Project Title: A Study to Assess the Utility of a Canadian Web-Based Research Ethics Board (REB) Protocol and Consent Review Template

Background:

Clinical Trials (CT) are the cornerstone of evidence-based medicine. REBs are the gatekeepers of CT’s. Presently there are no standardized tools with which to process the research ethics framework of CT protocols and consents across Canada, nor are there any international examples that can be used as a model. A system is required to provide a generalizable, reproducible research ethics CT protocol and consent review with a high degree of inter and intra-observer reliability. A web-based review template would offer ethical and legal rigour, and the advantage of assuring that Canadian research protocols would be available to patients in a timely, efficacious and consistent manner that would present increased accountability and added safeguards. Geographically and demographically Canada is the ideal country to develop and embrace an electronic approach to REB protocol and consent standardization.

Hypothesis:

A standardized web-based platform to review clinical research proposals would lead to a more efficient, effective and consistent REB clinical trial review system.

Purpose:

To develop and evaluate a web-based REB review and education platform for clinical research protocols and consents.

Study Design/Objectives: 

We will 1) investigate existing environments in which REBs review trials across Canada and conduct subsequent needs assessments 2) develop a common electronic REB platform based on an existing prototype template 3) evaluate the platform at representative selections of REBs across Canada 4) assess the platform’s applicability and utility to other REBs on a case-control basis.

The study objectives are to determine the following:
1) Can a web-based Internet REB protocol and consent review template be designed, developed and implemented?
2) Will this template…
a.  Provide consistent CT review and documentation at all levels across Canada?
b. Improve patient safety through a standardized protocol review system?
c. Increase public confidence in REB credibility?
d. Improve accrual rates?
e. Enhance investigator and REB staff satisfaction?
f. Provide REB transparency and facilitate access to CT REB review data from across the country enabling REB activity streamlining at local, regional and CIHR levels, as desired?
It will be important to identify REB independent variables and establish any possible linking data.

Methods:

Qualitative and quantitative research techniques will be used throughout the iterative design process and evaluation of the REB platform. These techniques will include surveys, meeting notes, expert interviewers, user evaluations, focus groups, log file user data, and feedback from the development team, and will provide a means of exploring and describing experiences with the web-based template from the perspective of stakeholders. The study will detail the development, implementation and evaluation of the platform and its role in improving the REB and CT process, building on the existing pilot study data.

Relevance:

By establishing a standardized web-based ethics review process through this study, effective and safe trials will be ensured and education and training at all levels will be enhanced. The hypothesis could form the basis for standardized REB review process that ahs the potential to become the foundation for national REB methodology and accreditation. More effective evidence based treatment decisions could be delivered to our patients sooner in Canada and could potentially further promote international collaboration. This REB study will be one step towards the Canadian REB governance process.