3.6 Subject Recruitment Through Direct Invitation

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for subject recruitment through direct invitations to participate. Subject recruitment through advertisements is described in HRPP policy 3.5.


2.0 Policy

It is the policy of the Organization that


3.0 Definitions


4.0 General Prohibitions


5.0 Invitations to Patients


6.0 Invitations to Prospective Subjects who are not Patients

This section applies to prospective subjects who may be eligible for participation in research but who are not primarily eligible because they have a disease or condition being diagnosed or treated at UNMC/Nebraska Medicine (including hospital and/or clinics), Bellevue Medical Center, or Children’s Nebraska (including Children’s Physicians Clinics). They may be patients or former patients, but that is not the primary reason they may be eligible.

Note: Examples of this subject population would be public or private school students; college, trade or professional school students (e.g., UNO freshman, enrollees at a particular trade school, UNMC School of Medicine students); cultural, ethnic or religious groups (e.g., Sudanese immigrants, members of a particular church); trades or professions (e.g., farmers, physicians, prison guards).


DOCUMENT HISTORY:

 Written: 8/23/2018 (Approved: 8/23/2018) - original author not recorded

 Revised 9/25/2024: Revised definition of “Opt-In” (section 3.1); deleted definition of Honest Broker since not used in policy; clarified how distribution list obtained, processed and used (sections 4.1.1 and 4.3); clarified and simplified method of contact of potential patient subjects thru OneChart Patient Portal or Children’s Connect (section 4.6); provided regulatory reference for TCPA (sections 4.7.5 and 5.3.3); specified that phone calls must originate from a UNMC/NM, CN or UNO telephone number, unless specifically approved by the IRB (section 4.7.2 and 5.3.2). {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised 3/5/2025 - Reformatted and revised to make requirements consistent for all routes of contact with potential subjects; clarified information that must, may, and may not appear in recruitment materials; specified IRB number format; stylistic changes. {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}


Revision #9
Created 24 October 2019 21:31:46 by Autumn M Eberly
Updated 17 March 2025 13:51:14 by Robert A Lewis