Which review your study will receive
Boards sort submissions before they read them, and the sorting decides your calendar. An exempt determination can be settled by an administrator; an expedited review is read by one or two members; a full board review waits for a meeting held on a fixed cycle. Designing a study without knowing which of the three it draws is how a term disappears.
Certain features push a study upward, and they are worth checking against your own design before submission rather than after.
- ◆Identifiable data, or data anybody could re-identify from what you intend to keep
- ◆Participants a board treats as protected, including your own students or staff
- ◆Anything beyond minimal risk, or any topic a participant may find distressing
- ◆Deception, or purpose withheld from participants until afterward
- ◆Recruitment inside an organization that has to agree in writing first
The packet, and the two pieces usually missing
A complete submission is a set: the protocol on the board's own form, consent and where relevant assent documents, recruitment wording exactly as participants will see it, every instrument appended rather than described, and current training on file for everyone touching the data.
Two items go missing more than the rest. The first is written permission from the site, which most organizations will give and few students request early enough. The second is a data plan saying where the data will live, who can reach it, how long it is kept and how it is destroyed. Boards ask for both every time.
Three kinds of item in a letter, three kinds of reply
The first kind requires a change. Make it, then say in one line what was altered and in which document, and attach the document. The second kind wants a clarification, and the mistake is answering it only in the reply: if a reader was confused once, the protocol itself has to say the thing, or the next reader will be confused too.
The third kind is a question about intent, usually phrased mildly, and it decides how long a review runs. Answer it directly, occasionally by conceding a design change. A reply that argues its way past a board member has not saved a round; it has bought one.
After approval, which is not the end of it
Approval covers the study you described and nothing adjacent. Changing recruitment wording, adding a site, altering an instrument or widening the population each need a modification filed and granted before the change happens. A study drifting past its own approval creates a problem at writing-up rather than at the time.
Longer studies carry a continuing review date, and every study eventually needs a closure report. Both are ordinary and both are missed. Where the same study also needs chapters, the long document is quoted separately, and research counsel is the standing form of this work for candidates who want the whole ethics side held.
Send the design and the form
Your study, your program, the board's template if you hold it, and any letter already received. Reading it costs nothing.
The category is settled
You are told which review the study is likely to draw, and what would push it into a slower one, before drafting begins.
The set goes in together
Protocol, consent, recruitment wording and instruments are reconciled against one another and filed as a set, from your own account.
Questions put to the house
Do you submit the protocol for me?
No. The submission is made by you, from your own account, in your own name, because a board record naming anyone else creates a problem far larger than the one it solves. Everything up to that point is prepared here: the documents, their consistency with each other, and the covering answers. Pressing send is deliberately left where it belongs.
How long does a board usually take?
It depends on the review category rather than on the study, which is why the category is settled first. Exempt determinations are administrative. Expedited reviews turn on how busy one reviewer is. Full board review waits for a scheduled meeting, then a letter, then your revision, then the meeting after. Two avoidable defects can cost far more than two weeks.
My project is quality improvement, not research. Do I still go to the board?
Usually you still need a determination saying so, and getting that in writing protects you later. Many DNP projects sit exactly on this line, and the distinction turns on whether findings are meant to be generalized beyond the setting. Write the project so the answer is obvious from the first page, and ask your board for the determination rather than assuming one.
A letter has already arrived. Can you take it from here?
Yes, and that is a common point of arrival. Send the letter, the submitted documents and the board's template. Each item is sorted by what it actually wants, the documents themselves are corrected rather than only the reply, and the revision goes back promptly, because time between rounds is the expensive part of any review.
Can approval be promised?
No, and nobody honest promises it, since the decision belongs entirely to your board. What is offered is a submission written into their own template, internally consistent, with instruments and permissions attached instead of mentioned, so that review is spent on the study rather than on defects the form had already anticipated. That is what shortens a review, and it is all anyone can sell.
