Ethics Approval for Human Subjects Research
”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 Regulations on Research Activities (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. At VinUniversity, Dr. Le Cu Linh and Dr. Huynh Dinh Chien are voting members of the ERC.
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.
The high-level process for the VinUni IRB-Vinmec ERC review is as follow:
How to apply to review and approval?
- For studies involving no more than minimal risk to participants, please complete this application form.
- Please use the Short Consent Template or the Long Consent Template. If you choose to use another form, please ensure that it covers all the points outlined in the VinUni template.
- For studies that involve more than minimal risk and require full-committee review by the Vinmec ERC, complete the Full ERC Form. Submit all documents to the Research Management Office at VinUniversity at firstname.lastname@example.org.
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 email@example.com.
- 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).
For any questions about this process or about your study, contact firstname.lastname@example.org.