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Research guide

Purpose

This Roadmap is to ensure that research conducted by MNCLHD employees or our facilities, adhere to the appropriate legal, regulatory, ethical, scientific State and Local policies.

This web page information applies to research projects:

  • conducted at MNCLHD facilities by MNCLHD employees
  • conducted at MNCLHD sites where members of the project team are not employees of the MNCLHD
  • involving MNCLHD employees, clients or patients, their relatives/carers
  • using MNCLHD data.

This web page information does not apply to research conducted by MNCLHD contracted staff eg Visiting Medical Officers, who undertake research in their private rooms. In such cases the individuals will be responsible for their own research.

Definitions

Access request review is for limited projects where researchers are requesting access to participants, tissue or data without conducting the research at any MNCLHD facility. This review is a mechanism used by Public Health Organisations to ensure that the proposed research project complies with minimum governance requirements.

Evaluation “is a term that generally encompasses the systematic collection and analysis of information to make judgements, usually about the effectiveness, efficiency and/or appropriateness of an activity. The term is used in a broad sense to refer to any set of procedures, activities, resources, policies and/or strategies designed to achieve some common goals or objectives.”

Clinical trial means any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy.

“Commercially sponsored trial”, for the purpose of this policy directive, is a clinical trial where a commercial entity that is a pharmaceutical or device company:

  1. Initiates the trial and makes an application to conduct the trial under the Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX) Scheme administered by the Therapeutic Goods Administration.
  2. Is directly funding the conduct of the trial, that is, making payments to the relevant hospital or investigator. This does not include trials where a commercial entity is providing in-kind support (e.g. provision of investigational product or funds) but has no other involvement in the conduct of the trial; and
  3. c) Is the primary author or custodian of the clinical trial protocol.

Co-Investigator, an individual involved with the principal investigator in the scientific development or execution of a project. A co-investigator typically devotes a specified percentage of time to the project and is considered “key personnel.”

Co-ordinating Investigator is the individual who takes overall responsibility for the research project and submits the project for ethical and scientific review. They are responsible for ongoing communication with the HREC and passing on any outcomes from this to the Principal Investigators. For single centre research, Coordinating Investigator and Principal Investigator are synonymous.

Human research is research conducted with or about people, or their data or tissue as described in the National Statement on Ethical Conduct in Human Research (2007).

Human Research Ethics Committee (HREC) is a committee constituted in accordance with the National Statement on Ethical Conduct in Human Research (2007) to review and where appropriate approve and monitor the ethical and scientific aspects of human research.

Joint project is where a project involves the MNCLHD and an employee / student from another organisation.

Multi-centre research is research conducted in more than one Local Health District (LHD) within the NSW Public Health System.

National Mutual Acceptance is a National system for mutual acceptance of ethical and scientific review for multi-centre clinical trials conducted in publically funded health services. Current states participating include New South Wales, Queensland, Victoria and South Australia.

National Statement is the National Statement on Ethical Conduct in Human Research (2007).

NSW Health means the NSW public health system and the Ministry of Health.

NSW Health HREC is an HREC established by a Public Health Organisation and registered with the National Health and Medical Research Council.

Online Forms Website is an online system that enables users to electronically complete their applications for ethical and scientific review and site authorisation.

Principal Investigator is the individual who takes responsibility for the overall conduct, management, monitoring and reporting of research conducted at a site and submits the research project for ethical review or site authorisation.

Project for the purpose of this document includes all quality, evaluation and research activities conducted at a site within MNCLHD.

Project Team includes any person who is involved in working on the “Project”.

Public Health Organisation under the Health Services Act 1997 (NSW) is an Area Health Service, statutory health corporation or affiliated health organisation in respect of their recognised services.

Relevant Organisational Policy is the policy, procedure or guideline of the employer/educator of the researcher(s) or the owner of the research subject/data.

Quality Assurance / Improvement is “an activity where the primary purpose is to monitor or improve the quality of service delivered by an individual or an organisation” .

Research is original investigation undertaken to gain knowledge, understanding and insight as described in the Australian Code for the Responsible Conduct for Research (2007)

Researcher is any person involved in the development and conduct of research taking place at any organisation within the MNCHRC.

