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Recruit, screen, enroll, & retain study subjects

Information:

  • 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.
  • 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.

Resources:

Clinical Research Program Lunchtime Seminar Series: Considering the Research Subject’s Perspective
ClinicalTrials@Partners
Dana-Farber/Harvard Cancer Center Health Communication Core
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

Courses:

ONLINE:
Harvard X's Fundamentals of Clinical Trials
Guide to the Research Patient Data Registry
Introduction to Clinical Research at MGH
Series on Subject Recruitment and Retention

LIVE TRAINING:
Advanced RPDR Training Demonstration
An Introduction to the Enhanced RPDR Query Tool
Good Clinical Practice in Research at an Academic Research Institution
Guidance for Obtaining Surrogate Consent
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

Please click here for a list of CRP current offerings. Many of the CRP's courses are recorded, click here to access our recordings and handouts.