Conducting the research

The research team should think carefully about the settings where they may be able to recruit participants who are eligible and able to participate in their research study. Ethics approval is likely to be needed at each institutional setting. Developing practical strategies for identifying patients who are eligible is essential. Liaising with the clinicians who care for the patient population is important. Make sure they are aware of the study and understand its value to care and to the patients. Communication processes like regular meetings or updates, newsletters or posters, may also be useful.

Sometimes it is possible to promote the study directly to patients (or their families or caregivers) via posters, newspaper articles or other publicity, and at other times referral from clinicians will be the more appropriate strategy. Ethics committees will normally  want to see and approve the actual promotional materials.

Once a possible participant has been identified, they will typically be screened for eligibility. A study protocol always describes the inclusion and exclusion criteria for the study, and these must be reviewed during recruitment. Keeping a screening log, wherein all referrals are listed, including those who are not eligible along with the reasons why, is an important practice. It allows problems with recruitment to be identified and addressed quickly, and studying the screening log may sometimes suggest changes to the study eligibility criteria that will make a study much more successful.

Once eligibility has been determined, the study can be discussed in detail with the potential participant, and the Participant Information Sheet which has been developed for the study can be discussed and given, and informed consent collected.

The study team needs to work out in detail who will do each of the necessary activities for the research project. This may include (depending on what type of study is being done):

• Screening and consenting participants
• Randomising participants
• Collecting background information from medical records or other sources
• Doing interviews
• Administering surveys or running focus groups etc
• Administering assessment tools or performing physical or psychosocial assessments
• Reviewing participants’ progress, case notes, or checking for adverse effects
• Administering study treatments
• Following up participants
• Entering results for analysis
• Analysing data
• Managing study documents
• Liaising with ethics committee/s
• Managing and accounting for funds.

Sometimes all of these tasks are done by a specifically funded researcher, at other times some of these tasks are done by the clinicians involved in the participants’ usual care, and / or an unpaid investigator. Ensuring that there are enough staff with the right skills available to do all of the necessary activities is an essential part of good research practice. Where a study requires blinding to minimise bias, it will be necessary to ensure the people collecting outcomes data do not know which group participants have been randomised to.

Sometimes a study will also affect the clinicians who are looking after the patient - they may need to alter their management (if a patient is on a study and their treatment must be completed according to the study protocol), or it may involve clinicians in assessment or treatment activities as part of the study.

Sometimes clinicians have concerns about their patients participating in trials, or they may experience the extra work of the study as burdensome themselves. Communication and liaison are therefore very important to the success of research projects which recruit patients in clinical settings. Specific problems can occur when there is “gatekeeping” - that is, when potential participants are excluded from participation in research by someone involved in the referral process. This can occur for many reasons. It is important to identify gatekeeping early and consider ways to overcome it. Possible factors to consider may include:

• Minimising participant, caregiver and staff burden
• Documenting recruitment issues in different settings to allow analysis of issues
• Streamlining of referral processes
• Review of inclusion and exclusion criteria.

Support and mentoring from experienced researchers can be very helpful here, as many will have had this experience themselves and they may be able to come up with strategies to deal with the issue.

There are specific challenges and benefits from involving several centres in a single research study, which is called multi-site research. When numbers of potential participants are limited (eg, the problem under study is not common) or if recruitment and retention is likely to be difficult for other reasons, a multi-site approach makes it more likely that the study will be able to recruit and retain enough participants to provide a valid answer the question.

The other significant benefit is that new researchers have an opportunity to work with, and be mentored by, experienced researchers and clinicians from multiple disciplines and to contribute to rigorous studies.

Multi-site approaches may be used for qualitative psychosocial studies aiming to learn about a diverse range of experiences, clinical trials that need large sample sizes, and also for health services research which looks at different ways of organising services. However, issues to do with managing research, ensuring consistent processes and high quality data, and having clear communication processes between researchers, become absolutely critical in a multi-site trial.

Specific processes are used in most multisite research studies to deal with these challenges - they include start-up meetings for each research site, where the protocol and all the associated processes are gone through, research management committees involving research staff from all sites at which issues are identified and dealt with, a range of regular review processes for each site, and use of shared Standard Operating Procedures (SOPs) which provide a detailed manual for how research is done.

Ethical approvals for the study and for participation at individual sites also needs to be managed. 

Within a research collaborative where sites are used to working with each other, the processes become easier over time. However for any new collaboration, researchers need to be aware that there is a significant amount of set-up work involved in dealing with these issues.

Research involves the collection, management and analysis of data. Data may include information about participants, audio or other recordings, transcriptions of these, completed survey forms, Case Report Forms (CRFs), and so on. The quality of the results is dependent on quality of the data, and so careful attention to each step in the process is needed. Study data may also be derived from existing data sets.

Large studies will involve processes of checking data to ensure that it is reliable and complete. Piloting of the data entry processes is also worthwhile in the preparation stages of a study. Studies which have received ethics approval may sometimes be audited, at which point all of the processes for managing and storing data may be examined. Ethics applications will require you to describe and commit to responsibility for appropriate data management during the study and after the study’s completion

Storage of data is a significant consideration, and issues to do with confidentiality and security of storage, de-identification of data, and the length of time for which data must be held in secure conditions are part of the ethical approval for research.

Many universities and research organisations will have access to data collection such as Qualtrics and Redcap and data analysis systems such as SPSS, Stata and NVivo.

Data management planning from the beginning of a research project helps to outline how data will be collected, formatted, described, stored and shared throughout, and beyond, the project lifecycle. Understanding the data cycle can be helpful to ensure you have considered data at all points in the research cycle.

• The Research Data Management Cycle (672kb pdf) has been produced by the Countway Library of Medicine at Harvard University.
• A range of resources, including information and guides on the elements of data management and data management planning, can be found on the Australian Research Data Commons (ARDC) website. 

Governance of research occurs at multiple levels. The Australian Code for the Responsible Conduct of Research developed by the NHMRC establishes a framework for responsible research conduct that provides a foundation for high-quality research, credibility and community trust in the research endeavour.

Clinical trials conducted in Australia are subject to various regulatory controls to ensure the safety of participants. The Therapeutic Goods Administration (TGA) has advice on clinical trials governance including the Australian clinical trial handbook. The NHMRC and TGA resources provide the framework within which ethics committees' work, while the Human Research and Ethics Committee (HREC) provides the oversight of governance at the local level.

An important focus of both ethics and governance is participant safety. Clinical trials require procedures for monitoring and ensuring participant safety, and reporting and investigation of adverse events, including whether or not a study should continue to recruit. Researchers’ responsibilities in this area are also covered by the GCP guidelines.

Increasingly the contribution of consumers in the supporting the research cycle has been acknowledged. The NHMRC Statement on consumer and community involvement in health and medical research helps institutions, researchers, consumers and community members address the active involvement of consumers and community members in all aspects of health and medical research.

Another governance issue relates to intellectual property. The ownership of protocols and research projects may sometimes be a source of conflict, especially in large research groups, multi-organisational collaborations and academic institutions. Students and post-graduates also have rights with regard to intellectual property and credit for research for which they have been responsible, and these may need to be specifically protected.

Expert legal assistance may be needed in developing contracts and confidentiality agreements for research collaboratives. Copyrighting of protocols and research instruments may also be appropriate.