Research Governance can be defined as the framework by which institutions, investigators and their managers share responsibility and accountability for research conducted according to ethical principles, scientific, regulatory and professional standards and the principles of risk management. The framework should describe the roles, responsibilities and accountabilities of all parties and define the processes used to ensure compliance, monitoring and ongoing review of the quality of research.

Research Governance Officer is the individual appointed within the Public Health Organisation who is responsible for the management of applications for site authorisation and oversight of authorised research projects.

Research taking place in Public Health Organisations means research (i) conducted at sites under the control of Public Health Organisations; and (ii) involving participants, their tissue or data accessed through Public Health Organisations.

Single centre research is research that does not extend beyond the boundaries of one Local Health District (LHD) within the NSW Health System.

Site is a facility, location or service where the research is being conducted.

Site authorisation is the authorisation granted by the Chief Executive or delegate of the Public Health Organisation for the commencement of a research project.

Site-specific assessment is a mechanism used by Public Health Organisations to ensure that the proposed research project complies with minimum governance requirements, and to consider whether the research should be conducted and supported at the proposed site.

Sponsor of a clinical trial is the company, institution or organisation, body or individual that takes overall responsibility for the conduct of the trial and usually initiates, organises and supports the clinical trial.

Supporting Department means a department, unit or facility which provides services or support for research project but does not have any members on the research team, for example: medical records, pharmacy, pathology, imaging, radiology.

The Code refers to the Australian Code for the Responsible Conduct of Research. This document guides institutions and researchers in responsible research practices and promotes research integrity.

Acronyms

AH&MRC Aboriginal Health & Medical Research

CSU Charles Sturt University

DACMS Durri Aboriginal Corporation Medical Service

GAHS Galambila Aboriginal Health Service

GCP Good Clinical Practice

MNCHRC Mid North Coast Health Research Collaborative (“The Collaborative”)

