Form 6
Submission Form
For Faculty of Dentistry/Faculty of Pharmacy, Mahidol University Institutional Review Board
(MU-DT/PY-IRB)
1. Title of research of project ______________________________________________________
2. Title of investigator ____________________________________________________________
Status ❏ Staff from Faculty ____________________________________________________
❏ Student from Faculty _________________________________________________
❏Bachelor Program ❏ Master Program ❏ Doctoral Program
❏ Other, Please specify _____________________________________________
Contact address__________________________________________________________
Telephone number________________________________________________________
E-mail address: __________________________________________________________
3. Co-investigator (– name, affiliation, contact, address, phone number, email address)
4. Funding source ❏ No
❏ Ongoing process, Source_______________________________
Budget______________________________________________
❏ Funding, Source______________________________________
Budget______________________________________________
5. Background & rationale of research project
6. Objective of the study
7. Research design
❏Biomedical / Clinical Research
❏ Experiment
❏ Drug/Vaccine/ Medical device /Procedure/Intervention ❏Phase…………………..
❏ Others…………………………
❏Observational study
❏Descriptive study
❏Analytical study
❏ Repository, please specify………………………………………..
❏ Other ………………………………………………
❏Social / Behavioral Research
❏Experimental study
❏Quasi-Experimental study
❏Observational study
❏Descriptive
❏Participatory action research
❏ Other …………………………………………
7.2 Subject selection and allocation
7.2.1 Inclusion criteria
7.2.2 Exclusion criteria
7.2.3 Subject withdrawal criteria
7.2.4 Study termination criteria
7.2.5 Subject allocation
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Form 6
7.3 Sample size calculation
7.4 Sample size _________ cases
❏ Vulnerable subjects ❏ Children
❏ Mentally disable
❏ Chronic illness
❏ Others (please specify) _________________
❏ Healthy volunteers
❏ Not vulnerable subjects
7.5 Replacement procedure (if subject withdraw from the study)
8. Study procedures
9. Study site ❏ Single center _____________________________________________________________
❏ Multicenter
❏ within Thailand, please specify ___________________________
❏ specify other countries and sites) __________________________
10. Having specimen sending out of Mahidol University
❏ No
❏ Yes ( MTA will be required. Contact Center for Intellectual Property Management, Office of the President,
Mahidol University 999 Phuttamonthon 4 Road, Salaya, Nakhon Pathom 73170 Thailand Tel. 02-849-6055-9)
11. Duration of study _______________________________________________________________________
12. Data collection process (Case record form, questionnaire, interview, in-depth interview, other tools)
13. Outcome measurement/Data analysis
- Primary outcome and secondary outcome (if any)
- Assessment of efficacy
- Assessment of safety
- Statistical analysis or data analysis
14. Recruitment process (describe all process from the beginning of how you approach the volunteer, such as when, by
whom. etc.)
15. Informed consent process (describe the process to get the Informed consent) which:
❏ 15.1 Immediately after recruitment process
❏ 15.2 Not immediately after recruitment process. Please specify when ____________by whom____
❏ 15.3 Provide separate documents of volunteer information sheet and informed consent form
❏ 15.4 Waiver document for informed consent and provide only volunteer participant information (Must explain the reason
of waiver)
16. Ethical consideration
16.1 Reason to be carried out in human, please specify the extent of problem that lead to research question, previous
information and its controversy
16.2 Possible benefit for research subject personally and for all society
16.3 Foreseeable risk of research related injury
16.3.1 Explain information from previous study about severity and probability of adverse events
16.3.2 Management and Protection procedure for adverse events
16.3.3 Responsible person for research related injury
16.3.4 Contact person in case of adverse events
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16.3.5 For clinical research, how can principal investigator give the information about research participation to
subject’s family doctor?
16.4 Reference for safety
16.5 Privacy and confidentiality protection, please specify the person who can reach the data; place to collect the
data, archiving are living duration, and method of destroy the data.
