Most amendments may be approved administratively or may be handled through the expedited review process. Please review the below definitions to determine what type of change you wish to pursue. Any proposed change to an already approved human subject research protocol, measures, or informed consent document during the period of IRB approval must be submitted using your Kuali protocols dashboard. The OPRC has created a Kuali Protocol User Guide to assist you this action.
An investigator cannot initiate the procedures/changes stated in the amendment until IRB approval has been obtained. Investigators are encouraged to contact the ORPC (compliance@umbc.edu.) with any questions.
Examples of minor amendments (administratively approved)
- Minor editorial changes to recruitment procedures, recruitment materials or submission of new recruitment materials to be used in accordance with approved recruitment methods
- Minor editorial changes to study documents such as surveys, questionnaires or brochures
- New study documents to be distributed to or seen by subjects that are similar in substance to those previously approved
- Changes in participant compensation or the amount subjects are paid or compensated that are not significant enough to affect the risk/benefit ratio of the study
- Decrease in the number and volume of sample collections as long as they do not negatively alter the risk/benefit ratio of the study
- Editorial changes that clarify but do not alter the existing meaning of a consent document
- Addition of or changes in study personnel
- Addition of a new study site (with applicable new site IRB approval)
- Translations of materials already reviewed and approved by an IRB
Investigators will be notified of approval of requests for minor amendments in approximately one (1) week following submission.
Examples of major amendments (will require Expedited or Full Board approval)
- Changes that adversely affect the risk/benefit ratio of the study or specifically increase the risk to subjects
- Changes in inclusion/exclusion criteria that impact the risk/benefit ratio of the study
- Significant changes in study design, such as the addition of a new subject population or the elimination of a study arm
- New risk information that is substantial or adversely affects the risk/benefit ratio of the study
- Significant changes to the study documents to be distributed to or seen by subjects
- New study documents to be distributed to or seen by subjects that include information or questions that are substantively different from materials already approved by the IRB
Investigators will be notified of approval of requests for major amendments following the completion of the Expedited or Full Board review process.
Exempt Protocols
Amendments to exempt studies do not need review unless the change would make the study non-exempt.
Note about changes to informed consent
Federal regulations (46.116) do not require reconsenting of subjects who have completed their active participation in the study, or of subjects who are still actively participating, when the proposed change will not affect their participation. However, when changes do occur in the conditions or the procedures of a study which alter how consent was previously obtained, the investigator should once again seek informed consent from the subjects. Those subjects who are presently enrolled and actively participating in the study should be informed of the change and reconsented if it might relate to the subjects’ willingness to continue their participation in the study. If reconsenting in necessary, requests must be submitted by accessing the Kuali Protocols Portal. Upload the Addendum to Informed Consent in the Attachments section.
Click to download the Addendum to Informed Consent Form
Have a Kuali technical issue or problems with access? Contact the ORPC on this online form and we’ll send your issue to VPR Research Administrative Systems