changing an approved project
The approval covers the project you described.
Every fact the board approved — the questions, the people, the setting, the papers, the handling of what is collected — is part of what was approved, and altering one of them takes it outside the letter until the board says otherwise. Herzing's own application puts it in a single line: additions and changes go to the board for written approval before they are put into practice.
Helen Marsh, PhD · filed 2026-08-23
Ask before, not after. Any addition or change to an approved project needs the board's written approval first; only a step taken to remove an immediate hazard is done ahead of approval, and that is reported at once. Minor changes may go by expedited handling.
Where does the rule actually come from?
From two places that agree. Herzing's published Research Protocol Application carries it in the acknowledgements the applicant signs: additions or changes are to be submitted for written approval before those changes are implemented. The federal rule under which the board operates says the same from the institution's side — written procedures must ensure that proposed changes reach the board promptly, and that a project keeps running as approved until those changes have been through review, unless the change exists to remove an apparent immediate hazard (45 CFR 46.108(a)(3)(iii)).
Two consequences follow, and neither is intuitive. First, the test is not whether a change feels significant to you; it is whether the paperwork the board holds still describes what you are doing. A survey item swapped for a better one is a small edit and a real change, because the instrument in the file is the instrument that was approved. Second, permission is prospective. A change described afterwards in a report is not an amendment; it is a discrepancy, and it puts what you collected in the interval in an awkward position.
Where a project sits on Herzing's improvement and innovation application rather than the research protocol form, the same duty is worth confirming with the board directly: the bylaws' expedited category exists precisely for minor changes to previously approved work, which presumes changes come back. Verify the route and the wording against Herzing's current IRB handbook or portal.
Which changes wait for approval?
Read the table as a habit rather than a lookup: if a line of the approved paperwork would have to be retyped, the change waits.
| The change | Waits for written approval? | What to send with it |
|---|---|---|
| A question added, dropped or reworded in a survey or interview guide | Yes | The instrument as it will now be used, stamped as a new version, with the altered items marked |
| Who takes part, how many, or how they are approached | Yes | The revised recruitment description on the form, plus any invitation or notice in its new wording |
| A second setting, unit or organisation added | Yes | Permission from the added site in its own name, and any outside board's application and approval where that site runs one |
| Someone new working on the project | Yes | Their role, their qualifications for it, and their current human-subjects training record |
| Anything a participant reads or signs | Yes | The new consent or notice, and a line saying what people already taking part will be told |
| Where material is stored, who can reach it, how long it is kept, how it is destroyed | Yes | The data-security answer rewritten to name the new arrangement, not to describe it generally |
| The start or completion date on the form | Yes | The revised dates, and what continues in the meantime |
| The aim, the improvement framework, or the measures that define success | Yes — and read it twice | The rewritten overview; a shift of aim can move the project across the line between improvement work and research |
| A typographical correction in an approved paper | Yes, as a version change | The corrected paper, stamped, so the board's copy and yours remain the same document |
| A step taken to remove an immediate hazard to someone | No — act, then report at once | What you did, when, why it could not wait, and what you propose to keep in place |
The last row is the only exception in the whole subject, and it is narrow. Federal guidance for investigators frames it the same way: a modification of approved work needs the board's approval before it is implemented unless the change is designed to eliminate an apparent immediate hazard, and such changes are reported promptly afterwards. Herzing's bylaws hold the mirror image of that authority on the board's side — the Chair may authorise emergency changes to avoid immediate hazards and reports them onward.
What makes a request easy to approve?
Five parts, short and in this order.
- What changes, in one sentence a reader can repeat.
- From what, to what. The old wording and the new wording, side by side, for anything a participant sees.
- Why. A reason from the project — recruitment ran differently than expected, the site moved the clinic, a measure proved unreadable — not a reason from your calendar.
- What it touches. Every paper that has to be retyped, named with its new version, and the answers on the application that now read differently.
- What it does to risk and to permission. Whether the change adds any burden or exposure, and whether anyone already taking part needs to hear about it.
That fifth part is the one people skip. If a change alters what a participant was told, the consent document changes with it and the board approves the new one before it is used; where something has come to light that could bear on somebody's willingness to carry on, they are entitled to hear it (45 CFR 46.116). A request that has already thought about this reads as a project in control of itself.
How is a modification reviewed?
Usually more lightly than the original. Federal rules let a board handle minor changes to previously approved work through the expedited procedure, and Herzing's bylaws repeat that in their own words, giving the Chair or a designated experienced member the authority to review proposals involving no more than minimal risk or only minor changes to protocols already approved. A change that adds exposure, opens the project to people who may be susceptible to pressure, or rewrites the aim is not minor, and it goes where the original went. The board decides which it is — describing your change as minor in the covering line does not make it so, and overstating it costs nothing but a reading.
When is it not a modification at all?
When the thing you are describing is a different project. A new question about a different population, a second organisation studied in its own right, a data set kept for a purpose the original never mentioned — these arrive as new applications, and trying to carry them in on an existing approval is the version of this mistake that is hardest to unwind afterwards. When it is unclear which side of that boundary a change sits on, the honest move is to put the question to the board in writing before any work starts.
What if the change already happened?
Report it, promptly and plainly, without dressing it as something else. Say what changed, when, why it happened without approval, what was collected in the interval, and what you propose to do about that material. Boards are considerably better at absorbing a straightforward account than a discovered one: Herzing's bylaws give the Chair authority to suspend work that does not comply and to report the suspension onward, and a pattern of changes made ahead of approval is the kind of thing that draws that authority. A single acknowledged lapse, described in full and corrected, is a much smaller matter.
What follows an approved amendment is ordinary care of the file: the new version becomes the current one, superseded copies leave the folder, and the change is summarised at the next look the board takes at the project. That rhythm — reporting, the annual look, the close — is set out in continuing review, reporting and closing the project. If the change came out of a board note rather than out of the work, answering revisions is the neighbouring piece.
What to do next
Before altering anything, write the five parts above and see whether they hold together; if they do, the request is nearly drafted. Where the change reaches into consent, a site, or the aim itself, the free application review reads the approved folder against the change you are contemplating and says which papers move and what the board will want to see. How it works sets out what the desk carries after approval, amendments included. The project stays yours; what may be done to it under an existing approval is the board's to say.
Sources
- Herzing University IRB Application for Research Protocol Approval — the acknowledgement that additions and changes need written approval before implementation.
- Herzing University IRB Application for Improvement or Innovation Project Approval — the doctoral improvement route and its checklist.
- Herzing University IRB Bylaws — expedited handling of minor changes, emergency changes authorised by the Chair, and suspension of non-compliant work.
- Herzing University Institutional Review Board — current forms and submission route.
- 45 CFR 46.108 (govinfo) — written procedures for proposed changes, and the narrow hazard exception.
- 45 CFR 46.110 (govinfo) — expedited handling where the changes to approved work are minor.
- 45 CFR 46.116 (govinfo) — consent requirements, including new findings that bear on continued participation.
- OHRP, Investigator Responsibilities FAQs (hhs.gov, read via the Internet Archive) — approval ahead of implementing a modification, and reporting hazard-driven changes at once.
Named forms and routes belong to Herzing 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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