MNCLHD Mid North Coast Local Health District

NCNSW HREC North Coast NSW Human Research Ethics Committee

NCNSWML North Coast NSW Medicare Local

NH&MRC National Health & Medical Research Council

NSW MOH NSW Ministry of Health

SCU Southern Cross University

UNSW University of NSW

UON University of Newcastle

WAC Werin Aboriginal Corporation

  1. The Mid North Coast Health Research Collaborative (MNCHRC) may act as a broker to link potential MNCLHD researchers with partner organisations. Complete and submit the MNCHRC Brokerage Form to request assistance from university researchers, where the project requires collaboration with the Aboriginal Community Controlled Health Services or with primary healthcare workers external to the MNCLHD. Access the brokerage Procedure MNCHRC Brokerage Procedure.
  2. There are a number of online and internal resources to assist in the development of the research question:
    • A 6 part series of Evidence Based Practice is available on HealtheTube for MNCLHD staff presented by Dr Steve Kamper from the George Institute:
      • what is evidence based practice? (Part 1)
      • asking a clinical question (Part 2)
      • study design (Part 3)
      • systematic reviews and RCTs (Part 4)
      • locating evidence (Part 5)
      • putting it all together (Part 6).
    • CIAP eLearning have a number of modules designed to introduce the user to CIAP, and develop the skills to locate information, search a citation database and integrate evidence with practice.
    • HETI online have developed two modules for basic understanding of research: ‘Research – An Introduction‘ and ‘Planning the Research Process‘. The modules are 30 minutes in length and supply a certificate of achievement which can be used towards 0.5 CPD points for each course. (MNCLHD Stafflink username and password is required to enrol). The Evidence-Based Practice e-learning course, EBP Online, is a free resource developed by the staff at the International Centre for Allied Health Evidence at the University of South Australia.
  3. MNCLHD Clinical Librarians at Port Macquarie may assist to define your research question
  4. It’s strongly recommended that you undertake a literature review before embarking on your research, to find out what research has already been undertaken in the area, compare previous findings and identify knowledge gaps. To help you with this:
  5. The design and development of research projects must observe:
  6. Useful forms and templates including protocol template/guideline, tip sheets for ethics and governance, may be found on the NCNSW HREC Resources/Forms website.
  7. The Ministry of Health Office of Health and Medical Research commissioned the Sax Institute in 2016 to develop 2 documents for the Translational Research Framework and can assist in the development of research projects:
    1. Translational Research Framework – testing innovation in policy, programs and service delivery
    2. Translational Research Framework: Source book.
  1. There are a number of methods of monitoring and evaluating health care with the aim of improving its delivery. These quality assurance/improvement (QA/QI) activities include incident monitoring, root cause analysis, sentinel event monitoring, peer review, morbidity and mortality review and other forms of audit.
  2. Please consider the following when determining if your project is QA or QI:
    • Quality Assurance (QA) is monitoring the known desired level of quality or expectation, e.g. auditing a policy, procedure or process. It’s ensuring we are doing something that is required. (Data is more about compliance and outcomes)
    • Quality Improvement (QI) – is a systemic approach to improving a practice/performance. QI is about implementing evidence based practice, e.g policy, procedure. (Data is more about outcomes, processes changes, unintended consequences). 
    • Research is defined as the creation of new knowledge and/or the use of existing knowledge in a new and creative way so as to generate new concepts, methodologies, inventions and understandings. This could include synthesis and analysis of previous research to the extent that it is new and creative. (Australian Research Council website)
    • When assessing whether the project is a quality activity or research, ask what is the intent of the project?
      • Is it to review current practice to ensure it complies with expected standards? → Quality activity
      • Is it to implement an accepted model of care or known evidence? → Quality activity
      • Is it to change practice? → depends if the change is already proven or is it new? Will there be allocation to different groups? Need to assess risk.
      • Is it to test a new practice/procedure/intervention? → Research
  3. Sometimes journals require evidence or review of ethical considerations for quality projects for publication. Complete the Quality Project Registration Form. Completed forms to be submitted to the MNCLHD Research Office at the email address MNCLHD-Research@health.nsw.gov.au.
  4. Individuals engaged in quality improvement projects should consult the Quality Unit in order to identify the process adopted by the MNCLHD for the ethical review of such projects (contact details below).
  5. Consult Quality Improvement and Ethical Review: A Practice Guide for NSW (GL2007_020) to provide guidance in quality improvement activities by helping identify when that activity may require ethical review by a Human Research Ethics Committee.
  6. Research governance, or site specific assessment (SSA) review and authorisation is not required for QA/QI projects.

Quality improvement contacts:

Ashley Thomas
Network Quality Coordinator
Hastings Macleay Network
Phone: 02 5524 2057
Email: Ashley.Thomas@health.nsw.gov.au

Deanna Tune
A/Network Quality Manager
Phone: 02 6656 7064
Email: Deanna.Tune@health.nsw.gov.au

In addition to the general policies and guidelines referred to in this document, the following NSW Health Policy directives are specific to clinical trials:

In addition to the above NSW Policy Directives, please see the below MNCLHD guidelines for submission of clinical trials within the MNCLHD:

Clinical trials should be designed, conducted, recorded and reported according to good clinical practice guidelines.

Online GCP training may be found at the National Drug Abuse Treatment Clinical Trials Network (up to 2.5hrs).
A printable certificate is issued upon completion.

Additional Information: The SPIRIT checklist provides recommendations for a minimum set of scientific, ethical, and administrative elements that should be addressed in a clinical trial protocol.

General principles

This section refers to collaborative research projects involving the MNCLHD and one or more external institutions. Agreement of matters should be developed at the outset of the project. Research conducted within Public Health Organisations must adhere to NSW Ministry of Health Policy Directives regardless of the employee of the researcher.

Arrangement

Where MNCLHD is involved in a joint research project, it is a requirement that an agreement in writing be reached between the partners on the management of the research dealing with the following:

  • intellectual property
  • confidentiality and privacy – MNCLHD identification, privacy and confidentiality packages will be supplied to all external researchers accessing the site for contact with patients and/or medical records. The Research Governance Officer is responsible for ensuring these documents are signed prior to site visits and forwarding to the appropriate Heads of Department supervising the researcher’s visit
  • sharing commercial returns
  • financial management
  • responsibility for ethics and governance submissions and administration
  • reporting to appropriate agencies
  • authorship and publication
  • Management and ownership of primary research materials and research data
  • project risk
  • conflicts of interest.

