herzingirbthe entire IRB process, handled end to end

The board reads your folder before it reads your project.

Complete or incomplete is decided first; good or bad only after. An incomplete folder waits out a full review pass to learn a single fact — that it was incomplete. If the IRB step of your capstone, MSN or DNP project is next, the folder below is the one the board will open.

We are independent consultants who take on the entire Herzing IRB process end to end — the determination, every document in every pocket, the submission, every reply to the board until approval — every week. The project, the data and the findings stay yours; the board's decision stays its own.

the free application review

Tell us where the folder stands

Full pockets, empty pockets, the letter you are waiting on. We come back with the first reading, free, and the pocket to start today.

independent consultants; the project, the data and the findings stay yours

Two folders, filed the same day

Both folders got the same first pass. Only one of them learned anything about its project. How long a pass takes is the board's own calendar — which is exactly why you only want to spend one of them.

the practice's own record

900+ Herzing IRB application files prepared

2017 preparing Herzing files since

4.9 / 5 average rating from the professionals we've served

files read every week

Seven pockets, in the order a reviewer opens them. The tabs above are the map — each one opens its pocket, and the thin ribbon under them fills as you tick pockets in the pass at the end.

Editions of the handbook shift and portals get rebuilt, so verify every named requirement against Herzing's current IRB handbook and submission portal. What follows are the universals — the parts that do not move.

The application form

Every answer quotes the approved plan — word for word, number for number.

The form asks questions your plan already answers, and the reviewer reads the two side by side. Every paraphrase is a discrepancy they must stop and reconcile — a sample that drifted by two, a site renamed, a recruitment channel that appears in one document and not the other.

None of those are flaws in your project. All of them are findings against your folder. Quote the plan; give the reviewer nothing to chase.

Cross-reading — the reviewer's own habit

the plan says“twelve nurse preceptors at one practicum site”
the form says“twelve nurse preceptors at one practicum site”

matches — nothing to reconcile, the reviewer moves on

the plan says“recruitment by unit email, script attached”
the form says“recruitment by flyers and email”

where did flyers come from? — a question you now owe an answer

The site permission letter

The most often missing document, and the slowest to obtain — someone outside your project has to write it.

Three things make it real: the site's own letterhead; a signatory actually authorised to grant access; and the data named — the letter permits this chart pull, this survey, this staff interview. A warm letter that blesses “the project” permits nothing in particular, and reviewers read it that way.

For an MSN or DNP practicum project, the practicum site's letter is the one that stalls folders. It is the document in this file you least control — request it before you polish anything else.

the practicum site's letterhead — not yours

“…grants the project named above access to the fall-audit chart review described in the plan — the data named, not implied — for the activities described…”

A. Signatory
director of clinical education — a title that can grant access
  • a letterhead: the site's, on its own paper
  • b signatory: authorised, not merely willing
  • c data: named, so the permission means something

Instruments & interview guides

The board approves your questions, not your topic.

The instrument in the folder is the instrument: every survey item and every interview prompt exactly as it will reach a participant, in the words that will be used. “Questions will explore staff experiences” is not an instrument — it is a promise to write one later, and boards do not approve promises.

The discipline cuts both ways: a question reworded after approval is a question the approval no longer covers. Fix the wording now, while changing it costs nothing.

Interview guide — as it will be asked

  1. “Walk me through the last handoff on this unit.”
  2. “What does the current fall-huddle actually look like?”
  3. “When the protocol is skipped, what usually got in the way?”
  4. “What would make the change stick after I leave?”

read them aloud once — the folder's version is the spoken version

CITI certificates

Current, the right modules, for every person named on the application.

Two ways this pocket returns a folder: a certificate that has lapsed, and a certificate for the wrong modules — training that does not match the work the plan describes. Both are found in seconds, because this is the easiest pocket in the file to verify.

Open the records and read the module list before you file — for yourself and for everyone named on the application. Then put the certificates themselves in the folder; the completion numbers alone are not the document.

Completion record

modules match the work in the plan

every named person has one

current — files clean

Completion record

expiry passed unnoticed

found in the first minutes of a pass

lapsed — renew before filing

The data-security answers

Four blanks — each filled with something you can point to by name.

Vague security answers read as no answer. The four that matter: where the data lives — a named, access-controlled location; who can touch it — a list you could read aloud; when identifiers separate from responses — the de-identification step, and where the key is kept; and the destruction date — a date on a calendar, not a sentiment.

Write them as facts about your project, and this pocket never comes back to you.

Data-security section — the answers that hold

storage

“my laptop” the site-approved encrypted drive, in a folder only the project team can open

access

“the team” three people, named: you, your chair, the site mentor

de-identification

codes replace names before analysis; the key is kept apart from the data

destruction

“after the project ends” a written calendar date, stated in the application

The category claim — QI or research

Claimed by the design, not by the deadline.

Quality-improvement review and research review are different doors, and the design decides which one your folder walks through. Randomising participants, testing a hypothesis meant to travel beyond your site, publishing as research findings — that is research, whatever the cover page claims.

Claiming QI because it moves faster is the one shortcut that can restart the whole file: a category corrected in review does not return a document, it returns the design. Claim the honest door, then build the folder for it.

The two doors — read your own design against them

reads as QI

  • improves this unit's own process
  • measured against the unit's own baseline
  • shared as operational learning

reads as research

  • designed to generalise beyond the site
  • hypothesis testing, randomisation
  • published as research findings

the honest claim is the eighth question in the folder pass below

What's in your folder?

The same completeness pass a coordinator runs, run by you first. Tick what is already real — in the folder today, not planned for the weekend — then answer the honest question at the end.

The seven pockets

tick a pocket only if its document would survive the readings above

The eighth question — the honest one

does the design match the claim?

How it works

Four tabs, in the order the file moves. You can stop at any of them and take the folder the rest of the way yourself; most hand it over at the third.

1free review

The free application review

Tell us where the folder stands: which pockets are full, which are empty, which letter you are waiting on. You get the first reading, free, and the pocket to start today.

2determination

The determination and the plan

We read the design against QI and research and make the honest category call with you, then write the plan the application will quote, word for word.

3every pocket

Every pocket, built

Application, consent and recruitment materials, instruments, the data-security plan, the site letter drafted for signature, CITI guidance for everyone named. Complete before it is filed.

4filed and answered

Filed, and every reply answered

We file the submission and answer the board: revisions, amendments, continuing review, until the approval is in your hands.

Who keeps the folder

Three consultants, one file at a time. Each owns the pockets she knows best, and the whole folder is read by all three before it goes to the board.

Annika Brandstetter

DNP, APRN

Lead consultant — determinations and the plan

Annika makes the category call on every file that comes through the desk and writes the plan the application will quote. She has read more QI-or-research designs than she can count, and she will tell you plainly which door yours walks through.

Olivia Tremblay

MSN, RN

Consent, instruments, data security

Olivia builds the most-returned pockets in the folder: consent and recruitment materials version-matched and pitched at the people signing, instruments word for word, and data-security answers with a name on every blank. Her pockets do not come back.

Helen Marsh

PhD

Site letters, submissions, board replies

Helen drafts the site permission letter for the signatory's hand, files the submission, and answers every reply the board sends until the approval arrives. If the practicum site is the slow one, she is the one who moves it.

Filed, in their words

Four folders, four professionals, in their own words: the site letter, the complete folder, one pass.

“My first filing came back for a consent version that did not match the application. They rebuilt the consent pocket and the recruitment email to the same version and re-filed it. The second pass was the real review, and nothing came back.”
Brianna L., MSN candidate — returned once, filed complete
“The site letter was the thing I could not get moving. They drafted it for the clinic's director, naming exactly which records the project touched, and it came back signed without a single question. That was the pocket holding the whole file.”
Dana R., DNP candidate — practicum at a community clinic
“I thought the determination was a formality. They read my design and told me plainly it was research, not QI, before the board did. That one honest call saved the whole file from a restart.”
Tomás G., RN, MSN candidate — before project approval
“Every pocket, every reply, handled. When the board asked about the data-security answers, the response went back the way the file had gone in: complete. One more pass and it was approved.”
Karen W., DNP candidate — the whole process, end to end

average 4.9 / 5 across the professionals we've served — the folder's own record, above

What it costs

Packages are quoted after the free review, so the price fits your folder and not a menu.

Determination & Plan

The honest category call, and the plan the application will quote.

  • your design read against QI and research, with the call made plainly
  • the review path it points to, and why
  • the plan written so every form answer can quote it, word for word
  • the pocket to start today, named

Quoted in writing after the free review. Fixed fee; no hourly billing.

Start with the free review

The Complete Folder

Every pocket built, version-matched, ready to file.

  • the application form, quoting the plan
  • consent and recruitment materials at the signers' reading level
  • instruments and interview guides, every question as it will be asked
  • the data-security plan with a name on every blank
  • the site permission letter drafted for the site's signature; CITI guidance for everyone named

Quoted in writing after the free review. Fixed fee; no hourly billing.

Start with the free review

Full Handover

most chosen

The whole process, end to end: every pocket, the filing, and every reply until approval.

  • everything in The Complete Folder
  • the submission itself, filed through the portal
  • every reply to the board: revisions, amendments, continuing review
  • carried until the approval is in your hands; the project, the data and the findings stay yours

Quoted in writing after the free review. Fixed fee; no hourly billing.

Start with the free review

Asked at the desk

The questions that arrive with most folders, answered first and short enough to lift whole. The longer readings, and six more questions, live on the FAQ page.

Does a Herzing MSN or DNP project need IRB review?

Almost always, in some form. Any project that collects information from or about people — surveys, interviews, chart reviews, staff observations — goes to the IRB for a determination, and a quality-improvement project still needs the board to agree that it is QI rather than research. Assume your project goes through the IRB step; Herzing's current IRB handbook or portal states exactly how your program files it.

What changes between projects is the path, not whether the board reads the folder: not human-subjects research, exempt, expedited or full board. The category claim is the seventh pocket above, and the design decides it, not the deadline.

What does the board read first — my project or my folder?

The folder. Completeness is checked before quality: a coordinator or reviewer confirms that every required document is present, current and version-matched before anyone reads the design. An incomplete folder spends its first full pass learning one fact — that it was incomplete — and only a second pass reads the project.

That is why the seven pockets are laid out in the order a reviewer opens them, and why the folder pass asks whether a document is in the folder today, not planned for the weekend.

Can I start collecting data before IRB approval?

No. Recruitment, consent and data collection for the project begin only after the IRB's written determination or approval is in hand, and that includes projects expected to be called QI or exempt, because the board makes that call, not the project. Data gathered before the determination generally cannot be used and can put the whole file at risk.

Preparation that does not touch participants or their data can and should happen before filing: drafting the instruments, requesting the site permission letter, completing CITI training for everyone named.

Which CITI modules do I need for a Herzing IRB application?

The human-subjects research course that matches the work — Social-Behavioral-Educational for surveys, interviews and most practice-change projects, Biomedical where the design is clinical — current at filing, for every person named on the application. Herzing's current IRB handbook or portal names the exact course and any added modules; read that list before you register, and put the completion certificates themselves in the folder.

The two ways this pocket returns a folder are a lapsed certificate and the wrong modules. Both are found in the first minutes of a pass.

Why is the site permission letter the slowest document to get?

Because someone outside your project has to write it. The letter has to sit on the site's own letterhead, be signed by a person actually authorised to grant access, and name the data or activities it permits, and that person keeps their own calendar. Request it before you polish anything else in the folder.

For an MSN or DNP practicum project, the practicum site's letter is the one that stalls folders. We draft it for the signatory's hand, naming exactly what the project touches, so it comes back signed without questions. Pocket three shows the three things that make it real.

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

Three depths of reading, set by the risk and design of the project. Exempt covers minimal-risk work in defined categories such as anonymous surveys or review of existing de-identified records; expedited covers minimal-risk work outside those categories, read by one or a few reviewers; full-board review is for greater-than-minimal-risk or vulnerable-population work, read by the convened board. The board assigns the path from the folder — the application can propose one, never choose it.

Nothing about the path changes what the folder must contain. The categories come from the federal Common Rule; Herzing's current IRB handbook or portal states how its board applies them. The FAQ page reads each path on its own.

Which document is returned most often?

The consent form, with its recruitment materials close behind. Three readings catch it: the version in the folder is not the one the application cites, a required element is missing, or the language is pitched above the people signing. Version-match it, check every element, and write it at the signer's reading level rather than the filer's.

Pocket two shows the version stack and the element list. Recruitment materials ride the same three readings, matched to the same version.

What happens when the IRB returns my application?

The board sends written findings — the documents or answers it needs changed — and the file waits for your response; nothing is approved until the revised folder is read again. The response that works is a point-by-point reply in the board's own vocabulary, each revised document re-filed version-matched, and nothing changed that was not asked about.

A return for an incomplete folder and a return with questions about the design are different events, and the second is the one where the project actually got read. In Full Handover we answer every reply until approval; the FAQ page has the full reading of returns, revisions and amendments.

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

No — the project, the data and the findings are yours throughout; we handle the IRB process around them, end to end. Pricing is quoted in writing after the free application review, as one of three fixed-fee packages: Determination & Plan, The Complete Folder, and Full Handover, the premium, which takes the whole process off your desk — every pocket, the submission and every reply to the board until approval.

No hourly billing, and no figure published here, because the quote is written for your folder, not a menu. The three packages are above; the pricing page has the quote process in full.

We build every pocket, file it, and answer every reply — until approval.

Hand us the folder as it stands — full pockets, empty pockets, the letter you are still waiting on — and we carry the whole IRB process from there: the determination and plan; the application; consent and recruitment materials; the instruments; the data-security plan; the site permission letter drafted for the site's signature; CITI guidance for everyone named. Then the submission itself, and every reply the board sends back — revisions, amendments, continuing review — until the approval is in your hands.

The project, the data and the findings are yours throughout; the board's decision is its own. It starts with the free application review — tell us where the folder stands today. If it is ready to file as it is, we will say exactly that.

Start with the free application review independent consultants — we handle the whole IRB process; the research itself stays yours

Evelyn is at the desk. Which pocket is giving you trouble?