Updated April 22, 2020 2:34 pm
The interruption of research compliance oversight operations may cause the Office of Research Protections and Compliance (ORPC) to be unable to immediately process protocol submissions or respond to issues related research studies. These interruptions may be of varying scope, severity and duration may last hours, days, weeks, or months.
In considering the timing of recovery from a disruption, the goal is to be able to return to normal operations as soon as possible. In the event UMBC campus is closed and ORPC staff cannot come to campus, staff will review email during the campus downtime period. During campus closures, the ORPC requests that all questions or requests be forwarded to email@example.com. The office telephone line, 410-455-2737, will be monitored during this period as well.
All staff members have access to the compliance email box and will act upon requests and questions. Staff members will also use conference calling environments to collaborate on compliance concerns to better respond to investigators. Chairs of compliance committees are available via email or text in the event staff members need to contact them immediately during closure events. The ORPC staff will have the ability to connect to the Kuali system to review and process protocol submissions as well as other databases and document folders found in Box.
IRB, IACUC and IBC protocols
New human subjects research (IRB), animal use (IACUC) and biosafety/biohazardous material use (IBC) protocol applications will be processed following ORPC protocol processing procedures. The ORPC will forward new protocols to reviewers per the specific committee review process. Amendments to or modification of currently approved research will also follow the above processing procedure. ORPC staff will maintain contact with reviewers to ensure appropriate of research and return committee decisions to investigators as timely as possible. Communication of review questions and concerns or approval of protocols with investigators will be accomplished via Kuali and by using email.
Laboratories with biohazardous materials should follow UMBC Envrionmental Safety and Health (ESH) guidelines and requirements. Contact ESH staff for proper storage and potential disposal of materials when campus facilities are closed.
Principal investigators are expected to submit continuing review reports to the applicable compliance committees as stated on original approval documents. In the event protocols will close during campus downtime. ORPC staff will acknowledge and process closure reports upon receipt to officially conclude that protocol.
Unanticipated problems or adverse events must be submitted during campus downtime to the ORPC as soon as they occur. This requirement may differ from stated compliance committee procedures on the respective web pages. But, due to the ORPC staff not being available on campus, it is incumbent for principal investigators to submit promptly so that the ORPC staff can contact committee members for review of the specific issues and/or concerns.
IRB protocol guidance:
Current UMBC lab facilities are not available for conducting in-person interviews, focus groups or other participant interactions. A PI may plan is to conduct research during the current COVID-19 event at non-UMBC venues (such as libraries, workspaces on conference rooms) but are reminded that such venues will not be able to provide space for the recommended social distancing. The ORPC recommends the PIs to use telephone or virtual/online formats, such as WebEx, to interact virtually with and/or conduct interviews with participants.
The UMBC Department of Information Technology (DoIT) recommends using online conferencing tools that would provide security and confidentiality which would meet the IRB’s requirements for maintaining privacy and ensuring confidentiality. Remember, these are requirements stated in an approved IRB protocol. DoIT supports the use of WebEx for UMBC investigators to use for online conferencing. DoIT has certified it up to level 3 (see the IRBs guidance on security requirements), which means it is good with all data types (including HIPAA). DoIT has several FAQs and instruction guides posted to assist investigators if there are plans to add to a protocols.
Research activities that do not involve face-to-face interactions with human research participants (e.g., analysis of previously collected data) may continue following data security provisions stated in the protocol.
The IRB encourages investigators to use the Consent and Assent Guidelines to create the process and forms to appropriately consent persons for interview and focus group protocols. The IRB also recommends PIs view the UMBC WebEx Wiki for instructions to establish video conferencing with participants. Remember, if an investigator plans to add a platform such as WebEx use to an existing protocol and consent/assent document (where not previously stated), please be sure to forward a protocol modification and have it approved before using.
Investigators using animals in research must work with facility managers ensure there is adequate animal caretaker personnel for appropriate feeding and husbandry care during campus downtime. During a campus shutdown, investigators whose experiments in progress should continue only if considered essential. Follow IACUC approved caging and breeding procedures. No new experiments should start or breeding conducted unless considered essential to the research.
Please follow UMBC Procurement’s requirements (see email from Elizabeth Moss on March 18, 2020) for placing orders for new animals reagents and supplies; such purchases should be limited to those instances considered essential. Be prepared that such items may be on backorder, or unavailable, or delivery delayed or suspended. Even if research procedures cannot be conducted during a campus closure, animal care must continue. Facility personnel and animal users must be familiar and cross trained with facility and UMBC’s procedures in the event of a campus closure.
Emergencies, accidents, and injuries can occur at any time, without warning. The ability to respond to emergencies is a responsibility of the UMBC community to prepare for, respond to, mitigate and recover from various critical incidents, major events, emergencies, or disasters that may affect lives, property, and the institution of UMBC. (UMBC Emergency Response Plan, 2019).
The Guide for the Care and Use of Laboratory Animals as well as the Office of Laboratory Animal Welfare describe the requirements of disaster planning as well as offer resources for institutions such as UMBC to take into account the well-being of animals and personnel during unexpected events.
Facility personnel and animal users should be familiar with UMBC’s procedures in the event of emergencies. Principal investigators, facility managers, animal caretakers have shared responsibilities to follow facility standard operating procedures of appropriate husbandry and health monitoring of research laboratory animals. The UMBC attending veterinarian is available any anytime with questions or concerns. Any variation to the status of animals must be reported immediately to the veterinarian and the IACUC.
Additional resources can be found on the UMBC Environmental Safety and Health webpage, the UMBC Human Resources site as well as the disaster plan response for animal facilities in the 2011 UMBC Emergency Response Plan.
Use of Electronic Data
Data collected electronically for analysis and sharing with collaborators from human subjects research, electronic information subject to U.S. Export Control regulations and/or data subject to non-disclosure agreements, confidentiality agreements and data use agreements will be reviewed during a campus closure.
Investigators would continue to ensure that security requirements from a data sources are explained in an IRB application or in a request for export control review. Data use agreements will be reviewed by established processes from the Office of Sponsored Programs. The Department of Information Technology (DoIT) needs to be contacted in any instance where an assessment of the security risks is required before gaining access or taking custody of the data.
Key personnel identified in proposal submissions or in new awards will submit financial conflict of interest (COI) disclosures will be submitted via Kuali COI. Annual or other timely updates of COI disclosures are also submitted via Kuali. All disclosures will be processed following ORPC procedures.
Export Control Management
The ORPC staff requests faculty to forward export control questions to firstname.lastname@example.org. Questions and concerns will be acted upon accordingly and the ORPC staff will contact members of other VPR offices (e.g., OSP or OTD) during campus downtime to discuss questions of requests. If there is a requirement to create Technology Control Plans (TCPs), ORPC staff will contact faculty to review requirements to create TCPs and forward them to the Associate Vice President of Research for review and approvals.
Departments considering international visitor requests will need to contact International Education Services (IES) to determine if and when they have the ability to consider such requests. Departments who plan to host visitors can contact the ORPC staff and request they perform restricted party screening that may allow departments to move forward with such requests when the campus re-opens.
Other requests or concerns
As stated above, the goal of the ORPC is to be able to return to normal operations as soon as possible. During campus closures, the ORPC requests that all questions or requests be forwarded to email@example.com. Reports of complaints or concerns may be submitted to firstname.lastname@example.org, the OPRC telephone line (410-455-2727) or online in the ways listed below.
UMBC personnel may send feedback or ask questions through an online form
Anyone can send an anonymous submission via this form