MNCLHD Research Management Plan

The agreement may take various forms, including a legal form such as a written contract, an exchange of letters, a research management plan signed by all parties, or management plans signed by appropriate representatives from all parties. Situations where a written contract is required include but are not limited to when the collaborative research project involves the transfer of funds, the transfer or use of intellectual property and/or in accordance with funding body requirements.

The purpose of a research protocol is to describe the background, rationale, objectives, design, methodology, statistical considerations and organisation of a research project.

A template for projects may be found here. Time spent on writing a detailed protocol, which is kept up to date, will avoid problems during the ethical review process and during the project itself.

Participants will need to be informed of the research study and provide consent via an Information Sheet and Consent form (template).

Both of these templates are in PDF format. Use the headings as a guide in developing your document.

REGIS is the Research Ethics and Governance Information System used for managing ethics and site governance of health and medical research projects in NSW and ACT Public Health Organisations (PHOs).

All Site Specific Assessments (SSAs) must be submitted via REGIS for site governance review within the MNCLHD.

All research projects conducted within the MNCLHD must seek and obtain ethical approval by an accredited Human Research Ethics Committee (HREC) and authorisation to commence the project by the MNCLHD Research Governance Officer.

The HREA enables the HREC to consider whether the research project is ethically and scientifically acceptable and whether it meets the requirements of the National Statement on Ethical Conduct in Human Research (2007).

The purpose of the site specific assessment (SSA) is to allow the MNCLHD to elicit information about the research project, thereby enabling it to consider whether the research meets its research governance requirements. These requirements are additional to the ethical and scientific acceptability of research and include consideration of:

  • the investigator’s skills, training and experience
  • availability and suitability of facilities and resources for the proposed research
  • funding for the project
  • insurance and indemnity arrangements, and
  • contractual arrangements; and compliance with legislative requirements.

It’s necessary for the investigator to complete a separate SSA application form for each site the study is to be conducted, in addition to the ethics application form, as they seek different information. Only the MNCLHD has responsibility for considering matters of research governance (not the HREC).

Research projects must not commence at any site within the MNCLHD until the applicant has received written notification of HREC approval and research governance (SSA) authorisation by the Chief Executive or their delegate.

It is preferred that the SSA is not submitted until HREC approval has been obtained.

Fee policies

The NSW Health Office for Health and Medical Research has released new application fees for research ethics and governance review and approvals. Please see below documents to assist in determining what fees will be applied to your studies. These fees will apply across all NSW Health public health organisations.

Research ethics

  1. All research involving all NSW Health patients, staff and/or data must be approved by a NSW credentialed Health Human Research Ethics Committee (HREC).
  2. The North Coast NSW HREC (NCNSW HREC), which incorporates both the MNC and Northern NSW (NNSW) LHDs, can review and approve clinical and non-clinical studies that are proposed to be conducted within either or both the MNC and NNSWLHD. The NCNSW HREC is not a certified Lead HREC and therefore cannot review multi-centred studies outside of these LHDs.
  3. Multi-centre clinical trials conducted in public health organisations may be ethically and scientifically reviewed only once by a public health organisation HREC that has been certified by the National Health and Medical Research Council (NHMRC) to review clinical trials via the National Mutual Acceptance Program.
  4. Research targeting Aboriginal and Torres Strait Islander peoples must also be reviewed and approved by the Aboriginal Health & Medical Council Human Research Ethics Committee (AH&MRC HREC) prior to final approval by a NSW Health HREC. As part of the site authorisation, the RGO may request that a MNCLHD Aboriginal Impact Statement be completed and submitted as part of the submission.
  5. Other specialist HRECs within NSW include:
    • Justice Health HREC – all human research projects undertaken with people in the correctional environment in NSW MUST be reviewed by this HREC
    • NSW Population and Health Service Research Ethics Committee – this is a Cancer Institute NSW and NSW Ministry of Health joint committee – all research involving access to statewide data collections owned or managed by NSW Health must be reviewed by this HREC
  6. All applications for ethical and scientific review to a NSW Health HREC must be submitted the Human Research Application Form (HREA).
  7. The form must be completed online via the REGIS website. 

