Introduction

The component of the module focuses on the following objectives:

2. Be able to design and conduct a research project in accordance with the guidance provided by the National Statement and other relevant regulatory requirements
3. Be able to write a research proposal that can provide the basis for an application for HREC approval

The ethical principles that guide human research are:

• Research merit and integrity
• Respect autonomy
• Promote good outcomes (beneficence)
• Avoid harm (non-maleficence)
• Be fair (justice)

Weighing up these principles in different the contexts that arise in human research can be a challenge. The National Statement, chapter 3.1, uses the elements of research as a framework to consider the application of these principles. I am going to follow this framework with a focus on issues that commonly arise in pharmacy practice research.

The elements of research:

1. Research scope, aims, themes, questions and methods
2. Recruitment
3. Consent
4. Collection, use and management of data and information
5. Communication of research findings or results to participants
6. Dissemination of research outputs and outcomes
7. After the project

Addressing the considerations that arise in each of these elements will help you to address the ethical dimensions of your project.

Research scope, aims, themes, questions and methods

Providing a clear research question and ensuring your methods and analytical approach are suitable to answer the question are critical for research to be ethically appropriate.

It is hard to justify a project for which the research question is irrelevant, or poorly framed, or the methods are unlikely to meet the research aims. If the probability of benefit is small any risk of harm will be enough to undermine the project.

When things go wrong at this stage, it is usually due to a lack of planning or poor communication. You need a well planned research proposal before you write your ethics application. You won’t get ethical approval for a project that you are yet to plan (a good plan will consider all of the “elements of research”).

If you have completed the planning and preparation make sure your communication doesn’t let you down. HRECs are interdisciplinary committees. HRECs include a variety of health professionals, researchers, lay members, lawyers and people who provide pastoral care. A comprehensive, logical, well written research plan provides the backbone of your application. Some suggestions:

• Don’t assume knowledge. Clearly state what you are doing and why. If relevant, be clear about what current practice is. Write for an intelligent non-expert audience.
• Avoid jargon and acronyms.
• Take time and care with plan English (“lay”) summaries. Everyone in the committee uses them. It is a good idea to have it in your study proposal.
• Review and edit your application before submitting. Online submission forms allow you to print a version prior to submitting. Review it. (It is clear when you don’t).

Recruitment and consent

Read these sections carefully if you are recruiting participants.

If you are gaining consent from participants. Consider what type of consent you are seeking: specific, extended, or unspecified (National Statement, 2.2.14). Consider also how you might share and store the data after the project. It is becoming more common for journals and funding bodies to expect a deidentified dataset to be available at the conclusion of the study. (See, for example, information regarding BMJ Open Data).

Many drug use evaluations and projects using electronic medication records raise questions regarding consent to access, collect or analyse data related to drug use.

If it is practical and feasible to gain consent for use of data, it is often the best way to go. But gaining consent is not always feasible or possible. Be familiar with the conditions on waiving consent (National Statement, 2.3.9–2.3.12). It is not uncommon for these conditions to apply in drug use evaluation projects.

Collection, use and management of data and information

Your research proposal needs to be clear about what data you are going to collect, where you are going to collect it from, how you are going to store the data, and what plans you have for sharing the data.

You might be collecting different types of data (from different places), and you might need to store and share those different types of data in different ways. How you store the video from a focus group is likely to differ from how you store and share the de-identified transcript from the focus group.

For the benefits of open science and sharing datasets to be maintained it is important that there are suitable protections on participant privacy. There are a number of high-profile cases in which people have been able to identify individuals using (supposedly) “de-identified” datasets. For a recent sample, see Office of the Australian Information Commissioner on the re-identification of PBS data shared publicly.

The university has policies on the storage of research data and a range of tools to ensure it is stored securely.

Communication of research findings or results to participants

It is often considered appropriate to have a summary of the project available for participants as recognition of their involvement.

Returning individual results related to research often requires careful consideration and forward planning for the kinds of situations that might arise. If you are evaluating some aspect of practice, you might need to have a plan for what you are going to do if you identify a potential or actual harm. For example, studies that assess medication administration will often have procedures to follow if they witness a significant error about to occur.

Genetic research provides a good example for thinking through some of the issues surrounding return of results.

• Should investigators return the results of genetic tests that provide information about the risk of a disease in an individual even if there is no intervention that can be made?
• What responsibilities do researchers have for returning incidental findings to participants not related directly to the research?

See National Statement, chapter 3.3 for details.

Dissemination of project outputs in outcomes

Intention to publish is an important consideration in the ethical review of research. It can be hard to justify a project if there is no intention to publish, or if publication will only occur if the results are favourable.

Intention to publish needs to be interpreted broadly. In the context of some pharmacy practice research, it might be appropriate that the dissemination plan is focused on local forums and departmental reports.

After the project

What is your data storage plan? How long will it be kept and and who is the custodian? Will you be able to access and understand your data (and, if necessary, re-do your analyses) in 3 years time when a researcher contacts you regarding a systematic review?

There are requirements for the storage of research data following a project. There are often institutional policies on how long data needs to be stored as well as state regulations. The length of time depends on the type of research and data. A minimum of 5 years from the data of publication is stated in the Australian code for the responsible conduct of research—link to documents.