Procedures

Requesting Exemption from Human Research Ethics Review - Procedure

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1.  Purpose and Objectives

These procedures outline the process and steps for researchers who wish to apply for a human ethics exemption, as permitted under Section 5.1.22 of The National Statement on Ethical Conduct in Human Research (2007).

2.  Definitions, Terms, Acronyms

Evaluation Activities – Generally encompass the systematic collection and analysis of information to make judgements, usually about the effectiveness, efficiency and/or appropriateness of an activity.

HREC – Human Research Ethics Committee, registered with the NHMRC. These Committees review the ethical implications of all projects the risks of which are higher than low risk research.

Low Risk Research – Research in which the only foreseeable risk is one of discomfort. (National Statement 2.1.6)

LNR – low and negligible risk research.

National Statement – The National Statement on Ethical Conduct in Human Research (2007).

Negligible Risk Research – Research in which there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience. Where there is risk more than inconvenience, even if unlikely, the research is not negligible risk. (National Statement 2.1.7)

Non-identifiable Data - No specific individual can be identified using the data. The researcher using the data does not have the ability to ever link the data back to the individual participant.

NHMRC -   National Health and Medical Research Council.

Quality Assurance Activity – An activity the primary purpose of which is to monitor or improve the quality of service delivered by an individual or an organisation.

3.  Procedures Scope/Coverage

These procedures apply to all researchers at the University of Queensland who conduct research involving humans.

4.  Procedures Statement

Researchers can apply for exemption from ethics review; however, should the request not be approved, researchers will be required to apply to the relevant ethics body at the University (full HREC review or LNR Sub-Committee review). 

Requests for exemption must be made using the approved form and lodged with the Office of Research Ethics.

5.  Ethics Exemption

Most research activities involving human participants will require a human research ethics review and approval prior to their commencement.

The National Statement (5.1.22) states that “Institutions may choose to exempt from ethical review research that:

  1. is negligible risk research, AND

  2. involves the use of existing collections of data or records that contain only non-identifiable data about human beings.”

5.1 Existing Collections of Data

Researchers should first confirm that the consent from the participants covers the research to be conducted. If the original consent covers the research project (the participant gave consent for the use of their data in future research) then an LNR application would be more appropriate for your use of data.

If the original consent does not cover your research project, you will need to either obtain consent from participants for their identifiable data to be used for the project; or seek a waiver of consent for your ethics application (which requires full HREC review).

The majority of existing collections of data that would be eligible for Exemption are publicly available sources of information (please refer 5.2 below).

Researchers must also obtain permission from the data custodian prior to access to the data, no matter in which form.

Researchers are responsible for determining that their data are non-identifiable. The absence of names is not enough as the linked data or combination of collected information could potentially reveal a person's identity. The use of any re-identifiable data requires ethical review and approval. If you are unsure, please contact the Office of Research Ethics for advice.

5.2 Publicly Available Information

There are several types of publicly available information that researchers can access. These include, for example, Australian Bureau of Statistics data; Australian Institute of Health and Welfare data; Information in public archives; information available on the internet (including social media); Registry of births and deaths (including marriages and divorces); Official publications (government papers).

Ethics approval may be required depending on the risk to the individual. Considerations include:

  • Whether there is a reasonable expectation of privacy of the person or people the information is about;
  • Data linkage – linking two sets of non-identifiable data could result in the revelation of new types of identifiable data;
  • If the information is about illegal activities or other sensitive matters;
  • The information involves minors under the age of 16 years;
  • The information involves vulnerable populations identified in the National Statement;
  • If the information contains direct quotes or other matter that may potentially identify a participant.

6.  Quality Assurance / Evaluation Exemption

Most Quality Assurance and Evaluation activities involve minimal risk and do not require ethical review and oversight by a HREC. However, some of these activities may involve the use of research methods and/or approaches that may pose greater risks for individuals. In these circumstances, approval by a HREC may be required.

6.1 Matters that may affect ability to obtain Exemption for Quality Assurance and Evaluation activities

  • When the data collected from the Quality Assurance/Evaluation activity will be used for other purposes (i.e. they become secondary data);

  • Where the activity infringes the privacy or professional reputation of participants, providers or organisations;

  • Where data collected about the participant are beyond those which are collected routinely;

  • Comparison of cohorts;

  • Testing of innovative protocols or equipment;

  • The researcher/s wish to publish the Quality Assurance or Evaluation data.

6.2 Using previously collected Quality Assurance/Evaluation data for research

If the data are non-identifiable, an Ethics Exemption will need to be requested.

Should researchers collect identifiable or re-identifiable data for Quality Assurance or Evaluation purposes under an exemption and subsequently wish to utilise the data in research, an application to the UQ HRECs will need to be made if a waiver of consent is required (where the researchers are unable to obtain consent of the people whom the data concern).

6.3 Quality Assurance in Teaching

A teaching and learning project undertaken to monitor, evaluate or improve the quality of an existing teaching program delivered by the University may represent a Quality Assurance activity and may not require formal ethical review.

Quality Assurance of teaching activities is viewed as an essential and integral part of the delivery and development of professional practice.

7. Additional Resources

Ethical Consideration in Quality Assurance and Evaluation Activities, NHMRC 2014

https://www.nhmrc.gov.au/guidelines-publications/e111

NHMRC Guidelines under Section 95 of the Privacy Act 1988, 2014

https://www.nhmrc.gov.au/guidelines-publications/pr1

NHMRC Flowchart for determining whether the S95 Guidelines apply

https://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/flow_chart_s95_guidelines_150514.pdf

National Statement on Ethical Conduct in Human Research (2007) – Updated May 2015

https://www.nhmrc.gov.au/guidelines-publications/e72

Custodians
Deputy Vice-Chancellor (Research)
Professor Robyn Ward

Forms

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Request for Exemption from Human Research Ethics Review - Form

Request for Exemption from Human Research Ethics Review - Form

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Description: 

Request for Exemption from Human Research Review 

 

Custodians
Deputy Vice-Chancellor (Research)
Professor Robyn Ward
Custodians
Deputy Vice-Chancellor (Research)
Professor Robyn Ward
Custodians
Deputy Vice-Chancellor (Research)
Professor Robyn Ward