The Human Research Protection Office (HRPO) is fully functional and operating at normal capacity. We expect this to continue even if the university further suspends on-site operations for purposes of decreasing COVID-19 transmission.
For Human Subjects Research, the Tulane HRPO is giving highest priority to all inquiries, requests, applications, and modifications related to COVID-19. It should be clear in these requests to the HRPO/IRBs, that the inquiries or submissions are related to COVID-19. Contact the HRPO at firstname.lastname@example.org or 504.988.2665.
In-Person Interactions with Study Participants
The Tulane Office of Research recommends screening research participants for possible exposure or symptoms of illness related to COVID-19 before they are scheduled for any study-related visits and in-person interactions. The Research Study Screening Plan for COVID-19 issued by the Tulane SOM is available at https://medicine.tulane.edu/sites/medicine.tulane.edu/files/pictures/Clinical%20Studies%20Screening%20Access.pdf. This specific screening procedure does not require IRB approval.
Additionally, researchers should adhere to the following:
Some clinical studies require in-person study visits to conduct safety monitoring of the participants. For example, participants in a drug treatment study may need to have regular examinations, interviews, or laboratory tests for specific possible side effects. Researchers should plan for alternatives to in-person monitoring visits, if possible. For example, interviews could be conducted by video conferencing (such as Zoom), telephone, and/or email. Information for using the university’s Zoom subscription is available at https://it.tulane.edu/zoom-video-conferencing.
Visits to participants’ homes might be an alternative location for examinations or specimen collection. Consider whether the schedule of monitoring could be safely modified or delayed. Consider consulting with clinical trial Sponsors to seek clarity for which tests can be deferred. Investigators may decide to modify study procedures to replace in-person study visits with “remote” options for questionnaires, surveys, check-ins, screening, and consenting. These modifications should be approved in advance by the IRB, except when necessary to eliminate apparent hazards to a participant and there is not sufficient time to obtain IRB approval. Should it become necessary to implement changes to eliminate immediate apparent hazards, please report the changes to the Tulane IRB as soon as possible and no later than 10 business days, as outlined in the Reportable Event procedures described in Section 14 of the Tulane University Policies and Standard Operating Procedures for its Human Research Protection Program.
The Tulane HRPO staff are available for consultation on contingency plans for active research studies. Additionally, the Biomedical IRB is actively working with study teams seeking approval for research options for individuals who test positive for COVID-19. Please contact the HRPO at email@example.com or 504.988.2665.
Single Patient Emergency Use
The procedure for Single Patient Emergency Use of an experimental drug or device remains the same during the COVID-19 pandemic. Refer to Section 13.8.3, "Emergency Use,” of the Tulane University Policies and Standard Operating Procedures for its Human Research Protection Program.
The Tulane HRPO and IRB are ready to assist researchers who are planning COVID-19-related activities that may intersect or overlap with public health authority activities and/or U.S. Food and Drug Administration (FDA) emergency authorizations for diagnostics. In some cases, IRB approval will not be required. The Tulane HRPO can assess the circumstances, provide advice, and issue determination letters (if warranted). Contact the Tulane HRPO at firstname.lastname@example.org or 504.988.2665 for additional guidance.
Some studies are voluntarily halting participant enrollment or participation due to the COVID-19 pandemic. For studies (industry sponsored or otherwise) where implementing this safety measure might impose additional concerns resulting in failure to meet study milestones, missed visits that would result in protocol deviations, etc., this should be reported to the IRB as soon as possible and no later than 10 working days as described in the “Reportable Event” section of the Tulane University Policies and Standard Operating Procedures for its Human Research Protection Program. Be certain to describe how any actively enrolled participants will be managed, particularly in regards to any safety monitoring/follow-up. If this affects more than one study, a separate Event Report must be submitted for each affected study. All communications to and from sponsors regarding halting or changing protocols should be submitted to the IRB as part of the Event Report. Note, the IRB does not need to be notified of these changes with regards to minimal risk research, where halting participant enrollment or participation would not result in additional safety concerns. However, if a study will be paused indefinitely due to COVID-19, the PI should consider any reporting obligations to federal funding agencies (e.g. NIH), industry sponsors or other private funders, and participants.
Per additional guidelines issued by the School of Medicine on March 16, 2020, for researchers who need to submit research amendments to the Tulane IRB as a result of COVID-19 and do not have resources available, the Clinical Trials Unit (CTU) will prepare submissions for the IRB changes at no cost. Researchers who need to submit changes to Clinicaltrials.gov can also utilize the CTU free of charge. Please contact the CTU at CTU@tulane.edu for questions and assistance.
