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Yacca Library NWHHS: NWHHS Research Governance

Yacca Library is the Medical Library for the North West Hospital and Health Service (NWHHS).

Research Governance at North West HHS

 

 

 

 

 

 

 

 

Important information

All research being conducted with Queensland Health must have valid Ethics Approval and Research Governance for each Hospital and Health Service that the project will take place.  

 

There are two steps for approval to commence a research project in the NWHHS:

  1.  Ethics Review Process (see the next tab for more information)

  2. Research Governance (RG) Process - This page details this process.

    RG authorisation cannot be granted until HREC approval has been granted.  However, you are able to submit your RG application and the supporting documents to the RGO concurrently with your HREC application. If you choose to do this, please make this clear to the RGO at time of submission of the SSA and then send through your HREC approval letter once received.

Getting Started

Your first point of contact should be the Research Governance Officer (RGO), who can provide you with information on what process you need to follow for authorisation and direct you to which staff you need to discuss your project with and obtain signatures from.

RGO contact details

  (07) 4745 4521

  RGONWHHS@health.qld.gov.au

  Postal address:

ATT: Research Governance
Mount Isa Hospital,
PO Box 27, Mount Isa, QLD 4825


Collecting signatures and discussing your research project as part of the SSA

You need to discuss your project with relevant NWHHS staff members as they must provide a signature on the SSA form. This indicates during the review of your application that the project was discussed with NWHHS staff who confirm that they can commit time and support to your research project if it is approved.

  At this stage you must only discuss the feasibility of your project, do not start collecting any data or requesting data collection until you have both ethics and SSA approval.

Signatures required for your application to be valid (contact the RGO for relevant contact details):

  • Head of department/s : Provide brief overview of your project, the protocol and any other information they may ask for.
  • Investigators : Principal investigator and other investigators on the project must sign where required in the SSA form.
  • Chief Finance Officer :  Please complete the budget declaration template and list any NWHHS costs or in-kind costs (such as staff time). Our CFO signs off on all research budgets regardless of whether is it below $5000, the Research Governance Officer will seek this signature on the research team's behalf. See Budget outlay template at the bottom of page.

Submitting your SSA

  1. Complete your SSA on the ERM website  (this is the same platform used for the ethics application)
  2. Upload all documents listed below along with your SSA application to ERM.
    • Project Registration feasibility and checklist (contact RGO for this form)
    • HREC approval letter + any amendments
    • Study protocol
    • Participant Information Sheet and Consent Form – master and site specific* (if applicable, with version control and local contact statement, contact RGO for template)
    • Participant Information Sheet and Consent Form for Family and Carers – master and site specific (if applicable, with version control local contact statement, contact RGO for template)
    • Letter of Support from Aboriginal and Torres Strait Islander Community (If participants involved come from Aboriginal and/or Torres Straight Islander communities)
    • Research Agreement / CTA (if parties outside Queensland Health are involved).
    • PHA approval (if required, see Access to medical records and PHA)
    • Any other supporting documentation

Site specific documents (for multicentre projects)

We require localised PICFs that include local site details/contacts etc. to assist local participants. We can provide a template with all headers/footers already inserted. Please contact the RGO for a copy.

  1. The Master Participant Information Consent Form (PICF) or Master Information Sheet is approved by the reviewing HREC and listed in the HREC approval letter.
  2. From the Master PICF you need to create a Site Specific PICF with the local details outlined below. Nothing can alter from the Master except local details inserted.
  3. You will need to provide with your SSA submission the following documentation:
  • The Master PICF (approved by the HREC)
  • Tracked changes PICF Site Specific
  • Clean PICF – Site Specific

*Site specific documents should reference the master in the footer section including version details

Participant Information Sheet                                                    Master V3  20.03.18

Mount Isa NWHHS                                                          Site Specific  V1  25.05.18                    

Where Mount Isa is stated above, here you include the site where the study will take place i.e., Doomadgee, Mornington Island etc. 

Other elements required                                  

NWHHS logo - please contact RGO for a copy of the logo.

A collaboration logo if the study is being conducted with parties external to Queensland Health.

Details of the Local Principal Investigator with relevant phone number (if applicable).

Details of the local Site Contact/Coordinator with relevant phone number (if applicable). 


Once your SSA is submitted                                                

                                                                                                      


Research Committee dates

2021 dates

TBC

                                                                      Last updated 30.11.20

 

Guides, resources and templates for RG process

Where do I go for ethics approval?

North West HHS does not have its own Human Research Ethics Committee (HREC). The closest HREC is located at the Townsville Hospital. Visit their homepage for more information about submitting to their HREC.

A full list of HRECs for Queensland Health is available here


Useful links to get you started

Last updated 22.06.20

Access to identifiable medical or patient records or internal datasets

  1. Do you require access to medical records and other confidential information? If yes, discuss your project with the NWHHS data custodian.
  2. Check if you require Public Health Act Approval or... 
    • Are you a Queensland Health investigator seeking permission under section 150 Hospital and Health Boards Act 2011? If yes, the SSA form must be signed by the Data Custodian and address how the study meets section 150 requirements.
  3. Are you requiring medical records as part of your research? If yes, there may be a fee of $2.50 per record invoiced. Please discuss outline this in your budget outlay as part of the SSA process. 

last updated: 1.09.20

Getting started with your Case Report

The following are some free access options that health professionals of any specialty may find useful in writing their case report.

