External Researchers – Forms & Agreements

When do I need to apply for an Honorary Position at Northern Health?
If you are not a Northern Health employee and plan to conduct research activities at a Northern Health site that involves access to individually identifiable and re-identifiable information.

When do I need to complete a confidentiality form?
Please contact ethics@nh.org.au for more information.

Do I need to organise an agreement or contract for my project?
If your project involves Sponsors, Investigators or research team members that do not have an appointment with Northern Health, then you will require an agreement. This includes students from Universities, even though the Supervisor has an appointment at Northern Health.

If I am an external researcher, do I need a Northern Health employee to be part of my research team?
Yes. For high risk projects you will require a Northern Health employee as the Principal Investigator. For low risk projects you will require a Northern Health employee as a Principal Investigator or Associate Investigator or Northern Health contact.

Submitting Application

Who needs to approve my research project?
You need to obtain signatures on the Site Specific Application forms from the Northern Health Principal Investigator and Associate Investigators, Department Heads whose staff or departments are involved in or participating in the project and the Divisional Director of the Principal Investigator. In the case where the Divisional Director is the Principal Investigator then a signature from their senior manager is required.

How long will it take to approve my project?
Please note that approval is a two stage process. Ethics approval and Northern Health governance approval.
Ethics
High risk – generally at least 2 months. Projects need to be allocated to a meeting date, it is best to enquire with the ethics committee that you are applying to and check if you can book projects in prior to submitting your application. After an ethics committee has reviewed your project they will either fully approve with no modifications, approve with modifications (this means that the project requires modifications but it does not have go back to the full committee prior to full approval being given), not approved and modifications suggested and does need to go back to the full committee for review prior to approval. Ethics committee usually only meet once a month.

Low & Negligible Risk: – generally at least 2 months. Projects need to be allocated to a meeting date, it is best to enquire with the ethics committee that you are applying to and check if you can book projects in prior to submitting your application. After an ethics committee has reviewed your project they will either fully approve with no modifications, approve with modifications (this means that the project requires modifications but it does not have to go back to the full committee prior to full approval being given), not approved and modifications suggested and does need to go back to the full committee for review prior to approval. Ethics committee usually only meet once a month.

Northern Health Governance ( Site Specific Approval or SSA)
High risk, low risk and negligible risk – generally two weeks from submission date. This may be longer if modifications are required or additional documents are requested by a Northern Health governance officer. If projects require contracts then it is a good idea to start negotiations early, even prior to ethical approval. Governance approval will not be granted until contract signatures are obtained and heads of departments and/or divisional directors have authorised the study.  Authorisation of the  governance application (SSA) can be indicated electronically within the ‘ERM’ application or by a generating a paper copy of the signature pages of the SSA. Paper copies can be printed from within  the ERM system after the SSA is submitted electronically, printing after submission will remove the ‘DRAFT’ watermark from the submission and have an electronically allocated submission code on the bottom of the page. Northern Health governance officers will accept copies of paper signatures after submission.

If your project is considered to have ‘negligible risk’, this may be approved at Governance level and may not need to go to an Ethics committee for review. Please contact ethics@nh.org.au to assist in determine if your project is at a level of ‘negligible risk’

Quality Assurance/Audit Activities:- generally 2 weeks

How long will ethical approval be granted for?

This is dependent on the ethics committee decision, generally ongoing approval is granted.  Yearly reports are required to be submitted to the approving ethics committee and  to Northern Health governance. Final reports to be submitted when the study closes.

How many copies of the research agreement do I need to prepare?

Please contact ethics@nh.org.au for detailed information.

New Researcher

Is my project high or low risk?
Complete the checklist available here to assist in determining the if your project is a high or low risk project.

I have never done a research project, is there any support that Northern Health can offer me when preparing my research project / study design / ethics application ?
Yes. Contact the research office on nh.research@nh.org.au or phone 84680763 and assistance and guidance can be provided by appointment. You can also contact a Northern Health governance officer at ethics@nh.org.au or phone 84652918

What sample size is required to address the aims of my study?
The sample size required depends on a number of aspects for your study including the study design (i.e. cross-sectional audit, cohort, randomised controlled trial, etc), the level of statistical rigour (power or margin of error) required, the population size you will be sampling from, and the expected values for the primary outcome variables you will be assessing.  Some of these aspects may not be apparent when beginning to formulate your study protocol, thus you are encouraged to speak to a research supervisor available in your area, best placed to advise on this is issue  is a  statistician.

Why do I need to estimate an appropriate sample size in advance?
The majority of research studies provide a cross-sectional view of the current status or are seeking to show the effectiveness of an intervention or program.  Thus, it is important to ensure that an appropriate sample size is collected to either provide confidence that an estimated value is within a suitable margin of error (e.g. compliance of 50% with a margin of error of ±5%) or that a difference or effect size you would state as being clinically relevant is also statistically significant, thus decreasing the likelihood that the observed difference or effect size is not due to chance alone.  In some situations, is not possible to retrospectively increase the sample size, particularly for a pre-intervention period, after the study has begun or concluded.

Why do I need to provide details on the analysis methods for the study?
The provision of a summary of the analysis methods will provide the ethics reviewers detail so they can determine whether the proposed analysis approach are appropriate to meet the study aims.  If you are unsure about aspects relating to the proposed analysis, please speak to a research supervisor available in your area or statistician.

I am unsure of what level of risk my research project is, how do I find this out?
Complete the checklist available here to assist in determining the if your project is a high or low risk project.

Do I need to use the ERM system when completing an ethics application?
Yes, you will need to register with ‘ERM’ to submit your ethics and governance application.

Is there a guide on how to use the ERM system?
Yes, to the ERM help page to access assistance pages.