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re: fifteen questions, each answered in a line

Short replies — the questions that arrive most, answered in a line

Fifteen questions reach this desk more often than all the others together. Each gets its answer in a line first, the way we would give it across the desk, with the longer reply beneath. Where a specific of Walden's process could change between terms, the answer points you to Walden's current handbook or IRB portal, which governs; where the answer is the board's to give, the reply says so.

In a line — at Walden the ethics review comes after your committee approves the proposal and the University Research Reviewer concurs; nothing touches participants or data until the approval letter exists; the board decides the path and the determination; and the desk handles the entire IRB process end to end while the study stays yours.

Before you file

the sequence, the reviewer, the training — and what you can do early
Short replieson the order of things re: five questions asked before filing

When does Walden's ethics review happen in the doctoral sequence?

Walden's ethics review comes after your doctoral committee approves the proposal and the University Research Reviewer concurs, and before any recruitment or contact with data. The approval letter carries a number, and Walden expects it printed in the final study.

Exhibit A on the homepage draws the five letters in order. Where Walden's current handbook or IRB portal fixes a step differently for your program, the handbook governs; the order above is the one every Walden file we have prepared has followed.

What does the University Research Reviewer do before the IRB?

The University Research Reviewer is the second methodological reader Walden places between your committee and the board; the reviewer's concurrence on the proposal comes before the IRB reads the application, and the application must match the proposal the reviewer concurred with.

This matters for the file because the board reads the application against the signed, concurred proposal and returns drift between them. The exact form the reviewer's sign-off takes is set by Walden's current handbook; the desk builds the file to the proposal as signed, not to an earlier draft.

Can I prepare the IRB application before my proposal is approved?

You can and should draft the IRB file while the proposal is in committee, but it is not filed until the committee has approved the proposal and the reviewer has concurred, because the board reads the application against the signed proposal and any drift between the two returns the file.

Drafting early is where the desk's plan earns its keep: the determination, the review path and the enclosure schedule can all be settled while the committee reads, so the file goes in the week the proposal is signed rather than a month after. Whether anything may be filed earlier for your program is a question for Walden's current handbook or IRB portal.

Does a Walden DNP project need IRB approval?

Yes. A Walden DNP project files with the IRB even when it is framed as quality improvement; the board issues the determination, and nothing touches participants or data until that determination is in hand.

The determination is the board's to make, not yours to declare — which is why the first thing we settle, before a single form is opened, is which letter you are actually writing: human-subjects research or quality improvement. The homepage carries a note on the distinction; How it works sets out where that reading sits in the process.

Do I need CITI training?

Yes. You need current CITI human-research training, in the modules matching your study, under the same name the application carries; the board checks the date.

Which modules your study calls for is set by Walden's current handbook and IRB portal. An expired or mismatched certificate is an avoidable reason for the board to write back, so the desk checks the report against the application before anything is filed.

The file

your own workplace, the site's letter, the records you can already open, and the review path
Short replieson what the file must enclose re: four questions about the documents

What if I am researching my own workplace or my own patients?

The board examines conflict of interest and your dual roles closely. Plan the separation — who recruits, who consents, who opens identifiable data — and secure the partner site's cooperation before filing, not after the board asks.

Most Walden capstones run inside the building where the candidate already works; the board does not forbid it, it asks about it precisely. The own-workplace reading on the homepage tells you how exposed your file is, and it ends honestly — sometimes with "you can reasonably file this yourself."

What is a letter of cooperation, and why does it hold files up?

A letter of cooperation is the partner site's written permission, on its letterhead, signed by someone with authority, naming what you will access there. Organizations sign slowly, so the file waits on that one page.

Goodwill is not a document. If the site is willing but unsure what the letter must say, the desk drafts it on their letterhead for signature — it is the page Lauren Petrakis writes most weeks.

Can I use records or data I already have access to at work?

Not for research until the board approves it and the organization that owns the records agrees in writing, usually through a data use agreement or a letter of cooperation; your routine access to a chart or a database at work does not change that.

