Many of the projects we review include some type of recruitment strategy. The method of recruitment varies depending on the population of interest and may include one or more of the following
- Internet posts
- Media advertisements
- Email or letters
- Word-of-mouth – snowball sampling
What may not be intuitive is the relationship between recruitment and informed consent. The informed consent process begins with the initial contact with the participants. For this reason, the IRB must review recruitment materials. The recruitment information cannot be misleading or coercive. 45 CFR 46.111 states that the selection of participants must be equitable. If the recruitment materials do not accurately describe the risks and benefits, this concept is violated.
What does Solutions IRB consider when conducting a review of the recruitment materials? Let’s consider advertisement first:
- All advertising must clearly state that the participants are being recruited for research purposes.
- Materials should identify the PI and the contact person and contact information (phone number, email, website).
- If the potential benefits are listed, it must be in a manner that does not overstate the benefits.
- If the risks are listed, they must be listed accurately and not understated.
- The purpose of the research should be clearly stated in a manner appropriate for the population of interest.
- If the recruitment materials are targeted for children, the need for parental consent should be stated if the IRB has not granted a waiver of parental consent.
Now for a look at the recruitment materials:
- If you are using snowball sampling: consider whether any breach of confidentiality or privacy laws has occurred. Generally, you want the potential participant to contact the PI about the study. You do not want a third party to provide the contact information, as this could be a breach of confidentiality.
- Make sure you have obtained the appropriate permissions prior to using posting, flyers or emailing a distribution list.
- If you are posting online, review the terms of agreement to make sure the recruitment materials do not violate the terms.
- If you are using verbal scripts for either the advertising or recruitment, the IRB must review those.
Advertising and recruitment activities serve an important role in all research and evaluation projects. The IRB considers this as the initial contact with the participant and thus part of the informed consent process. If you have questions as you draft these materials, please contact us. We are always happy to brainstorm with our evaluators and researchers!
Written by Dana Gonzales, PhD, MHSA, CIP for Solutions IRB, LLC.