D. Student Research
D1. Do all student research require ethical review?
Yes, if the student research uses data from
human subjects and qualifies as “research[1]”.
No ethical review is required
if the student activity is part of a class assignment and is not construed
as “research”, unless otherwise required by the Faculty or Department
Heads.
D2. What is considered human subject research?
·
“A human
subject is a living individual about whom a researcher obtains:
a)
data
through an intervention or interaction with the individual; or
b)
identifiable private information.” (US Federal Code)
·
Using
tissues that are associated with potentially identifiable private
information, either through linked information, codes, or DNA analysis.
·
Educational interventions.
· Blood
drawing and finger sticks for research
purposes where there is an interaction with a living individual.
D3. What are some examples of projects which are defined as
research?
· A
retrospective report of a single case typically is not considered
research, but a report of five
cases involving more systematic organization of knowledge may be
considered research.
· A “pilot
study” will require ethics review before data collection if it is
possible that the data collected will be used solely or in combination
with other data for publication purposes.
D4. Why is IRB review required for a human research that will be
published?
The intent to publish
is usually one criterion for a project to be considered
research. Most reputable journals
would require the research to be reviewed by the IRB before they will
agree to publish the results of the research.
D5. Who will conduct the ethical review of my research?
The ethical
review may be conducted by the NUS Institutional Review Board (NUS-IRB)
or the Department or by a Departmental
Ethics Review Committee (DERC).
D6. When
do I need to submit a proposal to the IRB?
All proposed research
involving the use of human subjects requires ethical review and approval
before the research is initiated.
D7. My research was a class project but the results, if published,
would benefit the public. Can I submit a request for a retrospective
review?
NUS-IRB does not
encourage retrospective reviews. If you intend to publish your research,
you should submit your IRB application before the research
begins.
In the event that your supervisor decides that the results of
a completed class project should be published, he/she can submit the
application for retrospective IRB review. However, he should provide
justification(s) for the application.
NUS-IRB will review this research as if the research had not
yet begun. If there are strong ethical considerations, the board can
disapprove the research.
D8. Can a student apply for IRB review as the Principal Investigator
of his/her project?
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”.
D9. How
long would the review process take?
·
“Exempt”
research is reviewed approximately one week upon receipt.
· Some
non-exempt research that does not present greater than minimal risk can
be reviewed by expedited review within four weeks. Research that
presents greater than minimal risk requires Full Board reviews.
· Some
non-exempt research that does not present greater than minimal A full
review involves the full Board which meets monthly. Revisions suggested
by the full Board may be brought back to the Board for final approval.
This may takes 6 to 8 weeks.
D10. How
do I know if my research can be exempted from IRB review?
Student research whose
primary purpose is learning the method and procedures of research is
typically not subject to IRB review. A good example of this is research
that is carried out by students as part of a research methods class.
Educational exercises are normally not construed as “research”.
Please refer
to
IRB-GUIDE-006 at IRB’s website for categories of research that
qualify for exemption. Research projects that are not eligible for
exemption will have to undergo an ethical review.
D11. What are some common issues that may disqualify research as
“exempt” research?
·
Use of
identifiable private information of research subjects
·
Use of
minors or other vulnerable populations
·
Use of
prisoners or institutionalized subjects
·
Use of
sensitive information
·
Research
that is more than minimal risk.
D12. What
is considered “minimal risk”?
Minimal risk is defined
as the probability and magnitude of harm or discomfort anticipated in
the research that are not greater than those ordinarily encountered in
daily life or during the performance of routine physical or
psychological examinations or tests.
D13. What
is a Consent Form?
The consent form
contains the basic elements of informed consent as identified in and
required by the Singapore Good Clinical Practice (SG GCP) regulations
regarding the protection of human subjects. The informed consent for
non-exempt research must be reviewed and approved by an IRB. The IRB’s
Guidelines on Consent Forms can be downloaded from IRB’s web-site.
Please contact us if you have any queries.
Research means a systematic investigation, including research
development, testing and evaluation, designed to develop or
contribute to generalizable knowledge (or publications).
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