Service III — protocol, consent, approval

IRB and research counsel

Boards rarely refuse a study on principle. They send it back because a form was answered out of order, because the consent document promised something the protocol did not describe, or because a recruitment script arrived a fortnight after the thing it recruits for. Delay is usually clerical.

Written into your board's templateConsent drafted alongsideRevisions answered in orderCITI records in hand

What actually holds a protocol up

Very little of it is ethics. The usual causes are contradictions the writer cannot see: a sample described one way in the design and another in the recruitment plan, a risk named in the consent form and absent from the protocol, an instrument mentioned but never appended. Each is trivial, each buys a round of review.

A round is not a day. It is the board's next meeting, the letter afterwards, your revision, and the wait for the meeting following, which is why two avoidable defects can cost a term. Everything here is arranged to spend as few rounds as possible; approval belongs to the board.

The documents travel together or not at all

A submission is a set, and boards read it as a set. The consent document has to describe the procedures the protocol describes, in language a participant can actually read, and the recruitment script may promise only what both of the others allow. Written separately, in the order they occurred to you, they will disagree somewhere.

So they are drafted together and reconciled line against line before filing, which is slower once and faster overall. Where a study runs among colleagues or in your own workplace, the consent and confidentiality provisions get particular attention, since boards read those arrangements with a sharper eye than candidates expect.

The revision letter, answered in the order it was written

A letter from a board is a numbered list, and it wants a numbered reply. Reordering its items into a sequence more flattering to your study reads as evasion, and merging two points into one answer suggests one of them was not addressed. Each item gets its own response, stating what changed and where.

Answered that way, a second round is usually confirmatory rather than substantive. The same discipline carries into the study: quantitative work is planned with a statistician before data is collected rather than after, in SPSS or R as the analysis requires, so the method section describes something defensible.

Where this sits beside the rest of the work

Research counsel is quoted on its own, so a candidate may bring the protocol and keep every other part of the doctorate. It is most often taken beside dissertation mentoring, since chapters and protocol describe one study and are easier to keep consistent when one house holds both.

Where a rotation must be arranged before a study can begin, the placements desk runs in parallel rather than in sequence. The two are separate engagements, and neither is a condition of the other.

I

Describe the study

Your topic, your program, the board's template if you have it, and any letter already received. A specialist prices it inside two hours, at no cost.

II

The set is built together

Protocol, consent forms, recruitment scripts and instruments are drafted as one set and reconciled against each other before filing.

III

Letters are answered promptly

Each numbered item receives its own reply, stating what changed and where, and the revision goes back within days rather than weeks.

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Questions put to the house

Can you promise my protocol will be approved?

No, and any house that does is selling something it does not control. Approval is the board's decision. What can be offered is a submission built into the board's own template, internally consistent, with consent documents and instruments attached rather than promised, so that the review is spent on the study itself and not on defects the template had already anticipated.

My study is in my own workplace. Is that a problem?

Not in itself, but it changes what the board looks at. Studies among colleagues or one's own students raise questions of voluntary participation, confidentiality and whether a participant could feel obliged, so those provisions are drafted explicitly rather than left implied. Handled openly at the outset, it is ordinary. Handled implicitly, it is the item that returns your protocol.

How are revision letters handled?

One at a time, following the board's own numbering, with each response saying what has been changed and in which document the change appears. Nothing is merged, nothing is reordered, and no item is answered by argument alone where a revision was clearly wanted. That discipline is the main reason a second round tends to be short.

Is the statistical side covered as well?

Yes, and preferably before data is collected. A doctoral statistician plans the analysis so the design supports the questions being asked, using SPSS or R as the work requires, and writes the method section in the language a committee expects. Analysis planned after collection is where most methodological revisions come from, and it is the expensive way to arrive at them.

May the protocol be brought here on its own?

Yes. Research counsel is quoted as an engagement in its own right, so a candidate may bring only the protocol and its documents. Many do, particularly those whose chapters are already written or already supervised elsewhere. Where dissertation mentoring is taken too, the two are kept consistent with one another, which is the practical argument for pairing them.

Elsewhere in the house
IRB approval serviceDissertation and capstoneAll seven servicesThe consent form nobody reads

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