Ethics

PROCEDURES FOR EXPEDITED REVIEW BY
SCHOOL OF HUMAN MOVEMENT AND EXERCISE SCIENCE
HUMAN RESEARCH ETHICS SUB-COMMITTEE

The Chief Investigators of a research project that involves humans may seek Human Ethics Approval from the School of Human Movement and Exercise Science Human Research Ethics Sub-Committee (HRESC) if the project is of minimal ethical significance. This web page describes procedures and issues relating to creation and submission of the Human Research Ethics Sub-Committee Application.

If your research involves the subjects receiving an intervention then the project plan and ethics has to address the issues of Clinical Trials Insurance and Assessment of subjects at risk of cardiovascular incidents for which details can also be found on this web page.

Special clearance procedures exist if your study involves the X-rays, CT scans or use of the DEXA and information is also provided on this web page.

Contents

Creating a Human Research Ethics Sub-Committee Application

Human Research Ethics Sub-Committee submission and review procedure.

Known issues that warrant application submission to the Central University of Western Australia Human Ethics Committee

Studies that involve interventions

• Clinical Trials Insurance
• Assessment of subjects at risk of cardiovascular incidents

Projects that involve exposure ionising or non- ionising radiation (X-rays, CT Scans, DEXA etc)

Questions on Human Research Ethics Sub-Committee review procedure.

Creating a Human Research Ethics Sub-Committee Application

The applicant must complete a full application package, which consists of the following documentation and conforms to the NMHRC requirements for research involving humans.

• For an Application to Undertake Research Involving Human Subjects (Application), please complete
  
  
  • a Submission Form
    • for the form go to Submission Form
      
      
  • a Subject Information Sheet
    • create this document as per guidelines at Subject Information Sheet Guidelines. For an example of a Subject Information Sheet follow this link.
      
      
  • a Consent Form
    • create this document as per guidelines at Consent Form guidelines. For an example of a Consent Form follow this link.
      
      
  • the Checklist
    • for the check list go to Check list form
    • print out entire document with instructions and complete the check list for submission (Do not fill in the annual report form from this document, just remove the part of the document)
      
      
  • the Application Review Sheet
    • for this sheet go to Application Review Sheet
    • print out this sheet and fill in the details required by the applicant.
      
      
  • For other ethics information and for all of the above go to UWA Human Ethics Web page
    
    
• All Research Involving Human Subjects needs to conform to two NHMRC documents and the applicants should read these documents
  
  
  1. National Statement on Ethical Conduct in Research Involving Humans
     
     
     • Applicants should especially read section: 1. Principles of Ethical Conduct and other appropriate sections related to your research plan.
       
       
  2. Values and Ethics: Guidelines for the Ethical Conduct in Aboriginal and Torres Strait Islander Health Research
     
     
• Note, if a research student (PhD, Masters or Honours) is seeking HRESC clearance, then
  
  
  • The supervisor must submit the full application package,
    
    
  • The ethics for the whole research programme needs to be submitted.
    
    
• When the full application is complete it must be submitted for review.

Human Research Ethics Sub-Committee application submission and review procedure.

1. A complete full application package described above must be submitted to Brenda Churchill, secretary of the HRESC. The application will assist the HRESC to ascertain if the project can be reviewed on the basis that it is of minimal ethical significance.
   1. If the HRESC believes that the project is of minimal ethical significance then, and if it is a student's project, following the student's proposal, the HRESC, under the umbrella of the School's Higher Degrees and Human Ethics Committee, will complete the HRESC review of the project (steps 2-5)
   2. If the HRESC believes that the project has major ethical issues, the HRESC will recommend that Chief Investigator submit the application to the Central University of Western Australia Human Ethics Committee. Major ethical and other issues that warrant submission to the Central committee are listed later on in this web page.
      
      
2. The HRESC review procedure will ensure that the application conforms to the National Statement on Ethical Conduct in Research Involving Humans, and Values and Ethics: Guidelines for the Ethical Conduct in Aboriginal and Torres Strait Islander Health Research
   
   
3. As part of the HRESC review procedure, the HRESC may call upon an External Expert who is external to the HRESC to review the application. The Expert will provide a written report listing the ethical concerns with the project, if there are any concerns to be addressed.
   
   
4. If the HRESC deems that there are ethical issues that have to be addressed then the HRESC will list the concerns in letter to the applicant. The applicant is then required to address each concern and resubmit the full application to the HRESC. The resubmission should have a letter stating how each ethical concern has been addressed.
   
