Taipei Medical University Hospital (TMUH):

• Human Research (as defined by the Human Subjects Research Act): The Principal Investigator (PI) is not required to be a full-time staff member of TMUH; however, at least one team member must hold a full-time position at TMUH.
• Clinical Trials (as defined by the Medical Care Act and the Pharmaceutical Affairs Act): The PI must be a full-time attending physician within the TMU system, and at least one co-investigator must also be a full-time attending physician at TMUH.

Taipei Municipal Wanfang Hospital:

• The PI is not required to be a full-time staff member of the hospital; however, at least one co-investigator must hold a full-time position at Wanfang Hospital.
• If the PI is a resident physician, at least one attending physician must serve as a co-investigator on the study.

Shuang Ho Hospital, Ministry of Health and Welfare:

• The PI is not required to be a full-time staff member of the hospital; however, at least one co-investigator must hold a full-time position at Shuang Ho Hospital.

Note: The above requirements are based on internal policies of each hospital. In case of any updates, please refer to the latest official announcements of each institution. For questions regarding eligibility or affiliation verification, please contact the Department of Education and Research of the respective hospital.

Assessment of radiation dose is an essential element of the research ethics process for clinical trials involving exposure to radiation.

If the subjects need to be exposed to any additional dose of radiation which is not as part of standard medical care (i.e., "extra" procedures), you must submit the results from the following website.
X-ray Risk: https://www.xrayrisk.com
UC San Diego: https://ehs.ucsd.edu/Radiation_Risk/request/home

Taiwan Academic Research Ethics Education (AREE) have some e-learning English courses about research ethics. Since ”Academic research ethics” is not as same as “human research ethics”, we list some courses (highlight in yellow) which can count as IRB certificates. And there are some courses with a red checkmark is providing the English version. Please see the attachment.
 
Noted: Each course can counts 20 minutes.

There are some online courses for your reference.

• Free course Center for Taiwan Academic Research Ethics Education, “AREE” https://ethics.moe.edu.tw/newuser/2

They have some e-learning English courses about research ethics, each course on AREE can count for 20 minutes. Since “Academic research ethics” is not totally as same as “human research ethics”, we can’t count all the courses. Please try to access the course which highlights in yellow on IRB website’s announcement. (https://ohr.tmu.edu.tw/en/news/93)

• Free course NIDA Clinical Trials Network https://gcp.nidatraining.org

Full English courses. We accept all the course on this training program.

• Fee-based/Paid course TRREE https://elearning.trree.org/

Full English courses. Since there is a commercial contract between TRREE and HuSPAT (https://huspat.org) in Taiwan, the user will be ask to contact HuSPAT to arrange an exam at a specific venue to obtain an official certificate.

• Fee-based/Paid course The Association of Clinical Research Professionals, “ACRP” https://acrpnet.org

Full English courses. Mainly target audience is clinical trial-related personnel.

We suggest you to choose the 1st and/or 2nd online courses (AREE and NIDA) as the first choice, It's a fastest way to obtain the certificate.

According to SOP of TMU-JIRB, demerit points will be accumulated for the following situations. In any case, if the points reach three demerit points, the principle investigator will be suspended.

1. Please pay attention to the IRB approval period of the study, and submit the continuing report or final／suspension／termination report on time. If a project exceeds the approval period, it will be counted once.
2. The deadline for supplementary documents and reply is 15 calendar days. If the time limit is exceeded, the report will be frozen and counted once.
3. If there is a non-compliance （NC）／unanticipated problem （UAP） report, please reply within 10 working days after receiving the committee meeting resolution. If the time is exceeded, it will be counted once.

If it annual accumulates 3 demerit points, the PI will be suspended from applying for new application for 3 months （i.e. suspension）, and will not be able to participate in any other study in any role （i.e. cannot join other research teams）. After the suspesion of three months, if PI don't handle those overdue studies
the suspension period will be extended for another three months, and so on until the situation is eliminated.
When suspension, the PI will be notified by email. The reason of suspension and the relevant projects will be listed. If any question, please contact us: tmujirb@gmail.com

There are many differences between clinical trials and human research; therefore, we do not provide a standard form. Please design a table to show all the information you will collect from participants. If you are conducting a questionnaire survey, please submit the questionnaire or interview outline.
The research team may present the study data entry interface (e.g., data sheets or document forms) in a collective format; it is not required to create a separate CRF for each individual subject. If using a data sheet format, the table should clearly list the data to be collected and include designated fields for entering subject-specific information. This ensures that the Case Report Form (CRF) is functional and usable.

If you need to make a payment, please come to our office:
3F., Biomedical Technology Building, No. 301, Yuantong Rd., Zhonghe Dist., New Taipei City 235, Taiwan (R.O.C.) (Shuangho Campus)

Payment procedures, standards, and forms can be downloaded from https://ohr.tmu.edu.tw/en/news/367, scan the receipt and copied together with the document file. We will check the files and provide them to the reviewer.

In TMU-eJIRB system, the allowed maximum size is 95MB each file.

Reminding: If some training documents are too long ago, you can remove them from the file. It is also recommended not to use graphic or photo files in order to reduce file size.

Review comments are emailed to PI and contact, as you provided. Please check your email box. The deadline period is 15 calendar days each reply. If you go abroad or unable to respond within the deadline, Please inform us. We will in accordance with SOP for extension of deadline to 1 month （which is only once）.
*For projects whose serial number does not start with N, please notify us by email: tmujirb@gmail.com
*For projects whose number starts with N, please submit the reply directly in the system before the time limit, and explain in the "Comments to the next person" that the report still needs to be edited and corrected, and we will return the case to the PI for correction.
 
If you don't reply within the deadline, the report will be frozen and cannot be edited. And if you want to continue to edit and reply to review comments, please inform us. We will lift the freeze in accordance with the aforementioned regulations and extend the reply deadline once. If the reply time is exceeded again, the review of the report will be canceled according to the standard operating procedures of TMU-JIRB （that is, the case will be withdrawn）, and the relevant review fees will not be refunded. If the project is still to be carried out in the future, it needs to be resubmitted for review. And you shoud paid the review fee again if required. 

If you have any quiestion about the review comments, please contact us. We will clearify it to shorten your wait time and enhancing efficiency.
 
Reminding: According to the SOP, when the reply time exceed 15 calendar days, it will be counted once when the report is frozen. If the annual accumulative points reach three points, the PI will be suspended for 3 months （that is, the PI can't submit a new application）.

If you have any questions regarding ethical concerns in your study design, or if you need assistance with English for your IRB review submission, please contact us at the following email address: tmujirb@gmail.com
 
In addition, the Office of Global Engagement (OGE) is in charge of the foreign students.
For more overall informations about international students, please visit the website of OGE. (Website)