Preparing an Ethics Application

All human research ethics submissions to the NCNSW HREC with more than a low level risk will be required on the National Ethics Application Form (NEAF) via the online forms website. Research of a low or negligible risk (LNR) is now required to be on the Application Form for Ethical and Scientific Review of Low and Negligible Risk Research.

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

Low Risk Research The National Statement of Ethical Conduct in Human Research 2007 describes research as “low risk” where the only foreseeable risk is one of discomfort. Discomforts may include minor side-effects of medication, 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

Negligible Risk Research The National Statement of Ethical Conduct in Human Research 2007 describes research as “negligible risk” where there is no foreseeable risk of harm or discomfort; and any foreseeable risk is 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.

The types of low and negligible risk research that may undergo expedited review include research where:

  • The threat to participants’ privacy and confidentiality is remote
  • The project does not (or does not have the potential to) involve sensitive information and participants
  • The level of intrusiveness and disruption to participants is minimal.
Examples of research with low and negligible risk include:
  • Research involving questionnaires and general surveys on non-controversial, non-personal issues that also include only basic demographic data and where, in all instances, respondents are not identified
  • Research involving the use and/or disclosure of information from existing data collections, where the identity of the person cannot reasonable be ascertained from the information to be disclosed to researchers
  • Research involving human tissue where participant consent is not required because broad consent has been provided for use of the tissues in research and specific individuals cannot be identified from specimens used eg: where specimens have never been labelled with individual identifiers or individual identifiers have been permanently removed
  • Research requiring access to individual medical records or to information stored electronically, through the site’s medical records department or other department/speciality, but where participant consent is not required because, in all instances, individuals cannot be identified from data extracted or provided.

Research that is not eligible for low or negligible risk review

In line with National Statement on Ethical Conduct in Human Research 2007, research projects that include any of the following are not eligible for low or negligible risk review and will require full review by a 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
  • Research specifically targeting Aboriginal or Torres Strait Islander peoples.
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 a cognitive impairment
  • People with an intellectual disability or a mental illness
  • People who may be involved in illegal activities.
In addition, research projects involving people with sexually transmissible infections or blood-borne virus infections are not eligible for low or negligible risk review, except where the research uses collections of non-identifiable data and involves only negligible risk.

Research projects specifically affecting the health and wellbeing of Aboriginal people and communities

Approval from the Aboriginal Health and Medical Research Council Ethics Committee is required where a research project involves research in, or concerning, NSW and any one of the following applies:

  • The experience of Aboriginal people is an explicit focus of all or part of the research
  • Data collection is explicitly directed at Aboriginal people
  • Aboriginal peoples, as a group, are to be examined in the results
  • The information has an impact on one or more Aboriginal communities or
  • Aboriginal health funds are a source of funding
Approval from the Aboriginal Health and Medical Research Council Ethics Committee is required prior to final approval from the NCNSW HREC.

Link to the Aboriginal Health and Medical Research Council Ethics Committee: http://www.ahmrc.org.au/index.php?option=com_content&view=article&id=13&Itemid=12

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! Important Information about the
Human Research Ethics Application (HREA)

In November 2016 the National Health and Medical Research Council (NHMRC) launched the Human Research Ethics Application (HREA), a new online ethics application for all research involving humans.  The HREA will be replacing the National Ethics Application Form (NEAF), and is designed to guide applicants through the ethical principles of the National Statement on Ethical Conduct in Human Research (2007).
 
Ethics applications to one or more public hospital Human Research Ethics Committee (HREC)

Public hospital HRECs participating in the National Mutual Acceptance Scheme (NMA) are currently working to integrate the HREA into their existing IT platforms and processes.  In the interim, please continue to use Online Forms to generate and submit NEAF applications to Australian public hospital HRECs in the following NMA jurisdictions: Australian Capital Territory, New South Wales, Queensland, South Australia and Victoria.   This will ensure that the reviewing HREC can process the application using their current IT infrastructure.  If you are submitting an ethics application to an HREC that is located in a jurisdiction that is not currently part of NMA (Northern Territory, Tasmania and Western Australia), please contact that HREC to obtain their local submission requirements.
 
Plans for public hospital transition to the HREA

The public hospital transition to the HREA is anticipated to occur in mid- to late-2017. The transition and related instructions will be communicated broadly well in advance, so that all applications will undergo ethics review without complication.  Please check on this website for any updates on this transition.

If you have any questions, you may contact your local public hospital HREC or the State/Territory Department of Health office in the relevant jurisdiction.

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Where do I complete the NEAF?

The NEAF must be completed online via the Online Forms Website at https://ethicsform.org/au/SignIn.aspx.

The Online Forms Website provides guidance on how to complete the application forms and supporting documents required for making an application. The

When completed, the NEAF/LNR application form must be generated and saved in PDF format from the online forms site.

Please be aware that there is no requirement to upload supporting documents onto the Online Forms Website.

Supporting documents:

Other documents that will be required for submission with your application include:

  • A Protocol or Research Proposal/Plan
  • Applicable Brochures / Manuals / Product Information
  • Participant Information Statement/Sheet/s
  • Participant Consent Form/s
  • Data Collection Tool/s
  • Advertisements/Flyers etc
  • Surveys / Questionnaires / Interview Schedules / Semi-structured Interview/Focus Group Questions
  • Other relevant information – as/if required

NOTE: All supporting documents must have the document identification including the version number and document date in the footer of each page

 

Please contact the NCNSW HREC Executive Officer well in advance to the submission of your application and be aware thatcomplete applications only will be accepted for review. Incomplete applications will be returned to the researcher for rectification and re-submission.

Contact Details are:

Executive Officer – NCNSW Human Research Ethics Committee
PO Box 821 Murwillumbah NSW 2484
02 6672 0269 04 2102 8924