This essay responds to an article, ‘Variation in university research ethics review’, published in this issue. It argues that the authors of that paper do not fully distinguish the usual function of university research ethics committees from that of a gatekeeper. The latter term more accurately describes the task they happen to have asked them to fulfil in the course of conducting some empirical research. Whilst they are not alone in making it, the result of this conflation is that the (...) reflections they offer are misguided. In this short comment I briefly discuss the distinction between a REC and a gatekeeper, and indicate how it impacts on the proposals sketched by Vadeboncoeur et al. (shrink)

While the need to protect vulnerable research participants is universal, conceptual challenges with the notion of vulnerability may result in the under or over-protection of participants. Ethics review bodies making assumptions about who is vulnerable and in what circumstance can be viewed as paternalistic if they do not consider participant viewpoints. Our study focuses on participant vulnerability in Scholarship of Teaching and Learning (SoTL) research. We aim to illuminate students’ views on participant vulnerability to contribute to critical analysis of the (...) role and processes of ethics review. Additionally, we aim to highlight the importance of seeking the views of participant communities, especially in research environments beyond ethics review’s medical origins. Thirty-four students from a health-related faculty at a university in Aotearoa New Zealand, participated in five focus groups. Participants discussed factors affecting their potential participation in research drawing upon a series of vignettes based on examples of published SoTL projects. Themes, generated using reflexive thematic analysis, built a participant-informed picture of vulnerability. Findings indicate that students do not generally consider themselves vulnerable and instead consider participation in SoTL research through an agentic lens. Students expect that participation will be voluntary, not negatively impact their grades, and not single them out so that others could judge them. Our study also highlights the value students place on relationships with one another and teaching staff and the implications these have for SoTL research participation and future professional practice. This research challenges research ethics committees to think further about vulnerability in the context of SoTL whilst highlighting the importance of providing opportunities for research participants more broadly to explore and vocalize their views as members of participant communities. (shrink)

A previous research ethics article by the authors provided evidence to support the claim that the New Zealand Ethics Committee was a powerless ethics committee. Ethics review applicants were not formally obliged to seek ethics review, and any committee recommendations were given on a ‘take it or leave it’ basis. One year later, the capacity of applications has doubled, and NZEC finds its core assumptions challenged as funders and government agencies now compel contracted researchers to make use of this free (...) service. Moreover, NZEC has expanded into research areas inhabited by market researchers, long shy of ethics review. Review requirements and remit expansion challenges some, but not all, aspects of NZEC’s assumption of powerlessness as NZEC remains committed to research ethics, not research governance, and it adheres to the principles of the New Brunswick Declaration to respect applicants the same way it expects applicants to respect participants. This annual survey of applicants makes NZEC accountable to its applicants, providing evidence once more that NZEC’s expeditious and cordial review of applications is considered different from traditional ethics review. (shrink)

This study examines a significant gap in the role of providing ethical guidance and support for community-based research. University and health-based ethical review committees in New Zealand predominantly serve as ‘gatekeepers’ that consider the ethical implications of a research design in order to protect participants and the institution from harm. However, in New Zealand, community-based researchers routinely do not have access to this level of support or review. A relatively new group, the New Zealand Ethics Committee, formed in 2012, responds (...) to the uneven landscape of access for community-based research. By offering ethical approval inclusive of the review of a project’s study design outside institutional settings, NZEC has endeavoured to move beyond a gatekeeping research governance function to that of bridge-building. This change of focus presents rich possibilities but also a number of limitations for providing ethical review outside conventional institutional contexts. This paper reports on the NZEC’s experience of working with community researchers to ascertain the possibilities and tensions of shifting ethics review processes from research governance to a focus on research ethics in community-based participatory research. (shrink)

‘Vulnerability’ is a key concept used to understand the ethical implications of conducting refugee-focused research. This case study illustrates the need to follow Luna’s call for a shift fr...

BackgroundInformed consent as stipulated in regulatory human research guidelines requires that a volunteer is well-informed about what will happen to them in a trial. However researchers are faced with a challenge of how to ensure that a volunteer agreeing to take part in a clinical trial is truly informed. We conducted a qualitative study among volunteers taking part in two HIV clinical trials in Uganda to find out how they defined informed consent and their perceptions of the trial procedures, study (...) information and interactions with the research team.MethodsBetween January and December 2012, 23 volunteers who had been in the two trials for over 6 months, consented to be interviewed about their experience in the trial three times over a period of nine months. They also took part in focus group discussions. Themes informed by study research questions and emerging findings were used for content analysis.ResultsVolunteers defined the informed consent process in terms of their individual welfare. Only two of the volunteers reported having referred during the trial to the participant information sheets given at the start of the trial. Volunteers remembered the information they had been given at the start of the trial on procedures that involved drawing blood and urine samples but not information about study design and randomisation. Volunteers said that they had understood the purpose of the trial. They said that signing a consent form showed that they had consented to take part in the trial but they also described it as being done to protect the researcher in case a volunteer later experienced side effects.ConclusionVolunteers pay more attention during the consent process to procedures requiring biological tests than to study design issues. Trust built between volunteers and the research team could enhance the successful conduct of clinical trials by allowing for informal discussions to identify and review volunteers’ perceptions. These results point to the need for researchers to view informed consent as a process rather than an event. (shrink)

Lack of supportive workplaces may be depriving babies and mothers of the health advantages of breastfeeding. This citizen science pilot project set out to engage women in photographing and sharing information on the available facilities for breastfeeding and expressing and storing breastmilk in Australian workplaces. While some useful insights were gained, the project failed in the sense that 234 people ‘liked’ the project Facebook page set up to recruit participants, but only nine photographs were submitted. The heaviest loss of participation (...) occurred after the ethics committee requirements were explained, in particular, the requirement for employer consent to take a photograph, or alternatively, for a participant to agree to bear the risk of taking a photo without permission. The ethics committee also made stipulations about the formality of language to be used. Thus, the project’s potential role as an enabler for health action was neutered. We argue that the ethics requirements worked contrary to our purpose and possibly acted to reinforce the powerlessness some women experience at work. (shrink)

W ostatniej dekadzie można zaobserwować postępującą w naukach społecznych kodyfikację i instytucjonalizację etyki badań. Powstaje coraz więcej kodeksów etycznych, które standaryzują zasady etycznego prowadzenia badań oraz komisji etycznych kontrolujących projekty badawcze. Za kodyfikacją oraz instytucjonalizacją etyki naukowych badań społecznych stoi między innymi przekonanie, że kodeksy i komisje etyczne znacząco przyczynią się do etycznego postępowania badaczek i ochronią podmioty zaangażowane w badania, szczególnie ich uczestników, przed krzywdą. W artykule argumentuję, że to nie wystarczy, gdyż zarówno osoby prowadzące badania, jak i komisje (...) etyczne powinny kierować się w swoich decyzjach etycznych wyobraźnią moralną. (shrink)

Ethics committees enjoy both a long history and a strong presence in Anglophone countries, although simultaneously their functioning provokes debate in the social research community. In this paper, I analyse selected contested issues that revolve around three questions: 1) Who do ethics committees protect, and who should they? 2) Should ethics committees protect all research participants in the same way? 3) When can ethics committees intervene in the methodology of the research project under review? Analysing these disputes is important since (...) it may help to improve the functioning of ethics committees for social research in Poland. Their number has increased significantly in the last decade, but this has not been accompanied by a broader reflection on either their functioning or the concerns associated with this kind of control. (shrink)