REC – Standard Procedure
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APPLICATION TO IJNREC
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:
- Research proposal and supporting documents – 15 copies
- A cover letter
- A completed IJNREC Application Form (CRD-QR-A02)
- A completed application should be received not later than 10 working days before the next scheduled IJNREC meeting
- 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
- An application that has been accepted for review and assigned a reference number should not made any revisions, prior to the IJNREC meeting
- 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it necessary to revise the application form or supporting documents prior to review, the application should be withdrawn from meeting agenda
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APPLICATION MATERIALS
1. The following documents are mandatory for submitting for ethical review:
- IJNREC Application Form (dated and signed)
- Research protocol (version number and dated)
- Participant information sheet (version number and dated)
- Participant informed consent form (version number and dated)
- Investigator(s) curriculum vitae (updated, signed and dated)
- Evidence of insurance or indemnity (if applicable)
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2. Other types of supportive documents may include, whenever necessary:
- A summary (as far as possible in non-technical language), synopsis, or diagrammatic representation (‘flowchart’) of the protocol
- A description of the ethical considerations involved in the research
- Case report forms, diary cards or questionnaires intended for research participants, advertisements, where applicablea
- 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)
- A written participant information sheet and informed consent form in translated version, whenever necessary
- Confirmation that external funding for the project costs has been granted subject to ethical approval (letter of offer or equivalent)
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3. All documents must have version numbers and dates
FULL BOARD REVIEW
APPLICATION TO IJNREC
1. Investigator submit the application to IJNREC
2. Secretariat of IJNREC will review the application and determine the eligibility for full review (IJNREC Determination Form – CRD-QR-A05)
3. If the research project is not eligible for exempt or expedited review, the research project shall be reviewed during the IJNREC meeting
4. Secretariat of IJNREC will notify the applicant in written
5. In order to approve human subject research, IJNREC shall determine that the following criteria are satisfied:
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- Proposed research scientifically sound
- Risk is minimized and risk to research participant are reasonable in relation to anticipated benefits and the importance of the knowledge gained from the research
- Selection of research participant is equitable
- Informed consent will be obtained from each prospective research participant or legally authorized representative (LAR)
- Adequate provision for monitoring of data collected to ensure the safety of research participant
- Adequate provision to protect the privacy of research participant and to maintain the confidentiality and security of data and research information
- Additional safeguards have been included in the research to protect the rights and welfare of research participant when involve a vulnerable participant
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SAFETY REPORTING
SAFETY REPORTING
1. As a condition of approval of the research proposal the IJNREC will require investigators to immediately report any serious or unexpected adverse events on participants/volunteers or unforeseen events that might affect the benefits/risks ratio of the proposal.
2. A serious adverse event (SAE) is defined as any occurrence that:
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- Results in death.
- Is life threatening.
- Requires in-patient hospitalisation or prolongation of existing hospitalisation (in the case of a clinical trial).
- Results in persistent or significant disability/incapacity.
- Congenital abnormality
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3. An unexpected event is an adverse reaction, the nature and severity of which is not consistent with relevant information available at the time of original approval.
4. Investigators may take urgent safety measures to eliminate immediate jeopardy to the research participants/volunteers prior to approval by the IJNREC. However, investigators should provide the Committee with a written report of any action taken at the earliest opportunity. The Committee will review the new material and decide whether there are sufficient grounds for changing its initial decision to grant approval to the proposal.
5. IJNREC shall require, as a condition of approval of each project, that researchers report SAE and other Adverse Event to the IJNREC according to the following procedure:
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- Serious Adverse Events (SAEs) (submitted on the Single or Periodic SAE form)
- All internal SAEs must be notified to the IJNREC within 24 hours after the investigator first learns of their occurrence. A detailed, written report must be submitted within seven (7) working days (using Single SAE form)
- External SAEs must be reported in a prompt manner (within 24 hours after the investigator first learns of their occurrence). A detailed, written report must be submitted within fifteen (15) working days if the information impacts the continued ethical acceptability of the trial (using Single SAE form)
- All other external SAEs need only be submitted if they are suspected or unexpected (SUSAR) and may be submitted as a periodic listing. A periodic listing of SUSARs must be submitted at least six monthly (using Periodic SAE form)
- IJNREC shall review and make decision within fifteen (15) working days
- a) Continue, no further review
- b) Suspended, need further review
- c) Terminate
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6. Any other event that occurs as part of a research such as deviation from or violation of the protocol which affects participant safety, requires a change in the inform consent and protocol, must be submitted in letter format to the IJNREC.
7. Notifications of SAEs are submitted by the Investigator to the IJNREC on a SAE form which includes:
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- Advice from the Investigator as to whether, in his/her opinion, the adverse event was related to the protocol
- Advice from the Investigator as to whether, in his/her opinion, the adverse event necessitates an amendment to the protocol and/or Informed Consent Form
- Advice from the Investigator as to whether the event has been notified to the “Independent Safety and Data Monitoring Board” (if applicable)
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