COVID 19- Guidance

 

Guidance and Announcements

Guidance and announcements on Coronavirus Disease 2019 (COVID-19) will be posted and updated on this page as new information from sponsoring agencies and the University become available. Please contact your OSP Specialist who will provide guidance in case you can't meet a proposal deadline. FAQs and SBU's up-to-date information can be accessed here.

 

  • NEW: Guidance from SUNY/RF Central Office available here

 

  • The RF is working with SUNY to provide up-to-date information on the 2019 Novel (New) Coronavirus. Their website includes information on what you need to know

 

  • The Office of Proposal Development has created a webpage that includes funding opportunities specific to COVID-19. The information can be accessed here, and will be updated as new opportunities arise.

 

  • Brookhaven National Laboratory released a COVID-19 letter to subcontractors and vendors that support the efforts at BNL. Click here to read the letter. 

 

  • In light of the unique circumstances presented by COVID-19 virus with respect to previously arranged travel reservations, OVPR offers the following guidance for travel on externally sponsored awards. (Posted by OSP on March 10, 2020)

 

  • Helpful Information for those using ADVARRA IRB Operations - Advarra IRB Operations Continue as Normal During Coronavirus Outbreak (Posted by OSP on March 11, 2020)

Advarra continues its standard practice of having 15 IRB meetings a week, and the IRB has been prioritizing the review of coronavirus protocols as well as amendments relating to changes in the conduct of the research because of unforeseen circumstances.

IRB meetings and processes are not impacted by any restrictions on travel. The IRB meets remotely via video conference technology, and Advarra staff have the resources and flexibility to work remotely. Read this news item for more information on IRB reporting and other recommendations for research conduct during this public health event.

Planning for Disruptions of Laboratory Operations

PLANNING FOR DISRUPTIONS OF LABORATORY OPERATIONS

CORONAVIRUS (COVID-19) PLANNING GUIDANCE

March 12th, 2020

As the University continues to plan and prepare for possible impacts related to the 2019 novel coronavirus (COVID-19), Principal/Senior Investigators and Laboratory Managers should develop plans for the possibility of disruptions to operations caused by absences, or unavailability of equipment, materials or supplies that are essential to assure safe operation.  

Please review the following list of things to consider and take appropriate action as applicable.
 

LABORATORY OPERATIONS AND COMMUNICATION

  • Update and post emergency contact information for key personnel (PI, Director of Labs, Building Manager, etc) on laboratory signage
  • Develop an Emergency Communications Plan for all lab personnel
  • Assess duties of key personnel and cross-train others as appropriate
  • Assess critical operations which require active monitoring or management
    • Avoid high-risk procedures/protocols if working alone
  • Unattended experiments should be discouraged
    • If unable to postpone, alternate contacts need to be posted at the fume hood
  • Develop plans for how to secure or suspend ongoing experiments if circumstances warrant it.
    • Shutting down sensitive equipment
    • Securing chemical, biological, and/or radioactive materials  
    • Close sashes on all chemical fume hoods, shut off gas valves, and close and lock laboratory doors before leaving
  • Develop plans for how to create more distance between workers in the lab
    • Plan for the possibility to conduct work remotely if necessary/applicable
    • Ensure staff understand how to use VPN services or are set up with access to shared Google folders for remote access
    • Consider varying work schedules to prevent overcrowding and to limit close contact
      between personnel
  • Plan for the care and maintenance of research animals
  • Avoid scheduling large meetings
  • Consider putting any new experiments on temporary hiatus
    • Single-use kits can be costly – assess whether there may be interruptions to an experiment rendering the kit useless
       

MATERIAL AND EQUIPMENT

  • Develop a plan for possible interruptions in supply and delivery of gases
  • Ensure there is an adequate supply of dry ice / liquid nitrogen for critical samples
  • Ensure adequate materials on hand to maintain cell cultures
  • If Personal Protective Equipment (PPE) such as respirators, gloves, lab coats, etc., are required for normal lab operations, ensure that an adequate supply is available. Respirators in particular are becoming harder to obtain
    • NOTE: IF THERE IS AN INADEQUATE SUPPLY OF PPE THAT IS REQUIRED TO PERFORM EXPERIMENTS, THEY SHOULD BE SUSPENDED UNTIL SUPPLIES ARE AVAILABLE.
  • Maintain an adequate supply of laboratory cleaners and appropriate disinfectants, as necessary
  • Core facilities and services may also be experiencing staffing issues, plan accordingly
     

