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Categories of Human Research Ethics Proposals

Categories of Human Research Ethics Proposals

The Research Office website for Ethics and Governance is currently under review

Please call the Research Office for the most up to date information regarding research applications  

Research involving humans or human tissue is divided into three ethics categories:

1. Full Ethics (NEAF);
2. Low and Negligible Risk (LNR); and
3. Quality Assurance-Quality Improvement-Audit (QA)

Please find below a brief explanation along with links to the guides, information and documents required to complete submissions for each type of research.

It is helpful to use the NBMLHD Guide to HREC Submission whilst completing the documentation for your submission as it contains step by step instructions on the process.

Full Ethics Submission (NEAF)

All research involving humans or human tissue is required to have ethical approval prior to the project beginning. Project ethics are assessed by the Human Research Ethics Committee (HREC). If the project also involves subjects or tissues accessed through a Public Health Organisation, for instance a Local Health District facility, then Research Governance approval is also required.

The National Ethics Application Form (NEAF) and the Site Specific Application (SSA) must be completed and the 'submission code' generated online at the following NSW Health website: www.ethicsform.org/au/SignIn.aspx

Refer to the document, NBMLHD Guide to HREC Submission, for important information you should know prior to completing your application.

The following links will take you to the documents required to complete your Full Ethics Submission: 

NBMLHD Guide to HREC submission
HREC Submission and Meeting Dates 2015
HREC Questionnaire, Checklist and Cover Sheet
HREC Application Submission and Site Specific Assessment (SSA) fee schedule
Internal Fee Transfer Form - Ethics
External Fee Tax Invoice for payment of submission fees by external parties
Direct Deposit Authority Form for payment of submission fees by external parties
NSW Privacy Declaration Form

LNR (Expedited Review for Low and Negligible Risk Research)

NSW Health HRECs now provide an expedited review process for certain research projects that are considered to be low or negligible risk to participants. Guidelines are available to assist researchers with their LNR submissions. If this does not answer all of your questions please check the guidelines for a full ethics submission or contact the Research Office.

The Low and Negligible Risk Research (LNR) application form and the Site Specific Application for Low and Negligible Risk Research (LNR SSA) must be completed and the 'submission code' generated online at the following NSW Health website www.ethicsform.org/au/SignIn.aspx

Refer to the document, NBMLHD LNR Advice to Applicants, for important information you should know prior to completing your application. The following links will take you to the documents required to complete your LNR Submission: 

LNR Advice to Applicants
Internal Fee Transfer Form

QA (Quality Assurance/Audit)

The guidelines for Quality Assurance / Quality Improvement / Audit have been prepared to assist researchers in determining if their research proposal meets the criteria for a quality assurance / audit project. These guidelines are based on the advice to institutions, human research ethics committees and health care professionals as endorsed by the National Health and Medical Research Council in 2007. Refer to the NBMLHD the QA application Form and Checklist for important information you should know prior to completing your application. The following links will take you to the documents required to complete your QA Submission:

QA application form and checklist
Internal Fee Transfer Form

"Research” or “Quality Assurance”?

There is sometimes uncertainty as to how a project should be classified, and whether or not it requires ethical approval. Regardless of whether a project is considered to be “research” or “quality assurance”, it requires ethical consideration if:

It involves a direct approach to patients or staff
Personally or culturally sensitive information is to be collected
Consent is to be sought
Individuals (or groups) could be disadvantaged as a result of participation
Medical or electronic records of groups of patients are to be accessed
Information collected could have ethical, legal or commercial implications
Identifying information is to be collected
The results might be submitted for publication

Examples of projects that do not require ethical approval are:

Laboratory QA programs where no identifying information is recorded
Anonymous patients satisfaction questionnaires
Statistical summaries of hospital activities  

 

 

 

Monday, 8 April 2019 12:43:03 PM