Article type
Abstract
Background: Ethics reviews conducted by research ethics committees (RECs) are inconsistent in their requirements for researchers to adopt an evidence-based research (EBR) approach. Not using EBR and failing to synthesize prior research in a systematic and transparent way creates research that is unethical and wasteful and exposes participants to unnecessary harm. A working group of the Evidence Based RESearch (EBVRES) Consortium (a European-funded project seeking to promote the use of EBR) focusing on the role of RECs identified that risk is an important factor that RECs consider when judging justification for new research. For instance, where RECs do require greater transparency and systematic use of evidence, it is normally within the context of a research methodology with a potentially high risk to participants.
Objectives: The aim of this study was to determine how REC members link risk to specific research methodologies.
Methods: A cross-sectional survey was conducted between November 2020 and January 2021, recruiting participants representative of researchers, REC members, and individuals with an interest in research ethics. Participants were asked to rate the level of risk they thought was characteristic of 31 different research designs (1 [not at all risky] to 10 [extremely risky]). Participants were asked to also respond to 3 open-ended, probing questions about whether concepts of anonymity or consent are mitigations for risk.
Results: 283 participants completing the survey primarily were from the United Kingdom (51.1%), considered themselves to be both a researcher and REC member (44.%), and had job descriptions explicitly including the conduct of research (50.9%). Phase I and Phase II studies were identified to be the riskiest type of research, and anonymous secondary data analysis and nonintrusive questionnaire studies were identified as the least risky research designs. Both anonymity and robust consent processes were considered to reduce risk to participants.
Conclusions: A continuum of risk can be created based specifically on research methodology. This can be used to guide RECs as to the level of transparency and systematic use of prior evidence that they may require to ethically justify new studies. A 1-page guidance document for RECs was created.
Objectives: The aim of this study was to determine how REC members link risk to specific research methodologies.
Methods: A cross-sectional survey was conducted between November 2020 and January 2021, recruiting participants representative of researchers, REC members, and individuals with an interest in research ethics. Participants were asked to rate the level of risk they thought was characteristic of 31 different research designs (1 [not at all risky] to 10 [extremely risky]). Participants were asked to also respond to 3 open-ended, probing questions about whether concepts of anonymity or consent are mitigations for risk.
Results: 283 participants completing the survey primarily were from the United Kingdom (51.1%), considered themselves to be both a researcher and REC member (44.%), and had job descriptions explicitly including the conduct of research (50.9%). Phase I and Phase II studies were identified to be the riskiest type of research, and anonymous secondary data analysis and nonintrusive questionnaire studies were identified as the least risky research designs. Both anonymity and robust consent processes were considered to reduce risk to participants.
Conclusions: A continuum of risk can be created based specifically on research methodology. This can be used to guide RECs as to the level of transparency and systematic use of prior evidence that they may require to ethically justify new studies. A 1-page guidance document for RECs was created.