International Coordination of Research Ethics Review: An Adequacy Model

International direct-to-participant (DTP) genomics research involves the use of mobile technology to recruit, consent, and study participants remotely. This model can facilitate research across broad geographies and many countries, but must also comply with the norms of multiple recruitment jurisdictions, with each jurisdiction typically requiring at least one local research ethics review. Each additional research ethics review increases bureaucratic hurdles without necessarily strengthening the protection of participants’ rights and interests. For DTP genomic research, obtaining a review may in fact be impossible in the absence of a local research partner. This paper proposes an “adequacy” approach, inspired by data protection law, to coordinate the regulation and oversight of international DTP genomics research. This involves one country voluntarily assessing whether another country’s research ethics reviews are equivalent to its own, in terms of objectives and effectiveness. Ethics-approved projects led by researchers from countries recognized as adequate are deemed to comply with local norms, eliminating the need for a duplicative local review. Adequacy preserves the sovereignty of countries to determine their own regulatory aims and which other countries to trust. It therefore provides a voluntary, incremental path towards greater global coordination of health research oversight.

Reshaping the review of consent so we might improve participant choice

Consent is one necessary foundation for ethical research and it’s one of the research ethics committee’s major roles to ensure that the consent process meets acceptable standards. Although on Oxford ‘A’ REC (an NHS Research Ethics Committee based in the UK) we’ve been impressed by the thought and work put into this aspect of research ethics, we’ve continued to have concerns about the suitability and effectiveness of consent processes in supporting decision making, particularly for clinical trials. There’s poor understanding of what people want to help them decide; current processes don’t provide the best grounding for informed consent and there’s inadequate public involvement. We’ve also found a lack of proportionality with researchers failing to adapt consent procedures in proportion to the burdens and consequences of the study. As a result, people are often not best helped to make an informed choice when asked to join a research study. To address these concerns, we considered how we might improve this aspect of research ethics review. Recognising the central importance of the dialogue between the volunteer and researcher, we’ve drawn up a model or flowchart of what we deem good consent practice, proposing consent should be built around four simple steps: Step 1: Introducing the study and the choices: helping the potential participants get an overview of the proposal and introducing the key issues. Step 2: Explaining all the details of the study using the detailed Participant Information Sheet. Step 3: After a gap, if necessary, reviewing and checking understanding. Step 4: Reaching agreement and recording consent. These steps, we believe, could help all involved and this article lays out ways we might improve participant choice while complying with accepted principles and current regulations.

Bringing Ethics Review Home to Cowichan: Indigenizing Ethics Review in British Columbia, Canada

Cowichan Tribes’ territory, located in the Cowichan Valley on Vancouver Island, British Columbia, Canada, is experiencing an alarmingly high rate of preterm births compared to the national average of Indigenous Peoples in Canada. In response, and in partnership with the First Nations Health Authority (FNHA), Cowichan Tribes is in the first year of a 3-year study to investigate causes. Cowichan Tribes’ Elders and community members are guiding the study to ensure it follows Cowichan Tribes’ research processes and to support self- determination in research. Furthermore, as a way to enhance reconciliation, Elders and community members guided an on-site ethics review on Cowichan Tribes territory. This article outlines the collaborative, in-person research ethics review process that Cowichan Tribes, Island Health, and FNHA completed on August 21, 2019. The purpose of this article is to provide suggestions other First Nations could use when conducting a research ethics review, and to explain how this process aligns with the principles of ownership, control, access, and possession (OCAP®), the United Nations Declaration on the Rights of Indigenous Peoples, the Truth and Reconciliation Commission of Canada, and above all, the Cowichan snuw’uy’ulh (teachings from Elders).

Sex Work Research, Ethics Review Processes, and Institutional Challenges for “Sensitive” Collaborative Research

This article examines challenges and barriers seemingly endemic to the research ethics review process. We argue that these challenges and barriers disempower community stakeholders in sex work research and that they put our studies and those who consent to participate in them at risk. To advance this position, we interrogate three of our own encounters with research ethics boards (REBs) in the context of current scholarship on meaningful collaborative research and REB roles and responsibilities in relation to sex work and other sensitive research. As these encounters illustrate, there is an urgent need for established REB processes to be opened up to allow for and respect non-academic expertise. We suggest that such policy and process revisions are particularly important given the growing requirement for meaningful stakeholder involvement in all aspects of studies that engage marginalized groups. In this new anti-oppressive collaborative framework, stakeholder community expertise thus informs study development and design, as well as the collection and analysis of data, and decisions regarding where and how study findings are to be shared. Research ethics review processes must be revised accordingly to acknowledge and give due consideration to community-based expertise. We conclude by proposing institutional and community-based strategies for resisting and revising current research ethics review structures and processes. Applying the lens of whore stigma to select REB encounters, this article contributes to existing research about ethical and anti-oppressive sex work research methods and methodologies, arguing that we must account for REB encounters in the growing body of theory that seeks to understand and articulate how best to conduct sex work research in partnership with sex workers.

Implementing a National Approach to Research Ethics Review during a Pandemic – the Irish Experience

The surge of coronavirus disease 2019 (COVID-19) research studies involving human participants in response to the pandemic has meant that research ethics committees across the world have been challenged to adapt their processes to meet demand while retaining high standards of review. Ethics review during this pandemic remains essential to ensure the safety, dignity and well-being of research participants, however research ethics committees are now faced with new, and often complex, ethics considerations and logistical challenges. This Open Letter looks specifically at the Irish experience of establishing a national approach to research ethics review amidst a global pandemic. This represents Ireland’s first National Research Ethics Committee, which provided the research community with an expedited and ‘single national opinion’ for ethics review for COVID-related research. The insights gleaned and lessons learned from the Irish experience may inform emergency responses to future pandemics or public health emergencies.