Amending approved research
Requirements
The IRB must review and approve all changes to previously approved research prior to implementing the change. Amendments to Human Research include any change from what was previously approved, including but not limited to: title, key personnel, study procedures, recruitment text or locations, data collection measures, or eligibility.
The only exception to this policy is when a change is needed to eliminate apparent immediate hazards to human subjects. If this occurs, then the IRB must be notified within five (5) days as outlined in the HRPP Guidance, Reporting Local Information.
Level of review and type of amendment
Full committee review: Amendments that do not meet the regulatory criteria for expedited review must be reviewed by the full committee at a convened meeting. Researchers should allow approximately a month for a full committee review and approval of a major amendment.
Expedited review: Amendments that meet the criteria for expedited review will be reviewed by a chair or chair designee according the expedited review procedures. Researchers should allow at least a one week for an expedited review and approval of a minor amendment reviewed by the expedited process.
Protocols initially approved by expedited review that may be reviewed as expedited
- The amendment continues to pose no more than minimal risk to subjects
- The amendments do not involve any procedures that do not meet Expedited categories 1 through 7
Protocols initially reviewed by full committee review that may be reviewed as Expedited
- Amendments do not pose an increased risk to subjects, AND the amendment constitutes a minor change
- Any added procedures that fall within expedited categories 1 through 7
Amendments that do not fulfill the above criteria may require full committee review.
Examples of minor changes (generally reviewed via expedited review) and major changes (generally reviewed by full committee):
Minor changes
- Typographical, format, and grammatical changes to previously IRB-approved documents (NOTE: These changes cannot change the meaning or intent of the previously approved language)
- Updates to contact information (not for PI changes)
- New recruitment tools using IRB approved language
- Translations to documents where the English version is IRB approved
- Adding site authorization for research site
- Minor changes to study documents such as surveys, questionnaires, or brochures
- New study documents to be distributed or seen by subjects that are similar in substance to those previously approved
- Changes in payment to subjects or the amount subjects are paid or compensated that do not affect the risk/benefit ratio
- Decrease in the number and volume of sample collections as long as they do not affect the risk/benefit ratio
- Addition/changes to study personnel
Major changes
- Changes that adversely affect the risk/benefit ratio of the study or specifically increases risk to subjects
- Changes in inclusion/exclusion criteria that impact the risk/benefit ratio
- Significant changes in study design, such as the addition of a new population or elimination of a study arm
- New risk information that is substantial or adversely affects the risk/benefit ratio
- Significant changes to study documents to be distributed or seen by subjects
- New study documents to be distributed to or seen by study subjects that includes new information or substantially different information from materials already approved
- New or revised financial conflict of interest management plans
Investigator responsibilities
An investigator must submit to the IRB the requested change, justification for the change, and all revised documents for review. Amendments may not be implemented until after IRB approval is received, unless to eliminate immediate or apparent hazard to subjects which must be reported to the IRB within five (5) days. When revising documents, please use tracked changes to help facilitate the review process.
See HRPP Guidance, Exempt Research, for information if the Human Research project was deemed to be exempt.
Only one amendment, per project, may be submitted to the HRPP at a time for review and approval. Once you have received approval for a submitted amendment, a new amendment may be submitted for review. Please contact the HRPP if you have an issue that needs immediate attention. Investigators can submit multiple changes on one document.
Emergency deviation from an approved IRB protocol
If a deviation is required to eliminate an apparent immediate hazard to a research subject or group of subjects, then the researcher should make whatever changes are needed to protect the safety and welfare of the subjects and may do so without prior IRB review. However, a reportable problem report must to be submitted within five days of the change.
Anticipated deviation from the approved protocol-single subject exceptions
If an investigator anticipates the need to deviate from the previously-approved protocol for a particular subject, the investigator should submit a request for amendment for prior IRB approval of the deviation.
Two examples of the most common sorts of these requests are to change the schedule of the procedures or to waive an inclusion or exclusion criteria for one subject. The following information will be requested:
- Whether the sponsor has approved the request for a protocol exception for this subject, and to provide any documentation from the sponsor of their approval
- A description of the protocol criteria for which the Principal Investigator is seeking exception, and an explanation why the requested exception is appropriate or necessary
- Whether the exception increases the risk or lowers the potential benefits for the subject
- Whether an amendment will be submitted to reflect the protocol exception for future subjects
- Whether the current informed consent document adequately covers the exception, and if not, a revised consent form is requested
Updated protocols
The IRB is required to review the protocol, in its entirety, to continue to determine that the elements for approval are met. The protocol should be updated regularly so that a current protocol document exists. For sponsored research, a separate protocol is usually updated and supplied by the sponsor of the research throughout the course of the research. Frequently for social and behavioral researchers or for investigator initiated studies, the IRB application may be the actual protocol document that is used by researchers to conduct the study.
The IRB understands the logistics of continually updating protocols for each and every change made. Therefore, the IRB has instituted the following requirements for making revision to protocols during the course of the research activity:
- The IRB will use submitted amendments during the course of the approval period, and the last updated protocol submitted, to determine if the approval requirements in 45 CFR 46.111 have been met.
- The IRB will require that at least every five (5) years, the protocol (which may be the IRB application, or maybe a separate protocol document) be updated to reflect all changes made over the course of the five years, If an updated protocol has not already been submitted in that time period via an amendment.
- The IRB may require, at its discretion, more frequent updates to the protocol if the changes to the protocol are extensive.
Version 2019-8