Recruit, screen, enroll, & retain study subjects
- If your research project involves direct interaction with study subjects it is key 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 IRB requirements but will facilitate recruitment, prevent delays, adapt to issues that arise during the ongoing study, and improve retention.
- Your recruitment plan should delineate who on your team will be responsible for which aspects of it 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.
- Depending on your study population you may have to find subjects through various methods. Make sure that you review the Partners IRB Policy and Guidelines on the Recruitment and Remuneration of Research Subjects and that all advertisement 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 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 in order to enroll them into 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. It is key that potential study subjects or their surrogates understand (in simple and appropriate language) what your research involves and what might be the risks and benefits of participating in your project. Review Partners IRB Policy and Guidance about the Informed Consent Process as well as the policies on Consenting People with Limited English Proficiency, and consult the Partners QI Program’s Informed Consent Compliance Checklist for further guidance.
- It is essential that each research participant be associated with your study protocol in Epic if patient research services will be billed through the Hospital or the MGPO Professional Billing Office. This should be an item on all study checklists to ensure consistency to this process. Once the informed consent has been signed, a study team member must “enroll” that patient to the study in Epic. This is key to begin the 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 were able to complete your study. At the same time, it is key to remember that research subjects are volunteers and that they do have the right to withdraw from your project at any point in time. 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. When planning additional retention tactics it is key that they are in no way coercive of study subjects. 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 ensure that your project is a success.
▪ Epic Research Resource Page
▪ Harvard Catalyst Health Communication Core
▪ Harvard Catalyst Research Subject Advocacy (RSA) Program - Videos for Participants and Investigators
▪ Partners HealthCare System, Inc. Subject Payment Listing
▪ Partners Human Research Affairs/Research Management Policy: Cash Control and Accountability for Payments to Human Subjects for Participation in Research
▪ Partners Human Research Affairs/Research Management Policy: Exception from Informed Consent Requirements for Emergency Research
▪ Partners Human Research Affairs/Research Management Policy: Informed Consent of Research Subjects
▪ Partners Human Research Affairs/Research Management Policy: Payments to Subjects for Participation in Research
▪ Partners IRB Guidance on Research Using the Internet: Informed Consent in Online Research
▪ Partners IRB Guidelines for Advertisement for Research Subjects
▪ Partners IRB Policy: Obtaining And Documenting Informed Consent Of Subjects Who Do Not Speak English
▪ Partners IRB Policy: Pre-Screening of Research Subjects During Recruitment
▪ Partners IRB Policy: Recruitment of Research Subjects
▪ Partners IRB Policy: Remuneration of Research Subjects
▪ Partners QI Program Eligibility Checklist
▪ Partners QI Program Informed Consent Compliance Checklist
▪ Partners QI Program (Pre) Screening Log
▪ Partners QI Program Subject Enrollment Log
▪ Research Patient Data Registry (RPDR)
▪ RSVP for Health
▪ Advanced RPDR Training Demonstration
▪ An Introduction to the Enhanced RPDR Query Tool
▪ Epic Research Functionality Overview
▪ Good Clinical Practice in Research at an Academic Research Institution
▪ Guidance for Obtaining Surrogate Consent
▪ Introducing New Research Subject Advocacy Materials for Research Nurses and Research Coordinators
▪ Involving Children in Decisions about Research
▪ IRB and QI Roundtable Series: Consent Form Writing
▪ IRB and QI Roundtable Series: Informed Consent Process
▪ Research Subject Remuneration and Reimbursement: Policy Review and Navigating the Process
▪ Subject Recruitment and Retention Series
▪ Using Social Media in Clinical Research
▪ Working with Subjects with Limited English Proficiency
▪ Workshop: Developing a Recruitment Campaign using Social Media