When is a protocol officially closed?
The procedure differs depending upon whether the study is minimal risk or higher. In cases where the project is minimal risk or less, protocol closure may occur when the research is permanently closed to enrollment of new participants, all participants have completed all research-related interventions, and the research has progressed to data analysis, including analysis of identifiable private information or identifiable biospecimens. Data analyses should allow the investigator to conclude with reasonable certainty that there are no further impacts from the study on the participants. If the investigator has stated in the protocols or informed participants that identifying information, which could be linked to participants, this deletion must be made prior to closing a protocol. Note that a protocol closure does not affect an investigator’s ability to write articles or publish. Should the investigator decide future contact is needed with the participants or collect additional data, they must notify the IRB.
Transfer of Ongoing Research to UMBC
Previously approved IRB approvals cannot be directly transferred to UMBC. When leaving a current institution and bringing the entire protocol to UMBC, a PI will need to submit an UMBC Kuali Protocols application for review by the IRB. More than likely, the prior IRB protocol will close out. Therefore, a protocol closure report from the prior institution should accompany the UMBC IRB application. Upon UMBC IRB approval, the research may continue. Additionally, if a current PI and any collaborators at the prior institution plan to participate together (be “engaged” in the research), a reliance agreement spelling out the roles and responsibilities of each institution may be in order. Review the IRBs Reliance Agreements page for more information.
Transfer a Study to Another UMBC Investigator When Leaving the University
When a PI leaves UMBC, they should close their protocol(s) in Kuali Protocols or submit an Amendment to transfer the protocol to another UMBC PI. Transfer of a study to a different PI is considered a modification to the study and will require IRB review and approval. Then, that “new” PI would submit appropriate changes to consent forms, advertisements, etc. via an amendment to the IRB for review. This transfer must occur before the current PI leaves the university. Please refer to the Lab Close Out procedures below. If not submit, study procedures may not be performed by any remaining study personnel, including obtaining consent, review and analysis of study data or other Kuali Protocol functions.
Transfer a Study to Another Institution When a UMBC is Leaving the University
If study activities are not complete but the PI will be continuing his or her work at the new institution, then the IRB at the new institution will need to approve the study. Depending on the institutional requirements, the study consent forms, recruitment materials, etc. may need to be altered before receiving approval. Once the new institution has approved the study, then the PI should follow the Data Use Agreements process to receive approval for transferring data. If specimens are involved, a Material Transfer Agreement may also be necessary. Once the above processes are complete, submit a closure report at UMBC.
Lab Close Out
PIs are responsible for following UMBCs Separation check list on lab close-out. If the research involves the disposition of his funding award, pending proposals, or final reports for work, refer to the Office of Sponsored Programs Financial Extramural Award Closeout Procedures for Contract and Grant Accounting. The transfer of data or specimens to another institution would require the creation of a data use and/or materials transfer agreement. Refer to OSPs Data Use Agreements page for guidance.
Submitting a Closure Report
A Closure Report must be submitted using the Kuali Protocols Portal within 30 days of receiving a notification. Protocols with an exemption determination are not required to submit a closure report; the ORPC, however, may follow up with investigators to determine if protocol activities are complete. The Kuali Protocol User Guide has a searchable table of contents to the specific sections of Guide to assist you in creating this report.
In the Attachments Section, upload copies of any results, reports, articles (etc.) deemed necessary to support the closure of the protocol.
Students completing research for their independent studies, thesis or dissertation must, upon completion of the project activities (as defined above) prior to leaving the university. Faculty advisors for student research have the obligation to ensure that the Closure Report is filed with the IRB in a timely fashion.
Retention of protocol files
As stated in the IRBs protocol files guidance, records associated with human subjects research are subject to federal and UMBC record-keeping requirements. When an investigator leaves UMBC, a copy of the protocol record must remain on campus. The protocol file guidance provides a list of all items required for the record. Students investigators – coordinate storage of research records with your faculty advisor(s) and/or departments.
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
Reopening a closed protocol
On occasion a principal investigator may make a request to the IRB to reopen a closed research study in order to continue with the research.
To reopen the study, investigators must submit should a new protocols using the Kuali Protocols Portal. Upload all consent documents, measures, recruitment fliers, etc. that accompany a human subjects research protocol. In addition, upload a brief cover letter to the IRB Chair requesting that the study be re-opened. The following information must be provided:
- an assurance that no participants have been enrolled during the time the study was not approved, that data collection during this unapproved time was discontinued and this is a continuation of the same study
- details of all pertinent information as to why this needs to be re-opened
- any amendments or changes in the study protocol, personnel, or consent documents (using the previously approved format)
- any documents relating to unanticipated events (i.e. Adverse Events)
- if participants need to be notified, indicate how this will be accomplished and by whom. Provide any documents—letters, email notifications, etc.
Requests to reopen a study must be made within 30 days of a protocol closure.
Note:
Investigators may conduct data queries after closure without reopening the study. Such queries occur without IRB approval if both of the following apply:
The data being queried is limited to that originally collected for the study as specified in the consent and authorization forms signed by subjects and/or the study protocol. No new data may be collected after study closure without prior IRB approval
AND
The data being queried is limited to the original timeframe during which data was collected for the study. No data outside the original timeframe for data collection can be queried after study closure without prior IRB approval.