Application Process for Human Research

FAQs

FAQs

You can find all the information on our website including templates, guidelines, checklists and more. When you have explored the WSLHD’s Research Office website and are still unable to find what you are looking for, then please do not hesitate to contact us on 9845 9007.


Section 1: Human Research Ethics and Research Governance

What is Human Research?

To conduct research in Australia it is a requirement that you obtain approval from an NHMRC certified Human Research Ethics Committee (HREC). The HREC reviews the study's ethical acceptability. The National Statement on Ethical Conduct in Human Research (2007) defines human research as follows:

“Human research is conducted with or about people, or their data or tissue. Human participation in research is therefore to be understood broadly, to include the involvement of human beings through:

  • taking part in surveys, interviews or focus groups
  • undergoing psychological, physiological or medical testing or treatment
  • being observed by researchers
  • researchers having access to their personal documents or other materials
  • the collection and use of their body organs, tissues or fluids (e.g. skin, blood, urine, saliva, hair, bones, tumour and other biopsy specimens) or their exhaled breath
  • access to their information (in individually identifiable, re-identifiable or non-identifiable form) as part of an existing published or unpublished source or database.”

It is important to note that this includes research that the participants themselves are not aware of. An understanding of the levels of risk defined by the National Statement will help you to assess if your proposal requires ethical approval. If you have ethics approval this does not mean that you can commence your study at a NSW Public Health Organisation, in order for you to begin your research at such organisation you must complete a site specific application for Research Governance.

What’s the difference between ethics and governance?

Human Research Ethics is conducted with or about people, or their data or tissue. Institutions are responsible for establishing procedures for the ethical review of human research. That review can be undertaken at various levels, according to the degree of risk involved in the research.

Human Research is governed by Australian law that establishes rights for participants and imposes general and specific responsibilities on researchers and institutions. The National Statement focuses on the ethical aspects of the design, review and conduct of human research. Ethical review is guided by the values and principles of ethical conduct: 

  • Research merit and integrity
    • Justifiable by its potential benefit
    • Designed using methods appropriate for achieving the aims
    • Based on a thorough study of the current literature
    • Designed to ensure that respect for participants is not compromised
    • Conducted or supervised by persons with experience/qualifications/competence
    • Conducted using facilities and resources appropriate for the research
    • With a commitment to searching for knowledge and understanding; conducted honestly and with a commitment to disseminate results whether favourable or unfavourable
  • Justice
    • Selection, recruitment, exclusion and inclusion categories that are fair
    • No unfair burden
    • Fair access to and distribution of benefits of the research
    • No exploitation
  • Beneficence
    • The likely benefit must justify the risk
    • Research designed to minimise risk, and potential risks and benefits are clarified
    • Where there is no benefit to participants the risk should be lower than would be ethically acceptable if there were benefits
    • Where risks to participants are no longer justified research should be suspended
  • Respect
    • Having due regard for the welfare, beliefs, perceptions, customs and cultural heritage – individually and collectively
    • Having due regard for privacy, confidentiality and cultural sensitivities – individually and collectively
    • Having due regard for the capacity of human beings to make their own decision• Empowering and protecting those without the capacity to make their own decisions

Human Research Governance can be defined as a framework for effective oversight of research, such that it meets appropriate standards of quality, safety, privacy, risk management, financial management and ethical acceptability in the Public Health Organisation. It provides a framework for the Local Health District, hospital/facilities, managers and researchers in a shared responsibility and accountability for the conduct of research.

Each research proposal is also subject to local governance review for each site at which the project is to be conducted. There are no governance equivalent of a lead HREC.

Research governance ensures that: 

  • the appropriate use of LHD resources (such as facilities, staff and equipment)
  • each project adheres to site-specific policies (such as sign-offs from appropriate heads of department)
  • the research workers proposing a project have the relevant training, expertise and experience
  • projects adheres to any other regulatory requirements (such as insurance and indemnity).

Who can be a Principal Investigator?

A junior researcher, for example, RMO, registrar, student, PhD candidate cannot be listed as the Principal Investigator for a study as a senior researcher needs to be responsible. The role of the Principal Investigator is to provide oversight and guidance on all stages of the research process. WSLHD requires a senior clinician with research experience employed by the LHD to be listed as Principal Investigator on all NEAF, LNR, QA and SSA applications. The senior researcher can delegate principal investigator duties to a junior researcher listed on the SSA.

What do I need to know before commencing a research project?

Before you begin your project you should read the relevant guide for the type of project you wish to undertake. The guidance documents for each type of research can be found on the Submitting a Research Proposal page. Once you have read the guides and developed your study protocol you should make an appointment to discuss your project with the Ethics and Governance staff.

What is the process for a research project from application to commencement?

 The simple diagram below shows the basic process. The full process flow is shown on the first page of the Research Approval Process.

Human research submission summary.png

Section 2: Human Research Ethics

What is the difference between Quality Assurance, Low or Negligible Risk or NEAF projects?