HEALTH AND HYGIENE

The CDC recommends everyday preventive actions to help prevent the spread of respiratory diseases, including:

  • Wash your hands often with soap and water for at least 20 seconds, including after removing gloves, before leaving the laboratory, and after coughing or sneezing
  • Hand sanitizers are not a substitute for good hand washing practices but can be used when hand washing is not practical
  • Avoid touching your eyes, nose, or mouth with unwashed hand
  • Avoid close contact with people who are sick
  • Stay home while you’re sick and limit close contact with others
  • Cover up your mouth and nose when you cough or sneeze.
    •  Coughing/sneezing should be done into the crook of the elbow or tissue, which should be disposed of immediately
  • Keep things clean in your living space to avoid spreading the virus
  • Inform all staff if they have a fever, do not attend class or come to work. If they are experiencing any symptoms, please seek medical attention right away. They should call their healthcare provider first to alert them of their recent travel history and/or symptoms.
    • If they’re a student, they can make an appointment at Student Health; just call ahead at 631-632-6740 so they’re ready. 
  • Implement a program to disinfect common surfaces and touch points with 70% ethanol, 10% bleach, or an appropriate disinfectant registered with the EPA
    • Doorknobs, sink fixtures, freezer doors, fume hood sashes, telephones
  • Additional information about Environmental Cleaning and Disinfection can be found below.

 

MORE INFORMATION

The most current information regarding COVID-19 can be found on the websites listed below.  If you have any questions contact the EH&S Laboratory Safety group at LabSafety@stonybrook.edu

Stony Brook University’s Coronavirus Information
CDC’s Coronavirus Disease 2019 (COVID-19)
CDC Environmental Cleaning and Disinfection Recommendations

Updated Guidance for Laboratory Research Activities

UPDATED GUIDANCE FOR LABORATORY RESEARCH ACTIVITIES

March 18, 2020

Please review the guidance that was provided on March 12th to researchers about planning and preparations for possible disruptions to research activities due to the COVID-19 threat.  This document provides further guidance for researchers conducting laboratory-based research in all campus facilities. 

At the present time, essential laboratory-based research activities may continue, with the provisions noted below.  Non-essential research should be curtailed.  Principal investigators should be aware that SBU leadership, in consultation with SUNY and health officials, may determine at any time that curtailment of all research is necessary in any laboratory. Continuity of research operations must account for all current SBU guidance relating to essential and non-essential personnel and alternate work locations, and recognize that the health and safety of students, postdocs, and staff remain the highest priority. 

All Principal Investigators must create a research continuity plan for their lab and forward it to the department chair no later than Friday, March 20th.  The continuity plan should address:

ESSENTIAL ACTIVITIES

  • Identify essential operations (subject to review by the Chair and, if necessary, the Dean) needed to support ongoing experiments and research that would suffer a major impact if temporarily discontinued, such as loss of years of effort, data, or loss of a major investment.  Maintenance of essential equipment, cell lines and other essential samples, as well as care of research animals may also meet the criteria for essential operations. 
  • Curtail non-essential research projects and postpone initiation of any new experiments. 
  • Immediately develop plans for a lab shut down if so directed.

PERSONNEL 

  • Create a communication plan for lab personnel (including all students) and ensure its effective functioning.
  • Identify minimum personnel needed to ensure continuity of essential or high-priority research.  Ensure that lab personnel know their responsibilities.  Account for possible changes due to illness or inability to come into work.
  • Identify and encourage all opportunities for work at different locations (e.g., home), and ensure their remote access.
  • For personnel who must have some presence in a lab, implement social distancing and/or staggered work days/hours.  If applicable, account for high-risk activities (e.g., not working alone).  Maintain recommended hygiene and PPE usage.  Eliminate in-person group meetings; use on-line alternatives.

EQUIPMENT AND CRITICAL SUPPLIES

  • Establish usage and maintenance policies (including extra cleaning/disinfecting) for instrumentation, facilities, and common areas. 
  • Develop plan for shut down or standby operation of instrumentation if conditions or lack of supplies, reagents, or PPE require.    
  • Ensure that high-risk materials (biohazards, radioactive materials, hazardous chemicals) are properly secured.

