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.
Last updated 11 January 2018