Ethical clearance

Reviewing body: Human Research Ethics Committee (HREC)

Form: Human Research Ethics Application (HREA)

Site specific assessment authorisation

Reviewing body: Research Governance Office/r

Form: Site Specific Assessment (SSA)

More information regarding the site specific assessment authorisation process.

Low and negligible risk process

Greater than low risk (standard risk)

How do I submit my forms online?

• All new ethics applications need to be submitted through via ERM Applications

  • Login to ERM Applications or create an account if you do not already have one

  • Select Create Project from the list of actions on the left-hand side.

  • Enter the Project Title, choose your jurisdiction/s and HREA Form as the Main Form type, then select Create Project.

  • Complete the questions as prompted, uploading required and supporting documents.

  • A SSA form can be generated after you create an ethics form (HREA).

• Training material and Instructions on how to use the system can be found here.

How do I make an amendment to my research project?

• To amend an existing research project, you will need to complete an amendment sub-form within the ERM Applications portal. 

How long does the ethical clearance process take for low and negligible risk review?

• A low and negligible risk HREA is reviewed, electronically, throughout the month by members of the MSHREC and therefore these do not need to be submitted by the submission deadline for the MSHREC meetings.

• From receipt of the application to final ethical clearance can take approximately two - three weeks. This is dependent on the availability of the MSHREC members to review, given their involvement is voluntary and they may have competing priorities.

How long does the ethical clearance process take for greater than low risk (standard risk) review?

• A greater than low risk HREA will not have a final determination until the MSHREC meets on the first Tuesday in the month.  Greater than low risk (standard risk) HREAs must be submitted by the submission deadline.

• Any subsequent re-reviews are undertaken by the Chair - often in consultation with other MSH HREC members.  

• It is strongly recommended that the SSA form, (and associated documents), are submitted in tandem with the MSH HREC submission to facilitate parallel review and timely authorisation of a research project.

• Upon receipt of a valid submission including partially executed contracts and signatures from the principal investigator, Head of Department and Finance/Business Manager, clinicians and researchers can expect to receive an authorisation letter within one week.

Do I need to get the signatures of all coordinating principal investigators/principal investigators on the HREA?

• No, only the investigator with overall responsibility for the conduct of the study needs to sign the HREA application.

• It also needs to be signed by an appropriate Head of Department — these signatures can be in an electronic format via ERM Applications.

How do I respond to MSH HREC queries letter following a meeting?

• Following the monthly MSHREC meeting, and usually the following week, the principal investigator will receive a letter from the MSHREC, via ERM Applications, with queries or concerns to be addressed in order to proceed to ethical clearance.  In responding, please consider the following:

  • All responses to queries raised by the MSHREC are to be addressed via ERM Applications.  This can be done by uploading documents with additional information/clarification as requested.

  • Inclusion of a cover letter which addresses each of the points raised in the MSH HREC letter is mandatory and submissions without this will be returned.

  • Provision of any updated documents such as a research protocol or PICF with tracked changes and version control. Submissions without these will also be returned.

  • A response to MSHREC comments is required within three months and four meetings.

  • Email or hardcopies of the response will no longer be accepted by the MSHREC office.  All correspondence in relation to a research protocol, must be done via ERM Applications.

• The submitted documents are reviewed by the Chair of the MSHREC — often in consultation with other MSHREC members out of session.

What style of language do I use for my application — what is ‘lay’ language?

• The MSHREC comprises members of varying backgrounds and skill sets.

• When writing an application and associated documentation, please keep in mind that the person reviewing the application may not have a background in science or clinical care.

• Therefore, lay language is recommended in an application and avoidance of jargon that may be confusing to a reviewer. This is particularly relevant for any participant documentation as they need to be able to easily understand what is needed of them in the research project to give informed consent. It is recommended that clinicians and researchers write to a Grade 8 reading level, which means that someone 12 or 13 years old could easily understand the document.

• Please also review all submission documentation for grammar, punctuation and accurate spelling. This will greatly assist in getting an application through the review process.

Is there a research fee associated with ethical clearance and research governance authorisation and when do I need to pay it?

• A research fee may be applicable to an application depending on individual circumstances. A fee is always applied to commercial research projects where there is a named sponsor in the application, and they are invoiced directly; so please ensure the relevant invoicing details are included.

• For non-commercial studies, a fee may still be applicable depending on whether the clinician or researcher is from Metro South Health, Queensland Health or an external party.

• Should a clinician or researcher have any further questions about whether a fee is applicable please contact us discuss further.

How do I make an amendment to my research project?

• Post approval - amendments, reporting and closure

Do I need to submit an amendment to the MSHREC for typographical errors on study documentation?

No - Amendments which do not affect either the ethical acceptability or site acceptability of the protocol (eg typographical errors) do not need to be submitted to the MSHREC. Rather the Principal Investigator or Study Co-ordinator should maintain a site study log/Master File of any such changes made to study documentation.

Do I need to submit an amendment to the MSHREC to extend my ethical clearance?

No – In early 2020 MSHREC adopted a rolling ethical clearance model. There are now no longer any expiry dates for MSHREC approved studies. The continuation of ethical approval is contingent upon meeting the requirements as set out in the original approval letter and the receipt of an Annual Progress Report, which is to be submitted for all studies by 30 April each year.