HUMAN SUBJECTS AND ANIMALS

  • PIs must be aware of temporary changes to human subjects research described here.  Describe plans to curtail such research if so directed.
  • Prepare for continued animal care and access to DLAR facilities.

 

Each lab should begin implementing their research continuity plans immediately.  And please be aware that this guidance may be updated at any time.

Urgent Guidance for Laboratory Research Activities: COVID-19

March 20, 2020

 

Dear Stony Brook researchers,

In view of the announcement by Governor Cuomo today, and in an effort to protect the health and safety of Stony Brook students, staff, and faculty, all laboratory-based research activities must be ramped down by 5 p.m. on Saturday, March 21st.  The only exceptions will be critical activities, including care of animals, maintenance of unique reagents, and monitoring of essential equipment and materials.  Research that is directly related to COVID-19 may continue providing that health and safety guidelines are observed.  If a lab or core facility has a need for such critical maintenance, one person must be designated as essential with authorized access; there may be an additional person designated as a back-up.  We encourage PIs to share critical maintenance responsibilities where possible to reduce the number of personnel on campus.  The names of these individuals with essential authorized access must be provided to the Chair and Dean.  No other access to Stony Brook research laboratories will be permitted.  We will continue to assess the situation at regular intervals.  This document may be helpful for PIs as they ramp down their lab operations.

Faculty should direct their students and postdocs to continue research and scholarship (e.g., analyzing data, writing and reviewing manuscripts, preparing presentations, developing new grant proposals, convening online discussions with students and lab staff, etc.) at their home as best possible.  

Thank you for your cooperation and understanding.

Regards,

 

Rich Reeder 
Vice President for Research  

DOE Updates and Guidance

Posted by OSP on March 16, 2020

MEMORANDUM FOR APPLICANTS AND AWARDEES

FROM: CHRIS FALL DIRECTOR, OFFICE OF SCIENCE

SUBJECT: Accommodating Interruptions from Coronavirus Disease 2019 (COVID-19)

As the Department of Energy and Office of Science (SC) continue to monitor and examine the ongoing developments and impacts of the COVID-19 outbreak in the U.S. and internationally, we provide this update regarding associated disruptions that may have impacts on the research community. This guidance may be updated as circumstances change.

The Office of Science is assessing its current soliciations that have due dates that occur through mid-April to make a determination on extensions to those due dates. Please check the specific Funding Opportunity Announcement (FOA) or DOE Laboratory Announcement for the most up-to-date information.

A list of all FOAs and DOE Laboratory Announcements may be found at https://science.osti.gov/grants/FOAs/Open, and https://science.osti.gov/grants/Lab-Announcements/Open, respectively.

The Office of Science extends the following flexibilities to its applicants and awardees:

Applicants preparing a pre-application, letter of intent, or application:

If the lead principal investigator (PI) or the applicant institution are subject to a quarantine or a closure, deadlines for submitting pre-applications, letters of intent, or applications may be extended by no more than fourteen (14) days from the applicable due date. Please contact the Program Manager identified in the FOA or DOE Laboratory Announcement under which the pre-application, letter of intent, or application is being submitted prior to the applicable due date.

Awardees preparing progress reports:

If the lead principal investigator (PI) or the applicant institution are subject to a quarantine or a closure, deadlines for submitting pre-applications, letters of intent, or applications may be extended by no more than fourteen (14) days from the applicable due date. Please contact the Program Manager identified in the FOA or DOE Laboratory Announcement under which the pre-application, letter of intent, or application is being submitted prior to the applicable due date.

Awardees preparing progress reports:

If the lead principal investigator (PI) or the applicant institution are subject to a quarantine or a closure, progress reports for grants, cooperative agreements, and interagency awards may be submitted through the PAMS website at https://pamspublic.science.energy.gov as soon as practicable. Note that delays in submitting progress reports may cause unavoidable delays in continuation funding.

PIs from DOE National Laboratories should contact their program manager if there will be a delay in submitting progress reports.

