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Defence Health

Australian Defence Human Research Ethics Committee

Application for Ethical Review


New Applications

Before conducting human research on Defence personnel, it is mandatory to seek ethical approval from the ADHREC. This includes research in the form of interviews, questionnaires, surveys, clinical trials, or any other research that involves contact in any way with Defence personnel.


How to submit an application:


What happens next?

  • You will receive an acknowledgement that your submission has been received.
  • An administrative review of your protocol will be conducted by the ADHREC Executive Officer to identify any discrepancies or omission of information. Once this has been completed, the Secretariat will advise whether amendments are required or if they will confirm when ADHREC will consider your submission.
  • Note: If significant amendment is required, you will need to submit a revised protocol.
  • If the protocol if tabled for ADHREC consideration, members will thoroughly review submissions at their meeting and allocate the following decisions:
    • Approved outright
    • Approval pending
    • To be resubmitted following the necessary amendments (this may be either out-of-session or require a full committee review)
    • Not Approved
  • After the meeting, the minutes are drafted and researchers will receive a response letter from the ADHREC Executive Officer (on behalf of the Chair) on the outcome of their submissions. This usually occurs a week after the meeting.
  • The response letter will give further directions on how next to proceed, depending on the outcome.

Common things that the ADHREC will look for in reviewing submissions:

Depending on the quality of the application, the ADHREC process can be long and involved, if your protocol needs to be repeatedly resubmitted. To assist you in having a good chance of ‘getting it right the first time’, some tips to consider:

  • Familiarise yourself with the NHMRC’s National Statement and the policy and guidelines provided on this website
  • Submissions must be in ‘plain English’ and easily read by a lay person
  • Ensure that all questions are answered
  • Attach all relevant Command letters of approvals (approval).
  • If your research involves a military medical unit, do you have approval to use the facility and/or unit personnel (approval letters from the unit must be attached)
  • Do you have appropriately qualified people conducting the research?
  • Have you attached all necessary forms eg the Participant Information Sheet and Consent Form and any survey or interview questions that you may be using.
  • Ensuring the privacy of participants’ details is documented.
  • Secure storage of research materials.
  • Clearly state what the outcomes of your project are.

Remember: Thoroughly explain your aims, objectives and processes. If it’s complex and ambiguous to ADHREC and the average reader, then it will be to research participants, and you will be asked to resubmit.


Preliminary advice prior to submission

The ADHREC team are friendly and approachable and are also happy to provide you with feedback and advice on a draft version of your submission, as long as you give us enough time before the submission date. The aim of this quality assurance is to identify any basic anomalies prior to submission to the Committee. We ask that you review the submission deadlines page, and ensure you contact us as early as possible, if you require this service.

Please note that the Secretariat is not the Committee, and the Committee may identify further ethical concerns that you may need to address.


Resubmissions

National Statement 5.2.21 A review body may approve, request amendment of, or reject a research proposal on ethical grounds.

National Statement 5.2.22(b) Where amendments are requested, communication may be written or, where appropriate, informal. Reasons should be given for the requested amendments.


What is a resubmission?

If a protocol is tabled for ethical review by the ADHREC, and members decide the protocol does not meet some of the requirements of the National Statement in its present form, you may be asked to amend your protocol and resubmit to ADHREC for reconsideration.

A letter will be sent to the researcher explaining why the study was not approved and detailing any amendments or issues that should be addressed in a resubmission.


How to resubmit an application

A resubmission requires the full application including information sheet, consent form, questionnaires, surveys, etc to be resubmitted. A covering letter addressing ADHREC’s concerns is also to be submitted.

Your letter, full application and any attachments are to be PDF’d into one document and emailed to ADHREC@defence.gov.au and submitted to the next available ADHREC meeting (see Submission deadlines).


Amendments

What is an amendment?

An amendment is when an approved human research protocol is changed by the researcher. That change is not to be implemented until ethical approval from ADHREC has been received, except where such change is related to an immediate safety issue for participants. Prior to seeking ADHREC clearance for amendments the agreement of the relevant area of Defence with strategic responsibility should be sought; the request to ADHREC should indicate that agreement has been obtained.


How to I submit an amendment?


What happens next?

  • The ADHREC Executive Officer, as the committee’s delegate, will consider the request and
    • advise if further information is required
    • if the request requires review by ADHREC, what date the request will be tabled with ADHREC for further consideration
    • advise you of the outcome of the amendment request
  • If your request requires ADHREC consideration, members will thoroughly review the amendments and allocate the following decisions:
    • Approved outright
    • Approval pending clarification / amendment (this may be done out-of-session)
    • Not approved.
  • After the meeting, the minutes are transcribed and you will receive a response letter from the ADHREC Secretariat on the outcome of your amendments. This usually occurs 4-5 days after the meeting.
  • The response letter will give further directions on how next to proceed, depending on the outcome.

Extensions of Ethical Approval

Researchers are notified of the duration of the ethical approval for their research and the expiry date in the initial ADHREC letter of approval. The normal period of ethical approval granted by ADHREC is for 3 years. If your research looks like it will continue past the expiry date, you will need to request an ethical approval extension request from ADHREC.

How do I apply for an ethical approval extension request?

Before ethical approval on your project is due to expire:

  • Request an extension of ethical approval in the Progress Report in the preceding period prior to expiration of ethical approval, or
  • Draft a letter to ADHREC that outlines the reasons for the extension request. PDF your letter and any attachments into one document and email to ADHREC@defence.gov.au.

What happens next?

  • You will receive an acknowledgement that your extension request has been received
  • The Executive Officer will review your request and
    • advise if further information is required
    • if the request requires review by ADHREC, what date the request will be tabled with ADHREC for further consideration
    • advise you of the outcome of the request for an extension
  • If your request requires ADHREC consideration, members will thoroughly review the modifications and allocate the following decisions:
    • Approved outright
    • Not approved
    • Approval pending further clarification (this may be done out-of-session)
  • After the meeting, the minutes are transcribed and you will receive a response letter from the ADHREC Secretariat on the outcome of your request.
  • The response letter will give further directions on how next to proceed, depending on the outcome.