Research governance

All research projects conducted at MNCLHD sites must undergo site specific assessment submitted to the Local Research Governance Officer before any related activities can take place.

Within the MNCLHD, Projects are accepted via two research review pathways depending on the nature of the study:

  • SSA, or
  • Access request

An SSA form must be completed and submitted via REGIS following HREC approval. 

A separate SSA must be submitted for each site at which the research project is to be conducted. For example, even if the project is to be conducted at Coffs Harbour Health Campus and Port Macquarie Base Hospital, both under the control of MNCLHD, a separate application must be made for each site.

To ensure all components of the SSA are submitted correctly, please see the following checklists:

Once the SSA has been submitted within REGIS, the SSA will undergo the research governance process.

Compliance with Policy Directives developed by NSW Ministry of Health is mandatory. Further details may be obtained from the MNCLHD Research Governance Officer.

An Access Request may be accepted on the understanding the project meets the following criteria:

  • The study has been approved by an NHMRC Registered Human Research Ethics Committee (HREC);
  • MNCLHD will not be conducting the research, nor will any of its staff be involved;
  • Data supplied from the MNCLHD will be non-identifiable.

Please see Submitting an Access Request – Information for Applicants or contact the MNCLHD Research Governance Officer for further information or to discuss what review pathway your project can be reviewed under.

Once the Access Request has been submitted to the MNCLHD RGO, it will undergo an research governance review process.

CTMS

NSW Health has implemented a Clinical Trial Management System (CTMS) for all NSW public hospitals and health services conducting clinical trials.

The CTMS is a software system which will manage clinical trials in NSW. The system maintains and manages planning, performing and reporting functions, along with participant contact information, and tracks deadlines and milestones. This system does not replace REGIS.

See our CTMS page for more information. 

All research must be conducted according to the Australian Code for the Responsible Conduct of Research (The Code). The practice of research, from initial planning through to the completion of output, will be guided by The Code.

Researchers are obliged to achieve and maintain the highest standards of intellectual honesty and appropriate standards of rigour in the conduct of their research. Staff engaged in research should be committed to the highest standards of ethical and professional conduct. Research misconduct will be defined by and dealt with according to The Code (2007).

Researchers who have access to personal health information must respect the privacy of clients.

The following legislation and policies must be followed:

  1. Privacy and Personal Information Protection Act 1998
  2. Health Records and Information Privacy Act 2002
  3. Policies and guidance found on the NSW Health Privacy Policy .

An accredited storage facility must be used for archiving research data off-site.

General principles

A central aim of the Australian Code for the Responsible Conduct of Research is that sufficient data and materials are retained to justify the outcomes of research and to defend such outcomes should they be challenged.

Sharing of data

Sharing of research data that relates to people can often be achieved using a combination of obtaining consent, anonymising data and regulating data access. Refer to the Australian National Data Service for guidance on the ethical issues and legalities to sharing data.

Reasons for sharing data:

  • new discoveries from existing data
  • integration of sets of data for new analysis
  • re-analysis of expensive, rare or unrepeatable investigations
  • a DOI (Digital Object Identifier) to be assigned to your data so that it can be cited, its use tracked in the same way as journal articles and your research recognised and rewarded.

Data storage and retention

Research material and data, and registers of that material and data, must be kept in a format, and for a period, that conforms to the requirements of the NSW State Records Act, funding agency or publisher guidelines or in accordance with discipline norms, whichever is the longer period. Refer to NSW State Record Act for the retention periods of research data.

In the absence of discipline-based practices, codes, or guidelines and in line with the above provisions of the Act, research data and primary materials will be retained for a minimum of:

  • clinical studies/projects: fifteen (15) years from the completion of the study/project or date of publication – whichever is the later
  • non-clinical studies/projects: five (5) years from the completion of the study/project or date of publication – whichever is the later.

