Recruitment materials the Capella IRB approves: flyers, emails, scripts, exactly as they will run

Why does the board treat a flyer as part of consent?

Because it is the first thing a prospective participant reads about your study, and the board's job under 45 CFR 46.111 is to confirm that consent will be sought and that the selection of participants is equitable, taking into account "the purposes of the research and the setting in which the research will be conducted." Capella's Research Integrity SOPs say the IRB evaluates the recruitment strategy and selection of participants with particular attention to that criterion. Federal guidance that IRBs across the country follow treats direct advertising as the start of the informed consent and selection process, which is why the board wants the final copy of printed material, the final version of any audio or video, and the script of anything spoken, rather than a description of them.

Capella's application asks for the materials as uploads. Its FAQ on completing the IRB application lists "draft recruitment materials" among the documents a study collecting new data must attach, and its FAQ on forms tells you to arrive with drafted copies ready. "Draft" here means not yet approved; it does not mean rough. The document you upload is the document you will use, and if it is approved with a change, the changed version is the one that runs.

Which materials does a Capella IRB application have to include?

One artifact for every channel, and every channel you will actually use. A study that recruits by email through a hospital's distribution list, posts a flyer in the break room, and follows up by phone has three materials, not one. The usual set:

1. The flyer or poster, as it will be printed or posted, with the contact route on it.
2. The recruitment email or letter, including the subject line and who it comes from. If it is sent by a gatekeeper at the site on your behalf, say so, and the site permission letter has to permit that distribution.
3. Social media or forum posts, each platform's version, with the exact wording and any image.
4. Scripts for anything spoken: the announcement at a staff meeting, the call-back when someone expresses interest, the in-person approach at a clinic. The board cannot read what you have not written down.
5. Screening questions, if you determine eligibility before consent, since those questions collect information and are part of the approved procedure.
6. Reminder and follow-up messages, including how many and how spaced, because reminders are where pressure creeps in.
7. Snowball or referral text, the message a participant would forward to others, if your design uses it.

Capella's FAQ is candid that the IRB provides no templates or examples for these, since recruitment "varies widely from study to study," and points instead to the iGuide's list of required and prohibited content. That guidance sits behind the portal login and changes; what follows is what the board reads for in every file we prepare, aligned to the federal guidance, and Capella's current portal governs the exact list.

What must each material say, and what must it never say?

Every material should let a reader decide whether they are interested and possibly eligible, and nothing more. The content that belongs is consistent across the guidance IRBs rely on:

Capella's SOPs add the incentive rule in their own words: incentives must be described specifically, may not be coercive, and "cannot be listed as a benefit for participating in the study." The same SOPs list exerting undue influence while recruiting among the findings the Research Compliance Committee treats as non-compliance, which is why the tone matters as much as the content. A material that reads like a favour being asked of subordinates is a material that comes back, however accurate its facts.

What does "exactly as they will run" mean in practice?

It means the board approves artifacts, not intentions, and the approval attaches to the artifact. Three consequences follow. First, the file needs the final wording, layout and image of each material, not a paragraph describing them; a flyer submitted as bullet points cannot be approved as a flyer. Second, once approved, the material runs as approved. Policy 3.03.01 requires IRB approval before changing approved "procedures, sites, or forms," and the SOPs treat a change in recruitment strategy as the kind of major modification that can send a study back for re-review. The SOPs do carve out grammar and typo fixes to participant-facing materials, which still must be summarised to the IRB Office by email before the revised material is used. Third, nothing runs early. Capella's FAQ is explicit: recruiting may not begin until the study reads Approved in the portal and the approval letter has issued, and approval with conditions does not permit recruitment. A "soft launch" to gauge interest is recruitment.

The channel also decides the paperwork around it. Capella's guidance on site permission notes that recruiting through an organisation's email lists, website or newsletters counts as using the site, so the email through the hospital's list needs the hospital's letter, as the site permission letter article explains. Recruiting Capella's own learners, alumni, faculty or staff requires permission through Capella's separate formal review, granted in limited circumstances.

What do recruitment materials have to agree with?

The consent form, first and always. The time commitment, the procedures, the incentive, the eligibility criteria and the confidentiality promise must read the same on the flyer as on the form, because the board checks them against each other, and a participant who reads one thing on the flyer and another on the consent has been misled on the way in. The consent form requirements article lists the facts that must match across the file. Then the approved research plan: sample size, sites and population named in the SMR-stamped plan set the boundaries the materials must stay inside. Then the site permission letters, which must cover the channel. When any one of those changes, every material is regenerated from it; the common failure is a flyer updated and an email left behind.

What happens when a material is returned?

Usually it is approved with conditions rather than deferred: Capella's SOPs give "minor corrections to informed consent forms or recruitment materials" as the typical example. The fix is a revised artifact, not a rewrite of the study, and the revised artifact has to be re-uploaded and re-checked against the consent form. Until full approval issues, the status still bars recruitment. The application checklist shows where the materials sit among the documents the board expects, and the how-it-works page shows how the practice builds them inside the whole process: one artifact per channel, drafted from the approved plan and the consent, version-stamped, and revised point by point if the board writes back. The research and the people you reach stay yours; the board's decision is its own.

What to do next

If your recruitment plan currently lives in a paragraph of the application and a flyer you meant to tidy later, the fastest way to find out what the board will say is to let someone read it the way the board will. Request the free application review: send the plan, the consent and whatever recruitment materials exist, and a consultant will list every channel that needs its own artifact, every line that does not match the consent, and every channel that needs a site letter. If the set is complete and consistent, you will hear that too, and nothing is filed until you say so.

Sources

• Capella University, Doctoral Support FAQ, "Does the IRB have templates for recruitment materials?" — capella.libanswers.com/doctoralsupport/faq/132857
• Capella University, Doctoral Support FAQ, "How do I complete the IRB Application?" — capella.libanswers.com/doctoralsupport/faq/132954
• Capella University, Doctoral Support FAQ, "What forms do I submit to the IRB?" — capella.libanswers.com/doctoralsupport/faq/132864
• Capella University, Doctoral Support FAQ, "When am I able to start recruiting, consenting, and collecting data?" — capella.libanswers.com/doctoralsupport/faq/132932
• Capella University, Doctoral Support FAQ, "Do I need site permission to conduct my study?" — capella.libanswers.com/doctoralsupport/faq/132841
• Capella University, Research Integrity Standard Operating Procedures (RI SOPs), version 6.0: Selection of Participants & Recruitment, Incentives for Participation, Study Modifications, IRB Review Outcomes, Non-compliance — capella.edu/assets/pdf/policies/HRPP-SOPs.pdf
• Capella University, Policy 3.03.01 Human Research Protections — capella.edu/content/dam/capella/PDF/policies/3.03.01.pdf
• 45 CFR 46.111, Criteria for IRB approval of research — law.cornell.edu/cfr/text/45/46.111
• University of Utah IRB, "Advertisements" guidance (drawing on FDA's Recruiting Study Subjects criteria for IRB review of recruitment materials) —irb.utah.edu/guidance-series/advertisements/

Capella's portal guidance on recruitment content changes; where this article and Capella's current handbook or IRB portal differ, the portal governs. This practice is independent of Capella University.