Full Board Review
A full-board review is required when a proposed research project is considered to be “greater than minimal risk” (in other words, the project does not meet certain criteria for an expedited review or exempt determination) and is reviewed by a duly-convened meeting with a quorum of voting members present.
PrimeIRB will review your project at one of our regularly-scheduled IRB meetings or we can provide a PrimeIRB On-Call™ review for an on-demand review.
PrimeIRB will contact the CRO/Sponsor or Investigator within 24 hours of a full board meeting to relay the Board’s determination.
Documents will be posted to LINQ ™within 48 hours.
According to Merriam-Webster, “expedited” means fast. But in the IRB world, “expedited” means that the research project presents not more than minimal risk and does not have to be reviewed by a Full IRB Committee. The IRB Chairperson or designee can review the submission and has the full authority of the duly-convened IRB with the exception that the Expedited Reviewer cannot disapprove a project. When a reviewer cannot approve a submission under the expedited process, the item is referred to the full board for discussion.
A list of categories of research that are eligible for an Expedited review can be found on the OHRP Website.
Any minor change to previously-approved research may also be eligible for an expedited review, such as new recruitment materials and administrative changes. Generally, non-scientific submissions that do not change the risk/benefit ratio are considered minor changes.
Documents for an Expedited review will be posted to LINQ™ within 48 hours.
The Code of Federal Regulations identifies several different categories of minimal risk research as being exempt from the regulatory requirements and IRB oversight. This does not mean that they are exempt from IRB review, simply that the research project is exempt from ongoing, periodic IRB oversight.
Documents regarding an Exempt determination will be posted to LINQ™ within 48 hours.
Not Human Subject Research Determinations
45 CFR 46.102 lists very specific definitions about what constitutes “research” and what is meant by a “human subject”.
Although the federal regulations do not require official IRB review of studies that do not involve human subjects research, investigators may be required to obtain documentation that their project either is not research and/or does not involve human subjects (Journal editors, for example, may require this determination prior to publication of a manuscript).
If it is determined that the submission does constitute research involving human subjects, the project will be referred to an Expedited reviewer for further consideration.
Documents related to this type of determination will be posted to LINQ™ within 24 hours.