EC Review Process

Do I need Ethics Approval?

If your project involves human subjects, you require ethics committee approval. This is to ensure the safety of the subjects, protection of confidential information, and appropriate ethical treatment of those involved in your research. There are two panels, one for clinical studies, and one for non-clinical (biomedical and observational) studies, and there are three routes to EC approval, full board review, expedited review, and exemption from review. To learn more about each route, please click the links below.

Process diagram

Full Board Review

Full Board Review is the standard review conducted by the EC. These reviews are conducted once a month. The schedule for the meetings can be found here: Panel 1 (clinical studies), Panel 2 (non-clinical studies).

Below is a general overview of the full board review process:
  1. Studies that cannot be reviewed and approved at an Exempt or Expedited review.
  2. Studies determined by the EC Chairperson as involving more then minimal risk.
  3. Studies involving elements, procedures or interventions that require additional provisions or safeguards, as stated by federal regulations and guidance.

If you have further questions, please do not hesitate to contact the EC via email (tmectropmed@mahidol.ac.th) or visit our office on the 4th floor, of the 60th Anniversary of His Majesty the King's Accession to the Throne Building.

Once the research proposal and all appropriate submission forms have been submitted, the EC assistant secretary will distribute the materials to each EC member seven working days before the scheduled meeting. The EC chairperson will assign two primary reviewers for each proposal. All EC members will complete a Reviewer's Assessment Form for Initial Review, while primary reviewers and non-scientist members will also complete additional forms that take further details into considerations. During the meeting, the following points must be discussed:

  1. Risks to the research participants are minimized.
  2. Risks to the research participants are reasonable in relationship to the anticipated benefits.
  3. Selection of the research participants is equitable.
  4. Informed consent will be obtained from the research participant or legally authorized representative.
  5. The proposal/protocol ensures research participant's safety through the monitoring of the data.
  6. The proposal/protocol ensures the research participant‟s privacy and confidentiality of the data, if applicable.

After discussing the project according to the points above, members must reach a consensus to decide the outcome of each proposal. If there is no consensus, there will be a vote:

  1. Unconditional approval – approved as presented
  2. Conditional approval – approved, subject to specific clarification/amendment
  3. Deferred – no decision can be made yet, pending evaluation of additional requested information
  4. Disapproved – the board has decided that they cannot ethically approve the research

If the EC decides on conditional approval, it must specify whether the changes will require a full board review or only primary reviewers.

The EC will also provide a summary of the discussion to the researcher.

Expedited Review

Expedited review is a speedier approval process available for certain projects which have specific characteristics:

Criteria for an Expedited Review of Research Proposal

Expedited review allows certain kinds of research to be reviewed and approved without convening a meeting of the EC. The EC will review certain categories of research through an expedited procedure only

Expedited review applies to research with the following characteristics

  1. Minimal risk
  2. May include identifiers (direct or indirect)
  3. Topics that are not sensitive OR may include some mildly sensitive topics, but where confidentiality is secure
  4. Populations may include regulated vulnerable populations & others with adequate protection
  5. Consider a formal informed consent process OR justify a waiver of consent
  6. Requires continuing IRB review, at least annually
  7. Fits one of 9 expedited categories below

Categories of research which may be considered for expedited review include the following:
  1. Clinical studies: IND (Investigating New Drug) /IDE not required
  2. Blood sample collection (routine methods–small amounts)
  3. Prospective collection of biological samples—noninvasive means
  4. Data collected though noninvasive means (routinely practiced in clinical settings)
  5. Materials (data, documents, specimens, etc.) have been collected or will be collected for non-research purposes
  6. Collection of voice, video or digital data for research purposes
  7. Low risk non-participatory observation, surveys, interviews, oral histories
  8. Research involving the collection or study of existing data, documents, medical records, stored, or identifiable leftover specimens, if these sources are available through authorized permission, or if the information is recorded by the investigator in such a manner that research participants cannot be identified directly or through identifiers linked to the research participants. Leftover- or stored specimen can be stored as quality of specimen is available, but not more than ten (10) years
  9. Research proposal of multi-center study approved by the Central Research Ethics Committee (CREC) of which FTM EC is a member (See FTM ECS-009-RR), and project conducted outside Thailand by FTM staff/ student and has been approved by the local EC
  10. Continuing review of research previously approved by FTM EC as follows:
    • where the research is permanently closed to the enrollment of new subjects; all subjects have completed all research-related interventions; and the research remains active only for long-term follow-up of subjects; or
    • where no subjects have been enrolled and no additional risks have been identified; or
    • where the remaining research activities are limited to data analysis

Exemption Review

Projects can be exempt from Ethics Committee review if they involve minimal risk to participants, do not include identifiers, or if the topic is deemed non-sensitive.

Criteria for an Exempt Review of Research Proposal

An exempt review applies to research that involves

  1. Minimal risk
  2. Does not include identifiers, with some exceptions
  3. Topic generally not sensitive
  4. Non-vulnerable populations
  5. Exempt from formal informed consent requirement, but subjects deserve to know about the research
  6. Exempt from continuing IRB review
  7. Fits one of 6 exempt categories below

Categories of research which may be considered for exemption include the following:
  1. Typical educational practices
  2. Educational tests, and surveys
  3. Research with elected public officials, appointed public officials, candidate for public office
  4. Existing data, documents, pathological specimens (if publicly available or rendered unidentifiable) and anonymous leftover specimens, data/ de-identified/ no identifiers maintained such as online survey
  5. Evaluation of public benefit service programs
  6. Taste and food quality evaluation and consumer acceptance studies

Post-Review

Below is a brief overview of the post-review process. For full details, please read the EC SOP documents, or get in touch with the EC directly via email (tmectropmed@mahidol.ac.th) or by visiting our office on the 4th floor, 60th Anniversary of His Majesty the King's Accession to the Throne Building.

CEA is valid for one year. Therefore, PI must submit annual progress reports requesting CEA extension. In addition to these scheduled reports, PIs must submit reports in case of Serious Adverse Events (SAE), Adverse Events (AE), Protocol Amendments , or other unanticipated problems. SAE and unanticipated problems must be reported to the EC within 5 working days of event. The protocol deviations must be submitted in 1 month.

These reports are reviewed by the EC Chairperson or by the primary reviewers (unless an amended protocol is considered to contain major revisions, in which case a full board review is necessary), and once a decision has been made, the PI and the other EC members are notified.

    The following decisions can be reached in the post-review process:
  • CEA extension - valid for another year
  • Study closure - if the project has completed, the final progress report results in a study closure.
  • Study Termination - the study must be cancelled, either because circumstances prevent the PI to continue, or because the EC deems the project too high-risk to progress.
  • Protocol Amendment - changes in project protocol can be accepted or denied only after review.
  • SAE/Unexpected problems reports - These are submitted within 5 days of the event, and depending on the problems encountered, may result in a range of actions, from an acknowledgement without action, up to a CEA suspension/withdrawal. The protocol deviations must be submitted in 1 month.