“Use of Human Participants in Research: VinUni must ensure that the rights and interests of human participants involved in VinUni research are protected, that research is conducted with appropriate informed consent, and that the benefits of any research involving such participants outweighs the risks to them and others. Any research that involves research with human participants must be reviewed and approved by an ethical review board duly constituted with the appropriate expertise and authority to review, approve, require amendments to, or deny the research. Such research is subject to regular monitoring for continued compliance with the approved protocols.”

Excerpt form VinUniversity Research Management Policies and Procedures (VinGroup login required).

Review and Approval by the Committee for the Ethical Review of Studies that Involve Human Subjects

VinUniversity has partnered with VinMec Company for the ethical review of studies conducted by VinUniversity faculty, staff and students. For an excellent introduction of the Vinmec ERC and the regulations that govern studies involving human subjects in Vietnam, refer to [This presentation] by the Chair of the Vinmec ERC, Dr. Cuong.

How to apply to review and approval?

If this is the applicants’ first time seeking IRB’s approval, they should send to the RMO

1) certified application form (a shortened form if the study involves no more than minimal risks to participants and a full form if it involves more than minimal risks and thus requiring full review).

2) consent form (if used, and translated into Vietnamese if it involves VNM participants) –  Please use the Short Consent Template or the Long Consent Template. If they choose to use another form, please ensure that it covers all the points outlined in the VinUni template.

3) verified CV(s)

4) Project-specific documents such as research proposals, questionnaire surveys, interview forms, etc.

There are specific requirements for these documents as noted in the table below:

IRB application form (either shortened or full form)	Two versions: One version in MS Word One verified and scanned version (signed by the appropriate representative, sealed with VinUni’s seal, scanned) RMO will first review the IRB Application Form. If the form is complete and valid, RMO will arrange for the required signature and VinUni’s seal before the package is submitted.
Consent form	MS Word or PDF format
Verified CV of the research team	For faculty: Signed by HR, sealed with VinUni’s seal, scanned For students: (i) A CV; (ii) Official Enrollment Certification Letter from Registrar and scanned
Project-specific documents	MS Word or PDF format

 

Submit all documents in soft copy to the Research Management Office at research@vinuni.edu.vn. No need to send hard copies of these documents, unless required later by the committee.

Request for amendment approval?

• Fill out the form: Request for Amendment Approval and Details of Changes
• Submit all documents to the Research Management Office at VinUniversity at research@vinuni.edu.vn

Remark:

• Under normal circumstances, the RMO aims to send out applications to the IRB for approval twice a month, usually at the beginning and middle of the month.
• Expected decision time:
  • Expedited reviews: 2-3 weeks
  • Full reviews: 4 -5 weeks
• The RMO staff will conduct a preliminary review of the study to ensure that it meets the VinUni requirements and convey its recommendation to the Vinmec-VinUni ERC for approval.

What does approval mean?

• Vinmec-VinUni ERC will issue the final approval: a stamped and signed letter of approval from the Chair of the ERC. No other approvals can be accepted.
• Approvals cannot be given retroactively (if researchers conducted any research activities including contacting participants, collecting or analyzing data, before the ERC issued its final approval, those data and activities will be considered unapproved research and cannot be used).

IRB Requirements for External Partners

• For research activities involving human subjects conducted by VinUni partners, partners are encouraged to follow the IRB review process.
• If a partner already has IRB approval from an external institution, they should provide the approval letter and related documents to RMO. RMO will then consult the Vinmec–VinUni IRB to determine whether an internal review is still required.

For any questions about this process or about your study, contact research@vinuni.edu.vn.