The inspection notice

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What a notice covers

• A revision to the handbook or policy that governs IRB review for Aspen programs, where it changes what a file must contain.
• A change to the IRB portal or its forms — a new application template, a retired one, a field the board has started requiring.
• A shift in what the board is writing back — a finding that has started appearing in revision letters across the files we read.
• A change to how the practice works that affects a file in progress.

What a notice never is

• A newsletter on a calendar. If nothing has moved, nothing is sent.
• A sales message. The offer on this site is on this site; it does not arrive by email unless you claimed it.
• Shared. The list is the practice’s own and is never given to anyone.

Each notice says what changed, what it means for a file at each stage — before approval, approved and not filed, returned — and what, if anything, to do. Where the change is Aspen’s, it points you to Aspen’s current handbook or IRB portal for the text itself. If your file is with us, you do not need the notice: the change is already applied to your documents.

The archive

The longer pieces the notice points to — one question about Aspen’s IRB process, worked through from the first form to the board’s determination — filed here newest first, each pointing to Aspen’s current handbook or IRB portal for the text itself.

• Quality improvement or research? At Aspen you file either way — the board writes the determination

  Aspen expects a submission from every doctoral project whatever it is called, because the determination of whether the work is research belongs to the board and not to the candidate — and what settles it is the intent behind the design, not the label on the form or any plan to publish.

  2026-08-23
• How long does Aspen IRB approval take? Counted in gates and passes, not dates

  The honest answer to how long approval takes is not a number but a count: the gates a file has to clear before the board reads it, and the passes the board may take afterwards — the first set is largely within your control, the second is not, and a complete, consistent file is the only lever anyone actually holds.

  2026-08-23
• Surveying the people you work with — consent, pressure and the anonymity you can actually promise

  A survey of colleagues at your own workplace is read for pressure before it is read for method: the board wants to see who invites, who can tell that somebody declined, whether the responses are genuinely unlinkable, and whether any incentive looks like something the employer is offering.

  2026-08-23
• The site permission letter Aspen’s IRB will accept: the nine lines, the signatory, the wait

  Aspen’s Appendix C prints the letter as a specification — letterhead, your name, the title, a short purpose, a statement that the protocol was read, the permitted activities, restrictions, a signatory attesting to authority — and because somebody else signs it, it is the finding that takes longest to cure.

  2026-08-23
• Aspen’s revision letter, answered: the memo that closes every item

  A revision response is a document, not a reply email: it answers each of the board’s findings in the board’s own order and words, says what changed and where, attaches the corrected page to the item that asked for it, and adds nothing the letter did not raise.

  2026-08-23
• Exempt, expedited, full board — or no human participants at all: what sets an Aspen project’s review level

  An Aspen project’s level of review is assigned by the IRB Chair or a designee after four questions are answered in sequence, and what moves a file up the ladder is never the label it claims but four readable features of the design: what it touches, whom it touches, how identifiable the record is, and how sensitive the subject matter.

  2026-08-23
• Recruitment materials as filed: the flyer, the email and the script Aspen’s IRB reads word for word

  Aspen’s application checklist asks for participant recruitment materials themselves — flyer, social post, email, script — because the board reviews the artefact a person will actually see; every channel also carries a permission behind it, and nothing may run before the approval letter arrives.

  2026-08-23
• The Aspen IRB process in order — from a defended proposal to a written determination

  At Aspen the IRB is a downstream gate, not the first one — the application is filed only after the proposal has been defended and approved and the chair has signed the form, and the board answers with one of four written dispositions, after which the file stays open until a close-out form retires it.

  2026-08-23
• Running the Aspen project where you work: dual roles and what the board asks

  Aspen permits the workplace as a venue and its own guidance sets the boundary — off the clock, outside your usual duties — but the handbook counts subordinates of the researcher among those who need safeguards, so a workplace file has to answer for the relationships as well as the design.

  2026-08-23
• Changing an approved Aspen project: the Change Request Form, and what waits

  Once Aspen’s IRB approves a project, the approved file is the project: the handbook routes a change to any aspect of it through the IRB Change Request Form and requires approval before you proceed, with the only recognised exception being a change made to remove an immediate hazard to a participant.

  2026-08-23
• Talking to people — what an interview or focus-group file has to carry before anybody speaks

  An interview or focus-group file is approved on four documents — the guide as it will actually be spoken, the recording and transcription plan, the consent with its confidentiality limits stated honestly, and the account of what becomes of the audio — and in a group the one promise nobody can make is that the others will keep quiet.

  2026-08-23
• Nine findings the Aspen IRB writes most, and the question underneath each one

  Almost everything an Aspen board writes back about is a defect in the file rather than a judgement on the project, and each of the nine recurring findings is a plainly worded question the documents failed to answer — which means every one of them can be found and cured in private, before the submission line.

  2026-08-23
• Two boards, one project — when a hospital or employer reviews alongside Aspen, and which reads first

  Where the organisation hosting your project runs its own review board, Aspen’s handbook has you seek that approval before submitting to Aspen; a site can also require its own sign-off without being engaged in the research at all, and the two files have to stay identical while both are open.

  2026-08-23
• Secondary data and old records — the line where a spreadsheet turns into human-subjects work

  Old records become human-subjects work at the point where whoever analyses them could trace a row back to a person; Aspen expects the application either way, the Privacy Rule governs the source separately, and the determination belongs to the board rather than to whoever holds the spreadsheet.

  2026-08-23
• The data security plan Aspen’s IRB reads: storage, access, de-identification and destruction, named

  Aspen’s IRB application asks what you will gather, by what means, where it rests, who may reach it, what protects it, and by what method and moment it ends; naming each answer — and escalating where the material is sensitive — is what separates a clean file from a returned one.

  2026-08-23
• After Aspen approves: continuing review, reportable events and closing the file

  Aspen’s approval is a term, not a status: a project that will run past it goes back on the Continuing Review Form, events and deviations go on the Events Reporting Form while the work runs, and the Close Out Form follows acceptance of the final manuscript — after which the retention and data-destruction promises still stand.

  2026-08-23
• Consent for Aspen’s IRB: the elements, the ninth-grade rule, and staying in step with the protocol

  A consent document is measured against three rulers at once — the elements the Common Rule requires, the plain-language standard Aspen’s template sets beneath the ninth-grade level, and the protocol version it claims to describe — and it is the third ruler that catches most files.

  2026-08-23
• Your Aspen IRB application came back: reading the letter before you answer it

  A returned Aspen application is a disposition, not a verdict: the IRB Handbook names approved, modifications required to secure approval, disapproved and deferred, and each one asks for a different answer — so the letter is read and sorted before a single page is rewritten.

  2026-08-23
• Every document in an Aspen IRB submission, and how the board reads them against each other

  An Aspen submission is not a stack of separate forms but a single object the board reads for internal agreement, built from three documents required in every case and ten more that become required the moment a specific fact about your design is true.

  2026-08-23
• CITI for Aspen: which modules, keeping the certificate live, and what an expired one costs

  Aspen requires CITI training completed before the IRB application is submitted and the certificates uploaded with it — one of only three attachments required on every application — which makes training the earliest item on the file’s critical path and a lapse visible on sight.

  2026-08-23