The Chamberlain IRB application checklist: one project, two files, every document named

Which documents does Chamberlain always require?

Chamberlain's IRB Handbook names three items for every initial submission, regardless of design:

1. The IRB Application Form for review.
2. Confirmation of human subjects protection training as required by Chamberlain.
3. Prior submission of the IER Research Project Review Form. Note the word prior — the decision tree treats this as a step that comes before, not a document you enclose.

Most DNP projects, of course, never file this package at all: Chamberlain expects most to clear prescreening as work that is not human subjects research, filing the Prescreening Review Form in NR-705 instead. Treat the list below as the map for the project that does cross into research, and as the standard your prescreening file should meet anyway — because the site's board may ask for all of it regardless of what the school concluded.

Which documents are required "when germane"?

Chamberlain's handbook lists these as materials to submit when they bear on the study. In practice, most projects touch several.

• Recruitment and advertisement materials
• Study instruments — surveys, questionnaires, assessment tools, protocols, interview guides
• A copy of the consent form participants will sign
• Information letters and directions given to participants
• Assent forms for minors, and parental consent forms
• Copies of approvals from other or collaborating IRBs
• Letters of support
• Other documents, such as HIPAA forms, authorisations and certifications

The sixth item is the one to notice. Chamberlain expects the other board's approval inside its own packet where one applies — which is the documentary reason the site's track opens first, argued at length in the piece on which board goes first.

What does the application form itself ask for?

Chamberlain publishes the form openly, and reading it before drafting is worth more than any summary. It runs from identification through to closure and asks, among much else, for a lay abstract of the study within a stated word limit, the study's aims, the hypotheses or questions with an account of how each will be measured, the categories of participants to be recruited, and an itemised checklist of the personally identifiable and sensitive information the project will collect.

Four features surprise people, and each one is a design instruction in disguise.

1. The start date is not yours to fill in. The projected-dates section carries a start date of "upon IRB approval" as fixed text. You supply an end date. The form will not let you propose beginning before the answer arrives.
2. There is a Supervising Faculty block, to be completed where the study is conducted in partial completion of the investigator's academic programme, with a signature line at the end. Your faculty member is part of the filing, not a reader of it.
3. There is an Equity section requiring an explanation of why any category of participant will be limited or excluded. Exclusions have to be justified rather than assumed — a question best answered while the sampling plan is still being written.
4. Existing data has its own gate. Where a project uses existing data, documents, records or specimens, the form calls for a letter of authorisation to access anything not already available to you in your usual role or already public. Chart-review projects run into this one constantly.

The instructions carry their own rules: complete every item, state "non-applicable" where something does not apply, do not edit or revise the form itself, and do not convert it to a PDF. The form also records Chamberlain's policy of retaining data and study records for seven years in a locked file or password-protected device — which means your data-security plan should describe an arrangement that can actually last that long.

Which documents go in which file?

One project, two packets. The failure we see most is not a missing document but two documents that no longer match.

What has to be true of the consent documents?

Consent is where most revision requests land, and the federal requirements are specific. Consent must be sought in language the participant can understand and under conditions that minimise coercion, and it must open with a short, sharply focused account of the information most likely to help someone decide — not an institutional preamble. There is a set of basic elements that must appear, additional elements where relevant, and a bar on exculpatory language.

Documentation has its own rules. Consent is normally recorded on a signed form the board has approved, and whoever signs keeps a copy. A board may waive documentation in defined circumstances — including where that signed form would itself be the sole link between participant and study and a confidentiality breach is the main danger, or where risk is minimal and no comparable procedure would call for a signature outside research. Waiver or alteration of consent itself is a separate test with its own criteria.

Chamberlain publishes an informed consent template, and using it saves arguments about format. What it cannot do is decide your content, which follows from your design. Consent is a large enough subject to have its own article on Chamberlain consent form requirements.

Which Chamberlain forms exist, and where?

Chamberlain publishes its IRB forms openly rather than behind a portal login, which means you can read them before you need them. Alongside the application for review and the informed consent template there is a recruitment template, and — for after approval — a study amendment form, a continuing review form and a study closure form. Chamberlain also publishes the review checklist its own reviewers work from, which is the single most useful document on the list: it tells you what the file will be measured against before you write it.

Read the amendment form early, not late. Anything that changes after approval — a widened population, a new instrument, a second unit, a discovery that the site does keep a board after all — is an amendment, and amendments are far cheaper to anticipate than to explain.

How do you keep two files telling one story?

1. Version-stamp every document with a date and version, and let the two packets share the stamps. When a board quotes a line back to you, both of you should know which page it came from.
2. Write the measures once. If the school's file says three measures and the site's says four, both boards will ask which is true.
3. Write the consent materials to the stricter reading. A project prescreened out at the school may be research at the site; a consent sheet built for the stricter view is valid in both files, while the reverse is not.
4. Keep one data plan. One description of what is collected, where it lives, who can see it, and how it is destroyed — and make it survive the retention period.
5. Never let a "minor" edit travel alone. Change a document in one packet and it changes in both, the same day.

What to do next

Download Chamberlain's review checklist and its application form and read them side by side before you draft anything. An afternoon spent reading what reviewers are told to look for is the cheapest hour in this entire process, and it will reshape your design while reshaping it is still free.

Then request the free application review. We read the file against both tracks and send a written list: which documents exist, which are missing, which two disagree with each other, and what each board will want that you have not been asked for yet. How it works explains what we carry from there — every document for both boards, both submissions, and every reply until both approvals are in writing. The documents are yours; the boards' decisions are their own.

Sources

• Chamberlain's board handbook — what every first submission must carry, what joins it when relevant, packets left unread when items are absent, training, and the findings it weighs — Chamberlain IRB Handbook (PDF)
• Chamberlain's published application form — its instructions, the supervising faculty block, the immovable start date, the equity section, the authorisation needed for existing data, and the retention policy — IRB Application for Review (DOCX)
• Chamberlain's current DNP handbook (©2026) — the NR-705 prescreening filing, the Letter of Support and the affiliation contract — DNP Project & Practicum Handbook (PDF)
• Consent in general, including the requirement that it open with key information — 45 CFR 46.116 (Cornell LII)
• Recording consent, and the narrow cases where a signature may be set aside — 45 CFR 46.117 (Cornell LII)
• CITI's human subjects series, its tracks and its refreshers — Human Subjects Research, CITI Program

Chamberlain's current handbook or IRB portal is the authority here; where it departs from anything on this page, follow Chamberlain. This is an independent practice, unaffiliated with Chamberlain University. We have no connection to the CITI Program either.