1. Introduction:
1.1.
All student research[1]
involving humans as research subjects must be subject to ethics
review by either the NUS Institutional Review Board (NUS-IRB) or the
Department. This is an important learning experience for both
undergraduates and graduate students.
1.2. These
research projects may be carried out by individual students. The results from such
research may or may not be intended for publication or presentation
outside the classroom. They include experimental protocols,
observational studies, interviews, questionnaires, secondary use of
data that are not in the public domain and research involving human
remains, tissues, or biological fluids.
1.3. The Departmental review of student research can be conducted
by the Head of Department or his representative or a Departmental
Ethics Review Committee (DERC). They will determine whether the
research can be exempted or referred to the NUS-IRB for review based
on the risk to the research participants.
1.4. Educational exercises involving human participants that are
not construed as “research” (e.g., class demonstrations and
exercises that do not lead to publishable materials) do not require
ethics review, unless otherwise required by the Faculty or
Department Heads.
1.5. Retrospective reviews for ethics approval of projects tend to be
problematic and are not encouraged.
2. Responsibilities:
2.1. The
Department shall review all student research involving humans
subjects when:
2.1.1. they are construed as “research”;
2.1.2. the
research is eligible for exemption from IRB review (Please refer to
IRB-GUIDE-006 at IRB website for categories of research that
qualify for exemption);
2.1.3. the research does not involve deception or vulnerable
populations[2];
2.1.4. the
research is not part of a faculty member’s research project already
subject to review by NUS-IRB.
2.2. Student research that are supervised by individuals outside the
faculty (including persons not affiliated to the University) shall
also be reviewed by the Department, unless they are subject to
review by the NUS-IRB or by another IRB in compliance with the
existing guidelines.
2.3. All
research not eligible for exemption (refer to
IRB-GUIDE-006) will have to be reviewed by the NUS-IRB.
2.4. Research conducted by students and faculty members that are not part
of an undergraduate or a graduate course of study must be reviewed
by NUS-IRB.
2.5. The
supervisor of a student research, which forms part of the
supervisor’s own IRB-approved research, must inform the IRB on the
addition of a secondary title to the existing approved title and
submit a Protocol Amendment to the IRB to include the student’s
research as a secondary research.
2.6. For
applications to the NUS-IRB, undergraduates will have to do so with
their supervisors as the
main applicants.
Graduate students may apply with their supervisors acting as the
“Principal Investigator” or “Supervising Co-investigator”.
Please refer
to the Annex for a flowchart that illustrates the above.
3. Composition of the Departmental Ethics
Review Committee (DERC):
3.1. If
the Department should desire to set up a DERC, it is recommended
that the Committee consist of 5 members - 3 domain-specific academic
staff members and 2 “others” (who may be laypersons, alumni or
undergraduate/graduate students). The membership should encompass
expertise in various methodologies used in the department’s
research.
3.2. Where the volume of applications is not likely to be large, a
few Departments may come together to form a DERC.
3.3. The
Chair and members (and any necessary replacements) shall be
appointed by the Head of Department. Faculty members shall serve
for staggered 2-year terms while students serve 1-year terms. Terms
are renewable.
3.4. The
Committee is encouraged to consult relevant experts within the
faculty and NUS-IRB, if necessary.
3.5. The
Department is expected to submit reports to NUS-IRB once every 3
months on the student research that they have reviewed and approved.
Such reports should include the reasons for exempting a research.
[1]
A systematic investigation designed to develop and
contribute to generalizable knowledge.
[2]
Refers to subjects who may be unduly coerced or
influenced to participate (e.g. children, prisoners,
pregnant women, cognitively impaired persons, or
educationally disadvantaged persons who require special
consideration to protect their welfare.)
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