NUS Institutional Review Board (IRB)
RESEARCH WHICH CAN BE EXEMPTED
FROM FULL IRB REVIEW
All Principal Investigators who wish to apply for exemption from full IRB review for their
research proposals must write in officially to the Chairman, NUS-IRB using the IRB
Exemption Form (IRB-Form-008). The NUS-IRB will evaluate the application for
exemption and inform the researcher of its decision. The Board reserves its discretion to
make the final decision.
In the absence of local legislation, the following categories have been adopted from the
US OHRP Guidelines 45 CFR 46.101 as best practice. Unless otherwise required by the
Faculty or Department heads, research activities in which the only involvement of human
subjects will be in one or more of the following categories are exempted from full IRB
review:
(1) Research conducted in established or commonly accepted educational settings,
involving normal educational practices, such as (i) research on regular and special
education instructional strategies, or (ii) research on the effectiveness of or the comparison
among instructional techniques, curricula, or classroom management methods.
*(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures or observation of public behaviour,
unless: (i) information obtained is recorded in such a manner that human subjects can be
identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the
human subjects' responses outside the research could reasonably place the subjects at risk
of criminal or civil liability or be damaging to the subjects' financial standing, employability,
or reputation.
(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures, or observation of public behaviour
that is not exempted under paragraph (2) of this section, if: (i) the human subjects are
elected or appointed public officials or candidates for public office; or (ii) Federal statute(s)
require(s) without exception that the confidentiality of the personally identifiable information
will be maintained throughout the research and thereafter.
(4) Research involving the collection or study of existing data, documents, records,
pathological specimens, or diagnostic specimens, if these sources are publicly available or if
the information is recorded by the investigator in such a manner that subjects cannot be
identified, directly or through identifiers linked to the subjects.
(5) Research and demonstration projects which are conducted by or subject to the approval
of Department or Agency heads, and which are designed to study, evaluate, or otherwise
examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or
services under those programs; (iii) possible changes in or alternatives to those programs or
procedures; or (iv) possible changes in methods or levels of payment for benefits or
services under those programs.
(6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome
foods without additives are consumed or (ii) if a food is consumed that contains a food
ingredient at or below the level and for a use found to be safe, or agricultural chemical or
environmental contaminant at or below the level found to be safe, by the US Food and Drug
Administration or approved by the US Environmental Protection Agency, or equivalent
agencies in Singapore.
* Please refer to overleaf for the Explanatory Notes.
References:
OHRP Guidelines 45 CFR 46.101
IRB-GUIDE-006
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Version No: 4
Date of Revision: 27 Jan 2014
Explanatory Notes to IRB-GUIDE-006
1. There will be no exemption when deception of the subjects is an element in the research or if
the research involves vulnerable populations such as children, prisoners, persons with
cognitive impairments etc.
2. The NUS-IRB recognizes that some research may involve more than minimal risk even in the
absence of subject identifiers. For example, anonymous survey may contain invasive
questions that may cause the subject to experience emotional distress or discomfort when
answering them. Thus, although the research technically qualifies for exempt status because
there are no subject identifiers, the potential risks of the research should negate exemption 1.
3. According to Singapore BAC’s Guidelines for IRBs on Research Involving Human Subjects2,
the following categories of Indirect Human Biomedical Research could also be considered for
Exemption from full IRB review, taking current practice into account:
(a) Writing up or reporting of individual patients’ clinical results by the patients’ doctors,
provided that the patients’ consent for procedures and interventions in clinical
management have been obtained and the patients’ privacy protected. Researchers who
are not the attending physicians in the programme but wish to have access to such
information should send their proposals to the IRB in the usual way;
(b) Research using appropriately designed data escrow or other arrangements in which
personal or other identity information is securely withheld from researchers by a third
party provider of information, there being no possibility of researchers by themselves
being able to trace or reconstruct significant information on the identity of subject donor;
(c) The development of diagnostic tests using existing samples for test validation
purposes provided that the necessary consent for the taking and use of the samples has
been obtained.
References:
1 Bankert,
E. & Amdur, R. Institutional Review Board: Management and Function, Second Edition. Sudbury,
MA: Jones and Bartlett Learning, 2006
2 Singapore
BAC’s Guidelines for IRBs on Research Involving Human Subjects, November 2004
IRB-GUIDE-006
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Version No: 4
Date of Revision: 27 Jan 2014