LOW & NEGLIGIBLE RISK – RISK ASSESSMENT FORM

Version & Date:
Reference number (If known):
Project Title:
Principal Investigator/s:
  1. Research Participants

The National Statement (NS) identifies the need to pay additional attention to ethical issues associated with research involving specific populations.

The National Statement recognises the cultural diversity of Australia’s population and the importance of respect for that diversity in the recruitment and involvement of participants. This question aims to assist the Low Risk Ethics Panel (LREP) to identify any ethical issues that are likely to arise in your research, if its design includes one or more of these populations.

Select as many of the following 'types of research participants’ who will be included because of the project design, or their inclusion is possible. If none apply, please indicate this below.

If you select column (a) or (b), column (c) will not apply.

The participants who may be involved in this research are: / a)Primary Intent / b)Probable coincidental recruitment / c)Design specifically excludes
People whose primary language is other than English (LOTE)
Women who are pregnant and the human fetus. See NS 4.1
Children and/or young people (ie. <18 years). See NS 4.2
People in existing dependent or unequal relationships. See NS 4.3
People highly dependent on medical care. See NS 4.4
People with a cognitive impairment, an intellectual disability or a mental illness View Guidance. See NS 4.5
Aboriginal and/or Torres Strait Islander peoples. SeeNS 4.7
People who may be involved in illegal activity
None apply

1.1.If you selected ‘(b) Probable coincidental recruitment’, the National Statement identifies specific ethical considerations for these groups. Please explain how you will address these considerations in your proposed research:

1.2.If you selected ‘(c)’ indicating that the specific participant group is excluded from your research. Please consider if it would be unjust to exclude these potential participants?

  1. Does the research involve a practice or intervention which is an alternative to a standard practice?

Yes(Complete question 2.1.)No (Go to question 3.)

2.1.Explain how the practice or intervention differs from standard practice:

  1. What expected benefits (if any) will this research have for the wider community?
  1. What expected benefits (if any) will this research have for participants?See NS 2.1
  1. Are there any risks to participants as a result of participation in this research project?

See NS 2.1

Yes(Complete question 5.1.)No (Go to question 6.)

5.1.Please identify the major risks and how you intend to manage them:

  1. Explain how the likely benefit of the research justifies the risk(s) of harm or discomfort to participants. See NS 1.6
  1. Are there any other risks involved in this research? E.g. to the research team, the organisation, others

Yes (Complete question 7.1.)No (Go to question8.)

7.1.Please identify the major risks and how you intend to manage them:

  1. Is it anticipated that the research will lead to commercial benefit for the investigator(s) and or the research sponsor(s)?

Commercial benefit may include, for example:

  • financial payments or rewards for completing the research in addition to the cost of conducting it; or
  • interests in, or rights to share in, any intellectual property in the outcomes of the research, e.g. as a joint patent holder or share holder in a company owning patent rights.

YesNo

  1. Is there a risk that the dissemination of results could cause harm of any kind to individual participants - whether their physical, psychological, spiritual, emotional, social or financial well-being, or to their employability or professional relationships - or to their communities

YesNo

  1. What mechanisms do the researchers / investigators intend to implement to monitor the conduct and progress of the research project?NS 5.5
  1. Please detail your Data and Safety Monitoring Board (DSMB) and its nominee for this trial if applicable. See NS 3.3.20(c)

Also known as an Independent Data Monitoring Committee (IDMC), a Data Monitoring Committee (DMC) and a Data Review Board (DRB); a DSMB provides appropriate oversight and monitoring of the conduct of clinical trials to ensure the safety of participants and the validity and integrity of the data.

Applicable (Please clarify below)Not Applicable (Please state reasons why below)

Useful Link:

  • National Statement (2007) (NS)

Western Health LNR Risk Assessment Form version Jan2016Page 1 of 3