The data storage, retention and destruction process is incorporated into the NEAF/ LNR application process and undergo review and receive HREC approval. Any deviation from the approved process must be submitted to the HREC for approval and the relevant RGO/s for acknowledgement prior to being actioned.

All original information should be retained, except in specific circumstances where retention of original information is culturally or ethically inappropriate. Where research protocol allows the retention of original information, the individual researcher or the research group must retain a copy of all original data, indicating, through publication, the location and availability of public access to those data.

When research is carried out at multiple organisations, agreement must be reached in writing and these must clearly specify the principles of storage and retention of research data within each organisation in accordance with The Code. In some instances, researchers may be bound by the requirements specified by a funding body or external agency unless those agencies or bodies stipulate a period of retention less than that required by the law.

Data ownership and intellectual property

NSW Ministry of Health defines intellectual property (IP) as the legally recognised outcome of creative effort and economic investment in creative effort.

IP rights are rights to:

  • the protection of intellectual activity or the protection of ideas and information that have been created
  • control the distribution of such activity, ideas or information
  • receive benefits from such activities, ideas or information by way of exploitation and commercialisation
  • recognition and acknowledgement.

NSW MOH Policy Directive ‘Intellectual Property Arising from Health Research’ states requirements in accounting for IP related to research in the public health system compliance is mandatory.

In summary:

  • all IP created by employees of the MNCLHD during the course of their employment, is owned by the MNCLHD
  • IP created jointly by employees of the MNCLHD and in conjunction with other organisations will depend upon the contractual arrangements between the parties (in accordance with the NSW Health Policy Directive)
  • IP created by clinical academics that hold positions in both the MNCLHD and a University must clarify IP issues as early as possible in the identification/protection/commercialisation process
  • IP created by external researchers is owned by the researcher or the researcher’s employer and is dependent upon the terms of any agreement between the external researcher and the MNCLHD. This includes research projects through sponsors of clinical trials, universities and research institutes.

IP created by students:

  • where the student is also an employee of the MNCLHD, the IP belongs jointly to the MNCLHD and the University (arrangements may also be made between the university and the student which is beyond the scope of this document)
  • where the student is not an employee of the MNCLHD, the IP belongs to the University (arrangements may also be made between the university and the student which is beyond the scope of this document).

Consult the Policy Directive for clarification of definitions and further information.

In the event that an MNCLHD researcher moves outside the institution, the MNCLHD will remain the custodian of controlled research data and primary materials acquired during a researcher’s formal association with the institution.

Destruction of data

Disposal of research data should be planned and deliberate, using secure disposal mechanisms (for example using a professional data erasing service to remove data on hard disk drives) so that they cannot be re-used in unauthorised ways. In the event that results from research are challenged, all associated data and materials must be retained until the matter is resolved. Research records that may be subject to allegations of research misconduct must not be destroyed.

General principles

Publication and dissemination of research outcomes and findings, whether favourable or unfavourable, is an important aspect of the research process, passing on the benefits to other investigators, professional practitioners and the wider community.

Refer to the following for guidance on publication and dissemination:

  • Section 2.4 NSW MOH Policy GL2011-001 Research Governance in NSW Public Health Organisations
  • recommendations for the conduct, reporting, editing and publication of scholarly work in medical journals. (ICMJE)
  • reporting guidelines for different study types – the EQUATOR network.

Authorship

Where research is to be published or presented in a public forum e.g. conference, the MNCLHD Guideline for Presentations and Publications should be followed. It is the responsibility of the MNCLHD staff member as lead to complete the following:

The minimum requirement for authorship must be based on substantial contributions in a combination of:

  • conception and design
  • analysis and interpretation of data
  • drafting significant parts of the work or critically revising it so as to contribute to the interpretation.

Acquisition of funding, the collection of data, general supervision of the research group, provision of technical assistance or materials by themselves, do not justify authorship. An author’s role in a research output must be sufficient for that person to take public responsibility for at least that part of the output in that person’s area of expertise.

A person who qualifies as an author must not be included or excluded as an author without their written permission which should include a brief description of their contribution to the work.