   
5. The HRESC will assess if an application, and/or resubmission (if required), has addressed all the ethical concerns. Once the project has been finally accepted by the HRESC, the HRESC will approve and submit the full application package with the HRESC approval letter to the Central UWA Human Ethics Committee, which in-turn will send the Chief Investigator a letter of approval. A copy of the HRESC approval letter will be sent to the applicant.

Ethical issues that warrant application submission to the Central University of Western Australia Human Ethics Committee.

• If the research involves minority or cultural groups within the community (e.g. people who are Aboriginal or Torres Strait Islanders; religious minority groups),
  
  
• If the research involves people who are particularly vulnerable or at risk faster disease progression or death (eg. patients with cardiovascular disease, cancer patients, children with cerebral palsy),
  
  
• If the application is for a project that has received nationally competitive funding (eg. NHMRC, National Heart Foundation). This does NOT include small UWA grants.
  
  
• If the application is for a project that requires a WA Health Department or Agency confidentiality approval through the Confidentiality of Health Information Committee (CHIC).
  
  
• If the application has any form of ionising or non- ionising radiation exposure (e.g. X-rays, DEXA)

Studies that involve interventions

If your study involves some form of intervention (be it exercise, training - physical or psychological, drug or oral supplementation therapy) then two issues need to be addressed in the ethics application: a) clinical trials insurance, and b) assessment of subjects at risk of cardiovascular incidents. These need to be addressed to ensure that the subjects and you are covered by insurance in-case of an incident occurring, and that you have taken due care to ensure that the participants are not at undue risk of suffering cardiovascular incident as a result of your intervention(s).

• Clinical Trials Insurance
  If your research involves any intervention being trialled on subjects (be it exercise, training - physical or psychological, drug or oral supplementation therapy) then the study is generally classed as being a clinical trial. As such it is required that the study be registered with Clinical Trials Insurance Program. To do this the academic in charge of the study needs to fill out the Clinical Trials questionnaire located at this web site. If you have any questions regarding whether your study is classified as a clinical trial contact Mr Grant Wallace, the UWA Insurance and Risk Management Officer.
  
  
• Assessment of subjects at risk of cardiovascular incidents
  If your research involves an exercise intervention for people who are at risk of suffering a cardiovascular incident or have had history of cardiovascular disease then your subjects may need to have a medical examination and exercise testing prior to participation in regular exercise. To assess whether your subjects require these tests depends on whether the exercise is classified as moderate or vigorous. If your study involves exercise that is moderate then go to this web page for the algorithm to assess whether subjects require medical examination and exercise testing for moderate exercise. If the exercise is vigorous then go to this web page for the algorithm to assess whether subjects require medical examination and exercise testing for vigorous exercise. Follow this link to retrieve a pdf file of these guidelines to assess the need for medical examination and exercise testing prior to participation in regular exercise. (Thanks to A/Prof Danny Green for developing these algorithms)

Projects that involve exposure ionising or non- ionising radiation (X-rays, CT Scans, DEXA etc)

• Radiation Clearance
  If the research involves the subject being exposed to ionising or non- ionising radiation, such as from X-rays, CT Scans or DEXA, your Human Research Ethics application needs radiation clearances and then has to be submitted to the Central UWA Human Ethics Committee. Jonathon Thwaites, the UWA Radiation and Safety Officer can organise radiation clearances approval.
  
  
• Use of School of Human Movement and Exercise Science DEXA machine
  If you are going to use the HMES DEXA unit for your study, then you need to ensure that you comply with HMES requirements for its use. Associate Professor Tim Ackland is the HMES licensee for this machine and is required to ensure that you,
  
  
  1. have the training and experience to use the unit (only trained operators have permission to use the DEXA machine),
  2. are familiar with the operation the HMES DEXA machine,
  3. be aware of risks in using the machine,
  4. have radiation clearance to use the use the machine for your study, and
  5. have Human Research Ethics approval for your study.

Associate Professor Tim Ackland has radiation exposure estimates from Jonathan Thwaites for all scan modes (general skin exposure estimates for different types of scans on different size individuals). However, you will still require Jonathan Thwaites to provide radiation clearance and whole body exposure estimates for each project. Once you have the radiation clearance(s) for the use of the HMES DEXA in your research, you then need to submit the full Human Research Ethics application to Central UWA Human Ethics Committee.

Questions on Human Research Ethics Sub-Committee review procedure.

If you have any questions regarding the School of Human Movement and Exercise Science HRESC review procedure please contact Dr David Lloyd on 6488 3919 or by email at dlloyd@cyllene.uwa.edu.au.