QA An activity where the primary purpose is to monitor, evaluate or improve health service delivery through a systematic review of service/s against explicit criteria. No governance application is required for QA.

LNR - Section 2.1.6 of the National Statement on Ethical Conduct in Human Research describes research as “Low Risk” where the only foreseeable risk is one of discomfort. Negligible risk research is where there is no foreseeable risk of harm or discomfort and any foreseeable risk is no more than inconvenience.

NEAF All other research where the risk is considered more serious than Low or Negligible risk, as outlined above.

Common problems with Ethics (NEAF) applications:

  • Choose start and end dates allowing sufficient time for HREC and RGO process.
  • Research data should be kept according to the guidelines in the Australian Code for the responsible Conduct of Research, section 2.1.1.
  • All documents (such as protocols, Investigator Brochures, Participant Information and Consent Forms, etc) should have version numbers and dates. Version numbers must always be in whole numbers.
  • Complete a spelling and grammar check, get a colleague to review the submission to identify any mistakes the author may have missed. Remember to use lay language and avoid jargon. Documents to be given to participants should be aimed at a target audience of an average reading age of 14 year old.
  • All projects, regardless of level of risk, should have a study plan or protocol. (The NEAF or LNR Form is not your protocol or study plan). A guidance document can be obtained from the Research Office or the webpage to assist you with your protocol.
  • Protocol to include key references to support the study.

Single Site or Multicentre?

Single site

  • If your project is single site this means that it is being conducted at one facility e.g. Westmead Hospital. 
  • The documents you submit will be the same to ethics and governance
  • The participant information sheet and consent from will contain site logo and contact details etc.

Multicentre

If your project is multi-centre this means that it is being conducted at more than one facility e.g. Westmead Hospital, Blacktown Hospital, and Nepean Hospital.  The documents you submit will be master documents:

  • contain no logos, no site contact details or any local information
  • footer will read Master Participant Information and Consent Form version X dated dd/mm/yyyy

You will need to submit to the relevant research governance office for that site:

  • Approved Master documents
  • Site Specific version generated from the approved master document
  • Documents to contain site logos, site contact details and any local information
  • Footer will reference site to master document. For example: for Westmead Hospital -Westmead Participant Information and Consent Form version X dated dd/mm/yyyy, based on Master version X dated dd/mm/yyyy

What are the recommended supporting documents for an ethics application?

  • Ethics Submission Checklist.
  • NEAF/LNR/QA (depending on the type of project).
  • Study protocol (essential for all projects).
  • Investigators Brochure (if applicable).
  • Participant information and consent forms (using the standard wording templates).
  • Data collection sheet.
  • Current Curriculum Vitae’s for all researchers who have not submitted a CV within the last two years (signed and dated)
  • Draft eCTN/CTX form(s) (where applicable).
  • Questionnaires/Surveys/Patient ID Cards/Diaries etc (any document given to the participant).
  • Letters of invitation.
  • Advertising materials (transcript for advertisement, brochure, webpage, poster).
  • Sign off: Ethics applications: only the Principal Investigator’s signature is required; Governance applications: all signatures are required including supporting departments.

Participant Information Sheets:

  • Written for an average reading age of 14 year old.
  • Relevant and clear, written for a non-expert.
  • Includes contact details for researchers and reviewing HREC.
  • Clearly state if the consent will be for “future use of data and tissue in research”.
  • Refer to National Statement sections 2.2, 3.2, 3.4 and 3.5 for more detailed information on specific consent requirements.
  • Use of the WSLHD PICF standard wording templates. Sections not relevant to your project should be deleted and the section numbering corrected. Sections addressing Confidentiality, Compensation and Complaints should not be deleted. You can find these templates here.

What are the details I should put in the PICF for contact persons?

Different sites within WSLHD will have different complaints contact personnel. You can find the complaints contact details below:

Westmead and Auburn Hospitals Westmead Hospital Patient Advice and Liaison Service
T: (02) 9845 7014
e: wslhd-pals-mail@health.nsw.gov.au
Blacktown and Mt Druitt Hospitals Office of the General Manager - Amanda Lloyd
T: (02) 9851 6066
e:wslhd-bmdexec@health.nsw.gov.au
Mental Health Patients David Chircop
T: (02) 9840 4192
e: david.chircop@health.nsw.gov.au
Community Health Sue Briggs, Quality Improvement Facilitator
T: (02) 8887 4483
If study participants are not WSLHD patients, ie. staff members, and the study has not been approved by WSLHD HREC. The WSLHD Research Governance Officer
T: (02) 9845 9636
e: wslhd-rgo@health.nsw.gov.au

If my study goes from a single site to a multicentre study, will I need a new Participant Information Sheet and Consent Form?

Yes, your new PICF will now become a master version 1 submitted to the lead HREC as an amendment for ethics approval. Once approved you will need to submit the approved master with the site specific PICF’s to the Research Governance Officer at each site.

