This section provides information on conducting a research study, starting with participant considerations.
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 – this might include being able to access lists of patients attending a clinic or enrolled in a program, or admitted with a specific problem, etc. Liaising with the clinicians who care for the patient population is essential, so that they are aware of the study and are sufficiently persuaded of its importance to refer patients to it. Communication processes like regular meetings or updates, newsletters or posters, may also be important.
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. Often ethics committees will want to see and approve the actual promotional materials.
Once a participant has been identified for a study, 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.
Last updated 11 January 2018