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Registration of Institutional Research Ethics Committee

All the Institutional Research Ethics Committee should be registered in the Peruvian Clinical Trials Registry in order to create an inventory of Institutional Ethics Committees which review and approve clinical trials conducted in the trial sites of the country.

Requirements

  1. Application for the Registration of Institutional Research Ethics Committee (as per e-form) and printed form attached.
  2. Resolution issued by the higher authority of the Research Institution which authorizes the operation of the Institutional Research Ethics Committee.
  3. Institutional Research Ethics Committee Procedure Manual, including:
    • Administrative requirements for the submission of files.
    • Follow-up procedures for the authorized research protocols included in the files.
    • Procedures for the preparation of meeting minutes.
    • Filing procedures for related documents.
  4. Copy of the Ethics Committee Regulations approved by the institution.
  5. Short descriptive Curriculum Vitae signed by each member of the Institutional Research Ethics Committee.


NOTE: All the documents should be numbered, submitted to the National Institute of Health in a folder or binder and ordered pursuant to the stipulations set forth, indicating each document name by means of markers.


WARNING: Useful information for the lining-up of Institutional Research Ethics Committees, published by INS, is available here.

Institutional Research Ethics Committee registration e-form

Enter your data in the Institutional Research Ethics Committee registration e-form (including Annex 17 of Procedure Manual in force). After filling the form, click Save, a temporary registration number for the Committee will appear. Then, print the form, sign it and attach it to the documents to be submitted via INS’ Documentary Procedure Office – Headquarters.

 

Listado de Comités Institucionales de Ética en Investigación Registrados.