❏ Coded data/specimen
❏ Recorded by ❏ photograph
❏ VDO
❏ tape recorder
❏ None of the above
17. Submitted documents
1. ❏ MU-DT/PY-IRB Submission form: 1 original, 3 copies with electronic file
2. ❏ Protocol/Proposal: 1 original, 3 copies with electronic file
3. ❏ Volunteers Information Sheet: 20 copies with electronic file
4. ❏ Informed Consent Form: 20 copies with electronic file
5. ❏ Principal Investigator’s Curriculum Vitae: 4 copies
6. ❏ Commitment for Research Conduct: 1 original, 3 copies
7. ❏ The research tools used for collecting data; i.e. questionnaires, interview/observation guide: 4 copies with
electronic file
8. ❏ Case record form/case report forms: 4 copies with electronic file
9. ❏ Advertisement: 4 copies
10. ❏ Documents to be given to volunteers (specify type) (if any 4 copies)
11. ❏ In case of drug trial. Specify the registration number by the Food and Drug Administration Ministry of Public
Health or document to bring drug research and other necessary documents relating to the drug (Drug Registered
Number, IND, Investigator Brochure, Other Forms or Reports required by the MU-DT/PY-IRB) 2 copies
12. ❏ Permission from authorized to use medical records (In case of retrospective medical record review):4 copies
13. ❏ Permission from authorized person to use stored specimen (In case of stored specimen):4 copies
14. ❏ Permission from authorized to collect data and/or use research area: 4 copies
15. ❏ Permission from authorized person to exempt medical/dental fee: 4 copies
16. For post graduate students, attach the following additional document
16.1 ❏ The Faculty of Graduate Studies' Administrative Order for the thesis topic and the appointment of the
Thesis Advisory Committee or Form GR.39 if the thesis proposal examination is ongoing: 4 copies each
16.2 ❏ Advisor’s and student’s curriculum vitae: 4 copies each
16.3 ❏ The certificate of attendance or the certificate of achievement from the conference on Ethics in Human
Research: 4 copies
17. ❏ Certificate of Approval (Being subproject of the large project that has been approved by the Ethics Committee)
4 copies
18. ❏ Certificate of Approval (The project has been approved by the Ethics Committee of the data collecting site) 4 copies
19. ❏ Proof of fee payment or document for fee exemption
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18. Commitments
1. I, as the principal investigator, and my co-investigators as listed and signed in this documents will conduct this
study according to the protocol approved by MU-DT/PY-IRB. I will conduct the informed consent process by
providing adequate information as approved and sufficient opportunity to consider whether or not to participate
to potential subjects, with respect for person, without coercion and undue influence.
2. I will obtain pre-approval of any changes in research activity and informed research subjects about the change
for their considerations to continuing their participations in the study.
3. I will report MU-DT/PY-IRB all adverse events and unanticipated events and will do my best to help research
subjects.
4. I will provide reports concerning the progress of the research annually or when requested.
5. I and my co-investigator have adequate knowledge and training in procedural intervention needed in conducting
research and providing care for any research-related injury to research subjects.
Signature of principal investigator_____________________, date___________
(…………...(Name)………………)
Signature of co-investigator__________________________, date___________
(……………..….(Name)……………..….)
19. Permission from Thesis Advisor/ Direct Superior Authorized to Approve Research Projects
Signature ______________________, date_________
(……..……..(Name)………….…..)
Thesis Advisor/ Direct Superior Authorized to Approve Research Projects
Remarks:1. Since this MU-DT/PY-IRB submission form is applied to all types of research, if any statement is not applicable to your research,
put “NA” (not applicable) to that statement. (Do not skip any statement or leave it blank)
2. If you have any question, please contact:
Office of MU-DT/PY-IRB, Faculty of Dentistry, Mahidol University
The 50th Anniversary of HRH Princess Mahachakri Sirindhorn Building, 11st Floor,
6 Yothi Street, Rajthevi, Bangkok 10400, THAILAND Tel/Fax: (662)-200-7622
Email: dtpyirb@mahidol.ac.th
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