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RETURN TO RESEARCH ROADMAP

STEPS TO STUDY ACTIVATION

Return to Clinical Research Roadmap

Develop a Recruitment Plan

Study teams can consult the Recruitment Concierge Service (RCS) for guidance on recruiting and retaining research participants through the healthcare system or community. The RCS evaluates study needs and offers resources to enhance participant engagement and retention. Initial consultations are free, with possible charges for additional services.

Thoroughly Review Protocol or Proposal

  • Use the protocol to outline inclusion criteria, procedures, number of visits, visit duration, and study length.
  • Determine participant needs: payment, transportation, parking, food, stay duration, consent procedures (kids, LAR, etc.)
  • Consider protocol/proposal information during budget/feasibility planning. Include participant need costs in the budget.
  • Assess cohort availability. Estimate 1% recruitment from identified numbers; consider location proximity to the study center and comorbidities affecting participant identification.
  • This information aids in constructing a Recruitment Strategy & Determining Costs (participant payment, travel, marketing, etc.): includes EMR identification, recruitment time/staff, social media, community outreach, etc.
  • Determine participant flow based on study procedures and schedule (e.g., MRI duration and scheduling constraints).
  • If engaging non-English speakers, plan outreach to underrepresented communities and ensure resources are available (budget accordingly).
  • Evaluate consent complexity, simplify if possible, and determine if it can be obtained prior to the visit or electronically. Submit to IRB.

IRB Submission of Recruitment Strategy

Submit your strategy description and marketing materials to IRB, including any All IN for Health items like the study page or other promotions. All studies are listed on All IN for Health here. Contact Angie Anderson (aneander@iu.edu) for help with your page.

Additional Information for IU Affiliates (IU Health Teams)

Complete these tasks for your recruitment plan:

  1. Include an IU Health clinician as a co-investigator.
  2. Review policies and job aids on the IU Health Team Portal (access via PolicyTech):
    1. IU Health Recruitment Policy
    2. IU Health Data Sharing Policy
    3. IU Health Clinical Research

IU Health team members can access the portal from their device homepage, while IU team members must log into the Virtual Desktop. See the IUH Virtual Desktop Job Aid for more information.

Developing a recruitment plan is only one component of study activation. Additional requirements should be reviewed using the Clinical Research Roadmap.