Introduction
Research involving human participants needs to be conducted in a way that respects the voluntary nature of research participation and minimises risks to the participant, researchers and others. The National Statement on Ethical Conduct in Human Research (2023) provides guidance for the appropriate conduct of research involving people (their data, tissue, opinion, etc).
The overall objectives of this module are
- Be able to identify the appropriate approval processes for pharmacy practice research projects
- Be able to design and conduct a research project in accordance with the guidance provided by the National Statement and other relevant regulatory requirements
- Be able to write a research proposal that can provide the basis for an application for HREC approval
The section focuses on the first objective.
Approval processes for pharmacy practice research
Human Research Ethics Committees (HREC) play and important role in reviewing and approving human research. The National Statement provides guidance on the make up and processes of HRECs. The National Statement also provides guidance on alternative approval processes for lower risk research.
It is important to emphasise that individual researchers are responsible for ensuring that the research they conduct is appropriate.
While the processes of ethical review are important in this field, individual researchers and the institutions within which they work hold primary responsibility for seeing that their research is ethically acceptable. National Statement (2023, 5)
Identifying the correct approval process for pharmacy practice research can be challenging. The key features that determine the process are provided in the table. It can be helpful (and sometimes necessary) to seek advice from the primary HREC to ensure you are applying through an appropriate process
| Question | Determinants |
|---|---|
| Who are your participants? | This helps to determine the institution(s) from which you need to gain approval. Note: if you are undertaking the research as part of a university degree, you will also need to apply to the university committee. |
| What is the primary intention of the activity? | If quality assurance/quality improvement, there may be alternative processes within your institution for approval. See NHMRC (2014). |
| What is the level of risk to participants? | Alternative processes may be used for research that poses no more than low risk (i.e. a low risk committee), alternative processes may also be used for research that poses negligible risk. |
Who are your participants?
Participants, in this context, might be providing informed consent to participate, or you might be using data related to the participant in your project (with or without explicit consent). Participants might be patients or consumers, health professionals or other staff who work in an organisation.
Being clear on your participants helps you identify which institution(s) you need to gain approval from. While we are focusing on formal approval channels, this question can also help you identify people and departments that you should consider seeking support (and sometimes formal approval) to conduct the study.
Most hospitals will have an associated HREC—often one that will look after multiple hospitals in a district. In other settings, you may need to enquire as to whether there is a HREC responsible for approving research in the setting. Some aged care facilities have an associated HREC, others don’t. Few community pharmacies have an associated HREC. If the setting in which you are doing your research doesn’t have an associated HREC, the university HREC will be the primary HREC for the project. If you are conducting your project in multiple settings, you will likely need approval from multiple HRECs.
The primary HREC is the HREC associated with the site in which participants are recruited. If you are conducting the research as part of a university degree, you also need formal approval from the university HREC. You will need to gain approval from the primary HREC prior to seeking approval from any secondary HRECs (e.g. university HREC). If there is no HREC associated with the site, the university HREC will be the primary HREC.
Some examples below.
Assessing adverse events experienced by patients prescribed methotrexate for rheumatoid arthritis via an outpatient clinic.
This project would require formal approval from the HREC for the hospital, and support from the head of the rheumatology department.
Assessing quality of prescribing in an aged care facility
This project would require formal approval from the HREC for the aged care facility. If there is no HREC for the facility, the university HREC will be the primary HREC.
Assessing consumer satisfaction with influenza vaccination in community pharmacies
This project would require support (specifically: gatekeeper approval) from the owners of the community pharmacies, and, assuming there is no HREC associated with the pharmacies, approval would be required from the university HREC.
Who are your participants? can be a deceptively complex question. Who are the participants when you are evaluating a process? Consider an evaluation of antibiotic prescribing in patients presenting to emergency with suspected pneumonia? Possible participants include the patients, prescribers, other members of the care team, the emergency department, the hospital—whether it is all of these or a subset depends on the specific questions you are asking.
It gets more complicated when the project includes multiple sites. Consider an evaluation of discharge communication during transitions of care between a hospital and an aged care facility. Who are the participants?—patient, hospital, hospital staff, facility, facility staff, community pharmacy, community pharmacy staff…more? How you answer this will influence which HRECs you need to gain approval from and from whom you need to seek support for the study to be conducted.
What is the primary intention of the activity?
This question is especially important in pharmacy practice research. A considerable amount of pharmacy practice research could also be characterised as quality assurance or quality improvement projects.
Some institutions have different approval processes for quality assurance activities as distinct from research. The challenge is that there is considerable overlap between research and quality assurance/improvement projects, and no one set of criteria to determine whether a project is primarily quality assurance or research.
Different hospitals approach this in different ways. You might need to seek advice from a quality assurance committee or HREC to confirm the most appropriate process for approval.
An activity where the primary purpose is to monitor or improve the quality of service delivered by an individual or an organisation is a QA activity. NHMRC (2014), 2.
NHMRC (2014) recognises that (i) there is considerable overlap between quality assurance activities and research and a complete separation between the two is unlikely to be helpful and (ii) the recommendations provided in the National Statement regarding use of data and protections on participants are relevant to (and need to be adhered to in) quality assurance activities
The key determinants of whether a project should be considered quality assurance or research are the primary aims of the project and details regarding what data the project seeks to collect and analyse.
Summarising NHMRC (2014), a project might be quality assurance if:
- The purpose of the project is to compare practice against documented standards or guidelines
- All data collected and analysed are routinely collected
- “The data being collected and analysed is not linked to individuals” (NHMRC (2014), 3)
Triggers for ethical review include:
- The study involves an intervention or randomization
- The need to collect additional data or use data for a reason other than why it was collected
- “Where the activity potentially infringes the privacy or professional reputation of participants, providers or organisations” (NHMRC (2014), 3).
NHMRC (2014) recommends that institutions set up policies and processes for approving quality assurance projects. The formal and information criteria used to classify a project as quality assurance can differ between sites.
What is the level of risk to participants?
The appropriate approval process depends on the level of risk to participants. National Statement (2023, 7):
Research with a greater than a low level of risk (as defined in Chapter 2.1) must be reviewed by an HREC. Research involving no more than low risk may be reviewed under other processes described in paragraphs 5.1.10 to 5.1.14. Institutions may also determine that some human research is exempt from ethical review (see paragraphs 5.1.15 and 5.1.18).
Read National Statement (2023, chap. 2.1). Pay particular attention to the kinds of harms that can occur in research (13) and the definition of “low risk research”.
Low risk research describes research, including some types of clinical trials, in which the only foreseeable risk is no greater than discomfort. Accordingly, research in which the risk for participants or others is greater than discomfort is not low risk research. (2023, 13)
If there is a risk of the project causing distress (even if unlikely) or a risk of disclosure of embarrassing information or damage to social networks or relationships, the project poses risks greater than discomfort and need to be reviewed by a HREC.
Governance
In a hospital environment you typically need to apply of for governance approval after you have ethical approval to conduct a research study. Governance approval tends to focus on ensuring you have the appropriate authorisations and have considered and have approval for all costs associated with the project.
Governance approval processes can vary across institutions. It is wise to factor in some time to complete this process.