When researchers think about IRB review, they often think about the research protocol and informed consent form. But what happens before a potential participant ever reaches the consent process? How someone learns about a study, what they are told about it, and how they are invited to participate are also important parts of human subjects research.
That is why recruitment materials are an important part of the IRB review process.
The Office for Human Research Protections (OHRP) identifies recruitment materials, including advertisements intended to be seen or heard by potential research participants, as materials that may need to be provided to the IRB for review.
Recruitment Is Often the First Interaction with a Potential Participant
A recruitment flyer, email, social media post, website advertisement, or phone script may be the first information someone receives about a research study.
Before deciding whether to participate, a potential participant may form an initial impression based entirely on that material. The recruitment message can influence what they believe the study involves, whether they think they are likely to benefit, and what they expect their participation will require.
OHRP has described the informed consent process as beginning with the initial approach to a potential participant, which can include a flyer, brochure, or advertisement. Because recruitment can be an early part of the participant’s decision-making process, it is important that the information presented is accurate and appropriate.
The IRB Reviews Recruitment Materials for Accuracy
One reason the IRB reviews recruitment materials is to determine whether they accurately represent the study.
Recruitment materials should generally be consistent with the approved protocol and should not promise outcomes that the research cannot guarantee.
For example, researchers should be cautious about language that suggests participation will definitely improve someone’s health, solve a problem, or provide a personal benefit when that has not been established.
The IRB may also look at whether descriptions of the study’s risks, benefits, time commitment, eligibility requirements, and procedures are consistent with the information contained elsewhere in the submission.
Recruitment Should Not Be Unduly Influential
Recruitment materials should invite people to consider participating without creating inappropriate pressure.
The IRB may consider whether the wording, incentives, or presentation of a recruitment message could be coercive or unduly influential. This can be particularly important when research involves populations who may be vulnerable to pressure or when recruitment occurs in situations where potential participants may feel obligated to participate.
For example, an employee may interpret a message from a supervisor differently than a message from an independent researcher. The relationship between the recruiter and potential participant can therefore be an important consideration when evaluating recruitment procedures.
The Details Should Match the IRB Application
Researchers should make sure recruitment materials accurately reflect the study described in the IRB application.
If the application says participants will complete three online surveys, but a recruitment flyer says they will complete one survey, the inconsistency needs to be addressed.
The same principle applies to:
- Eligibility requirements
- Time commitment
- Study activities
- Compensation
- Contact information
- Location or method of participation
- General descriptions of the study
- Potential benefits or risks
For researchers working with Solutions IRB, it is especially important to remember that the IRB application serves as the primary record of the study. Recruitment materials should support the application and accurately reflect the procedures described within it.
What About Online Recruitment?
Modern research may use many different recruitment methods, including websites, social media, email, online advertisements, and other digital platforms.
The format may be different, but the underlying concern remains the same: what information is being provided to potential participants?
OHRP has specifically addressed online recruitment. It notes that recruitment tools can include web advertisements, social media posts, blog postings, videos, email solicitations, and text messages.
Researchers should therefore think beyond traditional flyers when determining which recruitment materials should be included in their IRB submission.
Submit Recruitment Materials Before Using Them
Researchers should not wait until after recruitment has begun to provide materials to the IRB. Recruitment materials should be submitted for review according to the requirements and procedures of the reviewing IRB before they are used to recruit participants.
If recruitment plans change after approval—for example, if a researcher wants to begin using a new flyer, advertisement, or recruitment method—the researcher should determine whether the change requires IRB review and approval before implementation.
Recruitment Materials Help Protect Participants
Recruitment is more than a marketing step for a research study. It is part of how potential participants learn about the research and begin deciding whether participation is right for them.
By reviewing recruitment materials, the IRB can evaluate whether potential participants are receiving accurate information, whether the recruitment approach is appropriate, and whether the materials are consistent with the approved research.
For researchers, carefully preparing recruitment materials—and making sure they match the IRB application—can help create a clearer and more transparent experience for potential participants from their very first interaction with the study.