My research will not involve a lot of people. Do I still need to apply for ethics approval?

Yes, please discuss this with the research office as a file audit/case review involving less than ten people may be undertaken as a case study and requires a different form to be completed.

How long after I submit my ethics application will I receive a response?

Once your application has been submitted, the principal investigator will receive an acknowledgement letter from the Research Office. Applications for drug studies will be sent to the Drug Committee which is held the first Monday of each month. All applications are sent out for review (LNR projects receive ethics review at this time also) and then presented to the Scientific Advisory Committee (SAC) which is held the second Monday of each month. NEAF projects, if recommended by the SAC, are presented to the HREC meeting which is held on the last Tuesday of the month. Following each of these review points correspondence will be sent to the Principal Investigator. Governance review will be undertaken in parallel with this committee process.

How do I amend my study?

You will need to complete the request for amendment/modification form. Ensure you answer every question, specifically question 6. Attach all relevant documentation in both clean and tracked changes with updated version number and date (1 original and 9 copies) and submit this to the Senior Ethics Officer in the Research Office. The HREC sub committee meets every fortnight and the dates can be viewed here.

What about the fees?

Section 3: Human Research Governance

Common problems with Governance (SSA) applications:

One of the roles of Research Governance is to review all personnel listed on the SSA and their accreditation to perform research within WSLHD Organisations. If you have a researcher involved in your study who is not an employee of WSLHD please contact the Research Office to discuss requirements for this researcher to be on site for any research activity.

For multi-centre research the only changes made between the Master Participant Information Sheet and Consent Form (PICF) (approved by ethics), and the site specific PICF are: 

  • The Site Name and Site Investigator names are added to the title. 
  • The Western Sydney LHD logo is added to the header on each page. 
  • The Footer lists site, version number and the HREC approved document that it is based upon. For example: Westmead Hospital PICF Version 1 dated 28 January 2016 based on Master PICF Version 2 dated 5 December 2015.

For studies approved by a reviewing HREC external to WSLHD please submit all documents listed on the ethics approval letter with the site specific submission to the Research Governance office.

Do I need a Master or Site Specific Participant Information Sheet and consent Form (PICF)?

  Single Site Project Multi-Centre Project
WSLHD Research Ethics Site Specific PICF submitted to ethics (NEAF/LNR) Master PICFsubmitted to ethics (NEAF/LNR)
WSLHD Research Governance plus WSLHD Ethics approval PICF will be forwarded from ethics to WSLHD research governance (You do not need to provide with SSA/LNRSSA) Master PICF forwarded from ethics to WSLHD research governance Researcher to submit Site Specific PICF to research governance (SSA/LNRSSA)
WSLHD Research Governance plus other (non-WSLHD) HREC approval
Researcher to submit PICF approved by HREC to WSLHD research governance (SSA/LNRSSA) Researcher to submit master PICF approved by ethics and site specific PICF to WSLHD research governance (SSA/LNRSSA)

Do I need to apply for site authorisation from the Research Office?

Any research being conducted in WSLHD will need to gain site authorisation from the Research Governance Officer for WSLHD. If the study is being conducted at multiple WSLHD sites (e.g. Westmead Hospital and Auburn Hospital) then a separate SSA must be submitted for each site.

What kind of application do I need to complete?

LNRSSA - A LNRSSA must be submitted when a LNR ethics application was submitted to the HREC

SSA - A SSA must be submitted when a Full Ethics application (NEAF) was submitted to the HREC for a study

Access Request – An Access Request Form can be submitted with either a LNR ethics or a Full Ethics application (NEAF).

What signatures do I need on my SSA?

  • Declaration by Head of Department (for each named investigator) must be provided with each SSA application. If the head of department is listed as an Investigator on the SSA they cannot sign, they must obtain this signature from their line manager.
  • Declaration by Head of Supporting Department must be provided by any departments that will be supporting study activity at the site. Common examples of this are blood tests being collected and analysed to assess study results. Pathology West ICPMR is a supporting department. Pharmacy must sign the declaration by Head of Supporting department for all drug studies.
  • If Radiology tests are involved then a C-Bird form must be filled in and submitted to radiology. The CBIRD form can be obtained by contacting the Radiology department Westmead Hospital. These forms are reviewed with radiology as a part of the Research Governance Site Authorisation process.

Do I need a contract?

Contracts must be provided for any research project being conducted within WSLHD organisations that are sponsored by an external Organisation (eg. Pharmaceutical company) or in collaboration with an external organisation (eg. Universities). There are standard contracts in place for this purpose and they can be found at the Medicines Australia (MA) and for devices Medical Technology Association of Australia (MTAA).

If you have any further queries contact research governance.

Who should be listed on the SSA as an investigator?

The WSLHD research team will need to be listed on the SSA/LNRSSA form, which is any research personnel who will be conducting study activity (eg. consenting participants, data collection, completion of CRFs) at the WSLHD site. This includes registrars, nursing staff, allied health professionals and clinical trial co-ordinators.