• Posted: January 03, 2017
  • Last updated: February 13, 2017

Ethics Review Recognition Policy

About This Work Product

Elaborating on the general principles and guidance offered in the Framework for Responsible Sharing of Genomic and Health-Related Data, this draft Policy on Ethics Review Recognition seeks to provide essential elements of the ethics review process specifically for multi-jurisdictional research involving health-related data. The two express purposes are: to both foster recognition of ethics review and improve the consistency thereof, as well as to promote efficient and responsible data sharing for human health and wellbeing. This Policy applies to both data collection/production and data access and re-use. It is intended to inspire confidence in the adequacy of an ethics review from another jurisdiction’s ethics review system on the basis of equivalent requirements, and the quality of the ethics review performed as part of that system. In turn, this enhances the responsibility of the research enterprise and adds to its credibility and quality. Ethics reviews undertaken in light of this Policy would reflect sufficiently similar procedural approaches to the assessment of the ethical acceptability of a health data-related study such that duplicative ethics reviews can be reduced through a recognition approach that enables ethics committees to accept the review of another ethics committee.

This Policy will be elaborated by subsequent Practical Guidance on particular ethical issues within multi-jurisdictional research involving health-related data and sharing of such data. The Policy and subsequent Practical Guidance should be used in projects around the world (whether Global Alliance “inspired” or not) such that they become the tools that ethics committees and other approval entities, recognized by different jurisdictions, will turn or refer to for guidance. Recognizing diversity of legal and ethical approaches and being responsive to emerging issues, both this Policy and subsequent Practical Guidance are intended to provide leadership in this domain for wider discussion.

Work Product Details

Working Group(s):

Regulatory and Ethics

Work Product Type:

Policy

Related Initiative(s):

Ethics Review Equivalency

Team