Recruitment materials as filed: the flyer, the email and the script Aspen’s IRB reads word for word

Aspen’s checklist asks for participant recruitment materials, not an account of them. The distinction decides the finding: a board can only judge what a person will be shown if it is holding the thing they will be shown — the flyer as it will hang, the email as it will send, the script as it will be spoken.

Isabel Rourke, PhD · filed 2026-08-23

In short. Aspen’s Appendix E asks for recruitment materials themselves — flyer, social post, email — among the attachments. Every channel also carries a permission behind it, and no approach to anyone may happen before the board’s written approval arrives.

Why does the board want the artefact rather than a description?

Because the artefact is where influence lives. A description says what you intend; the page shows what somebody reads at the moment of deciding. The two diverge precisely where it matters — a headline, a promise, the size of a number.

Federal practice has treated recruitment this way for a long time. The FDA’s guidance on recruiting study subjects treats direct advertising as where consent and selection actually begin rather than as a preliminary to them, and expects boards to read adverts within the initial package: whether the wording is unduly coercive, whether it implies a certainty of benefit the protocol cannot support, and — for printed material — the relative size of type and other visual effects. That last clause is the giveaway. Type size cannot be reviewed in a paraphrase.

Aspen’s application checklist arrives there by a shorter route: among the attachments filed where they apply, it names participant recruitment materials, with examples — a flyer, a social media post, an email. The plural does real work. Three channels running means three artefacts filed.

What counts as a recruitment material?

More than the poster. Anything a prospective participant sees or hears before consent is part of the approach, and that includes the pieces people forget to write down because they are spoken or automatic.

By channel: what is filed, and whose permission stands behind it
Channel	What is filed, exactly	The permission behind it
Printed flyer or noticeboard	The flyer as it will be printed, with its final layout and typography.	Posting the flyer named among the permitted activities in the site letter.
Invitation email	The message as it will send, including its subject line and signature block.	The organisation’s permission where the list belongs to the organisation.
Social or professional group post	The post as it will appear, with the group named.	The group owner’s permission — Appendix C uses precisely this example.
Verbal invitation or briefing	The script, written out, in the words that will be used.	The activity named in the site letter and in the application’s procedures.
Eligibility screening	The screening questions, and what happens to the answers of people who do not enrol.	The data answers in the application, which must cover screening data too.
Reminder or follow-up	Each reminder, in its own words, with its cadence described in the application.	The same permission as the original approach — a reminder is a second approach.

Screening deserves the extra attention it rarely gets. The FDA guidance treats the first contact — often a script followed by whoever answers — as something the board should be assured about, and says a bare promise of confidentiality tells a board nothing about the procedures that will actually be followed. It raises the questions a file ought to answer for itself: what happens to personal information if someone breaks off mid-conversation, who holds the answers, and what becomes of the records of people found ineligible.

What does Aspen check the wording against?

Three things, and only one of them is about tone.

The first is accuracy against the rest of the file. A recruitment piece names a purpose, a commitment and an eligibility rule, and each of those appears elsewhere — in the application, in the consent, in the site letter’s list of permitted activities. Where the flyer says one thing and the consent another, the board has two accounts and no way to choose between them.

The second is the quality standard Aspen applies to anything a participant will see. The board’s own review questions include whether public-facing materials are clear and free from spelling and grammatical errors. The handbook explains why in terms of the reader rather than the rule: errors in recruitment material may steer people away from the project or make them question its credibility, so the board may ask for revisions to anything participants will see, for accuracy and clarity. The quality section adds the blunt version: incomplete submissions, errors and inconsistencies delay a file.

The third is influence. An invitation is confined, in the FDA’s framing, to whatever somebody needs for judging eligibility and interest. That guidance sets out what may appear when appropriately worded — the investigator or facility and how to make contact, the condition or purpose, eligibility criteria in summary form, a brief note of any benefit of taking part, the time or other commitment asked of participants, and the location. It also draws the negative line: no claim of a certainty of favourable outcome, nothing beyond what the consent and protocol support, and where payment is mentioned it may be stated but not emphasised by bold or larger type.

Aspen carries its own remuneration rule alongside that. Payment or gifts are permitted so long as they do not unduly influence anyone to enrol or continue; the plan must be set out clearly in the consent process and on the form; receipt may not be made contingent on completing the work; and the board reviews and approves the arrangement. A flyer that leads with the payment while the consent mentions it in passing is inconsistent in the one direction boards read most carefully.

When may recruitment actually begin?

After the approval letter, and not a day before. Aspen repeats the sentence three separate times in a short handbook, set off from the body text each time: no recruitment of participants, data access, data collection, or project implementation may occur prior to IRB approval. It also states what failure to secure approval can lead to, and it is not a revision request.

The reason this catches careful people is that recruitment does not feel like data collection. Sounding out a unit about willingness, asking a colleague to mention the project at handover, putting the flyer up early so it is ready — each feels preparatory. Each is an approach to a prospective participant, and none of it can be repaired afterwards, because consent obtained before approval was never approvable consent. A file that has recruited early does not have a wording problem; it has a chronology problem, and chronology is the one thing a revision cannot edit.

What if the channel changes after approval?

Then it goes back to the board before it runs. Aspen’s Change Request Form is described as covering a change to any aspect of an approved project, and the handbook lists how participants are being recruited among its examples, alongside the instrument, the consent form and the location. Approval must come before you proceed.

In practice the amendments cluster. Enrolment is slower than expected, so a second site is added — which needs a second letter as well as a changed flyer. The noticeboard is replaced by an email list — which moves the approach onto someone else’s channel and needs the owner’s permission. A reminder is added — which is new material, not a repetition of approved material. Each is ordinary, and each is a submission.

What does a clean recruitment set look like?

It looks like a folder, not a paragraph. Every item in it is final, every item names the same project in the same words, and every item has a permission and a procedure standing behind it.

Every channel that will run has its own artefact, in final form, with nothing left as a placeholder.
The purpose in the invitation matches the purpose in the application, the consent and the site letter.
The eligibility statement matches the inclusion criteria in the plan, in summary form rather than in full.
The commitment asked of participants matches the duration and procedures the consent describes.
Contact details are real, monitored, and consistent across all the materials.
Any payment appears in the invitation, the consent and the application, described the same way in all three, and never as the headline.
Screening questions are written out, with the fate of non-enrolling responses stated.
Spelling and grammar are checked on every artefact, because the board treats this as substantive.
Nothing promises a benefit the protocol cannot deliver, and nothing implies a certain outcome.

That list is a cross-read, not a proofread, and it is the part of a file that is quickest to fix and easiest to overlook — which is why it appears as its own line in the inspection reports we write. The full sequence is set out on how it works, and the recurring questions are answered on the FAQ.

What to do next

Assemble the recruitment set as artefacts before the application is written, not after. Print the flyer, draft the email in the client that will send it, write the script as speech. Then lay them beside the consent and the site letter and mark every sentence where the three disagree. If the set is already drafted and you want a reviewer’s reading of it, send it — the findings come back in writing, with no obligation attached.

Send the recruitment set with the consent and the plan. We read them against each other before the board does.

Request the free application review

Independent consultants, unaffiliated with Aspen University. The project and its findings stay yours; the determination is always the board’s. Also filed: the route from proposal to determination and the nine lines of the site letter.

Sources

Forms and attachment lists change. Confirm anything specific against Aspen’s current handbook or IRB portal before you file.