After Aspen approves — continuing review, reportable events, and closing the file
Does approval close the board’s file on you? Aspen’s handbook puts the question in its own contents page and answers it in one word: no. What approval starts is three separate obligations running on three different clocks, each with its own form: the term of the approval, the events that occur while the work runs, and the close-out at the end.
Miriam Kessler, DNP, APRN · 2026-08-23
In short. Three forms follow approval at Aspen. The Continuing Review Form, if the work will run past the approval term. The Events Reporting Form, for unanticipated problems, deviations and violations. The Close Out Form, once the final manuscript is accepted by the university.
What does an approval actually start?
A term. Aspen’s handbook is explicit that approval is granted for a defined period and that a project still running at the end of it must go back to the board and receive approval to continue — not notify, not assume, receive. The period in force is stated in your approval letter and in Aspen’s current handbook, and it is the date to work backwards from rather than towards.
The federal architecture behind that is worth understanding, because it explains why some projects hear about continuing review and others do not. The Common Rule requires boards to conduct continuing review at intervals appropriate to the level of risk a project carries, and then carves out categories where continuing review is not required: work eligible for expedited review, work reviewed under limited IRB review within an exempt category, and work that has passed its data-collection stage and consists only of analysis or of accessing follow-up data already covered by an approved protocol. Which of those your project sits in is not your determination to make — Aspen’s handbook is unambiguous that the level of review belongs to the IRB Chair or designee. What is yours is knowing the term you were given and acting before it runs out.
Between the letter and the close-out, the same discipline governs everything: the work runs on the terms the board approved. Anything outside those terms is either a change that needed clearing first — see changing an approved Aspen project — or an event that needs reporting.
How does an extension work at Aspen?
On the IRB Continuing Review Form, submitted before the approval lapses rather than after. Aspen’s published policy describes what the board expects to receive: a letter from the principal investigator stating the intention to continue, documenting any modification made to the protocol, and giving a concise updated overview of the project. The board then re-reviews the protocol, and where it finds it acceptable, sends a notice of extension.
Three things there repay attention. It asks for an updated overview — the board re-reads the project as it now stands, rather than renewing its memory of the original file. It asks you to document modifications, which means the submission tends to expose changes never separately requested; better to have filed them at the time. And it is a review, not a renewal notice: the outcome is a determination, and determinations can carry conditions.
The practical failure here is procedural rather than scientific. Approval does not stretch to accommodate a form in transit, so a submission prepared at the last moment leaves a project with nothing covering it if the board comes back with questions. Prepare the continuing review while the work is still comfortably inside its term, with the file already consistent — that way the only thing the board is reading is the project.
What has to be reported while the project runs?
Aspen routes several different situations to a single document, the IRB Events Reporting Form. The handbook gives a three-part test for a reportable unanticipated problem, and all three parts must hold together: the incident, experience or outcome was unexpected; it was related or possibly related to participation in the research; and it places participants or others at greater risk of harm.
The same form carries two things that are not accidents at all — deviations from the approved plan, and violations of the terms of approval. A participant enrolled who did not quite meet the criteria, a session run in a way the protocol did not describe, an invitation that went out through a channel the board never approved: those are deviations, and the form exists so they are recorded rather than absorbed.
The handbook sets an explicit reporting window for these submissions, counted in hours rather than weeks; check the figure in force in Aspen’s current handbook and treat the form as urgent. Its standing advice is also the right instinct: contact your chair immediately when something unanticipated happens, and where there is any doubt about whether an event is reportable, write to the IRB and copy the chair. Failing to report is not merely an administrative lapse: a board may suspend or end an approval where work has departed from what it required, or where the work has been linked to serious harm nobody expected.
When and how does an Aspen project close?
At a point the university defines, not you. Aspen ties the IRB Close Out Form to acceptance of the final manuscript — filed once the oral defence is passed and the Dean or the Dean’s designee has approved it. The handbook describes the form precisely: a notification to the IRB to close out your file.