The file for a records-based study turns on three documents: the agreement that shows who owns the data and who may open it, the data security plan that names where it lives and when it is destroyed, and an application that states plainly whether identifiers are collected. Whether such a study sits on the exempt or expedited path is the board's call under Walden's current handbook.

What is the difference between exempt, expedited and full-board review?

Risk and population decide it: minimal-risk work may qualify as exempt or expedited, while studies involving identifiable data or vulnerable populations go to the full board. The board, not the applicant, makes the final call.

The path changes what the file must enclose and how closely the board reads it; the categories themselves live in Walden's current handbook and IRB portal. The review-path call is the first thing the desk puts in writing, under every package.

The line

what waits for the approval letter, and how long that takes
Short replieson the line the approval letter draws re: two questions about waiting

Can I collect data before approval?

No. Anything gathered before the board's approval letter exists can be invalidated and can put the whole study in question; recruitment, chart access and surveys all wait for the letter.

That includes pilot conversations, informal surveys, and pulling records you can already open at work. The line is the approval letter, not your intentions — Exhibit A on the homepage draws exactly where it falls.

How long does Walden IRB approval take?

Neither the board nor the desk publishes a guaranteed review time; Walden's current handbook or IRB portal describes the board's review cycle, and the part of the timetable that is yours to control is whether the file goes in whole, so that it comes back once rather than twice.

Every revision cycle is a full pass through the board, which is why a file built to answer the board's questions before they are asked is the only honest way to shorten the wait. We do not quote durations, and we do not promise outcomes; what we promise is a file that gives the board fewer reasons to write back, and a reply written whole when it does.

When it returns — and after it is approved

revisions, a site with its own board, and the letters after the approval letter
Short replieson the correspondence after filing re: three questions about what comes back

What happens when the board writes back with revisions?

The file is returned, not rejected. You answer every point in one point-by-point response and resubmit the whole file; each pass is a full review cycle, so a partial reply reopens the exchange.

The composite reply on the homepage shows what each polite sentence actually requires. Under Full Handover, the revision response — and every letter after it — is ours to write.

What if my research site has its own IRB or research office?

Some partner sites, such as hospitals, health systems and school districts, require their own review or research-office approval alongside Walden's; which board reads first and whether one relies on the other is settled between the site and Walden's IRB under its current handbook, and the desk prepares both files so that they agree with each other.

The usual failure is two files that describe the same study differently — a consent form for one board, a procedure for the other. Built together, the two pieces of paper say the same thing, and each board sees the other's letter where it expects to.

What happens after approval — amendments, continuing review, and the number?

The approval letter states the period it covers and carries the number Walden expects printed in the final study; changes to the study go to the board as amendments before they are acted on, and continuing review or closure follows Walden's current handbook.

A second site, a revised instrument, a new recruitment channel or a change in who may open the data each goes in as an amendment with the affected documents revised and the rest of the file brought back into agreement. Under Full Handover the desk writes and files them; How it works sets out each letter after the first.

The desk

what we do, what we do not, and what it costs
Short replieson the desk itself re: the question under all the others

Do you conduct my research, and what does it cost?

We do not conduct the research; we handle the entire IRB process end to end while the study stays yours and the decision stays the board's. Fees are quoted in writing after the free review: three packages, with Full Handover the premium.

Determination & Plan, The Complete File, and Full Handover — the premium, which takes the submission and every reply to the board off your desk. Fixed fee, never hourly; the reasoning and a side-by-side are on the pricing page, and the people who do the work are on the team page.

A question that is not here belongs in your first letter. The review is free.

The reply envelope

pre-addressed, postage paid — the review is free

the practice
consultants to Walden doctoral candidates
at the ethics step

To: the candidate whose proposal is signed, whose reviewer has concurred — and whose application hasn't gone in yet.

Request the free application review

We read what you have as the board will and tell you where it stands — including, when it is true, “file it as it stands.” Then we carry the whole process: every document, the submission, every reply, until the approval letter. No cost to begin, no obligation.

Fiona Castellan, DNP, APRN Senior IRB consultant online