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 investigator must submit at least the following documents:

1. Application note indicating the title of the study and available funding.
2. Identified study protocol with version number and date.
3. Informed consent.
4. Material to be used for the recruitment of participants (e.g., notices).
5. In clinical trials of diagnostic or therapeutic products, a summary or monograph describing the preclinical and clinical history.
6. In clinical trials with commercial or industrial sponsorship, a copy of the financial agreement with the sponsor and of the insurance or guarantee of medical coverage and compensation provided in case of harm caused to the participants by the research.

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

There is no specific timeline for approval of a clinical trial application.

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, ANMAT approves ethics committees.

3.5 How frequently do EC/IRB meet?

There is no specific schedule; this depends on the individual EC. The EC’s SOPs should state how often they will meet.

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

No.

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

The specific process will be dependent on the Ethics Committee. However, as outlined in the Ministry of Health’s Resolution 1480/2011 – Approval Guide for Research with Human Beings, the review process each Ethics Committee must follow is as follows.

The review process:

The main task of the REC is the review of research projects and supporting documents. For the review, RECs should consider applicable laws and regulations, the scientific aspects, the proposed recruitment mechanism, the informed consent process, and the protection of participants and communities involved, during and after the research.

The scientific evaluation of the study should consider at least the following:

1. The adequacy of the chosen design to the objectives, statistical methodology, and potential to reach sound conclusions of the study and to provide a benefit to society.
2. The adequacy of the proposed control or comparator, if any.
3. The balance between risks and disadvantages and potential and actual benefits for the participants and communities involved in the study.
4. Justification of the inclusion or exclusion of concomitant treatments.
5. Characteristics of the population to be studied, including sex, age, ethnicity, education, and socio-economic level, among others.
6. Specific criteria for inclusion and exclusion of participants.
7. The criteria for the premature withdrawal of research participants.
8. The criteria for suspending or terminating the research prematurely.
9. The adequacy of the research center; including equipment, facilities, and, in the case of clinical trials, access to emergency care.
10. How they will communicate and publish research results.

With regard to the informed consent process, the REC should consider the following:

1. The intended process for obtaining informed consent.
2. Relevance, clarity, and accuracy of the study information to be provided to potential participants or, where appropriate, their representatives.
3. Assurance that participants or their representatives will receive information on the progress of the study and its results and that they may ask or raise complaints during the same.

The REC shall review and approve the following precautions for the care and protection of research participants:

1. The qualifications, suitability, and experience of the investigator to conduct the research.
2. The medical care to be provided to participants.
3. Measures to minimize the risks of the research.
4. Procedures for participants who decide to withdraw from the research.
5. Ensuring access to study treatment when it concludes research.
6. Free participation in the research.
7. The remuneration provided for travel expenses or loss of earnings for participants.
8. Measures for treatment and guarantee of compensation in case of damage attributable to participation in the research.
9. Roles of the persons who will have access to the data of the participants and the measures that will be taken to ensure the confidentiality of personal information.

The REC should consider the following community-related aspects:

1. The impact and relevance of the research to the community where it will be conducted.
2. Measures to consult the community or its representatives before and during the study.
3. The future availability of any successful research products.
4. The availability of research results to the communities involved.
5. The contribution of the research to health services (e.g. training of human resources and provision of materials or equipment).

In clinical trials sponsored by a pharmaceutical or other commercial company, the ERC must verify that the agreement or contract between the investigator, institution, and sponsor:

1. Does not include clauses that limit or appear to limit participants' rights.
2. Does not present inconsistencies with the information to be provided to participants or requires actions that run counter to the ethical requirements of the EIC. 
3. States that the costs of the trial, including study treatments and procedures and full coverage in case of harm arising therefrom, will be covered by the sponsor.
4. It is explicit that the institution and the researchers will remain harmless in any case of claim for damages caused by participation in the trial, in the responsibilities that correspond to the sponsor, and that, in case of conflict between the parties, these will be settled in local courts with respect to research centers.
5. The sponsor has insurance or guarantee subject to Argentine legislation.
6. The budget realistically contemplates all the costs of the trial, in such a way as to guarantee its realization and that the payments for the researcher and his team are proportionate to the task and do not constitute an undue incentive to incur ethical misconduct.

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.)?

The fee is not stipulated; it will depend on the committee.

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?

Please refer to Section 3.8 above.

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

No.

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?

Where patient-facing materials are provided in electronic format, screenshots should be provided as part of the application.

