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As you begin a clinical research project at Massachusetts General Hospital, it is important to develop a comprehensive plan for recruiting, screening, enrolling and retaining study subjects.
If your research project involves direct interaction with study subjects, it is important that the recruitment plan section of your Standard Operating Procedures (SOP) contains a concrete and comprehensive plan for how you will recruit, screen, enroll and retain study subjects.
A well-thought-out recruitment plan will not only address institutional review board (IRB) requirements, but will facilitate recruitment, prevent delays, improve retention and help you adapt to issues that arise during the study.
Your recruitment plan should delineate who on your team will be responsible for which aspects of execution (outreach, advertisement, screening, enrolling, reporting, retaining, etc.) and should be updated on a regular basis. Make sure to include these duties in your Delegation of Responsibilities Log.
Your method of finding subjects will depend on your study population. Make sure that you review the Partners IRB Policy and Guidelines on the Recruitment of Research Subjects and the Remuneration of Research Subjects, and that all advertising methods are cleared by the IRB prior to initiation.
Screening research subjects appropriately is vital to both protecting human subjects and ensuring that you recruit the right subjects into your research projects. Follow the Partners IRB Policy on Pre-Screening Research Subjects During Recruitment and make sure to determine and document subject eligibility appropriately in a pre-screening log
Once you have established subject eligibility, all potential participants must formally undergo the informed consent process before they can be enrolled in your research project.
Informed consent is not only a document; it is a process that starts at the point of recruitment and screening of study subjects and continues throughout the lifespan of study participation.
Potential study subjects or their surrogates must be informed (in simple and appropriate language) about what your research involves and the potential risks and benefits of participating in your project.
Here are some good resources to review:
It is essential that each research participant be associated with your study protocol in Epic if patient research services will be billed through Mass General or the MGPO Professional Billing Office. This should be an item on all study checklists to ensure consistency in this process.
Once the informed consent form has been signed, a study team member must “enroll” that patient to the study in Epic. This is required in order to begin research billing for that patient.
Research subject retention is vital to the success of your study, as the statistical power of your results might be skewed if not enough people who enrolled are able to complete your study. At the same time, remember that research subjects are volunteers and have the right to withdraw from your project at any point.
Retention begins at recruitment, as you work to make sure that all potential subjects are fully informed about what they are committing to when enrolling in your study.
Retention tactics cannot be coercive of study subjects in any way. See the Partners IRB Policy on Research Subject Remuneration for further guidance. Reimbursement for study participants is managed through the Accounts Payable E-Check System.
Keeping monthly statistics on screening, enrollment and retention is vital for record-keeping and reporting as well as strategizing. Review these statistics regularly as a team and reassess your plans for subject recruitment and retention as needed to ensure that your project is a success.
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