If the research is entirely observational or must follow a covert research method, does the principal investigator still need to acquire informed consent?

A: Providing informed consent is suggested. In accordance with the different requirements in each research, however, the "Application for Exemption or Change/Correction of Consent Form" shall be submitted to the Committee, followed by a post-research debriefing. Please consult the Decision Chart provided on our website.

My research project only consists of one subject, do I still need to submit the case for review?

A: Regardless of the number of subjects, as long as the research involves human subjects, each and every one of them must undergo review.

Suppose I need to first finish collecting data from a case, in order to then decide on what research I wish to undertake and publish, or if before executing the research, I temporarily decide not to publish the research, would I still need to submit the case for review in these circumstances?

A: Undergoing review is suggested. Please consult the Decision Chart provided on our website.

Research such as "the relationship between a grand justice's background and his/her disposition when passing judgment" may exist within law studies. However, although the grand justice and his/her judgment are accessible as public data, such judgments are made by the grand justices, and it is hence not consistent with the University’s current exemption standards. The research project shall thus be one of minimal or higher risk. If information from such public databases is used to conduct the research, is any of it exempted from review? If the research is conducted using public databases, but consent is impossible to obtain from the parties involved, can the research still be conducted?

A: Documents or databases disclosed by government agencies are not classified as private information, but it is still appropriate to submit the case to the University's Behavior and Social Sciences Research Ethics Committee for approval to be "exempt from review". If it involves interviews with research participants, it is necessary to submit the case to the University's Behavior and Social Sciences Research Ethics Committee for review.

If a research project (e.g. with fully de-identified data from the NHI database) is clearly eligible for exemption, can it be exempt from review?

A: Whether or not the research project meets the conditions for exemption, it still needs to be handed over to the Research Ethics Office for preliminary judgment and confirmation by the convener. Therefore, "exempt from review" does not mean that there is no need to submit the case for review, but it refers to its "exemption from full Committee discussion or individual review by members." As such, a case eligible for exemption from review does not need to be submitted to the full Committee for discussion as in a general review, nor does it need to undergo a substantive and complete review such as with low-risk reviews which are reviewed by two members and then the results are reported in the Committee to reach a consensus. The director of the Research Ethics Office and senior managers will have preliminary discussions and provide suggestions, and then hand the case over to the convener to determine whether it belongs to the "exempt category".

If the research is transnational (for example, cooperating between National Taiwan University and parties from Germany), is an IRB/REC approval needed from both countries before conducting research?

A: If implementation of the research plan is exclusively carried out in the university/institution of only one of the parties, and each party has already signed a mutually recognized cooperation agreement, then the IRB/REC review of just one of the parties is sufficient. If there is no mutually recognized cooperation agreement, then applications for review shall be submitted to each party. However, if the implementation of the research plan is carried out in each of the cooperating parties' universities/institutions, then reviews shall be submitted to each party.

Is there any consulting service before or during submission for review?

A: Yes. Please call 02-33669956,02-33669980, or direct inquiries to the e-mail: nturec@ntu.edu.tw .

In the future, will there be a big difference in the research ethics committees' administrative procedures of both NTU's social and behavioral sciences (SBS) and biomedical review?

A: Administrative procedures may be slightly different, but the basic ethical principles and review principles remain consistent. Please refer to the information related to the review procedure on our website.

If I am conducting behavioral and social science research, but have already sent my project to NTU's affiliated hospital for review, do I still need to send it to NTU's SBS research ethics committee panel for review?

A: If the same research project has been reviewed and approved by the research ethics committee of NTU's affiliated hospital, it does not need to be sent to NTU's SBS research ethics committee for review. Please refer to the organization chart on our website.

Is it feasible to formulate different review implementation timetables for units belonging to different academic fields?

A: The basic ethical principles and review principles of research projects are the same regardless of the discipline, and will not vary from discipline to discipline. Hence, no differences exist regarding the time or procedure of reviews for different disciplines.