Guidelines on Ethical Review or Waiver 31 October 2006
https://leaux.net/URLS/General/GUIDELINES_ON_ETHICAL_REVIEW_OR_WAIVER_31_OCTOBER_2006.pdf
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p.000001: 3. The authority to exempt a proposed research from MREC review and approval may be delegated to
p.000001: an individual or body in the local institution. For MOH healthcare facilities, this would typically
p.000001: be the local Clinical Research Committee. Prior to authorizing exemption from MREC approval, the local
p.000001: authorizing body must verify that the proposed research is registered with the National Medical/Clinical
p.000001: Research Register to allow the MREC to track and review the appropriateness of exemption from MREC
p.000001: review. An investigator lacking access to a local body to authorize the waiver may apply instead to the MREC for
p.000001: the purpose.
p.000001:
p.000001: 4. The following types of research or data collection would be exempt from MREC review and approval:
p.000001:
p.000001: a. Study or data collection based entirely on data abstraction from existing medical or laboratory
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p.000001: 2. All research NOT involving human subject, as defined in (1) above, may be exempted from MREC
p.000001: review and approval. Such research is also automatically exempted from obtaining informed consent from study subject
p.000001: since by definition no human subject is involved.
p.000001:
p.000001: 3. The authority to exempt a proposed research from MREC review and approval may be delegated to
p.000001: an individual or body in the local institution. For MOH healthcare facilities, this would typically
p.000001: be the local Clinical Research Committee. Prior to authorizing exemption from MREC approval, the local
p.000001: authorizing body must verify that the proposed research is registered with the National Medical/Clinical
p.000001: Research Register to allow the MREC to track and review the appropriateness of exemption from MREC
p.000001: review. An investigator lacking access to a local body to authorize the waiver may apply instead to the MREC for
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p.000002: b. Subjects would be exposed to no more than minimal risk and the study involves only publicly available
p.000002: data,
p.000002:
p.000002: OR
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p.000002: c. The study involves private data but is carried out under legislative or public health authority.
p.000002:
p.000002: Source: CIOMS International Guideline for ethical review of Epidemiological studies
p.000002:
p.000002: 2. For this purpose, minimal risk means that the probability and magnitude of harm or discomfort anticipated
p.000002: in the research are not greater than those ordinarily encountered in daily life or during the
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p.000001: 1
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p.000001:
p.000001: c. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement),
p.000001: survey procedures (questionnaires), interview procedures or observation of public behaviour and with
p.000001: no collection of identifiable private information.
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p.000001: 1
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p.000001:
p.000001:
p.000001:
p.000001: c. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement),
p.000001: survey procedures (questionnaires), interview procedures or observation of public behaviour and with
p.000001: no collection of identifiable private information.
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p.000001:
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p.000001: Guidelines for Ethical Review of Clinical Research or Research involving human subjects
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p.000001: Medical Review & Ethics Committee (MREC) Ministry of Health Malaysia
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p.000001: Guideline 1: Waiver of MREC review and approval for research not involving human subject
p.000001:
p.000001: 1. A human subject (in the context of research) is a living individual about whom an investigator obtains
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p.000002: b. Subjects would be exposed to no more than minimal risk and the study involves only publicly available
p.000002: data,
p.000002:
p.000002: OR
p.000002:
p.000002: c. The study involves private data but is carried out under legislative or public health authority.
p.000002:
p.000002: Source: CIOMS International Guideline for ethical review of Epidemiological studies
p.000002:
p.000002: 2. For this purpose, minimal risk means that the probability and magnitude of harm or discomfort anticipated
p.000002: in the research are not greater than those ordinarily encountered in daily life or during the
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p.000002: Guideline 2: Waiver of informed consent for research involving human subject
p.000002:
p.000002: 1. The MREC may waive the requirement to obtain individual informed consent from the human subject
p.000002: participating in the research provided the MREC finds and documents that:
p.000002:
p.000002: a. Subjects would be exposed to no more than minimal risk and the requirement of individual informed consent
p.000002: would make the conduct of the research impracticable
p.000002:
p.000002: OR
p.000002:
p.000002: b. Subjects would be exposed to no more than minimal risk and the study involves only publicly available
p.000002: data,
p.000002:
p.000002: OR
p.000002:
p.000002: c. The study involves private data but is carried out under legislative or public health authority.
p.000002:
p.000002: Source: CIOMS International Guideline for ethical review of Epidemiological studies
p.000002:
p.000002: 2. For this purpose, minimal risk means that the probability and magnitude of harm or discomfort anticipated
p.000002: in the research are not greater than those ordinarily encountered in daily life or during the
p.000002: performance of routine physical or psychological examinations or tests.
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p.000002: Source: US Code of Federal Regulation Title 45 Part 46
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p.000002: consent:
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p.000002: a. Research not involving human subject, as defined in Guideline 1
p.000002:
p.000002: b. Clinical or disease registry or database, or large-scale non-interventional observational study, would
p.000002: also qualify provided the data collection is based on existing medical or laboratory records, the risk is minimal, it
p.000002: is impractical otherwise to conduct such study and the MOH is a sponsor of the registry or database or study.
p.000002:
p.000002: 4. Prior to waiving the requirement to obtain individual informed consent, the MREC must verify that
p.000002: the proposed research (all types of research) is registered with the National Medical/Clinical Research Register
p.000002: to allow the MREC to document and track the occurrences of such waiver.
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