RPA RPA
Research Ethics and Governance Office

Is my project low or high risk?

The following information is intended to provide guidance to researchers in completing an application for ethical and scientific review of low and negligible risk research by a NSW Health Human Research Ethics Committee (HREC).

Researchers are advised to review these guidelines and to discuss their proposed study with the Executive Officer of the Ethics Review Committee before completing an application form. If the Executive of the Ethics Review Committee decides that a study presented on the LNR-NSW is not, in fact, of low or negligible risk, then the researcher may be required to re-submit the application on the NEAF. This will result in unnecessary delays for the researcher.

1. Low risk research
The National Statement on Ethical Conduct in Human Research 2007 (the National Statement) describes research as “low risk” where the only foreseeable risk is one of discomfort. Discomforts may include discomforts related to measuring blood pressure or anxiety induced by an interview. Where the risk, even if unlikely, is more serious than discomfort, the research is not low risk.

2. Negligible risk research
The National Statement describes research as “negligible risk” where there is not foreseeable risk of harm or discomfort, and any foreseeable risk if not more than inconvenience to the participants. Inconvenience is the least form of harm that is possible for human participants in research. The most common examples of inconvenience in human research are:
• filling in a form
• participating in a survey or
• giving up time to participate in a research activity.
Where the risk, even if unlikely, is more than inconvenience, the research is not negligible risk.

Other examples of research with low and negligible risk include, but are not limited to, the
following:

• Research involving only questionnaires and general surveys on noncontroversial,
non-personal issues that also include only basic demographic
data and where, in all instances, respondents are not identified;
• Research involving only the use and/or disclosure of information from existing
data collections, where the identity of the person cannot reasonably be
ascertained from the information to be disclosed to researchers;
• Research involving human tissue held in a research tissue bank for which
consent was obtained for its use in research at the time of its collection and
storage;
• Research involving human tissue where participant consent is not required
because broad consent has been provided for use of the tissue in research and
specific individuals cannot be identified from specimens used, eg where
specimens have never been labeled with individual identifiers or individual
identifiers have been permanently removed;
• Research involving personal health information held in a research database for
which consent was obtained for its use in research at the time of its collection
and storage; and
• Research requiring access to individual medical records or to information
stored electronically, through the site’s medical records department or other
department/specialty, but where participant consent is not required because, in
all instances, individuals cannot be identified from data extracted or provided.

3. Research that is not eligible for low or negligible risk review
Research projects that include any of the following are not eligible for low or
negligible risk review and will require full review by an HREC:
• Interventions and therapies, including clinical and non-clinical trials and
innovations or new treatment modalities;
• Active concealment or planned deception of participants;
• Exposure of illegal activities; and
• Research specifically targeting Aboriginal and/or Torres Strait Islander peoples.
In addition, research projects that include any of the following are not eligible for low
or negligible risk review, except where the research uses collections of nonidentifiable
data and involves only negligible risk:
• Human genetics;
• Human stem cells;
• Women who are pregnant and the human foetus;
• People who are highly dependent on medical care who may be unable to give
consent;
• People with cognitive impairment;
• People with an intellectual disability or a mental illness; and
• People who may be involved in illegal activities.

4. Quality improvement / assurance activities
Quality improvement / assurance activities may raise ethical issues requiring review.
Individuals engaged in these activities within the NSW public health system should
refer to the NSW Health Guideline Human Research Ethics Committees – Quality
Improvement & Ethical Review: A Practice Guide for NSW (GL2007_020). They
should consult each Public Health Organisation (PHO) involved in order to determine
the process adopted by the PHO for the ethical review of quality improvement /
assurance activities.

5. Cell therapy
Studies involving cell therapy should be discussed in advance with the Director of the Department of Cell and Molecular Therapies, Professor John Rasko c/o: 
gabrielle.o'sullivan@sswahs.nsw.gov.au