The Tri-Council Policy Statement (TCPS2) is the framework guiding the ethical conduct of research with human participants in Canada. There are ten mentions of a requirement for knowledge dissemination (KD) throughout TCPS2, but little detail regarding expectations for content or process . Despite an obligation to disseminate research results, the lack of clarity in requirements for ethical KD plans has created an environment where researchers are able to put little effort into this aspect of their research planning at the ethics review stage, which in our view is not sufficient, particularly for certain methodological approaches like patient-oriented and community-based research (POR and CBR, respectively). Members of this research team initially set out to ask Research Ethic Boards (REBs) to raise the bar for researchers in the area of KD, but quickly realized that REBs may need support in understanding and analyzing the components of an ethical KD plan. Some guidance would help REBs conduct reviews and would lead to consistency of understanding. To our knowledge, there is currently no existing tool directed at REBs for the purposes of assessing KD plans.
To fill this gap, we have created an easy-to-use assessment tool to assist REBs in evaluating the ethical acceptability of KD plans in ethics applications, called the “Knowledge Dissemination in Patient- and Community-Oriented Research Ethics Assessment Tool” (KD-PCOREAT). We hope this Tool leads to improved KD planning evaluated at the ethics review stage, increasing the amount and quality of KD that is done in BC. The Tool requires validation, which is the purpose of this study.
We will use a modified Delphi approach to validate this Tool. This involves recruiting 10 content experts (BC REB members and administrators) to assess the tool on criteria including: importance, relevancy, usability, and clarity.
Specifically, we will provide the Tool and a questionnaire to participants. We will calculate the content validation index for each item, and provide a summary of results back to participants. In a subsequent focus group, participants will discuss the results and make suggestions. We will update the tool based on their suggestions and undergo subsequent rounds of feedback until we reach consensus. We intend to complete this process by March 2022.
The results of this study will lead to validation of the Tool, which we will disseminate using traditional methods in addition to a more thorough knowledge translation plan including: workshops delivered directly to REBs, research departments, and the health research community in BC; academic conferences; working with REBC to promote the Tool locally; and promoting the Tool on a national level with assistance from Canadian Association for Research Ethics Boards (CAREB) and SUPPORT/SPOR units across Canada. We will also share the results and finalized Tool with participants and patient-partner groups, encouraging them to share with their professional networks.
By helping REBs evaluate more inclusive practices of KD planning in POR and CBR, we hope that reviewers and researchers will be able to consider ways to make evidence more accessible to populations typically left out of academic discourse.
We are a multidisciplinary team made up of a patient partner, research ethics board members and administrators, and a knowledge translation specialist. We take a patient-oriented approach in this study, by working with a patient partner who is a knowledge translation advocate and technical writing expert. We consult with our patient partner in designing high quality questions, guiding research methods and materials, and identifying priorities in knowledge dissemination. Not only is this project patient-oriented itself, it also aims to advance a POR approach in the BC research landscape by systematically embedding it within the research ethics review process.Alia Januwalla poster