On June 30th, 2017 came into force the Supreme Decree N° 021-2017-SA that approved the Clinical Trials Regulation (CTR). This rule created the National Registry of Accredited Institutional Research Ethics Committees, and gave a period of one year from the approval of the Manual of Clinical Trial Procedures (that is, until November 17th, 2018) for all IREC to adapt their membership, responsibilities and procedures to the new regulations in order to be accredited (articles 58-66, CTR).
The General Office of Research and Technology Transfer of the National Institute of Health will accredit an IREC after reviewing its written procedures and conducting visits to verify compliance with the accreditation standards.
The following requirements need to be submitted to begin the accreditation process (article 63, CTR):
- Application for Accreditation/Renewal of Accreditation (Form FOR-OGITT-025 printed)
- Document issued by the authority of the Research Institution that creates the IREC.
- Copy of the IREC Policy approved by the Research Institution which includes at least (article 65, CTR):
- Membership Requirements
- IREC Meetings Schedule
- IREC Quorum Requirements
- Copy of the IREC Procedures Manual approved by the Research Institution which includes at least (article 66, CTR):
- Requirements for the Submission of Research Protocols
- Procedures for the Continuing Review of Approved Research Protocols
- Procedures for the IREC Meeting Minutes
- Procedures for the IREC Records and Documentation
- Declaration of Compliance with the Accreditation Standards (Form FOR-OGITT-026 printed).
- Members’ CVs signed, with Certificates of Basic Training in Research Ethics attached.
NOTICE: All documents must be paginated according to the National Institute of Health’s guidelines for the submission of documents.
Electronic Form for the Accreditation of new IREC
If the IREC that is going to begin the Accreditation Process doesn’t have a registration code, please complete the following Registration form. Once completed, click on ‘Save’ in order to generate your temporary registration code. Then, print the form, sign and attach it to the other requirements to be sent to The General Office of Research and Technology Transfer of the National Institute of Health.
National Registry of Accredited IREC
NOTICE: The term “EXPIRED” is referred to the validity of the IREC registration under the repealed CTR. This implies that these IREC can’t approve new clinical trials or new research centers of previously approved protocols until the accreditation is granted. Other IREC responsibilities concerning approved research protocols are not affected by the accreditation process.