ClinicalTrials.gov Registration Updates
Some studies registered at the federal site ClinicalTrials.gov are modifying their research procedures to include testing for and/or assessment of COVID-19 symptoms. The ClinicalTrials.gov information for the study should be updated to include these new procedures if they are done for research purposes. If they are being added as public health surveillance activities in coordination with public health authorities, the registration information does not need to be modified. The federal requirement about modifications is that any research-related changes that are communicated to the subjects (past, ongoing, future) must be added to the study’s ClinicalTrials.gov registration within 30 days after IRB approval of the modification.
While the university’s research operations are continuing, researchers are to take preventative measures including social distancing for purposes of decreasing COVID-19 transmission. The situation is fluid, so researchers should plan ahead in the event that laboratories need to ramp down or temporarily cease operations.
Researchers should have emergency plans in place to be able to conduct research visits via telephone or video conferences (such as Zoom) and to be prepared should Tulane Medical Center and clinic facilities need to prioritize access for treatment of COVID-19 patients. Researchers are to review their emergency plans to tailor them to the current COVID-19 pandemic, and researchers should review and practice using their emergency preparedness plans with their research team.
Please evaluate your clinical research activities and determine what actions you may need to take if there would be a reduction in available staffing/research team members. Some things to consider include:
Review plans for maintaining continuity of operations such as:
It is an investigator's responsibility to ensure that all of their study personnel (faculty and staff) receive appropriate training regarding proper screening for COVID-19, triage procedures for positive screens and proper use of personal protective equipment.
All research staff should self-screen before coming to Tulane facilities and are required to have IDs visible at all times.
The Tulane University School of Medicine (SOM) has issued Research Operations Guidelines as of March 12, 2020, which are available at https://medicine.tulane.edu/sites/medicine.tulane.edu/files/pictures/SOM%20Research%20Operations%20Guidelines_COVID19.pdf and include the following:
Administrative and regulatory aspects of all clinical research studies, including studies that are in process, should continue. Clinical research patients and volunteers should be prescreened for COVID-19 risk factors with the same questions being used to prescreen patients at our clinics and hospitals. If patients are screened as positive, they should be offered a mask and recommended to see their primary care provider. Coordinators are encouraged to reach out to CROs to discuss COVID-19 protocols as needed. Study monitors from out of state should not be allowed on-site; remote monitoring, if possible, should be implemented.
The SOM Research Study Screening Plan for COVID-19 is available at https://medicine.tulane.edu/sites/medicine.tulane.edu/files/pictures/Clinical%20Studies%20Screening%20Access.pdf. Check https://medicine.tulane.edu/faculty-covid-19-information for updates specific to the SOM. Additionally, other affiliated medical centers, such as Children’s Hospital of New Orleans, have issued their own requirements as to COVID-19 for research at their facilities, and researchers should comply with such requirements at each site.
The Office of Research issues this additional guidance for research activities across the university, in particular Human Subjects Research that is subject to review and approval by the IRB. Please note that these are the current recommendations and guidance. As COVID-19 issues evolve, these are subject to change.
Required changes to research practice based on the coronavirus will be posted on the Office of Research website, https://research.tulane.edu/. Please check the website frequently if you are interacting with research participants.
Tulane University COVID-19 website (information, FAQs, and current recommendations): https://campushealth.tulane.edu/health-center/primary-care/infectious-disease-care/coronavirus-covid-19.
Tulane University President’s announcements on university actions as to COVID-19: https://tulane.edu/tulane-university-moves-online-instruction-cancels-large-events.
Additional guidelines issued by the Tulane School of Medicine are available at https://medicine.tulane.edu/research-covid-19-information.
Recommendations from the Centers for Disease Control (CDC): https://www.cdc.gov/coronavirus/2019-nCoV/index.html.
Federal Wide Assurance #: FWA00002055
The primary goal of the Tulane University Human Research Protection Office is to balance the protection of human subjects while promoting and facilitating the research enterprise, and to maintain an open and cooperative relationship with the research community.
Tulane University is mandated to provide the US Department of Heath and Human Services (DHHS) with a formal assurance that it will follow procedures designed to assure the protection of all human subjects involved in research projects conducted at Tulane and elsewhere by faculty, staff, or other representatives of Tulane in connection with their institutional policies.
To this end, Tulane University has established two Institutional Review Boards (IRBs), one Biomedical and one Social Behavioral, to examine and approve research projects involving human subjects. The IRB members are chosen from within the research University and the outside community to represent a variety of scientific and non-scientific disciplines. While it is the role of the IRB to determine that the rights and welfare of human research subjects are protected, the investigator bears the primary responsibility for following the approved research protocol and meeting standards established by federal regulations and the IRB.
Before a research project involving human subjects is initiated, it must first be reviewed and approved by the IRB, then conducted according to the guidelines set forth by the FDA. This compliance is a crucial element of the IRB process, because it is the collective effort of individual investigators in this area that ensures the integrity of the University as a research institution.
Tulane University HRPO
1440 Canal Street, Suite 1705, TW-8436
New Orleans, LA 70112