A Panel on: Knowing what is OK: Recruiting participants for clinical research at UCI

Sample questions we will address

“So I got this list of people who meet my inclusion criteria from the Honest Broker—now what”?
“If I partner with a UCIMC physician, can I screen their patient schedule for potential research participants?”
“Am I allowed to view records in EPIC once I have my list of eligible patients?”
“I just want to collect app usability information from a small sample of people with prediabetes; can I recruit through UCIMC?”


Contact Information
Kai Zheng, PhD
Professor, Department of Informatics & Emergency Medicine
Director, Center for Biomedical Informatics, Institute for Clinical and Translational Science
Christine Hui, MPH
Chief Administrative Officer, Chao Family Comprehensive Cancer Center
Mary Alexander, CHRC, CHPC, CIP
Research Compliance Officer, UCI Health Compliance & Privacy Office
UCI Health IT
Website: https://it.health.uci.edu/index.asp
Service Desk: https://servicenow.hs.uci.edu/
Orange: (714) 456-3333
Irvine: (949) 824-3434
Center for Biomedical Informatics (CBMI)
Website: https://icts.uci.edu/services/Informatics%20.php
Email: CBMISupport@uci.edu
UCI Health Compliance & Privacy Office
Website: https://www.ucihealth.org/compliance
General Compliance and Privacy Inbox: hacompliance@uci.edu
Research Compliance Inbox: researchcompliance@hs.uci.edu



Do patients sign a document when they become a UCI patient that allows researchers to contact them?
A patient signs two documents when they register to receive care at UCI facilities. The documents inform the patient that UCI is an academic research organization and may use their health-related information to 1) contact them to recruit them for research projects, and 2) use health information for research without needing to contact them. One document is the “Terms and Conditions of Service” and the other is the “Notice of Privacy Practice” (required by HIPPA).

Before a researcher can contact a patient for research participation, the researcher must obtain Institutional Review Board (IRB) approval for the proposed project. The IRB will ensure patient health information (PHI) and patient safety are protected. The IRB also addresses requirements for informed consent or waiver of informed consent as well as HIPPA privacy requirements for HIPPA authorization or waiver of HIPPA authorization.


Why should a researcher include the provider in the recruitment process?
The IRB approves the recruitment methods for a research study and evaluates the recruitment methods on various factors to ensure protection of the patients’ safety and welfare. When a researcher seeks to recruit patients at UCIMC, one important factor is the partnership between researcher and health care provider. This partnership ensures there is appropriate expertise to oversee the study recruitment.
Moreover, the IRB can issue specific HIPPA waivers for a study, which may allow discussion between the researcher and the provider to determine eligibility of a patient before contacting a patient.


What are some best practices for creating a successful partnership between a researcher and a provider?
Before you start recruitment from a provider’s site, it is important to develop a strong partnership with the provider. Here are some recommended strategies:
• Be persistent when establishing the relationship. Providers can be busy and may need reminders of what the research project is trying to accomplish and why you need their support. An in- person visit can help you establish this relationship.

• Provide a succinct summary of the research protocol to the provider and discuss whether these procedures will affect the clinic’s workflow.
• Secure an agreement from the provider that will allow you to recruit from their clinic and keep the provider in the loop about when you will be in their clinic to recruit participants.
• Inform and involve the provider’s support staff to ensure you have their permission to approach the patients.


Resource Sheet Recruitment at UCIMC_8.27.2021 (1)

22 Aug 2021


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