Abstract

Research ethics reviews at the universities are in most cases performed by committees known as research ethics committees (RECs) or institutional review boards (IRBs). Often the review process is supported by research ethics professionals or research management and administration (RMA) staff specializing in research ethics administration and consultancy.
The academic members of the review committees, that is the ethics reviewers, are faced with a difficult task as they navigate the intricate terrain of ethical discussions. These discussions are often fraught with numerous dilemmas, and they lack clear-cut right or wrong answers. Which ethical principles should be prioritized when assessing the ethics of a particular study? Is it a deal breaker if participation in a study poses more than minimal risk to research participants and researchers, or can some level of risk be deemed ethically acceptable as long as the risks are disclosed, justified, and mitigated? Can ethical approval be granted for a project with significant knowledge potential, even when the study's consent procedures, in an effort to maximize research participation, may not align with the most stringent ethical standards? What about parental consent in research involving children or adolescents: Should an ethics committee always reject approval if the researchers do not obtain consent from participating children’s parents or guardian, or could there be circumstances that would in fact make such a requirement unethical?
The research ethics professionals that assist and support the committees in their work are faced with the challenge of figuring out how to best support the difficult discussions without interfering unduly. Part of this task may be to assist the committee in ensuring that its individual decisions align with the general values and principles that the committee may have decided to work from. The research ethics professional must strike a balance between challenging the committee’s decisions when this could benefit the process, without attempting to steer decisions in a particular direction.
The research ethics committee at SDU decided to experiment with the use of decision aid tools as a means to guide its ethics reviews. Developing the decision tool is itself a quality development effort, as it is a process that relies on the committee's thorough discussions about which ethical principles and values it considers particularly important. The tool is designed with inspiration from decision aid tools known from the healthcare sector, where the goal is to promote informed decisions, for example, regarding treatment choices. Unlike decision trees, with their built-in logic where specific choices lead to specific outcomes, this type of decision support tool is not designed to find the one correct solution. Instead, the goal is to assist the committee in reaching decisions that, to the greatest extent possible, have taken all relevant considerations into account and have identified and weighed all ethically significant aspects of the study.
The presentation showcases and discusses the SDU Research Ethics Committee’s experiences with developing and deploying a decision aid tool specifically for research ethics reviews of studies with children and young people.