Want to Publish?

Choose a journal that best suits your case study and check their website for their submission requirements, this usually includes referencing format, word count range and layout specifics.

BMJ (available on CKN) accepts Case Reports, review BMJ's support resources for authors and contact Yacca Library for a fellowship code so that you don't have to pay a publishing fee. 


Before you submit a case report for publishing it is important to have written patient consent and endorsement by a Queensland Health Human Research Ethics Committee (HREC), please contact the Townsville HREC

Last updated 02.07.20

Recommended Titles

Important information

Regardless of whether you are planning to present the audit in the future, all clinical audit activity must be registered with NWHHS Healthcare Standards Unit. Please contact this team in the first instance.


What is a Clinical Audit and how is it approved?

Definition: A clinical audit produces information to inform delivery of best care, and measures against an existing standard.

Approval: If you are planning to publish the results, present at a conference (poster or oral) or disseminate the findings outside of Queensland Health you will need to submit to the HREC Chairperson, via the HREC Coordinator, to arrange an endorsement of your project as non-research (see section 2).

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Image: Craig.parylo (2005)


Unsure if you are conducting a research or non research activity?

The Defining Research Vs Audit (PDF) may also be of use: download here

Last updated 22.06.2020

Important information

Regardless of whether you are planning to present the findings in the future, all service evaluation/quality improvement activities must be registered with the NWHHS Healthcare Standards Unit. Please contact this team in the first instance.


What is a service evaluation or quality improvement activity and how are they approved?

Definition: A service evaluation or quality improvement activity defines or judges current care, and may measure service without reference to a standard. It can involve analysis of existing data or may include simple interview or questionnaire.

Approval: If you are planning to publish the results, present at a conference (poster or oral) or disseminate the findings outside of Queensland Health you will need to submit to the HREC Chairperson, via the HREC Coordinator, to arrange an endorsement of your project as non-research (see section 2).

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Image copyright: NHS Improvement

 


Unsure if you are conducting a research or non research activity?

The Defining Research Vs Audit (PDF) may also be of use: download here

Last updated 22.06.20

Guidelines


The North West Hospital and Health Service acknowledges and pays respect to Aboriginal and Torres Strait Islander people and to the Traditional Owners/Custodians and Elders both past and present, on whose lands we provide health services to all Queenslanders.


The National Statement on Ethical Conduct in Human Research (2007) - Updated 2018 consists of a series of guidelines made in accordance with the National Health and Medical Research Council Act 1992.

Chapter 4.7 : Aboriginal and Torres Strait Islander Peoples provides guidance to researchers concerning research with Aboriginal and Torres Strait Islander peoples. Page 77 states:

The Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders are based on six core values identified as being important to Aboriginal and Torres Strait Islander Peoples. The message for researchers is that there is great diversity across the many Aboriginal and Torres Strait Islander cultures and societies. Application of these core values, and of additional cultural and local-language protocols, should be determined by the Aboriginal and Torres Strait Islander communities or groups involved in the research.

The six core values are: Reciprocity, Respect, Equality, Responsibility, Survival and protection, Spirit and integrity.

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Image: Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders, p. 3.

There should be evidence of support for the research project from relevant Aboriginal and Torres Strait Islander communities or groups and the research methodology should engage with their social and cultural practices (National Statement on Ethical Conduct in Human Research, 2007, p. 78).

Evidence of engagement by the research team is usually reflected in their discussions of the project with the community/committees they wish to work with, and by requesting a written letter of support.

Please contact the RGO or the relevant HREC for further information or any queries you may have. 

Last updated 09.12.20

Publications - Standards and Policies

Last updated 16.01.20

Other Useful Links

Contact details

  (07) 4745 4521

  RGONWHHS@health.qld.gov.au

Researchers should contact the RGO for submitting a site specific assessment (SSA) application. NWHHS staff can also contact the RGO if they have any inquiries about research activities.


For inquires for ethics applications please view the HREC contacts list

Library support to NWHHS staff

Are you conducting research or an audit/QI/SE activity? The library is here to help!

Library staff can assist you with:

  • Literature searches - request a literature search here
  • Planning your literature review and protocol / plan
  • Advisory information for seeking approvals for your project
  • Teaching  "the search in research" skills
  • Proof reading and referencing a range of documents

Contact / Visit us

Open

Monday, Wednesday & Thursday 8:00 am - 6:00 pm

Tuesday & Friday 8:00am - 5.30pm

email: mt_isa_library@health.qld.gov.au   phone: (07) 4745 4532

visit us: Mount Isa Hospital, located between the Renal Unit and CRRH

          

Yacca Library is jointly funded by the North West Hospital & Health Service and the Murtupuni Centre for Rural & Remote Health (James Cook University)