NTU IRB is established to meet the international standards and expectation in order to protect human subjects involved in research projects as well as to support the researchers and protect the standing of the institution. NTU-IRB will conduct ethical review on all research proposals involving human research participants or human biological materials. The setting up of NTU-IRB is not to hinder research but to promote ethical research. Usually funding agencies will only release funds to PIs for research when the research proposal is given the clearance on ethics issues, by IRB. Also many scientific journals will only publish research manuscripts if the research proposal has been reviewed and approved by IRB.
Forms to be filled for the following review:
Exempt from Full IRB review form (Biomed/Non Biomed)||
NTU IRB Application form (Biomed/Non Biomed)||
NTU IRB Application form (Biomed/Non Biomed)|
|Research using commercial human cell lines (if applicable)|
|Review by secretariat and approved by Chair||Review by Chair and a member of IRB with the expert domain||Review by the Board which meets once a month |
Vulnerable population refers to the following: (adopted from CITI)
· Children have a wide range of capacity depending on age, maturity and psychological state. There is potential for control, coercion, undue influence, or manipulation by parents, guardians, or investigators, particularly of young children.
· Embryos and Fetuses have absolutely no capacity and are under the direct control of the mother.
· Mentally Disabled Individuals have problems with capacity, which may be continuous or fluctuating, depending on the disability. In addition, they may have limitations on voluntariness because often they are institutionalized or hospitalized, are economically and educationally disadvantaged, and suffer from chronic diseases. As a result, they are potentially subject to control, coercion, undue influence, or manipulation.
· Emergency Situations create a situation where capacity and voluntariness is compromised. There are often limitations to capacity due to the emergency condition. There are often limitations on voluntariness due to time constraints or hospitalization. An example is research on heart attack medications, in which the subjects are asked to consent in the ambulance on the way to the hospital. There is potential for control, coercion, undue influence, or manipulation.
· Hierarchical Social Structures that confront hospitalized patients, nursing home residents, students, prisoners, military personnel, and some ethnic groups create situations where voluntariness can be compromised. There is potential for control, coercion, undue influence, or manipulation.
· Educationally Disadvantaged Subjects may have limitations on understanding of the study they will participate in, and may even be illiterate. The possibility exists for undue influence and/or manipulation.
· Economically Disadvantaged Subjects may be vulnerable due to a limitation on voluntariness. They may enroll in research only to receive monetary compensation (such as in Phase I drug studies), or they may enroll in research to obtain medical care they cannot otherwise afford. There is potential for undue influence or manipulation.
· Marginalized Social Groups may lack influence in society as a result of race, age, disease, or caste systems. These groups often do not have full access to social institutions such as the legal system. There is potential for control, coercion, undue influence, or manipulation.
· Individuals with Incurable or Fatal Diseases often have limitations on voluntariness, and in addition may have problems with capacity caused by disease or medications. These individuals may accept very high risks in desperation for a cure.
• Website: http://research.ntu.edu.sg/GuidelinesnForms/Pages/default.aspx Contact person :
Ms Germaine Foo, Secretariat of NTU-IRB
Address: Block N2.1 B4-07
76 Nanyang Drive
• Collaborative Institutional Training Initiative (CITI) website: https://www.citiprogram.org/default.asp