Application to IJNREC

• An application for IJNREC review in respect of proposed research must be made in writing and signed by an applicant responsible for the conduct of the research. All properly submitted and valid applications shall be reviewed in a timely fashion and in accordance with the review procedures. A valid application is one which has been submitted by an applicant, is complete, with all the necessary documents attached and is signed and dated.
• The application should include the following information and materials:
  1. Research proposal and supporting documents – 13 copies
  2. A cover letter
  3. A completed IJNREC Application Form (CRD-QR-A02)
  4. A completed application should be received not later than 10 working days before the next scheduled IJNREC meeting
  5. All applications shall receive notification in writing of the decision of the IJNREC not later than 90 working days after acknowledgement of receipt of completed application
  6. An application that has been accepted for review and assigned a reference number should not made any revisions, prior to the IJNREC meeting
  7. Where an applicant considers it necessary to revise the application form or supporting documents prior to review, the application should be withdrawn from meeting agenda

Application Materials:

1. The following documents are mandatory for submitting for ethical review
   1. IJNREC Application Form (dated and signed)
   2. Research protocol (version number and dated)
   3. Participant information sheet (version number and dated)
   4. Participant informed consent form (version number and dated)
   5. Investigator(s) curriculum vitae (updated, signed and dated)
   6. Evidence of insurance or indemnity (if applicable)
2. Other types of supportive documents may include, whenever necessary;
   1. A summary (as far as possible in non-technical language), synopsis, or diagrammatic representation (‘flowchart’) of the protocol
   2. A description of the ethical considerations involved in the research
   3. Case report forms, diary cards or questionnaires intended for research participants, advertisements, where applicable
   4. An adequate summary of all safety, pharmacological, pharmaceutical and toxicological data available on a research product (where one is being used) together with a summary of clinical experience with the research product to date (e.g. recent investigators’ brochure, published data etc)
   5. A written participant information sheet and informed consent form in translated version, whenever necessary
   6. Confirmation that external funding for the project costs has been granted subject to ethical approval (letter of offer or equivalent)
3. All documents must have version numbers and dates