Continuing review and closing a Chamberlain project: what each board expects after approval
An approval is a term, not a permanent condition, and it has an ending you are expected to file. Chamberlain publishes a continuing review form and a study closure form, so both ends of the cycle exist on paper. What is less obvious is that many DNP projects never enter the continuing-review cycle at all, because of the pathway they took — while the practicum site’s board runs its own oversight regardless, on its own forms. Knowing which of those applies to your file is the whole of this article.
Continuing review applies to some files and not others, and the pathway decides it. Chamberlain publishes forms for both continuing review and closure. The site’s board keeps its own expectations. A lapsed approval carries no grace period — new enrolment simply stops.
Does an approved Chamberlain project need continuing review?
Often not, and the reason is worth understanding rather than assuming either way. Under the Common Rule, the recurring re-examination obligation attaches to research that required review by the convened board, on an interval scaled to how much risk the work carries (45 CFR 46.109(e)). The following paragraph then removes the requirement — unless the board decides otherwise — for work eligible for expedited review, for work reviewed under limited review, and for a project that has progressed to the point where only data analysis or the collection of follow-up clinical data remains (46.109(f)). That last clause matters at the end of a practice project, when implementation is finished and only the numbers are left.
Chamberlain’s own published position runs along the same grain. Its IRB Handbook states that studies cleared through the lighter pathways are not subject to additional reviews unless changes to the study occur, or an audit is performed. And its DNP Project & Practicum Handbook routes these projects through a Prescreening Review Form rather than the full application package, saying most are expected to meet the criteria for a finding that the work does not constitute human subjects research. A file that never became human subjects research on the school side does not acquire a continuing-review cycle.
So the honest answer for most DNP projects is: probably not on the Chamberlain side, possibly yes on the site’s. But “probably” is not a basis for planning. Whether your particular file carries a term, and what that term is, is set by Chamberlain’s current handbook or IRB portal and by the language of the letter you were sent. Read the letter for an end point before you assume there is none.
What does Chamberlain’s continuing review ask for?
Where the cycle does apply, Chamberlain publishes a Continuing Review of Study Application Form, and its IRB page sets out what has to accompany it. Paraphrased into a working checklist, the board is asking for:
- A status report on the project as it currently stands.
- Any adverse events, unanticipated problems, withdrawals or complaints since the last review.
- Recent relevant literature, interim findings, and any amendments made along the way.
- Reports from other participating locations, where the work runs at more than one.
- Any new information bearing on risk.
- A clean, date-stamped copy of the consent document currently in use, and clean copies of any newly proposed consent materials.
- Clean copies of the recruitment materials.
Two features of that list repay attention. It is retrospective and prospective at once — what has happened, and what you now propose to keep using. And it asks for clean copies, meaning the board wants to read the current documents as a participant would meet them, not a marked-up comparison against last time. The lead time for filing, and the interval itself, are set by Chamberlain’s current handbook or IRB portal; check the letter rather than a cohort-mate’s memory.
What each board expects once the approvals are in
Post-approval obligations do not merge. Each board keeps its own file, its own forms and its own view of when your project ends.
| Obligation | The Chamberlain side | The practicum site’s board |
|---|---|---|
| Recurring review | Applies where the pathway carries a term; a published form exists for it. | Its own cycle and its own form, on its own calendar — independent of anything the school does. |
| Changes | A published Study Amendment Application Form, approved before implementation. | Its own amendment route; a change can also outrun the support letter that named your liaison. |
| Problems and events | A published reporting form for unanticipated problems and adverse events. | Frequently stricter, because the people and the records are theirs. |
| Closing | A published Study Closure Form. | Often a final or closure report of its own; a school closure does not close their file. |
| Records afterwards | A retention expectation set out in Chamberlain’s current handbook or IRB portal. | The site’s own retention and data-disposal terms, which may bind you separately. |
Nothing on the left tells the board on the right. If you close on one side and go quiet on the other, the open file stays open under your name.
