Considerations for approval
A study proposal generally should come with all forms required by the institution. These generally involve statements of the research’s aims, descriptions of its protocols, copies of the informed consent documents, copies of any documents used in the studies like questionnaires, surveys and interview scripts, the names, contact information and affiliations of all associated staff, outlines of budgets, copies of grants, and any other documents required to understand the study fully.
There is no complete list of considerations to be weighed when approving a study proposal. It must be reviewed and considered holistically. However, some concerns from federal regulations to consider are as follows:
Other considerations to give include:
A healthy part of IRB review is discussion and deliberation. These ideas must be discussed amongst the IRB and reviewed carefully before approval is given. In order to be approved, a study must secure a majority vote of “approved” from the board, or “approved with stipulations” (covered later). This approval must be given an approval period, an expiration date if applicable, and continuing review parameters. Approval period for full board review items that pose greater than minimal risk are at maximum one year.
After approval
After a study is approved, if it is a full board review study, it will be required to submit continuing review documents at an interval approved by the board. These documents generally provide basic overviews of a general progress report of the research, how many people have been enrolled, what next steps are, what protocols are going to be performed this next period, and if any unexpected problems have come up. These must be reviewed by the board, and used to inform a decision to approve the study for another approval period. An investigator must apply to renew studies if they are not finished by the end of their approval period.
If a study requires modifications to its parameters, informed consent or information gathered or how it is stored, it must submit a modification request which must be approved before the change can be made. In the instances of smaller changes (such as simply how information is stored), it may be approved by a single IRB member and reported to the rest of the board. If it involves additional parameters and especially more risk to subjects, it must be reviewed by the whole board. Changes must be approved before they can be made, except in urgent situations such as a breach of information. If necessary, current or past subjects involved may be required to receive and or sign an addendum outlining changes made to study parameters after approval.
In the event of unanticipated problems, these must be reported to the IRB immediately. The IRB is required then to assess if these have caused the research to no longer be ethically compliant or if they represent a danger to the study or the institution. Further, it must be assessed if the research staff has adequately handled the situation and taken necessary precautions for it not to happen again. The board can vote on paths that include continuing the research with modifications or restrictions, suspending the research pending inquiry, or terminating the research altogether.
Finally, another scenario after approval that may arise is non-compliance by a PI to the approved study parameters. This is to be discussed by the IRB board, including evidence and deliberation, and may result in sanctions or termination of research, or alteration of continuing review parameters.
As always, all decisions of the board must be delivered in writing.