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 HREA is not, in fact, of low or negligible risk, then the researcher may be required to re-submit the application to amend the pathway on the HREA. 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 non-identifiable 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.