Low and Negligible Risk
Research Update - Ethics
Andrew Thornton
Chairman, HREC
Royal Adelaide Hospital
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.
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.
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?
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?
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.
What is NOT LNR Research
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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 patient’s or relative’s 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.
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):
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Cover letter
Protocol
Informed Consent
Questionnaires
Advertising material
Any other material
Radiation Safety Report
EPA Notification form
SA Health LNR Application
Form - Headings
1.1.
1.2.
1.3.
1.4.
2.1.
2.2.
2.3.
2.4.
2.5.
2.6.
Project type
Project title
Project Short title
Research Category
Coordinating Principal Investigator
Principal Investigator/s
Associate Investigator/s
Supervisor details
Other personnel
Nominated Contact for project
SA Health LNR Application
Form - Headings
3.1. Name/ID of HREC reviewing the project
3.2. Site/s involved in this project for which ethical
and scientific approval is being sought from
this HREC
3.3. Previous ethical review
3.4. Peer review
3.5. Funding: What is the source of funds available
to conduct this project?
3.6. Conflicts of interest
3.7. Publications and Dissemination of results
4.1. Anticipated start and finish dates
4.2. Anticipated start date
4.3. Anticipated finish date
SA Health LNR Application
Form - Headings
5.1.
5.2.
5.3.
5.4.
5.5.
6.1.
6.2.
6.3.
6.4.
Project summary
Research aims and significance
Research methodology
Likely benefits of the project for the participants,
institution and/or community
Describe any potential risks associated with the
project
What categories or groups of participants will be
involved in the project? (e.g. patients, volunteers,
staff)
Number of participants
Inclusion and exclusion criteria (if applicable)?
Describe what processes will be used to identify
and recruit participants into the project (e.g.
advertisements).
SA Health LNR Application
Form - Headings
7.1. Will informed consent be obtained from
participants prior to study involvement?
8.1. Is there a requirement for the project to
collect, use, or disclose individually
identifiable or re-identifiable data of a
personal nature
8.2. Will prior consent be gained for the use of
the data specified in 8.1?
8.3. Storage and security of data
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 rereviewed at another.