- Ethical Concerns and Principles
- Acceptable Recruitment Methods
- Who May Recruit
- Recruitment Materials Needing IRB Review
- Special Cases
- Recruiting Diverse Populations
- Multisite Participant Recruitment
- Resources
Ethical Concerns and Principles
The researcher and the IRB must consider the following ethical concerns when evaluating a recruitment strategy:
Also keep the following principles in mind when developing your recruitment strategy:
Exceptions to these principles may be granted where necessary. The IRB application must explain why exceptions are necessary; approval is not automatic.
Acceptable Recruitment Methods
You will be asked to explain your method(s) of recruiting subjects in the IRB Application. The following recruitment methods have been used in studies conducted at UCSF and its affiliated institutions. Depending on circumstances, any of these methods may be in compliance with both the federal (45 CFR 46) and the federal HIPAA Privacy Rule (45 CFR 164), but there also may be ethical and practical problems with any of the methods.
Click on the proposed recruitment method for more details, important considerations and/or restrictions.
Who May Recruit
Individuals initiating contact (in person or by phone) with potential subjects must have basic knowledge about the study (so they can answer questions) and training in the voluntary nature of research participation. They also should be prepared to provide prospective subjects with
- a researcher’s name and phone number (for questions about the study) and
- the phone number of the IRB (for questions about a research subject’s rights).
Recruitment Materials Needing IRB Review
The following types of recruitment materials must be submitted as part of the initial application for IRB review. Any additions or changes to these items must be submitted as modifications of the study.
Recruiting Diverse Populations
UCSF is dedicated to promoting a diverse human research participant population, which includes non-English speaking individuals. Within the UCSF patient catchment area, approximately 42% of potential research study participants speak a language other than English as their primary language at home. Therefore, it is not appropriate to limit participation to those comfortable with English only. Excluding non-English speaking individuals would be inconsistent with our Diversity, Equity, and Inclusiveness goals. UCSF's Clinical & Translational Science Institute (CTSI) Participant Recruitment Program and the CTSI Integrating Special Populations Core offer tools, services, and consultations to support recruitment of underrepresented populations. For more information and to request a consultation, see: Bit.ly/UCSFRAGE
The UCSF IRB strongly encourages enrollment of people with disabilities. Please review the Participant Accessibility Guidelines, prepared by the UCSF Office of Disability Access and Inclusion. After reviewing the guidelines, if you have specific questions about accommodations, please submit a consultation request to UCSF CTSI Consultation Services.
Multiple Participant Recruitment
Multisite participant recruitment using EHR-derived cohorts (hereafter referred to as “EHR recruitment”) requires special planning and consideration due to complexities around patient privacy, data limitations and security, and variance in local administrative practices. UC BRAID (in coordination with systemwide privacy and compliance officers, IRB directors, data security experts, and UC patient advisory boards) created guidelines and best practices intended to aid researchers in creating a multisite EHR recruitment plan that is respectful to patients, minimizes the risk of loss of patient confidentiality, and helps researchers anticipate and prepare for patient feedback. Questions about this must be directed to David Grady at UC BRAID here: [email protected], not to the IRB. To view the Guidelines and Best Practices, please visit the BRAID site here.
Resources
- Participant Recruitment Program
- Research Action Group for Equity (RAGE)
- Multiple Participant Recruitment (UC BRAID)