Because the trigger is acceptance rather than the last interview, a stretch of project life usually sits between the end of data collection and the closing of the file — analysis, writing, defence, revisions. It is still inside the approved project: the consent’s data promises apply throughout, and a change made then is still a change.
| Form | When it is used | What it carries |
|---|---|---|
| IRB Continuing Review Form | Before the approval term ends, where the project will still be running | Intention to continue, any modifications made, and a concise updated overview of the project |
| IRB Events Reporting Form | Within the handbook’s stated window of an adverse event, unanticipated problem, deviation or violation | What happened, when, who was affected, and what has been done since |
| IRB Change Request Form | Before any change to the approved project is put into effect | What is changing, why, and every revised document |
| IRB Close Out Form | Once the final manuscript is accepted by the university | Notification that the project is complete and the file may be closed |
The obligations that outlive the close-out
Two of them, and both are commonly forgotten because they fall after the celebration.
- What you promised the data. The consent named where data would live, who could reach it, when identifiers would come off and when it would be destroyed. Those sentences do not expire with the approval; they are the terms participants agreed to. Aspen’s handbook notes the board may ask for data to be de-identified once analysis is complete and the final document has been approved by the university — which is precisely this window.
- What you owe the record. Aspen’s published policy expects the records of a project — the protocol as submitted, signed consent forms, correspondence with the IRB — to be safeguarded and retained for the period the policy states after completion, and destroyed by shredding or an equivalently permanent method when that period ends.
Aspen’s nursing handbook adds an obligation that surprises people, and it belongs in the closure phase: once the data is collected, analysed and documented, participants are to be given a copy of the project, with the opportunity to accept or reject the manner in which their data is applied — and participants keep the right to retract their data up to the time of formal publication. Plan for it while you still have working contact details, not after the last email address has gone stale.
What does a clean post-approval file look like?
- The approval letter and its term are recorded somewhere you will actually see them, with the continuing review prepared well inside the term.
- Every change since approval was requested before it happened, and the approvals sit with the file.
- Every deviation was reported on the events form rather than quietly corrected.
- The documents in use are the approved versions, with no superseded copy still in circulation.
- The consent’s data promises are being kept as written, not as remembered.
- The close-out is filed once the final manuscript is accepted, and the retention and destruction obligations are diarised rather than assumed.
Where the file left the route, the letter you get back reads like the ones covered in reading a returned Aspen application, and the reply follows the discipline in answering the board’s findings.
What to do next
Let us have the approval letter, plus an account of where the project actually stands. Both are read against Aspen’s current handbook and portal, and the findings come back in writing, free and with nothing owed: what is due, what has drifted since approval, and what a reviewer will be looking for. Ask for the free application review. Prefer to hand it over? The continuing review submission, the event reports, the close-out and every reply the board writes can be prepared here instead. How it works lays out the terms; the FAQ handles what tends to come up next. The work and its conclusions stay yours, and each determination stays the board’s.
Sources
- Aspen University, IRB Handbook 2025–2026 — “Once I have IRB approval am I done with the IRB”, the Close Out, Change Request, Continuing Review and Events Reporting Forms, the three-part unanticipated problem test, de-identification after analysis, review level determined by the IRB: aspen.smartcatalogiq.com/…/IRB-Handbook.pdf
- Aspen University, IRB Handbook (current edition landing page): aspen.smartcatalogiq.com/en/academic-year-2026-2027/irb-handbook/
- Aspen University, IRB Policies, Regulations and Rules — extension of approval by letter to the IRB and notice of extension; safeguarding and retention of project records: aspen.smartcatalogiq.com/…/irb-policies-regulations-and-rules
- Aspen University, DNP Handbook — participants receive a copy of the project and may retract data up to formal publication: aspen.smartcatalogiq.com/…/DNP-Handbook.pdf
- Common Rule, section 46.109 — review repeated at intervals matched to risk, and the categories exempted from repeating it: Cornell LII, 45 CFR 46.109
- Common Rule, section 46.113 — when an approval can be halted or ended: Cornell LII, 45 CFR 46.113