Types of IRB Review

The Prisma Health policy requires that the IRB determines if an activity is considered “Not Human Subjects Research” (NHSR). Making a Not Research determination can be challenging. The NIH developed a Decision Tool to assist researchers in determining if their projects are considered Human Subjects Research by the Department of Health and Human Services Office for Human Research Protection’s classification.

Projects that require this determination should be submitted in IRBNet and the IRB reviewer will process the submission as determined appropriate. Visit our guidance page for more information on NHSR definitions. 

Federal Regulations found at Code of Federal Regulations Title 45CFR46.104(d) delineate the criteria that justify studies to be reviewed under exempt review processes. Such studies must be submitted in IRBNet with a completed Prisma Health IRB application, protocol, and other supporting documents. Once the exempt determination is verified, it will be assigned to an IRB reviewer. Exempt studies must be reviewed by the IRB, but once the determination is made, continued IRB oversight is not required.

Please refer to the Policies and Guidance page for an IRB guidance document on the Exempt Review Categories. Exempt review submissions do not need to adhere to meeting dates and deadlines. For HHS guidance on exempt review and what constitutes minimal risk, click here.

Minimal Risk means that “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”

Studies involving no more than minimal risk are generally eligible for expedited review by the IRB Chair or designated reviewer.

An expedited reviewer may choose to request full IRB committee review if there are concerns about risks determination and/or required safeguards for a vulnerable populations, or if the reviewer feels the protocol should not be approved. In these cases, a determination will be made at convened meeting of the IRB Committee.  

Studies submitted for expedited review require completion of the Prisma Health IRB Application within IRBNet, in addition to submission of the protocol, consent forms, surveys, advertisements and other relevant documents, and are reviewed in accordance with all relevant IRB approval criteria (45.46.111).

Please refer to the Policies and Guidance page for an IRB guidance document on the Expedited Review Categories. For HHS guidance on expedited review and what constitutes minimal risk, click here. The specific categories of research that can be expedited are found here. Please note that there are different definitions of risk for studies involving women, human fetuses, and neonates and for studies involving children. New studies submitted for expedited review can be submitted at any time and are processed in the order received.

Review by a convened IRB committee meeting is required in the following situations:

• Research that does not meet any of the expedited review criteria as defined by one or more of the definitions published in the Common Rule or FDA IRB Regulation. Federal Regulations do not define “greater than minimal risk”, only minimal risk.
• Research that an expedited reviewer feels does not meet criteria for approval
• Research where local policies require full board review

The IRB assigned reviewers and full committee will verify that all the required, relevant approval criteria are met prior to issuing full approval.

The IRB Committee may determine the following:

• Full Approval of the submitted protocol, consent form, and any study residuals submitted for review
• Modifications Required
  • Substantive changes will require the changes be reviewed by the full committee
  • Non-substantive changes may be reviewed through expedited procedures
• Defer action/determination pending the provision of additional materials or modifications
• Disapproval of the submitted protocol

The IRB may approve a study for a period of no longer than one year. Based on determinations by the committee, the approval period may be for a shorter period. When this is the case, justification of the shorter approval period will be provided.

IRB Committee Meetings and Deadlines

To continue a study beyond the period for which it was initially approved, a Continuing Review package must be submitted. Studies that require Continuing Review will receive email notifications 60 days and 30 days prior to expiration via IRBNet. Continuing Review Submissions should be submitted prior to the meeting deadline in order to be reviewed prior to study expiration.

A Single-Use Investigational New Drug is used when a physician would like to request an Investigational New Drug (IND) application to use an unapproved drug or other product for a single patient for Compassionate or Emergency Use. Please reach out to the IRB for further instructions.

Compassionate Use of an investigation drug or device involves several steps, including prospective IRB review. Once a physician has identified an experimental treatment to try, the physician will ask the pharmaceutical/biotech company if it will provide its experimental product to the patient outside of a clinical trial. If the company agrees, the proposed treatment plan goes to the FDA for review. The FDA ensures that the proposal relies on sound medical reasoning and will not cause undue harm to the patient, and it makes any necessary revisions to the treatment plan. If the FDA allows the request to proceed, the IRB must approve the plan before the investigational agent can be administered to the patient.

Emergency use (EU) is defined as the use of an investigational drug or biological product with a human subject in a life-threatening situation in which no standard acceptable treatment is available and in which there is not sufficient time to obtain IRB approval [21 CFR 56.102(d)]. The emergency use provision in the FDA regulations [21 CFR 56.104(c)] is an exemption from prior review and approval by the IRB. The exemption, which may not be used unless all of the conditions described in 21 CFR 56.102(d) exist, allows for one emergency use of a test article without prospective IRB review.

If the strict emergency use requirements are not met, both the physician and the institution may suffer strong sanctions.

• Physician noncompliance may result in termination or suspension from treating patients in any and all FDA-regulated studies.
• If the institution fails to provide guidance to physicians and to establish clear procedures, the institution’s ability to conduct FDA-regulated research may be restricted.

To help physicians comply with emergency use regulations, the IRB determines whether each use complies. Most often, this is done when the physician discusses the proposed use with an IRB Chair or Vice Chair before the patient is treated.

For both the emergency use itself and for a waiver of consent (if applicable), the IRB will issue a letter certifying compliance or informing the physician of noncompliance. In the case of noncompliance, the IRB will follow its usual procedure to determine whether the noncompliance is a serious or continuing problem requiring additional action.

For more information regarding Expanded Access projects, please visit the FDA website here.