Biomedical Research Legislation
- Human Biomedical Research Act (2015)
- 23 Jun 2015 Ethics Guidelines for Human Biomedical Research
- 22 Sep 2010 Human-Animal Combinations in Stem Cell Research
- 03 Nov 2008 Donation of Human Eggs for Research
- 07 May 2007 Personal Information in Biomedical Research
- 25 Nov 2005 Genetic Testing and Genetic Research
- 23 Nov 2004 Research Involving Human Subjects: Guidelines for IRBs
- 12 Nov 2002 Human Tissue Research
- 21 Jun 2002 Ethical, Legal and Social Issues in Human Stem Cell Research, Reproductive and Therapeutic Cloning
- Bioethics Advisory Committee
- NHG Domain Specific Review Boards (NHG DSRBs)
- Singhealth Centralized Institutional Review Board (CIRB)
- NUS IRB
- Bioethics at the Council of Europe
- Office of Human Research Protections
- CITI Program
Other Relevant Documents
- AAHRPP - Accreditation Procedures
- Belmont Report
- Declaration of Helsinki
- Nuremberg Code
- Personal Data Protection Act (2012)
Frequently Asked Questions
- Is IRB clearance required for survey / interview done on NTU students?
Yes. All research conducted by NTU staff involving the use of human subjects, tissues, or personal data must be reviewed and approved by the NTU-Institutional Review Board (IRB).
- When will I know the status of my application?
All applications must reach IRB by the 1st work day of the month in order to be reviewed by the month. Status will be known by 3rd week of that month. Application must be complete to avoid any further delay.
- If my application qualifies for exemption review, do I still need to submit my application?
Yes as IRB need to review all research proposal which involve human subjects.
- Does late adolescence (18-20 years old) have to get parental consent to participate in research?
Yes unless participation rate will be greatly affected if parental consent is being sought. E.g.: It may not be practical to seek parental consent if the research is on premarital sex. For such cases PI is to explain in detail to the parents of the subject on why parental consent is not being sought immediately after the interview/ survey is conducted. This is to repair the trust that may have been damaged or it causes there is no more than minimal risk to the subjects.
- What kind of studies qualify for exemption review?
The study contains no risk to subjects. However, it is also dependent on the situation and the subject. E.g.: Seeking opinion about one’s gynae:-
- from a mother – no risk
- a pregnant woman – minimal risk, subject may feel distress
- woman who is in labour – highly stress situation, vulnerable group
- Is encouraging students to participate in research a form of coercion?
No. Participating students must be given the right to withdraw even after consent is given and their grades must not be in anyway impacted.
- What should be included in a consent form?
- Alternative (credit / treatment)
- Compensation for Injury
- Whom to contact (PI and IRB)
- Right to refuse or withdraw
- The questionnaire for Phase II of my research will only be formulated depending on the result of Phase I of my studies. Can I submit the questionnaire of my Phase II research later?
Yes. You are allowed to submit the questionnaires later. The approval given by IRB will be for Phase 1.
- Do I need to re-consent my subjects if I am going to use the data which I have previously collected for another research in this new study?
Yes. Very often subjects may expect data which has been collected to be discarded especially containing sensitive data. Unless it is made known to subject that the data collected will be used for other purpose at the point of initial consent is given. However PI still need to inform subject that the data collected will be used in another study even if blanket approval is given. In addition, PI need to re-consent subjects if data are to be used in other unrelated study.
- Can I attract participants by using lucky draw prize?
Yes. And the following must be stated clearly in the consent form.
- Probability of winning
- Mode of contacting the winner