Recruitment and Consent
Recruit participants using a recruitment plan
The recruitment plan for the study should be provided in the trial protocol or a separate recruitment plan and is vital to ensure:
- Recruitment targets are met
- Only participants who meet the entry criteria are recruited
- Maximise retention of participants in the trial
Recruitment at a site should not commence until the following milestones have been met:
The Sponsor-Investigator should delegate responsibility for recruitment, enrolment and consenting of participants to members of the clinical trial team with appropriate skills and training. This will depend on the type of intervention and the target population and may be the Study Coordinator or it may require someone medically qualified, i.e. a study nurse or study doctor.
As part of the trial feasibility assessment, researchers should use a data source such as the hospital electronic medical record (EMR) to determine the availability of potential trial participants that meet the trial eligibility criteria at the site. EMR technology allows researchers to extract the number of participants that meet the inclusion/exclusion criteria in a de-identified format and therefore this activity can be undertaken before the trial has received ethics approval.
For registry trials/r-RCT, patients may be identified through their pre-existing involvement in the registry if recruitment via this avenue has been described in the protocol and approved by the ethics committee. This process may not suit all trials, particularly for first-line treatment studies where patients have yet to be entered into the registry at the time of study recruitment.
To improve the recruitment process for participants, researchers should involve consumers in all stages of the recruitment process. Including during development of the recruitment plan, ongoing reviews of the recruitment process while the trial is recruiting, and when reviewing at the end of the trial. This partnership should focus on meeting the communication needs of participants and their carers and mechanisms to support retention of participants during the trial.
Ensure participants are fully informed about the trial and willing to participate
A process by which a participant voluntarily confirms their willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the participant’s decision to participate, TGA: ICH Guideline for Good Clinical Practice.
Researchers should develop an informed consent process for their trial that complies with the requirements of Good Clinical Practice, their institution’s informed consent process/policy, the National Statement and any applicable state or territory legislation – such as mental health Acts, guardianship and administration Acts, and human tissue Acts.
The use of standardised consent forms is recommended to ensure that participants are provided all the information they need to fully understand fully understand all study procedures, demands, risks and benefits related to participating in the trial. GCP lists 20 elements that must be included during the informed consent discussion and included in the written Participant Information and Consent Form (PICF). These forms also help ensure the informed consent process is documented in accordance with GCP requirements.
For multi-centre trials, it is recommended that the NHMRC: Standardised participant information and consent forms (PICFs) are used. For a single centre trial, consult with the site as they may have their own PICF template tailored to meet additional site-specific requirements.
The Site Principal Investigator and anyone to whom they have delegated responsibility for informed consent of participants, must comply with the requirements of TGA: ICH Guideline for Good Clinical Practice, section 4.8 Informed Consent of Trial Participants. The requirements are extensive and include the following requirements:
- Participants in clinical trials must provide written informed consent before they undertake any trial procedures, including screening tests to confirm eligibility
- Any written material provided to the participant should receive ethics approval prior to use
- All communication about the trial (oral and written) should use plain language. That is should be as non-technical as practical and understandable to the participant or their carer and the impartial witness (if applicable).
- An impartial witness is required to be present during the informed consent discussion if the participant or their carer is unable to read. In this case they must sign and date the form after the participant/carer.
- Participants must reconsent to their participation in the trial when there is new information, when the study changes, if there is a change in risk – benefit, if there are additional study visits/procedures, or when capacity to consent has changed.
For example, reconsent is required at age 18 for ongoing paediatric study participants and consent of adults who have regained competence, i.e. now conscious.
Researchers should also partner with consumers when developing the informed consent process for their trial, including the written materials. This may involve:
- Using the results of trial participant and carer experience surveys from previous trials to continually improve the process.
- Creation of trial participant information packages or resources about treatment and consent processes that are available in different formats and languages, consistent with the patient profile.
- Collecting feedback about the consent process from trial participants and carers after treatment to inform improvements for future trials.