  • If, for any reason, one or more of the co-authors is unavailable or otherwise unable to sign above, an email from them acknowledging that they are in agreement with the statements must be forwarded to the Research Unit. If this is also not possible the executive author may sign on their behalf, noting the reason for their unavailability on the Statement of Authorship form. This is to be followed up with a letter or email from the co-author within 6 months of the publication to the Research Unit.
  • If an author is deceased, the publication can proceed, provided there are no grounds to believe that this person would have objected to being included as an author.

A consensus decision-making process is most desirable when determining authorship order. The order of authorship should reflect the different amounts of intellectual and scholarly input. The person who made the greatest intellectual and scholarly contribution should be listed as the principal author using the discipline standard (either first or last named author) and others listed in order of relative contributions. Those participants whose contribution does not warrant being listed as an author should be accorded an acknowledgment.

When there is more than one co-author of a research output, one co-author, by agreement amongst the authors, should be nominated as executive author for the whole research output, and should take responsibility for record-keeping regarding the research output.

Disputes between authors should first be attempted to be resolved at the local level. Disputes between authors which cannot be resolved by the persons concerned may be referred to the MNCHRC Advisory Council who will attempt to resolve the dispute through mediation.

It’s advisable to apply for funding to conduct research for backfill or necessary resources. Grant applications also benefit the status of the organisations involved and the researcher. Refer to the MNCResearch Page for links to a selection of grant applications. Use a search engine on the internet for additional funding opportunities.

The impact tool is adapted from the Cooperative Research Centres (CRC Australia) to evaluate applications for funding criteria. This tool can be used to assist with other grant applications and submitting research proposals to relevant committees / managers with the intention of gaining support.

IMPACT Tool:

Input

> eg. grants, in-kind support, staff experience
Activity

> research project, education, collaboration, communication
Output

> eg. publication, conferences, training package, HDR
Usage

>eg. training package accessed by users, process change implemented
Impact

> eg. output gain, productivity improvement, decreased admissions/LOS, health improvement, higher quality workforce
Benefit

> estimated value of impact multiplied by probability of impacts being achieved, less cost of delivery and usage

Inform the MNC research office of grant applications and their outcome via email. The receipt, investment and expenditure of funds used for research should comply with NSW Accounts and Audit Determinations for Public Health Organisations.

Australian Code for the Responsible Conduct of Research (The Code)

The Code guides institutions and researchers in responsible research practices and promotes research integrity.

The National Statement

The National Statement (2007) consists of a series of Guidelines made in accordance with the National Health and Medical Research Council Act 1992.

It’s intended for use by:

  • any researcher conducting research with human participants
  • any member of an ethical review body reviewing that research
  • those involved in research governance; and
  • potential research participants.

Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders

The document contains guidelines for ethical health research on Aboriginal and Torres Strait Islander peoples. In accordance with guidance from Aboriginal people it is written around a framework of Aboriginal and Torres Strait Islander values and principles.

Statement on Consumer and Community Participation in Health and Medical Research

The Statement on Participation is intended as a guide to consumer and community participation at all levels and across all types of health and medical research.

Note for guidance on Good Clinical Practice (CPMP/ICH/135/95)

The Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) is an internationally accepted standard for the designing, conducting, recording and reporting of clinical trials.

The TGA has adopted CPMP/ICH/135/95 in principle but has recognised that some elements are, by necessity, overridden by the National Statement (and therefore not adopted) and that others require explanation in terms of ‘local regulatory requirements’.

Failing to abide by legislative and organisational policies for research may result in:

  • unethical practice
  • negative financial or resource impact on organisations involved
  • patient safety or privacy issues, inability to publish findings
  • commercialisation or intellectual property concerns
  • mismanagement of research funds
  • damage the reputation of the MNCHRC.

The concept for the MNCLHD Enterprise Wide Risk Management Plan (NC-MNC-PLA-6205-12 ) has been adapted from the implementation plan in the NSW Health PD 2009_039 on risk management. The document has been tailored to reflect specifically the direction of the MNCLHD.

For more information regarding the Research Roadmap please contact the MNC Res KT unit

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