Ethics reviews – carried out by Research Ethics Boards (REBs) – can only review the intentions of the investigators before the study begins. To the extent that participants need protection, it will be provided by research assistants (RAs) because they are closest to the participants themselves. Knowing that RAs play this important role, we wanted to improve our understanding of their interactions with participants in vulnerable circumstances.
Our main research question was: How do RAs understand their moral responsibilities in relation to their interactions with study participants who may be considered in vulnerable circumstances?
Our sub-questions were: 1) How do RAs describe the education, mentorship, and supervision they receive to work with participants in vulnerable circumstances? 2) How do RAs perceive their abilities to mitigate risks for participants during research studies?
We used focus groups to explore our research question. Five focus groups were held between September 2017 and March 2018 in the Rehabilitation Sciences Building at the University of Toronto. Of the 19 participants, all but one had worked as an RA for more than a year and the majority had done so for over three years. All participants had experience working with participants in vulnerable circumstances (e.g., people with cancer, men who had been incarcerated, drug users, etc.). All RAs were university educated; 16 held graduate degrees or were currently enrolled in graduate programs.
Our focus groups were taped and transcribed. From a theoretical perspective we were interested in understanding how Walker’s (2003) notion of moral competency, which describes ethics as interpersonal in nature and requiring virtues and emotional sensitivity, might help us understand how the roles and responsibilities of RAs are determined and carried out in their work with participants considered vulnerable. We used this theory as we reviewed the transcripts and carried out successive iterations of analyses. We then identified two themes along with their subthemes.
Theme One: Expressing Moral Competencies
In their examples of working with participants, RAs revealed the types and origins of the moral competencies that they possessed.
a) Recognizing power, privilege and vulnerability.
• RAs recognized their positions of power and privilege. They saw vulnerability in themselves as well as in those with whom they were working. Their interactions often caused them (moral) distress particularly when they questioned the potential benefits of the research, knowing it would not directly benefit the participants.
b) Adapting processes and providing support.
• RAs adapted usual study processes (e.g., explaining the study) to the groups they were studying. They provided support and accommodation to participants beyond what would be expected in research where participants were not considered in vulnerable circumstances.
c) Understanding the sources of their moral competencies.
• RAs identified their competencies as originating in previous life experiences and professional experiences, and some training specific to their research study. They also noted the importance of good interpersonal skills.
Theme Two: Negotiating and making transparent responsibilities for the well-being of research participants
RAs saw their role as complex and noted the difficulties of negotiating responsibilities for participant protection. They identified three areas in which there was potential for confusion.
a) Separating the responsibilities as a clinician from those of a research assistant.
For those who were clinicians and RAs, there were often conflicts around how much to help given their clinical ability to do so. RAs needed to decide what help would be beyond the parameters of the study.
b) Critically reflecting on the shared responsibilities of principal investigators and research assistants.
Many RAs expressed concern that they were shouldering the responsibility of protecting research participants without enough support. Many “learned on the job” and did not feel adequately prepared. They thought that the responsibility for training RAs should lie with principal investigators who should also mentor RAs and provide some supervision.
c) Identifying the role of the REB in relation to research participant protection.
RAs placed minimal value on the role of REBs for protecting participants during research. Instead they emphasized the roles of the principal investigators given their knowledge of the research itself, and the RAs given their proximity to participants.
In conclusion, our study suggests that RAs have an important, but largely unrecognized role, in protecting research participants who are in vulnerable circumstances. While they possess a variety of moral competencies, their work could be better supported by principal investigators. Although REBs play an important role in ensuring ethical research their role has limitations because they are distant from the actual conduct of research. Further inquiry into the roles and responsibilities of RAs and principal investigators can help ensure that participants in vulnerable circumstances are not only protected, but that they are not unnecessarily excluded from research that could be beneficial.
We are now finalizing an article for submission to the Journal of Empirical Research on Human Research Ethics. It will serve as a follow-up to our previous work in this area which was also published in that journal. (See Peter, E. & Friedland, J. (2017) Recognizing Risk and Vulnerability in Research Ethics: Imagining the ‘What ifs?” Journal of Empirical Research on Human Research Ethics (JERHRE), 12(2) 107–116.)
TCPS2 (2014). Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans
Walker MU. (2003) Moral contexts. Oxford: Rowman & Littlefield Publishers.
Professor Emerita Judith Friedland, PhD* and Professor Elizabeth Peter, PhD**
*Department of Occupational Science and Occupational Therapy, Faculty of Medicine
** Faculty of Nursing
The authors wish to thank their participants.
This study was supported by a grant from and Senior College