The reader is not the board
Candidates write consent forms upward, to the committee that will judge them, in the vocabulary of the proposal. That instinct produces a document full of constructs, instruments and inclusion criteria, and it fails on its own terms, because a board reads the form as a stand-in for the person who will eventually hold it. If the board cannot follow it easily, the participant certainly cannot, and the protocol has failed the only test this document exists to pass.
So write it the way you would explain the study to somebody in a waiting room. Second person, short sentences, ordinary words, no acronym that has not been spelled out, and nothing about theoretical frameworks. If a sentence would make a reasonable adult stop and reread, rewrite it. This is the one part of a doctoral submission where plainness is the scholarly virtue.
The elements, in the order they are looked for
Boards do not read the form from top to bottom either. They check for a fixed set of things and note which are missing, which is why a document organized in their order tends to clear review in fewer rounds. Use your own board's template where one exists, since a template is an instruction rather than a suggestion.
- ◆What the study is about and who is conducting it, including that it is being done for a degree, which participants are entitled to know.
- ◆Why this person is being invited, and what makes them eligible.
- ◆What will actually happen to them, step by step, with the time each step takes and where it takes place.
- ◆The risks, stated honestly, including discomfort, inconvenience and loss of privacy rather than physical harm alone.
- ◆The benefits, which for most studies means saying clearly that there is no direct benefit to the participant.
- ◆Payment or compensation if any, and what happens to it if somebody stops partway through.
- ◆What becomes of the data: what is gathered, where it lives, who may look at it, for how long it is retained, and the manner of its eventual disposal.
- ◆That participation is a free choice, that declining carries no penalty of any kind, and what happens to material already gathered should somebody stop partway.
- ◆Two contacts: you or your chair for questions about the study, and the board itself for questions about their rights as a participant.
Phrases that produce a revision letter
Six recur often enough to be worth memorizing. The first is any version of there are no risks, which no board believes; even an anonymous survey costs time and may raise an uncomfortable thought. The second is a benefit written as a promise, since improving care is a hope rather than something the participant will receive. The third is the assurance that data will be kept confidential with no account of how, which reads as a wish rather than a plan.
The remaining three are about pressure. A withdrawal clause that does not say what happens to data already gathered is incomplete. Recruitment language aimed at your own employees, students or patients needs someone else to do the asking, because a request from a supervisor is not a free choice however politely it is phrased. And an investigator who is also the participant's teacher, manager or clinician must say so in the document and describe what protects the relationship. Boards are far more forgiving of a disclosed conflict than of one they notice themselves.
Signatures, waivers and people who cannot consent
Not every study collects a signature. Where a signed page would itself become the sole document tying a participant to your study, boards will often permit documentation to be waived and the information delivered as a cover page instead, with continuing to the survey standing as agreement. That is a waiver of documentation, which is a different request from a waiver of consent altogether, and confusing the two in a submission is a reliable way to lose a fortnight.
Where participants cannot consent for themselves, the structure changes rather than disappears. Minors give assent in language suited to their age while a parent or guardian gives permission, and the two are separate documents. Adults with impaired capacity involve a legally authorized representative. Employees, prisoners and patients each carry their own protections. Candidates usually meet these templates for the first time at residency, which is one of the reasons the first residency repays close attention long before a protocol is written.
Answering the letter you are going to receive
Most protocols come back at least once, and a returned protocol is not a rebuke. Answer the letter as a table: the board's point quoted, your response, and the exact wording now in the document with a page reference. Do not argue in the covering note and do not answer three points while explaining why the fourth was unnecessary. Boards approve documents rather than arguments, and a reviewer who can see each change without hunting will approve faster than one who cannot.
Keep your ethics training current, keep the certificate with the file, and keep every version of the form. Where a resubmission season is genuinely unaffordable, because data collection has to begin before a term closes, patrons bring the whole packet to counsel who draft to the board's own template and answer the revision letter point by point, which is a narrower service than it sounds and usually the difference between one round and three.
Questions put to the house
How long should a consent form be?
As long as the required elements need and no longer. Boards are not counting pages; they are checking that each element is present and comprehensible. Anything that lengthens the document without informing the participant works against you, because a form nobody finishes reading has not obtained informed consent regardless of what was signed at the bottom of it.
Does an anonymous online survey need a consent form?
It needs the information, though frequently not the signature. Most boards will permit documentation to be waived where a signature would be the only identifiable record, and the elements are delivered instead as a cover page that the participant reads before proceeding. Ask your board which arrangement it expects, and use its template rather than adapting one from another institution.
Who is allowed to recruit my participants?
Anyone without power over them. Where you supervise, teach or treat the people you wish to study, boards will usually require a neutral third party to make the approach and will want your access to the identities limited. Disclose the relationship in the submission rather than leaving it to be discovered, and propose the safeguard yourself; that is treated as a sign of a careful investigator.
What is CITI training, and how long does it last?
It is the standard human-subjects research training most universities require before a protocol will be reviewed, covering the history and the rules of research with people. Institutions set their own validity period and their own required modules, so complete the ones your school specifies rather than a general course, and file the certificate with your protocol where reviewers can find it.
