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Changing an approved Aspen project — the Change Request Form, and what has to wait for it

Approval is not a licence to run the project you meant; it is permission to run the one in the file. Aspen’s handbook sends a change to any aspect of an approved study or project to the IRB on the Change Request Form, and states the sequence without softening it: the board must approve the change before you proceed.

Isabel Rourke, PhD · 2026-08-23

In short. File an IRB Change Request Form and wait for written approval before the change happens. The handbook covers any aspect — instrument, consent, location, recruitment. Only a change removing an immediate hazard to a participant may be made first and reported after.

Where is this rule written down?

In two places that say the same thing. Aspen’s IRB Handbook lists the Change Request Form among the reasons you contact the board after approval, and gives the trigger as broadly as it can be given: a change to any aspect of your study or project — the examples it offers are a survey instrument, an informed consent form, where the project takes place, and how participants are recruited. It then states that the IRB must approve the change before you proceed, and elsewhere that changes cannot be made without IRB review and approval, with the type of review depending on the magnitude of the change and its effect on the balance of risk and benefit.

Behind it sits the federal requirement every institution operates under: an investigator runs the activity on the terms the board approved, and any proposed change waits for review and approval before it is used. The regulation writes in one carve-out: a change required because a participant faces an apparent immediate hazard. That is a patient-safety valve rather than a convenience clause, and it carries an obligation to tell the board promptly afterwards.

The consequence is worth stating flatly. Between approval and close-out, the file is the project. Where practice and file have parted company, one of them must be corrected — and only one of them can be.

Which changes go on the Change Request Form?

Assume all of them, then check what has to travel alongside. The table below is our reading of Aspen’s published guidance and of what each change touches elsewhere in the file; the board decides how any given request is reviewed.

Common changes, and what has to move with them
The changeWhat travels with the requestWhat else it usually touches
A new or replacement siteA fresh permission letter on that organisation’s letterhead, signed by someone attesting to their authority, naming exactly what is permitted thereRecruitment materials that name the setting; the site’s own board, where it has one
Where the project takes place within a siteThe revised description of the setting and activitiesPrivacy provisions, if the new space is less private
How participants are recruited, or by whomThe recruitment set in the exact form it will reach peopleAnything in the consent about how you came to be asking
Wording of a flyer, email or scriptThe corrected material itself — the board may require materials seen by participants to be revised for accuracy and clarityNothing else, usually
Who may take part, and who may notThe revised criteria in the applicationThe consent and recruitment text wherever they state eligibility
An instrument added, swapped, or alteredThe instrument as it will be administered; the author’s signed permission where one is required — the handbook requires it outright if you modify an instrumentThe analysis described in the approved proposal
How data is collected — in person to video, paper to portalThe revised procedureConsent language on recording and platform; the data protection answers
Where data lives, who reaches it, when it is destroyedThe revised data protection plan — storage, authentication, encryption, secure location, destructionThe consent’s confidentiality statement
Adding participants who need safeguardsThe safeguards themselves, and the justification for including them at allAssent or guardian permission documents; the review level, which is the board’s to set
Introducing or increasing an incentiveThe remuneration plan — which the board reviews for undue influence, and which cannot be made contingent on finishingThe consent, which must set the plan out clearly
Records now coming from a medical fileA HIPAA authorization formThe whole data protection section
Running past the approval termNot this form — the Continuing Review FormSee continuing review and closure

What can happen before the board answers?

One thing only: a departure made because an immediate hazard has arisen and the approved procedure is what stands in the way of removing it. The exception is narrow by design, and it obliges you to report what you did.

Everything else waits — including the changes that feel harmless. Starting at the second site because the letter “is coming.” Using the clearer consent because it is clearer. Slipping an extra question into the interview guide because somebody said something worth chasing. Letting a colleague send the invitations because you are on shift. Each of these is the project departing from the file, and the board has a separate form for what that becomes.

When the change already happened

Then it is not a change request. Aspen’s handbook routes deviations from an approved plan and violations of the terms of approval to the IRB Events Reporting Form, alongside adverse events and unanticipated problems. The handbook’s test for a reportable unanticipated problem has three parts, all of which must hold: the event was unexpected, it was related or possibly related to participation, and it places participants or others at greater risk of harm. The handbook sets an explicit reporting window for these forms, stated in hours rather than weeks — check the figure in force in the current handbook, and treat the form as urgent rather than administrative.

The handbook’s standing advice on all of it is sound: if something unanticipated happens, contact your chair immediately, and if there is doubt about whether it is reportable, write to the IRB and copy the chair. The board would far rather read about a deviation from you than find it in the record later.

What does a change request have to carry?

A request that answers three questions on its face is a request that can be reviewed without a round of queries.

  • What is changing — stated as a before and after, not as a description of the new state alone. The reviewer holds the approved file; make the difference visible.
  • Why — in a sentence or two, and honestly. Recruitment is slower than expected, the unit reorganised, the instrument’s author released a newer version. Reasons are not held against you; unexplained changes are.
  • Which documents change — named, and attached in their revised form, stamped to one version, labelled clearly enough that the reviewer never guesses which file is current.

Then the documents themselves, in the same condition any Aspen submission is expected to arrive in: signed where signatures belong, spell-checked, templates fully tailored with the instruction text removed, and nothing left over from an earlier version. The handbook’s warning about incomplete submissions does not stop applying after approval. And keep the chair in the loop as the handbook asks: copy them on communication with the IRB.

What a change request cannot do

  • Re-argue the level of review. That determination belongs to the IRB Chair or designee — and a substantial enough change can pull a project onto a different path than the one it was first reviewed under.
  • Make a past action approved. Approval runs forward. Something already done is reported, not requested.
  • Buy a design the university does not permit. Aspen’s handbook rules out projects that require a participant to take a substance into the body by any route, however the request is framed.
  • Extend an expiring approval. A modification and a continuing review are different forms answering different questions.

How do you avoid most of these in the first place?

By fixing the plan before the application quotes it. Aspen’s own published guidance on the IRB makes the point in the plainest terms available: include every recruitment method you anticipate in the original application, so you are not filing change requests for them later. The same logic extends across the file — a second site you might need, a follow-up interview you might run, a reminder email you will probably send. Requested once, at the start, they cost a paragraph. Requested afterwards, each one costs a form and a wait. The sequence is laid out in the Aspen IRB process step by step, and if a change request comes back with findings, answering the board’s findings applies unchanged.

What to do next

Give us three things: the letter that granted approval, the application it approved, and a paragraph on the change you have in mind. Read against Aspen’s current handbook and portal, the findings come back free — whether this belongs on a change request, on an event report, or in front of your chair first, and what the file must carry in each case. Ask for the free application review. Where the change proceeds, the request, the revised documents and any fresh site permission are prepared here, and each reply the board writes is answered until it decides. How it works covers the terms; the FAQ covers everything else. What belongs to you is untouched by any of it, and the decision remains where it always sat.

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