3. Ethics Committee (EC)/ Institutional Review Board (IRB)

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant.

The following documentation must be submitted for ethics approval:

1. Research protocol
2. Protocol summary
3. Summary of previous studies
4. Summary of the therapeutic product research
5. Documentation stating research participants, research, institution, and if applicable, sponsor commitments
6. Reporting describing maintenance measures and life support for research participants and insurance policy agreements.
7. Report on procedures and people responsible for keeping participants informed of study developments
8. Investigator resume
9. Statement specifying external funding source information (if applicable)
10. A statement providing study costs and expenses, if no external funding source is available
11. Sponsor data report
12. Report on supporting material to be used for participants' recruitment
13. System/mechanism to protect participant privacy and maintain confidentiality during the study
14. Methodology to obtain informed consent
15. System and procedure to communicate results to participants
16. For previously rejected protocols, information on modifications made to address earlier issues
17. Informed consent letter
18. Investigator’s manual
19. Amendments to previously approved documentation
20. Required documentation for participants

https://clinregs.niaid.nih.gov/sites/default/files/documents/mexico/MX-GCP-COFEPRIS-GoogleTranslation.pdf

3.2 Time required for EC/IRB review and approval process and turnaround time if any query is raised during the review process.

Documents for ethics review must be submitted at least seven days prior to the meeting. It is then recommended that the REC’s decision be sent within a period not exceeding five working days after the committee has met, or if applicable, not to exceed 30 calendar days from the date of request for its review. The approval of a new application is valid for one year.

The REC should establish procedures for monitoring approved studies, from the point at which the decision was made until the completion of the investigation and reporting of results. RECs should conduct at least one review a year.

https://www.gob.mx/cms/uploads/attachment/file/420833/Gui_a_CEI_2018.pdf

3.3 Does EC/IRB have any fast-track or expedited review process?

No.

3.4 Does EC/IRB need to be registered and/or accredited/approved by RA/CA?

Yes. Ethics committees must be registered with COFEPRIS.

3.5 How frequently do EC/IRB meet?

RECs must meet at least six times a year, and at least once every two months.

https://dof.gob.mx/nota_detalle.php?codigo=5276107&fecha=31/10/2012

3.6 Is any additional approval required apart from the EC/IRB (e.g. scientific committee, subject matter expert committee, etc.)?

Normally, no. However, gene therapy products may require an additional review.

3.7 Please describe the process of the EC/IRB submission for clinical trial approval.

1. Applicants must submit the application to the ethics committee at least 7 days prior to the proposed meeting date.
2. Once the ethics committee has met, an outcome will normally be communicated within 5 days.
3. If the ethics committee has further queries, the responses must be submitted prior to the next meeting.
4. Once approval has been obtained from the ethics committee, the application may be submitted to COFEPRIS.

3.8 What is the relevant EC/IRB fee in local currency/USD? (e.g., is the fee different for notification/approval, initial submission, amendment, study with IMPD and study without IMPD, investigator site addition, etc.)?

Research Ethics Committees (RECs) do not charge sponsors/investigators for their review. Rather, the health institution must finance REC operating expenses, without this causing any conflict of interest in the committee’s functions.

REC financial support should not be used for purposes other than for its operation, and all activities must be handled with full transparency. Members should receive support for the following activities:

• Time for participation in committee meetings.
• Work recognition for their performance in the REC.
• Support for training in bioethics and research ethics inside and outside the institution.
• Physical space for the REC headquarters, both for meetings and receipt of documents, and safeguarding of documentation protocols, opinions, and minutes.
• Administrative assistance for REC activities

3.9 Does EC/IRB accept checks or can payment be made electronically? Please provide details on (1) A/C number; (2) A/C Name; (3) Sort Code; (4) Swift Code; (5) Bank address, etc. Where can remittance advice notices be sent?

RECs do not charge sponsors/investigators for their review. Rather, the health institution must finance the REC's operating expenses, without this causing any conflict of interest in the committee’s functions.

3.10 Is there any guidance tool available for making electronic applications? If yes, provide the link and/or step-by-step instructions.

As all applications are required to be submitted in Spanish, the instructions are also in Spanish.

https://www.gob.mx/cms/uploads/attachment/file/652277/COFEPRIS-04-010-A.pdf

3.11 Does EC/IRB require any mock screens/screenshots of participant-facing material on the app? If yes, do these need to be submitted in the local language?

No.

3.12 Does the EC/IRB have any template or specific element requirements on ICF and/or other participant-facing materials?

The ICF should include the following statements or descriptions, as applicable:

• The study rationale and objectives.
• Purpose and procedures, including all invasive procedures.
• Identification of experimental aspects of the study.
• Trial duration.
• Participant’s responsibilities.
• Investigator's responsibilities.
• The approximate number of participants.
• Circumstances that may terminate the study.
• Duration of study.
• Any expected risks or discomforts to the participant.
• Any expected benefits to the participant; if no benefit is expected, the participant should be informed of this point.
• Alternative treatments that may be beneficial to the participant.
• Trial treatment(s) and the probability for random assignment to each treatment.
• Compensation and/or treatment available for the participant by the health care institution in the case of trial-related injury.
• All drugs, products, and procedures are free.
• That participation is voluntary, and that the participant can withdraw from the study at any time without penalty or loss of benefits, including medical treatment, to which the participant is otherwise entitled
• Assurance that the participant will not be identified and that his/her confidential information relating to his/her privacy will be maintained.
• Confidentiality of records identifying the participant will be maintained, and permission given to monitors, auditors, the REC, and the COFEPRIS to access the participant’s medical records to verify the procedures or trial data, without violating the participant’s confidentiality, insofar as the applicable laws and regulations permit.
• Contact information for the sponsor and PI in the event of participant problems or trial-related injuries.
• The guarantee of receiving a response to questions and clarification of concerns about procedures, risks, benefits, and other matters related to the investigation and treatment of the participant.
• Foreseeable circumstances under which the PI(s) may remove the participant without his/her consent.
• Commitment to provide updated information throughout the study although this may affect the participant’s willingness to continue.
• Notification that any additional research study expenses will be absorbed by the research budget.
• Any anticipated prorated payment to the participant for participating in the trial.
• Any expenses the participant needs to pay to participate in the trial.

https://clinregs.niaid.nih.gov/sites/default/files/documents/mexico/G-RECs-Op-2018-GoogleTranslation.pdf

3.13 Is there any guidance tool on participant compensation including clinical study-related injury per local requirements?

There is no specific guidance tool. However, it is required that the sponsor or his/her CRO must comply with the Good Clinical Practice GCP which states that the compensation must be stated in the ICF along with the treatment available to the participant in the event of a trial-related injury.

3.14 Are there any specific local safety reporting requirements for clinical studies?

Please refer to Section 2.15 of this guidebook.

3.15 Does the EC/IRB require any periodic study reporting?

The PI must prepare and submit a progress report (also referred to as a partial technical or technical-descriptive report) to the Secretariat of Health at any time, but at least once a year, to communicate, and additionally provide a copy of every report to the head of the Research Ethics Committee (REC) and the Research Committee, and if applicable, the Biosafety Committee of the institution where the research takes place.

https://dof.gob.mx/nota_detalle.php?codigo=5284148&fecha=04/01/2013#gsc.tab=0