EXEMPTED FROM ETHICS REVIEW
Exemption from Review is the term used to denote an ethics approval application that is not subject to expedited, or full board review after a preliminary assessment by a designated member of the REC. The decision to exempt from review may be delegated by the REC to the Faculty/State Campus Research Committees or REC Associate Members who have been properly trained. Subsequently, these decisions shall be reported in the REC meeting. The REC, in its annual report submitted to the National Pharmaceutical Regulatory Agency (NPRA), shall include a list of applications that were exempted from review.
The applicant can apply for exempted from ethics review using the REC 11 form.
To the applicants, after submitting the form, the application will be subjected to reviewing process. If the reviewer is satisfied with the application and all the criteria for exemptions are met along with the Chair's approval, only then the approval letter will be issued by the Secretariat.
The following are the criteria for exempted from ethics review: