Project Approval Pathways

Looking for a quick summary? Start with Approval Process: Summary and then come back and work through the further detail that you need.

Background

PHRM7095 is the capstone course in the MClinPharm. Students complete an advanced practice project to meet the requirements of the course.

Feature PHRM7095
Size 2 units, 1 semester
Type of project Quality assurance project
Small research project
Component of a larger research or evaluation project
Leadership, education, management project
Supervision Student led
Workplace supervisor (recommended if conducting a project in your workplace)
Academic support (supervision possible)

The design of the course is deliberate. The flexibility of PHRM7095 aims to align with the professional development goals of MClinPharm students while at the same time facilitating development of knowledge and skills in project management, evidence synthesis, asking and answering questions that are important to practice, and analysing and communicating the outcomes of projects that aim to improve practice (broadly defined).

You have a responsibility for ensuring that you obtain the appropriate approvals for your project. The types of approval you need will vary by project and workplace. The purpose of this document is to provide guidance on the various approval pathways.

Additional sources of information include:

Is my project research or quality improvement?

A lot of what we call ‘pharmacy practice research’ could be considered research, quality improvement or both. Research projects involving people or their data require ethical review. Quality improvement projects may not require ethical review depending on the data you are using and the policies of your institution. Approval processes for quality improvement/quality assurance projects can vary by institution. NHMRC (2014) outlines the decisions that institutions need to make regarding approval for quality assurance projects.

The table below provides a guide. Some of the criteria are more clear cut than others. It is your responsibility to accurately represent your project. Some research projects can’t be described as evaluation, but many evaluation projects can easily be described as research. In these situations it often comes down to your intentions.

Research Evaluation (Quality Assurance/Quality Improvement)
Intention Contribute to knowledge: the primary aim is global Improve practice: the primary aim is local
Key question Variable:
How does something work? How should we do something? What are the effects of an intervention or change in practice?… 		Typically: How does practice compare to an established guideline or standard?
Data Might be routine clinical data or collected specifically for the project.

Surveys, interviews…

Often based on readily available data collected as part of routine care.
Some evaluation might include surveys, e.g. on the quality of an education session
Intervention May involve an intervention that is different to standard care Typically no intervention.
If there is an intervention, it is consistent with standard care and likely that you were going to do it anyway.
Participants Typically require informed consent.
A waiver of consent can be justified in some circumstances. 		Use deidentified data.
You might be able to use health data that you have available to you providing you protect confidentiality and the activity is justified within institutional policies and the Privacy Act. This will likely involve a process of deidentifying the data.
Publication Primary goal Secondary goal.
Sharing the results of a quality assurance project doesn’t make it research (e.g. professional conference).
Important that the activity is presented as quality assurance/evaluation rather than research.
May need exemption to publish. In some institutions this can be sought after the project (providing appropriate approval has been given for the QA project).

What approvals are needed for research?

Research involving people typically requires ethical approval. The various pathways and decisions are outlined in Human Research Ethics: Overview.

In summary:

  • If your workplace has an ethics committee, your primary approval needs to come from that committee. Once you have that approval, it is then submitted and ratified by the UQ committee.
  • If your workplace (or location of your research) does not have an ethics committee, UQ will be your primary committee. If your research is low risk, it will be considered by the Health and Behavioural Sciences LNR Committee

If your project is in a hospital you will need to obtain governance approval after your ethical approval. This process ensures the project meets hospital policies and that the hospital has the resources (and is happy to use them) to support the project. If you have supervisors outside of your workplace you may need to arrange a contract between the institutions regarding intellectual property and resources. There are standard contracts in place between most hospitals and universities (the process is usually straightforward, but it is another hurdle to be aware of).

The level of ethical review depends on the risk of the project. Many committees have separate processes for full ethical review, the review of low risk projects and the review of negligible risk projects (see the National Statement for definitions). See information at the UQ ethics link and in the UQ policy and procedures library (4.20.07).

What approvals are needed for evaluation projects?

This depends on your project and the institution. If the project is clearly an evaluation project and does not have any triggers for ethical review, you need to follow local processes for approval/review of quality assurance projects.

Different institutions make slightly different decisions regarding processes for approval or review of quality assurance projects and what is taken to be a trigger for ethical review.

Another avenue for approval for some evaluation projects is applying for exemption from ethics review at UQ. This is possible if you are conducting quality assurance that has some triggers for ethical review (but not enough to require review by an ethics committee). This is also an appropriate avenue for approval of projects in workplaces that do not have a formal process for reviewing quality assurance projects. Further information at the UQ ethics link and in the UQ policy and procedures library (4.20.07).

If you are in a hospital, I would confirm the appropriate approach with your head of department. It may be that you need to apply for exemption from ethical review from your local HREC, or delegate. If there is no process within the hospital, email confirmation from your head of department that the evaluation project can go ahead may be all that is needed. In this situation, you will also need to be sure (and be able to demonstrate) that your project is evaluation and doesn’t include any aspect that should trigger ethical review.

Triggers suggesting ethical review is required for an evaluation project

NHMRC (2014) suggests the following triggers:

  • Where the activity potentially infringes the privacy or professional reputation of participants, providers or organisations.

  • Secondary use of data - using data or analysis from QA or evaluation activities for another purpose.

  • Gathering information about the participant beyond that which is collected routinely. Information may include biospecimens or additional investigations.

  • Testing of non-standard (innovative) protocols or equipment.

  • Comparison of cohorts.

  • Randomisation or the use of control groups or placebos.

  • Targeted analysis of data involving minority/vulnerable groups whose data is to be separated out of that data collected or analysed as part of the main QA/evaluation activity.

UQ PPL 4.20.07 provides a similar list:

  • When the data collected from the Quality Assurance/Evaluation activity will be used for other purposes (i.e. they become secondary data);

  • Where the activity infringes the privacy or professional reputation of participants, providers or organisations;

  • Where data collected about the participant are beyond those which are collected routinely;

  • Comparison of cohorts;

  • Testing of innovative protocols or equipment;

  • The researcher/s wish to publish the Quality Assurance or Evaluation data.

What supervisors do I need? Are there any requirements on supervisors?

The role of supervisors in the projects conducted as part of PHRM7095 will vary considerably.

Having a supervisor is not a required part of the course. However, it is a good idea to have a supervisor (or supervisors) if you are conducting your project in your workplace. This is most clearly the case in hospitals where it might be important to have senior colleagues involved to support completion of the project. You will have multiple co-investigators if you are completing PHRM7095 as part of a larger research or evaluation project–who has overall responsibility for these projects will depend on the team.

PHRM7095 and the MClinPharm program is designed to ensure you receive adequate academic support to complete the project. An individual academic supervisor is not expected to be needed for each project.

If you are applying for ethical approval, the application form will likely ask you to indicate an academic supervisor. While School staff involved in the delivery of PHRM7095 will typically not be investigators on the project, we will provide a letter outlining the academic support you will receive while undertaking the component of the project related to PHRM7095.

It is important to explain your project and your situation in the cover letter accompanying your application. Make it clear in the letter if:

  • If this project is taking place whether or not you complete PHRM7095
  • The project has been identified as important within your pharmacy/department/clinical unit
  • You have workplace support as well as academic support

Some workplaces/committees may require an academic supervisor to be listed as a chief investigator on your application prior to approval. This is the case for projects that have the UQ HREC as the primary committee for approval or exemption from review. Further information on the required process is provided below.

Approval process: Summary

If your primary site of approval (HREC or QA process) is external from UQ, the following flowchart applies.

This flowchart applies to most projects conducted in hospitals.

If your primary site of approval is UQ, the following flowchart applies.

This is most often the case for projects conducted in community pharmacies.

Notes

  • The specific HREC process will depend on the level of risk for the project. Many HRECs have processes for full review, low risk review and negligible risk review
  • See the National Statement for definitions of risk levels (if in doubt seek advice)
  • If you are conducting an evaluation and your primary approval is external to UQ, seek local guidance regarding triggers for ethical review
  • If there is a formal local QA process and your project is approved you should seek to ratify that at UQ
  • If there is no formal local QA process in your institution, we may need to seek exemption through UQ depending on the details of your project
  • If your primary approval is UQ, you will need a UQ academic as Chief Investigator (supervisor) on your application. Further details regarding this process is provided below
  • If your evaluation project has sufficient triggers for ethical review, it is still important to present the project as evaluation. Research has to meet a higher bar in terms of merit compared to local evaluation projects.
  • Some quality assurance projects that don’t have any triggers might be sufficiently clear that they don’t require formal exemption. These projects will be reviewed at the course level.

UQ HREC Approval Process

This section outlines the process for seeking approval or exemption for your project when primary approval is needed from UQ. This will be the process for most research and evaluation projects that are being conducted in the community.

HREC Review

If your project is human research or and evaluation project that contains aspects that triggers the need for ethical review, you will need to seek HREC approval (or exemption) from a UQ HREC committee.

The level of review depends on the risk associated with the project: full review, low risk review at a Faculty committee and exemption on the basis of being a negligible risk research project (relying only on publicly available data).

Most projects being conducted in PHRM7095 are likely to be reviewed within the low risk pathway.

The process you need to follow is provided here. It is important to spend the time to understand this process and undertake it correctly.

The UQ HREC process requires that a UQ academic is

  • listed as the Chief Investigator on the application and
  • signs the application

This is a policy requirement of the university to ensure that there is sufficient oversight of the projects conducted by students. This oversight is provided within the program and the course. While a UQ academic needs to be listed as a Chief Investigator on the ethics application and will provide academic support, the project can still be student-led and it is not necessary that the academic is listed as an investigator on the project description.

Given these requirements, here is the process for applying for UQ HREC approval (for a low risk project):

  1. Complete your project proposal

  2. Prepare a Participant Information and Consent Form (if you are prospectively recruiting participants)

    See the templates and forms provided via the UQ HREC. See especially:

    • The Participant Information Sheet and Consent Form Checklist

    • Standardised Participant Information and Consent, NHMRC website

    • UQ templates: “Consent form” and “Participant Information Sheet”

      I recommend combining these two forms like they do in the NHRMC templates, but it is up to you.

    • Project Description Template - Low and Negligible Risk Research

      This is currently the template that the committee will ask you to submit for Low and Negligible Risk Research

  3. Complete the online MyResearch application see training for the system here.

    Take care with the form and read the information associated with each questions. It doesn’t take long to fill out the form once you have a well-developed proposal, but if you try to do it quickly, you are likely to cause more work for yourself. If the form asks you any questions that you haven’t addressed in your project proposal, update your proposal and then cut-and-paste your response into the form. It is recommended to download a preview of your application to proof read and amend prior to submission.

    Your application needs to be complete before you submit it:

    • You need to have decided on your methods and how you are going to analyse the data
    • You need a Participant Information and Consent Form if you are prospectively recruiting participants
    • If your project hinges on gatekeeper approval, it is best to provide evidence that you have it (e.g. email correspondence)
    • You need to provide your survey or interview guide (it is OK if you are going to further pilot it and refine it, but it needs to be complete and close-to-final)
    • You need to provide any advertising material you will use
    • You need to have an academic supervisor listed as the Chief Investigator who has signed the application

  4. So that we can review, approve and sign your application, you will need to share your application with your UQ supervisor.

    Email us beforehand to let us know it is coming and to confirm who will be listed as the supervisor. Follow the instructions for sharing the application here. IMPORTANT: do not submit the application prior to review and approval from your UQ supervisor.

  5. Once complete the online application is directly submitted to the relevant UQ committee.

Exemption from HREC review

Some projects may be eligible for exemption from ethical review.

This includes research projects that meet the following conditions:

  • you are conducting negligible risk research and
  • you are using “existing collections of data or records that contain only non-identifiable data about human beings”

And evaluation projects (quality assurance/quality improvement) that need confirmation that they don’t require formal ethical review. This is especially important if there if there is an aspect of the project which might be considered a trigger for ethical review, but can be adequately managed. Some committees use this process to exempt evaluation projects from ethical review that investigators wish to publish.

The UQ policy surrounding exemption from HREC review is provided in UQ policy and procedures library (4.20.07). The form that needs to be filled in and submitted is also provided at this website. The form is submitted to the Human Research Ethics Office via email: .

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Last updated on Jul 2, 2021