3- Interaction with the public and participants

 

Competency Definition: The individual understands the importance of community engagement in research activities and can design an appropriate community sensitisation strategy, adapting as required depending on the location and the needs of the study. They understand that different activities may be required at different sites for multi-centre studies, according to local variations. They can set up a Community Advisory Board, and know when to contact key opinion leaders and community chiefs or elders. They must ensure good communication is established in order to enable research/create a favourable context for research. Engaging with the community requires strong interpersonal skills and a good understanding of the area and culture where the research is to be held.

Abilities

  • Design and coordinate community sensitisation plans, e.g. community meetings, educational plans, advertising, leaflets, letters to GPs

  • Encourage, appreciate and value the contribution of study participants in all areas of research activity; promote patient and public involvement

  • Set up and manage a Community Advisory Board

  • Ensure that good relations are maintained at all times with locals

  • Develop a network of Community Liaison Personnel (CLPs) who can facilitate ongoing community engagement

  • Conduct Rapid Ethical Appraisal, or similar activities if necessary, which may involve interviews and focus group discussions

Related competencies

Similar tasks: Disseminating research findings; Initiating study; Collecting accurate data; Enrolling and retaining participants

Knowledge base: Ethics and human subject protection

Required skills: Interpersonal skills; Language and communication skills

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Competency Definition: The individual who recruits and retains participants will be involved in outreach activities (informing potential participants about the study), screening potential participants (e.g. by administering health questionnaires for eligibility check), and executing strategies for retaining randomised participants. 

The individual needs a good understanding of the means for enrolling subjects in the trial, including the inclusion/exclusion criteria and participant recruitment strategies. They can manage participant recruitment, track figures and suggest trouble-shooting actions when recruitment figures are not met. They coordinate the visit schedules of participants in the trial, assisting in the follow-up of individuals and retention strategies, and monitoring withdrawals. They understand the importance of using local languages to interact with participants, and ensure the research team is equipped with translators if needed. 

Abilities

  • Understand the application of inclusion and exclusion criteria, and can answer questions about enrolment when asked 

  • Coordinate participant visit schedules

  • Randomise participants into trial

  • Track recruitment figures and report to relevant groups when required

  • Assist in follow-up of individuals to ensure trial data is complete

  • Report withdrawals appropriately – if an individual withdraws from the study, make a reasonable effort to find out the reason

Related competencies

Similar tasks: Tracking study progress; Providing clinical care; Collecting accurate data; Engaging with the community; Supporting and advising throughout the informed consent process

Knowledge base: Ethics and human subject protection; Good Clinical (or other) Practice (confidentiality)

Required skills: Interpersonal skills; Language and communication skills 

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Competency Definition: The individual is aware of the legal requirement to gain and maintain informed consent for participants in a trial, and of the reasons for doing so. They explain the study in ways a potential participant can understand, paying attention to factors that can influence decision-making. The individual uses their excellent interpersonal skills and communication skills to deliver information about the study in a clear, accessible, non-technical manner, and can use creative means to explain difficult concepts (e.g. using illustrations when necessary). They are particularly sensitive to the requirements of vulnerable participants, and know when an impartial witness is needed to ensure transparency and fairness of the process. They also document the informed consent suitably, e.g. by adding a copy of the form to the patient record.

Once initial consent has taken place, the individual maintains good communication with the participant and continues to support them to ensure they are happy to continue, and ensures that they understand visit schedules, instructions on IMP or daily diary use, and any other trial procedures. Advising may also involve delivering general health advice to participants and their relatives.

Abilities

  • Contribute to the informed consent process, ensuring that the participant fully understands the trial, including for children, young people and vulnerable adults; use consent material (e.g. pictures) if appropriate

  • Understand that informed consent is an ongoing process, and continues to answer participants’ questions and to support them throughout the trial

  • Have an understanding of the issues that could occur during the informed consent process, and apply strategies to mitigate these risks 

  • Continuously ensure that participants have a full understanding of visit schedules and how to use the IMP

  • Counsel participants and point out when to seek healthcare advice at study sites or non-study sites, if necessary 

  • Keep subjects informed of any relevant new information that comes to light during the trial and that might affect their decision to remain in the study 

  • Ensure that suitable arrangements are made in the case that a legally acceptable representative is giving consent, rather than the participant

  • Ensure that the compensation or payment to trial subjects is clearly explained to subjects

Related competencies

Similar tasks: Risk and safety management; Providing clinical care; Ensuring appropriate use of IMPs; Enrolling and retaining participants

Knowledge base: Ethics and human subject protection; Good Clinical (or other) Practice

Required skills: Interpersonal skills; Language and communication skills 

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