What happens if an approval lapses?
Where a file does carry a term, this is the part with no soft edges. OHRP’s guidance on continuing review states that the regulations make no provision for any grace period extending the conduct of research beyond the expiration date. New enrolment cannot occur after approval has expired — that one is unconditional. Activity may continue only where it is determined to be in the best interests of people already enrolled; where it is not, the guidance directs that all activity stops, including interacting with participants and analysing identifiable private information.
One line in that guidance deserves to be pinned above the desk. Providing the information the board needs, in good time, is the investigator’s responsibility — and any reminder the board sends about it is a courtesy, not an entitlement. If your project has a term, the diary entry is yours to keep.
The same guidance closes a comfortable misreading: a board reviewing a proposed change, or a report of an unanticipated problem, has not thereby conducted continuing review of the project as a whole. Recent contact with the board is not the same as a current approval.
How does a project actually close?
On the Chamberlain side, closure is a filing rather than a fading-out. Its IRB page publishes a Study Closure Form, to be submitted once you are no longer interacting with participants or collecting private information, biospecimens or data. The useful discipline is to treat closure as a step in your plan from the beginning, so it happens while you still remember the file, rather than long afterwards when a compliance query prompts it.
On the site’s side, closure is its own event with its own form, and it is the one most often skipped — the implementation ends, the practicum courses move on, and nobody tells the council that the project on its agenda has finished. That leaves an open protocol attached to your name in a health system you may well want to work in afterwards. Close both, and keep the two closure confirmations together with the two approvals.
Before you close either, settle three things: where the data now lives and for how long, in the terms each board approved; who retains access; and what happens to any identifiers. If your findings are going to a poster, a manuscript or a presentation, check that dissemination is consistent with what each board was told — the site’s permission to run a project is not automatically permission to publish about their patients.
What do people most often miss?
- Assuming no letter means no obligation. Read your approval or determination for an end point before concluding there is not one.
- Assuming the reverse — filing continuing review on a file that never needed it, which is harmless but tells you the file was never understood.
- Letting an amendment substitute for the recurring review, or the other way round. They are separate filings answering separate questions.
- Closing with Chamberlain and leaving the site’s council holding an open protocol.
- Waiting for a reminder that the board is under no obligation to send.
- Finishing the work but never filing closure, so the record shows a project that simply stopped.
Who keeps track of this after the approvals arrive?
Post-approval obligations are where files quietly go wrong, because the pressure has lifted and the deadlines are no longer academic ones. We read both letters for their terms, tell you plainly whether a recurring cycle applies on either side, prepare and file whatever each board wants along the way, and carry both closures at the end so nothing is left open under your name. The project, the data and the findings stay yours; each board’s decision stays its own. How it works sets out the route from the beginning, and the FAQ takes the earliest questions.
What to do next
Forward both letters — Chamberlain’s and the site’s — and we read them at no cost for their terms, their reporting duties and their closing requirements, then tell you what your calendar actually holds. Request the free application review. If something about the project is about to change, which board must approve the change comes first; if a board has written asking for revisions, answering point by point is the format that closes it.
Sources
- Chamberlain University, Institutional Review Board — continuing review form and its required contents, study closure form, reporting forms: chamberlain.edu — Institutional Review Board
- Chamberlain University IRB Handbook — lighter-pathway studies not subject to further review absent a change or audit; closure and retention: chamberlain.edu — IRB Handbook (PDF)
- Chamberlain University, DNP Project & Practicum Handbook — the Prescreening Review Form route for DNP projects: chamberlain.edu — DNP Project & Practicum Handbook (PDF)
- 45 CFR 46.109(e)–(f) — when continuing review is required, and the circumstances in which it is not: ecfr.gov — section 46.109
- OHRP guidance on continuing review — no grace period, enrolment stops at expiration, and reminders from a board are a courtesy: hhs.gov/ohrp — continuing review guidance