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

There is no specific template to be followed. However, the requirements of what needs to be provided to participants are outlined in the Ministry of Health’s Resolution 1480/2011 – Approval Guide for Research with Human Beings.

In all informed consent forms used in a clinical trial (including the consent form for minors), the following text shall be included in red, in capital letters, squared, Times New Roman 11 or equivalent:

"BY SIGNING THIS FORM YOU ARE AGREEING TO PARTICIPATE IN MEDICAL RESEARCH IN CLINICAL PHARMACOLOGY OR EXPERIMENTAL MEDICAL TECHNOLOGY AUTHORIZED BY THE NATIONAL ADMINISTRATION OF DRUGS, FOOD, AND MEDICAL TECHNOLOGY (ANMAT). IF YOU HAVE ANY QUESTIONS ABOUT WHAT YOUR DOCTOR OR THE ETHICS COMMITTEE HAS EXPLAINED TO YOU, BEFORE SIGNING KNOW THAT YOU CAN CONSULT "ANMAT RESPONDE", TOLL-FREE LINE 0800 333 1234 OR 011 4340 0800 FROM MONDAY TO FRIDAY FROM 8 A.M. TO 5 P.M. (Subsection incorporated by Article 8 of Provision No. 6550/2008 of the National Administration of Drugs, Food, and Medical Technology B.O. 7/11/2008. See art. 9° of the same standard)".

In observational research requiring consent, the potential participant or his/her representative must be informed of the following:

1. The title of the research.
2. A record that the individual is invited to participate in the research and the reasons why it is considered appropriate to do so.
3. A record that participation in the research is voluntary and that the potential participant may refuse to participate or leave the research at any time, without having to state reasons and without loss of the benefits to which they are entitled (e.g.: without affecting the relationship with their doctor or with the institution where they are cared for).
4. The purpose of the research, the procedures to which the participant will be subjected, the visits which they are expected to attend, and the expected duration of their participation;
5. A record that the participation in the study will have no cost to the participant;
6. The remuneration available to the participant for the expenses derived from their participation. Where a payment for participation is acceptable, its amount and payment schedule need to be specified.
7. A description of the potential benefits of the research to the participant. If no direct benefit to the participant is anticipated, this should be specifically expressed.
8. A description of the expected benefits of the research for the community or society at large, or its contribution to scientific knowledge.
9. A description of the foreseeable risks or discomfort to the participant or his/her environment and, in case of pregnancy or lactation, for the embryo, fetus, or infant.
10. All commitments they make if they agree to participate.
11. The measures that will be taken to protect the confidentiality of personal data.
12. Limitations, legal or otherwise, on the ability of researchers to protect confidentiality and the possible consequences of its breach.
13. A commitment to provide timely responses to questions, clarifications, or concerns about research-related procedures, risks, or benefits.
14. A commitment to timely communication to the participant or his/her representative of all information related to his/her health status, or information about the study that could affect his/her safety or decision to continue participating in the study and the results of the research as soon as these become available.
15. The circumstances and/or reasons foreseen that the investigation or the person's participation could be terminated prematurely, specifying that, in such a case, the necessary measures will be taken to protect their safety.
16. A description of the individual's rights as a research participant, including the right to have, modify, or delete their data at any time during the investigation when required.
17. The contact details of the ERC that has approved the research.
18. Who the sponsors or sources of funding for the research are, the institutional affiliation of the researcher, and other potential conflicts of interest.
19. The contact details of the investigator and the ERC that approved the study.

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

There is no guidance tool that can be found. However, written in the National Administration of Drugs, Foods and Medical Devices Regulation 6677/10 is the following:

"The sponsor shall ensure medical care and an insurance coverage or the setting up of any other form of guarantee in the country, in case of injury to participants resulting from the study. 

Financing of the investigation needs to be documented in a written agreement signed by the sponsor, the investigator and/or the institution hosting the study, which shall show in detail the commitment of the parties to fulfill the obligations set out in the Regulatory Guideline herein. 

The REC shall check any financial agreement and foreseen payment for the participants. The sponsor shall verify that the REC approved them prior to research initiation. 

The investigator shall declare his or her potential financial conflicts of interest to the REC prior to initiating the investigation and at any time said conflicts arise. 

The approval or authorization of the study shall not release the sponsor, the investigator, or the host institution from any legal responsibility they might bear in case of participants incurring damages as a result of their participation in the study."

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 ethics committee requires regular annual reports. Research must be evaluated by an ERC prior to its commencement and then at least once a year until completion. Depending on the degree of the risk, the ERC may determine shorter intervals. The ERC may also exempt low-risk observational studies.