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Yacca Library NWHHS: NWHHS Research Governance

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

Research Governance

                                                              

 

  Important information:

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


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 HHS. Visit TRESA's homepage for more information about submitting to their HREC Townsville.

A full list of HRECs for Qld Health is available here


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

The Defining Research Vs Audit (PDF) is helpful in determining the correct processes for approval


Helpful links to get you started

Last updated 14.02.19

  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:

  1.  Ethics Review Process

  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 (site specific assessment or SSA exemption) 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: Julia House
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 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):

  • Chief Finance Officer :  Please provide the CFO with a brief on your project 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. You can use the template below to assist with this process.
     
  • Head of department/s : Provide brief overview of your project, the protocol and any other information they may ask for. You can use the template below to assist with this process.
  • Investigators : Principal investigator and other investigators on the project must sign where required in the SSA form.

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.
    • Cover letter to research governance officer (should include HREC code, title of project, brief explanation of your project)
    • HREC application (previously called NEAF)
    • HREC approval letter
    • Study protocol (final approved version by Ethics Committee)
    • Participant Information Sheet and Consent Form – master and site specific* (if applicable, with version control and local contact statement)
    • Participant Information Sheet and Consent Form for Family and Carers – master and site specific (if applicable, with version control local contact statement)
    • CVs of Investigators
    • 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 pertinent supporting information

Site specific documents

For multicentre research we require localised PICFs that include local details/contacts etc. to assist local participants.

  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                                                              

Local contact statement should state:

“If you wish to discuss the study with someone not directly involved, in particular in relation to policies, your rights as a participant, or should  you wish to make a confidential complaint, you may contact the Research Governance Officer on PH: 07 4745 4521 or email RGONWHHS@health.qld.gov.au


 

Once your SSA is submitted

 

                                                    

                                                                                                      


Research Committee dates

 

                                                                     
 

 

 

Last updated 14.02.19

 

Guides, resources and templates for RG process

Researcher checklist

  • Do you require access to medical records and other confidential informaiton? If yes, discuss your project with the NWHHS data custodian.
  • 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 the cover letter to RGO must address how the study meets section 150 requirements
  • 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 this with the Chief Finance Officer as part of your SSA process. 

last updated: 27.11.18

Important information

Regardless of whether you are planning to present the audit in the future, all clinical audit activity must be registered with the quality coordinator within your service group. See the NWHHS Clinical Governance Unit page on QHEPS.


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 Ethics Endorsement letter.

 Image: Craig.parylo (2005)

 


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

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 14.02.2019

Useful links

Important information

Regardless of whether you are planning to present the findings in the future, all service evaluation/quality improvement activity must be registered with the quality coordinator within your service group. Please see links below for contact information.


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. 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 Ethics Endorsement letter.

PDSA Image: University of Manchester (n.d)


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

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 14.09.17

Useful information links

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.

Wanting 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 guidelines for case reports and contact Yacca Library for fellowship code so you don't have to pay a publishing fee. 

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

 

Last updated 16.01.17

Recommended Titles

Useful Links

Guidelines


The North West Health and Hospital 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) 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 62 States:

The Values and Ethics guidelines 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.

Page 8, Keeping research on track: a guide for Aboriginal and Torres Strait Islander peoples about health research ethics

Image: Keeping research on track, p. 8.


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 pg 63). This is usually done through the researcher discussing the project with the community/committees they wish to work with and requesting a written letter of support. Please contact the RGO or the relevant HREC for further information. 

Last updated 14.09.17

Publications - Standards and Policies

Last updated 3.8.17

Other Useful Links

The RGO for NWHHS is Julia House

  (07) 4745 4521

  RGONWHHS@health.qld.gov.au

  Postal address:

ATT: Julia House
Mount Isa Base Hospital,
PO Box 27, Mount Isa, QLD 4825


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

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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 to Friday 8:30 am - 6:00 pm

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 NWHHS and CRRH JCU