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re: the whole process, from our desk

How it works — the whole process, in three moves

We handle the entire Walden IRB process end to end: the determination and the plan, every document the board will read, the submission itself, and every reply to the board until the approval letter arrives. Two things never move — the research stays yours, and the decision stays the board's. It begins with a free application review, and it ends with the letter that carries the number.

In a line — you bring the proposal your committee signed; we settle what kind of project it is and which review path it belongs on, build every enclosure so that each claim matches every other, file the application, and answer the board in writing — revision responses, amendments, continuing review — until the approval letter with its number is in your hands. You conduct the study. The board decides. We carry everything in between.

The three moves

what the desk does, in the order it does it

Every file runs through the same three moves. They are sequential on purpose: a document built before the determination is settled is a document built for the wrong letter.

The practicethe three moves, set out plainly re: what happens after you write to us
1.
The determination and the plan We read the signed proposal the way the board will and put three things in writing first: whether the project reads as human-subjects research or as quality improvement; which review path it belongs on — exempt, expedited, or full board, in the categories Walden's current handbook and IRB portal describe; and, if you are studying the building you work in, the dual-role plan the board will ask for — who recruits, who consents, who opens identifiable data, and where your authority stops. The plan names every enclosure the file will need before a single form is opened. The determination itself remains the board's to make; our reading tells you which letter to write and why.
2.
Every document, built and version-matched The application, answer by answer, consistent with the proposal your committee signed; the consent document, element by element, in plain language; recruitment materials the board can read verbatim — each flyer, email, script and post as a participant will see it; instruments and interview guides aligned to the proposal; the data security plan that names the device, the encryption, the access list, the retention period and the destruction date; and the letters of cooperation, drafted on the partner site's letterhead for the signature of someone with authority to grant access. One file, one version, every claim matching every other claim — because the board reads for drift.
3.
Submitted — and every reply answered, until the approval letter We file the application, then we carry the correspondence. When the board writes back with revisions, we write the point-by-point response and return the whole file in one coordinated resubmission. After approval, we handle the amendments when the study changes, the continuing review or closure Walden's current handbook calls for, and any letter the board sends in between — until the approval letter, with its number, is in your hands and printed in the final study where Walden expects it.

— the desk

Every document, and what the board reads it for

the enclosure schedule, with the job of each sheet and who at the desk builds it

A complete Walden IRB file is a set of documents that agree with one another. The table below is the schedule we build to; the homepage draws the same seven enclosures as the letter you send the board. Which forms carry which names in a given term is set by Walden's current handbook and IRB portal — the jobs do not change.

Exhibit Bthe enclosure schedule, annotated attached to: the complete file
The documents in a complete file, what the board reads each one for, and who at the desk builds it.
DocumentWhat the board reads it forBuilt by
CITI training reportCurrent human-research certification in the modules your study calls for, under the same name the application carries. The board checks the date.You complete the modules; the desk checks the report against the application before filing.
The IRB applicationEvery answer consistent with the proposal your committee signed — purpose, population, procedures, risks, and the review path claimed. The board reads for drift between the proposal and the form.Cecilia Whitmore settles the determination and path; Josephine Hale writes the answers.
The consent documentEvery required element — purpose, procedures, risks and benefits, voluntariness, withdrawal without penalty, confidentiality, and who to contact — in plain language a participant can follow.Josephine Hale, element by element.
Recruitment materialsEach flyer, email, script and social post exactly as a participant will see it, each as its own document. Paraphrase is the most common reason a file returns.Josephine Hale, verbatim, matched to the consent document.
Instruments and guidesEvery survey, interview guide and prompt, exactly as it will be used, aligned to the aims in the signed proposal.Josephine Hale aligns them to the proposal; the instruments themselves remain your work.
The data security planNamed storage, encryption, the access list, the retention period and the destruction date. "Securely stored" is not an answer.Josephine Hale.
Letters of cooperationThe partner site's written permission on its letterhead, signed by someone with authority to grant access, naming what you will do there and matching the application's claims.Lauren Petrakis drafts them for the site's signature.
The dual-role planWhen the site is your workplace: who recruits, who consents, who opens identifiable data, and where your authority stops. Asked for in writing whenever the board suspects overlap.Cecilia Whitmore, as part of the plan.
Data use agreements and permissionsWhere existing records, secondary data, or an organization's information are used — the agreement that shows who owns the data and who may open it. Required only when the design calls for it.Lauren Petrakis drafts and coordinates them.

