ABSTRACT
Research teams are increasingly interested in using cluster randomized trial (CRT) designs to generate practice-guiding evidence for in-center maintenance hemodialysis. However, CRTs raise complex ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, published in 2012, provides 15 recommendations to address ethical issues arising within 7 domains: justifying the CRT design, research ethics committee review, identifying research participants, obtaining informed consent, gatekeepers, assessing benefits and harms, and protecting vulnerable participants. But applying the Ottawa Statement recommendations to CRTs in the hemodialysis setting is complicated by the unique features of the setting and population. Here, with the help of content experts and patient partners, we co-developed this implementation guidance document to provide research teams, research ethics committees, and other stakeholders with detailed guidance on how to apply the Ottawa Statement recommendations to CRTs in the hemodialysis setting, the result of a 4-year research project. Thus, our work demonstrates how the voices of patients, caregivers, and all stakeholders may be included in the development of research ethics guidance.
Subject(s)
Informed Consent , Research Design , Humans , Randomized Controlled Trials as Topic , Renal Dialysis , Ethics, ResearchABSTRACT
To maintain public trust and integrity in organ and tissue donation and transplantation (OTDT), policymakers, governments, clinical leaders, and decision-makers must ensure that policies proposed to increase donation and transplant activity satisfy baseline ethical principles established by international agreement, declaration, and resolution. This article describes the output of the Baseline Ethical Domain group of an international forum designed to guide stakeholders in considering these aspects of their system. Methods: This Forum was initiated by Transplant Québec and co-hosted by the Canadian Donation and Transplantation Program partnered with multiple national and international donation and transplantation organizations. The domain working group members included administrative, clinical, and academic experts in deceased and living donation ethics and 2 Patient, Family, and Donor partners. Identification of internationally accepted baseline ethical principles was done after literature reviews performed by working group members, and a framework for consideration of existing or novel policies was completed over a series of virtual meetings from March to September 2021. Consensus on the framework was achieved by applying the nominal group technique. Recommendations: We used the 30 baseline ethical principles described in World Health Organization Guiding Principles, Declaration of Istanbul, and Barcelona Principles to generate an ethical framework-presented graphically as a spiral series of considerations-designed to assist decision makers in incorporating these ethical principles into practice and policy. We did not seek to determine what is ethical but instead described a method of evaluation for policy decisions. Conclusions: The proposed framework could be applied to new or existing OTDT policy decisions to facilitate the transformation of widely accepted ethical principles into practical evaluations. The framework includes adaptation for local contexts and could be applied broadly internationally.
