after approval
The approval letter opens a period, not a door.
What arrives with an approval is permission for a described project over a stated period, together with three duties: report the unexpected at once, keep the file matching the work, and return to the board before the period runs out. The project then ends by being closed on purpose, not by going quiet.
Annika Brandstetter, DNP, APRN · filed 2026-08-23
Read the letter for the period it grants. Report unanticipated problems and adverse effects to the board's Chair at once. Return for the annual look before the period ends — approval lapses on its own — then close the file deliberately and keep the records.
What does the approval letter actually fix?
Three things: the project as described, the papers as versioned, and a period of oversight. Herzing's bylaws state that all approved research remains under continuing oversight and is re-evaluated at least annually, and that the board also carries out periodic reviews of approved projects to confirm they are still being run as approved. The federal rule sets the same floor for work that needed the convened board: review that recurs at intervals suited to how much risk a project carries, and never less often than yearly (45 CFR 46.109(e)).
Not every file carries the same rhythm. Under the current rule, continuing review is not required as a matter of course for research eligible for the expedited route, for work reviewed under limited review, or for a project that has run on to the point where only analysis of already-collected material remains — unless the board decides otherwise for that file (45 CFR 46.109(f)). Which of those describes your project is the board's determination, not yours, and the answer is in your letter. If the letter does not state a period or a next date, ask, and put the answer in the folder.
The one duty that never depends on the route is the reporting duty. Herzing's application says it in the plainest terms available: once the project has begun, adverse effects or unanticipated problems connected with human subjects are to be communicated immediately to the board, and the bylaws name the Chair as the standing point of contact for those notices.
What has to be reported without waiting?
The federal phrase is “unanticipated problems involving risks to subjects or others”, and OHRP's guidance gives it three tests, all of which have to be met: the event is unexpected given what the approved papers describe and the population involved; it is connected, or may be connected, to taking part; and it indicates that participants or other people stand at more risk of harm than had been understood before — harm that can be physical, psychological, economic or social. Most difficulties in a practice setting fail one of those tests. The ones that meet all three go to the board straight away.
| Situation | Immediately | At the next review |
|---|---|---|
| Something unexpected happened that appears related to taking part and raises the risk picture | Yes — to the board's Chair, in writing | Summarised again |
| Information reaches you that would change how anyone weighs risk against benefit | Yes — the bylaws name new information of this kind explicitly | Summarised again |
| A participant complains, or withdraws for a reason connected with the project | Where it points to a protection failing | Yes — with the reason, where it is known |
| A step taken to remove an immediate hazard | Yes — report the change at once | Yes, with the board's response to it |
| Material was seen, stored or shared outside the approved arrangement | Yes | Yes, with what was changed to prevent a repeat |
| A planned change to the project | Before it happens — as a request, not a report | Listed among the approved changes |
| Routine progress: numbers so far, nothing untoward | No | Yes, as the progress report |
Note the sixth row. A change is not a report; it is a request, and it goes in ahead of the work. That distinction is the whole of changing an approved project, and mixing the two is how a well-meant improvement turns into an item in a compliance conversation.
What does the annual look ask for?
A picture of the project as it now stands, short enough to read and specific enough to check. Federal guidance recommends that boards ask for a brief summary and a progress report covering the ground below; Herzing's own requirements are stated in its current handbook or portal, and the letter you hold may name a form. Assemble these either way, because they are also the honest inventory of your own file:
- How many people have taken part so far, against what was planned.
- Every change the board has approved since the last look, listed.
- Anything new and relevant that has come to light about risk, published or not.
- Unanticipated problems and adverse effects, summarised — including, where it is true, a plain statement that there have been none.
- Withdrawals, with reasons where they are known.
- Complaints from participants or anyone else.
- The current approved papers: the protocol or project description and the consent as they now read.
- Anything you are proposing to change, which the board can then consider alongside the review.
Two habits make this painless. Keep a running note as the project goes — a line each time something is approved, someone withdraws, or a document changes — so that the report is a transcription rather than a reconstruction. And send it in time for the board to act inside the period it granted, which on Herzing's published cadence means writing to its calendar rather than to your own.
What happens if the period ends first?
Approval expires by itself. Federal guidance is unambiguous about the consequence: when review does not happen before the end of the approval period, the approval lapses automatically, and the work stops — no more interacting with participants, no more gathering identifiable material, no more analysing it — unless the board or the investigator determines that stopping would itself harm people already taking part. Activity resumes only after the board has completed its review and approved the project again.
Two pieces of comfort inside that. A lapse is not treated as a suspension or a termination, and OHRP does not regard it as reportable in that character; the board will normally record why it happened and what prevents a repeat. But a pattern — files that habitually run past their dates — can be read as continuing non-compliance, which is a different and heavier conversation. The board also holds standing authority to suspend or end approval for work that is not being run as required or that has been associated with unexpected serious harm, with reasons stated and reported onward (45 CFR 46.113); Herzing's bylaws give the Chair the parallel power to suspend and to report the suspension to the institution.
How does a project close?
By saying so. A file that simply stops is a file the board still believes is open, which is a poor position from which to answer a later question. Write to the board that the work is complete, state that no further interaction or identifiable collection is taking place, and follow whatever closing step Herzing's current handbook or portal names.
Herzing attaches obligations to the end of a project that outlast the file, and they are printed on the applications themselves. Consent documents are to be kept by the applicant for three years following the project's completion date — which matches the federal floor for records connected with research that was conducted (45 CFR 46.115(b)). A copy of the final deliverable goes to Herzing on completion, as do any later publications or presentations built on the project. And the applications carry a proprietary clause: material collected from the university's own community for the project is proprietary, and outward reporting may not identify, reference or implicate Herzing. That last clause is one to read before a manuscript is drafted, not after.
Closing well is mostly about leaving the file legible: the approval letter and every approved change together, one current copy of each paper, the reports you sent, and a note of where the material is held and when it is due to be destroyed. If the destruction date has arrived, destroy by the method the application described, and record that you did.
What to do next
Find the period in your approval letter today and put its end date somewhere you will see it. Then start the running note. Where a project is already past a date, or where something has happened that you are unsure how to report, the free application review reads the letter and the file and says plainly what goes to the board and in what order; how it works covers what the desk carries through continuing review and the close. The findings remain yours; what the board asks of the file remains the board's to set.
Related reading: the process, step by step, and the FAQ for shorter answers.
Sources
- Herzing University IRB Bylaws — continuing oversight and annual re-evaluation, periodic review, adverse events and unanticipated effects, suspension.
- Herzing University IRB Application for Research Protocol Approval — immediate communication of adverse effects, three-year retention of consent documents, final deliverable and publications.
- Herzing University IRB Application for Improvement or Innovation Project Approval — the parallel obligations for doctoral improvement work.
- Herzing University Institutional Review Board — current forms, contact and meeting calendar.
- 45 CFR 46.109 (govinfo) — continuing review intervals, and where it is not required.
- 45 CFR 46.113 (govinfo) — suspension or termination of approval.
- 45 CFR 46.115 (govinfo) — records, and the retention floor.
- OHRP, Guidance on Continuing Review (hhs.gov, read via the Internet Archive) — recommended progress-report contents, expiry of approval, and lapses.
- OHRP, Unanticipated Problems and Adverse Events guidance (hhs.gov, read via the Internet Archive) — the three tests, and the corrective actions that follow.
Forms, periods and closing steps are Herzing's own and change between editions; verify each against Herzing's current IRB handbook or portal. This practice is independent and not affiliated with Herzing University.
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