Applicants and awardees preparing revised budgets or public abstracts:

If the principal investigator (PI) or the applicant institution are subject to a quarantine or a closure, revised budgets and public abstracts may be submitted through the PAMS website at https://pamspublic.science.energy.gov as soon as practicable. Note that delays in submission may cause unavoidable delays in making awards.

Awardees with changed travel plans:

The Office of Science will not consider changes to planned travel caused by the cancellation of meetings, quarantines, closures, or other public health measures to be a change in the scope of an award requiring agency prior approval. Rebudgeting funds that does not create a change in scope does not require agency prior approval.

If a meeting has been cancelled, awardees must follow their institutional travel policies to determine whether costs may be charged to an award. If institutional policy permits travelers to purchase nonrefundable items (airfare, lodging, or other) and does not require travelers to reimburse the institution for change or cancellation fees, such fees may be charged to an award. If institutional policy prohibits the purchase of nonrefundable travel or travelers are required to reimburse the institution for change or cancellation fees, such fees may not be charged to an award.

Please review the attached Q&As. You are encouraged to contact the Administrative Contact for the FOA/Laboratory Announcement or your Program Manager with any concerns or questions regarding your circumstances.

 

Questions and Answers (Q&As):

 

Q: The scientific conference my lab group was scheduled to attend has been cancelled. Can our costs be reimbursed?

A: Yes, if your institutional travel policy:

  1. Permits the purchase of nonrefundable travel, and

  2. Does not require reimbursing the institution for change or cancellation fees.

Priority should be on costs incurred by students and postdocs, not by their departments.

Q: My institution told all employees to work from home. May I request an extension to a deadline?

A: Working from home—while it may introduce some complications—should not make it impossible to complete work or meet deadlines. If closure or remote access orders by your institution has occurred within a week of the deadline, please contact your Program Manager.

Q: My Sponsored Research Office has been closed. How do I request a deadline extension?

A: Please contact your Program Manager and include a copy of the closure order or other official notification.

Q: My Vice President for Research, who customarily signs all applications, has been quarantined. What should I do?

A: Please work with your Sponsored Research Office to determine how your institution is handling the situation. If your institution has established delegations of authority or if your Vice President for Research is capable of electronic signatures, there should be no impact on your ability to submit an application. However, if submitting an application is impossible, please contact your Program Manager.

Q: Our postdoc was quarantined after visiting family overseas. Our experiment has fallen behind schedule. Will this delay impact our continuation funding?

A: Please explain the situation—without disclosing protected personally identifiable information—in your progress report. SC may need to modify an award to be a prudent steward of taxpayer funds by delaying access to continuation funds, but SC’s interest is in seeing the research results—even if it takes longer than originally expected.

Q: What information should I include in a request for a deadline extension?

A: Please include official confirmation of the closure, quarantine, or other incident that makes a timely submission impossible. An institutional declaration requiring staff telework, in and of itself, will not warrant a deadline extension. There must be further complications that make the original deadline impossible. Requests to extend a deadline must be made before the deadline. SC does not expect to support every request for an extension.

Q: May I submit a letter of intent, preproposal, proposal, or progress report before its deadline?

A: SC always encourages prompt and timely submissions. Progress reports may not be submitted more than one month before they are due.

 

DOE COVID-19 response team letter (released by DOE, March 12, 2020)

NASA Updates and Guidance

 

Memo to Contractors (Guidance Sent to Contractors, Subject to Change, 3/24/20)

COVID-19 Impact to NASA SBIR/STTR Program (3/20/20)

Assistant Administrator for Procurement Message on Coronavirus (3/10/20)

https://nasapeople.nasa.gov/coronavirus/ (Posted by OSP on March 12, 2020)

Other Sponsors Updates and Guidance

OMB Guidance M 20-17OMB is allowing Federal agencies to grant class exceptions in instances where the agency has determined that the purpose of the Federal awards is to support the continued research and services necessary to carry out the emergency response related to COVID-19. Further, agencies are reminded of their existing flexibility to issue exceptions on a case-by-case basis in accordance with 2 CFR § 200.102, Exceptions. The Administration will evaluate if these flexibilities should be extended to recipients whose operations have been adversely impacted in the emergency response related to COVID-19 at a later date. (Posted by OSP, March 19, 2020)

OMB Guidance M 20-18 - