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Writing a revision response the Purdue Global IRB accepts on the next pass

The reviewer reopening your file has a narrow job: check that every item raised in the letter has been dealt with, and that dealing with it broke nothing else. A revision response earns its acceptance by making that confirmation mechanical. It repeats the board's items in the board's order, states each change in one or two plain sentences, and names every document where the change now reads — because a correction that lives in only one file has not been made, it has been mentioned. This sheet sets out the shape of a response built that way.

Short answer

One numbered item per board finding, in the board's own order. For each: what was asked, what changed, and every file the change now appears in. Attach stamped versions of everything touched. Say plainly where you disagree, and why.

What is the reviewer actually checking?

Two things, and only two. That each finding has been addressed, and that the file still satisfies the approval criteria after the addressing. Purdue Global publishes the worksheet its reviewers work from — IRB-314, Criteria for Approval — and it says in its own header that those criteria apply to initial review, to continuing review and to modifications alike. The bar does not move because the file is on its second pass. Risks minimised through sound design, risks reasonable against anticipated benefits, equitable selection of participants, adequate provisions for privacy and for the confidentiality of data, extra safeguards wherever a participant could face coercion or undue influence: those boxes are ticked again, on the revised file, as though it were new.

That is why a response that only argues is a weak instrument. Argument can persuade a reader that a criterion is met; it cannot show the reader where in the protocol it is now met. The response's real work is pointing, and it should be built for pointing.

What shape does the response take?

An item list, one row per finding, in the numbering the letter used. If the letter arrived as prose with no numbers, number the findings yourself in the order they appear and open with one line saying you have done so. Never reorder them into the order you found convenient to fix; the reviewer is reading down their own letter.

Each item carries three fields. What the board asked, in the board's words. What changed, in yours. And where it now reads — the propagation ledger, which is the field most responses omit and the field that most often decides whether the file comes back.

One item, three fields — worked twice
ItemWhat the board askedWhat changedEvery place it now reads that way
1Justify the number of participants and state how the figure was derived.The target enrolment is stated once, with the derivation written out: the estimate method, the source it follows, and the allowance made for attrition.Protocol, participant-population section; the recruitment message; the information given to participants; the covering application fields that ask for enrolment.
2The protocol describes an interview; the recruitment post describes a short survey. Reconcile.The study collects interview data only. The survey language was drafted for an earlier design and has been removed everywhere.Protocol, procedures section; recruitment post; consent document, procedures paragraph; the data-collection instrument's title page; the site permission letter's description of the activity.

Read the right-hand column of item 2 again. Five documents, one dimension. The reviewer quoted two of them. A response that edits only those two is a response that will be read a third time.

How do you find every place a change has to land?

Work from the dimension, not from the sentence. Before editing anything, write down the fact the finding touches — the enrolment figure, the instrument's name, the recruitment channel, who performs the recruiting, where data is stored, what participants are told they may withdraw — and then walk the whole file asking one question of each document: does this paper make a claim about that fact? Purdue Global's initial-review procedure lists what a submission contains, and that list is your walk: complete answers to every form question, participant instructions, questionnaires and assessment instruments, consent documents, assent documents where applicable, recruitment materials including advertisements, flyers and letters, data-collection instruments and debriefing information, and a letter from an appropriate administrator where the research or the recruitment happens in or through a school, business, care facility or other organisation.

Nine document types. Most studies carry six of them. A dimension that appears in four and is corrected in two is a return waiting to be written. The same discipline is what makes an application checklist useful before the first submission rather than after the second.

How should the attachments be prepared?

Every document you touched travels with the response, stamped so that the reviewer can tell at a glance which copy is current. Where the university's system asks for marked-up copies, mark them up; Purdue Global's amendment procedure requires a revised application and altered study materials submitted with tracked changes for post-approval modifications, and reviewers reading a pre-approval revision are working the same way — they want to see the delta, not hunt for it. A clean copy alongside the marked one saves the reviewer from reading edit marks as though they were text.

Then remove what is superseded. Purdue Global's guidance on modifications is explicit that updated documents must be provided so the study file stays accurate, and the same principle protects a revision: an obsolete consent version left sitting in the file is a second reading of a dimension you just corrected. Confirm through the university's current portal how superseded uploads are retired, because that mechanism belongs to the system, not to the memo.

What if you disagree with a finding?

Say so, in the item's own row, before you say anything else about it. Disagreement handled well reads like this: the finding restated fairly, the design reason it does not apply, the evidence for that reason, and then — this is the part that carries it — an offer. Either a change that answers the reviewer's underlying worry by another route, or an explicit request for the board's direction if the alternative is unacceptable.

What does not work is the silent decline. A file that returns with one item unanswered and unmentioned reads as an oversight at best and an evasion at worst, and it invites a closer reading of everything else. Neither does the over-concession: agreeing to a design change you believe damages the study, in the hope of getting through, buys an approval for a study you no longer want to run. Remember which decision belongs to whom. The board decides whether the study may proceed; what the study is remains yours.

Who reads the response before the board does?

Purdue Global routes protocols to the faculty member working with the researcher — or to the supervisor, where the researcher is an employee — for an administrative check before board review, and its SOP 302 states that incomplete submissions are not routed onward. Assume the same gate stands in front of your revision. That gate is also an asset: a reader who knows the study and did not write the response is the cheapest possible test of whether the item list can be followed by someone holding only the board's letter.

A last pass before you send

  • Every item in the letter has a row, and the rows are in the letter's order.
  • No row says only "changed" or "clarified"; each states what it now says.
  • Each row's ledger names files, not vague locations — the document and the section.
  • Every file named in a ledger is attached, stamped, and consistent with every other file named anywhere in the response.
  • Nothing was quietly changed that the letter did not raise; if something was, it has a row of its own explaining why.
  • No data has been collected. Approval precedes collection, and a revision under review is not approval.

What to do next

When the letter is on the desk in front of you, start by sorting the findings — what a returned application means and what to do about it sets out the four kinds and the move each takes. Then build the item list and walk the documents. If you would rather hand the loop over entirely, that is the work this practice does: we read the letter, correct the drawing across every document, write the response and answer the board's questions until approval exists. Send the letter and the file for a free review — what comes back is a written findings list and a plain verdict on whether the response is ready. How it works sets out the whole sequence; the FAQ handles the short questions.

Sources

Give us the entire IRB process. Keep the study.

The free application review is where it starts. From there we carry everything — the determination and the plan, every document drawn to the same dimensions, the submission itself, and every reply to the board until the approval letter exists. The study, the data and the findings remain yours; the board's decision is its own.

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