Every row is read against every other row. A consent form that promises anonymity beside a recruitment email that collects names is not two small errors — it is one file that contradicts itself, and the board will say so politely. The people named above are the desk; the whole file is read by more than one of them before it is filed.

The two truths

what stays yours, and what stays the board's
A note on the boundaryset down before any engagement begins re: the research, and the decision

The research is yours. The study, its questions, its design, the data you gather and the findings you draw from them are your work, under your name, answered for by you to your committee and to Walden. We do not conduct the study, we do not collect or analyze data, and we do not author findings. What we build is the file that asks the board's permission for the study you designed — and the correspondence that follows.

The decision is the board's. The determination — research or quality improvement, which review path, approved or returned — rests with Walden's IRB and with no one else. We will tell you our honest reading of how the board will read the file, and we will build the file to meet the board's questions before they are asked. We will not tell you what the board will decide, and we will not tell you how long it will take; the board does not publish a guarantee and neither do we.

Everything between those two truths — the plan, the documents, the submission, the replies — is ours to carry. That is the whole of the service, and it is the reason the premium package is called Full Handover.

— the desk

When it returns — and after it is approved

revisions, amendments, continuing review, closure: the letters after the first one

A returned application is not a rejection; it is the board asking for the rest of the file. Under Full Handover, every letter below is ours to write. Under The Complete File, we will have built the file so that the first one is short.

The correspondence after filingfour letters, and how the desk answers each re: what the board sends, and what goes back

The revision request

The board's reply arrives courteous and unhurried, and every sentence is a task with a document attached. We read it as a list, write a point-by-point response that quotes each request and states exactly what changed and where, revise the affected documents so that they still agree with every other document, and return the whole file in one coordinated resubmission. A partial reply reopens the whole exchange; a whole one closes it. The homepage translates a composite reply sentence by sentence, so you can see what each polite line actually requires.

The amendment

Studies change after approval — a second site, a revised instrument, a new recruitment channel, a change in who may open the data. Each change goes to the board as an amendment before it is acted on, with the revised documents attached and the rest of the file brought back into agreement. We write and file it; you keep working on what the original approval already covers.

Continuing review and closure

The approval letter states the period it covers. Where Walden's current handbook calls for continuing review, a progress report, or a closure notice at the end of data collection, we prepare and file it, so that the approval never lapses while the study is still open and the record closes cleanly when it ends.

The approval number in the final study

The letter with the number follows you: Walden expects the approval number printed in the final study itself. We make sure it is in the file you keep, and that the dates on the approval, the data collection, and the final study tell one consistent story.

— carried until the letter with the number arrives

Where it begins: the free application review

what we read, what you get back, and the honest "file it as it stands"
The entrythe free review, and what follows it re: your first letter to the desk

You send what you have — a signed proposal, a draft application, a consent form, a returned letter from the board, or only a description of the project and where it stands. We read it the way the board will and write back with where the file stands: which letter you are writing, which review path it belongs on, what is missing, what contradicts what, and what the board will ask about first.

Sometimes the honest answer is "file it as it stands." When that is true we say so, and you do not need us. When it is not, the same letter carries a written quote for one of the three packages — Determination & Plan, The Complete File, or Full Handover — fixed fee, never hourly, so what you pay matches your file and not a price list.

No cost to begin, no obligation to continue, and nothing leaves the desk. Write to the desk with whatever you have; the questions candidates ask before they write are answered in the short replies.

— the desk

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