Andrew Thornton

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Low and Negligible Risk Research Update - Ethics

• Andrew Thornton
• Chairman, HREC
• Royal Adelaide Hospital

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What is LNR Research?

• The expression low risk research describes
  research in which the only foreseeable risk is
  one of discomfort. Research in which the risk for
  participants is more serious than discomfort is
  not low risk.
• The expression negligible risk research
  describes research in which there is no
  foreseeable risk of harm or discomfort and any
  foreseeable risk is no more than inconvenience.

NHMRC (2007) National Statement on Ethical
Conduct in Human Research.
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Research that can be exempted from review

• Institutions may choose to exempt from ethical
  review research that
• (a) is negligible risk research and
• (b) involves the use of existing collections of
  data or records that contain only
  non-identifiable data about human beings.
• Quality Assurance activities
• Audit activities

NHMRC (2007) National Statement on Ethical
Conduct in Human Research.
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Quality Assurance and Audit

• An activity where the primary purpose is to
  monitor, evaluate or improve the quality of
  health care delivered is a quality assurance
  study.
• Quality assurance and research are activities
  that form a continuum. The ethical principles of
  integrity, respect for persons, beneficence and
  justice apply to all QA and research activities.
• Where quality assurance proposals could infringe
  ethical principles that guide human research,
  independent ethical scrutiny of such proposals
  should be sought.

NHMRC (2003) When does quality assurance in
health care require independent ethical review?
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Publishing and presenting QA or audit

• Journal editors or conference organisers may have
  a view that any results presented require ethical
  oversight.
• Where it is proposed that a report of a QA
  activity undertaken in accordance with this
  advice is to be published, an HREC may advise a
  journal editor that it is satisfied that the
  activity has been so undertaken. This will
  obviate any need for requests for retrospective
  approval.
• When in doubt consult the committee.

NHMRC (2003) When does quality assurance in
health care require independent ethical review?
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What is LNR Research at RAH?

• Non-invasive collection of specimens.
• Collection of blood samples by venipuncture, in
  amounts not exceeding 450 millilitres in an eight
  week period and no more often than two times per
  week, from subjects who are 18 years of age or
  older and who are in good health and are not
  pregnant.
• Moderate exercise by healthy volunteers.
• The study of existing data, documents, records,
  pathological specimens, or diagnostic specimens.
• Studies which involve exposure to ionising
  radiation of up to 1mSv in dose.

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What is NOT LNR Research

• Research involving investigational drugs or
  investigational therapies (NS3.3).
• Research involving randomisation to one or more
  experimental treatments (NS3.3)
• Research involving genetic studies which may have
  relevance to a patients or relatives current or
  future health (NS3.5).
• Research involving stem cells (NS3.6)
• Research which requires a third party consent or
  ICU research (NS4.4).
• Research in subjects with cognitive impairment or
  mental illness (NS4.5)
• Research involving aboriginal subjects (NS4.7)

NHMRC (2007) National Statement on Ethical
Conduct in Human Research.
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For LNR studies which may be suitable for
expedited review

• Check with Heather whether the study is
  appropriate for expedited review. Heather will
  consult the Chairman as necessary.
• Submit electronically (eg email)
• Cover letter
• Protocol
• Informed Consent
• Questionnaires
• Advertising material
• Any other material
• Radiation Safety Report
• EPA Notification form

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SA Health LNR Application Form - Headings
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SA Health LNR Application Form - Headings
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SA Health LNR Application Form - Headings
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SA Health LNR Application Form - Headings
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Reminder

• The NHMRC National Approach to mutual recognition
  of ethical review applies to clinical trials.
• There is no expectation that LNR research would
  similarly be covered under a mutual recognition
  arrangement.
• Within SA Health there is an expectation that LNR
  research approved at one institution does not
  need to be re-reviewed at another.

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