The CSA is tasked to: (1) formulate and update guidelines for the ethical conduct of human health research; (2) develop guidelines for the establishment and management of RECs and standardization of research ethics review; and (3) monitor and evaluate the performance of RECs in accordance with PHREB approved procedures outlined in a prior agreement including requiring an annual report.

The PHREB CSA awards any of the following levels of accreditation to an REC after an evaluation process:

Level 1 Accreditation

Level 1 accreditation is given to new REC applicants.  It allows new RECs to acquire experience in the review of research studies and gives opportunity to comply with the recommendations of the CSA. A level 1 accredited REC reviews all types of research projects except clinical trials required for FDA registration of new drugs.

The REC shall submit required documents according to Section VI.1.4 of the PHREB Policies and Requirements for Accreditation of Research Ethics Committees (RECs) within the first six (6) months.

Within the year, the PHREB-CSA/REMB-CSA may recommend either submission of application for Level 2 or extension of Level 1 provisional accreditation and require further training and submission of additional evidence of compliance.

Level 2 Accreditation

Level 2 accredited REC reviews all types of research except clinical trials required for FDA registration of new drugs.

RECs who have demonstrated satisfactory performance as a Level 1 REC (i.e., functional structure and composition, adequate SOPs, adequate administrative support, effective management of files and archiving) may apply for Level 2. RECs who have not been accredited but have been operating for more than six (6) months can apply for Level 2 accreditation provided they can submit all the necessary requirements.

Level 2 accreditation may be granted for one (1) or three (3) years depending on the degree of satisfactory compliance with the CSA recommendations with regard to quality and documentation of review.

Level 3 Accreditation

Level 3 Accredited REC reviews all types of researches including studies required in applications for marketing authorization of food, drugs and devices by a regulatory agency (i.e., FDA).

Level 3 accreditation may be granted for one (1) or three (3) years depending on the degree of satisfactory compliance with ICH-GCP standards and CSA recommendations with regard to quality and documentation of review.

The Committee members: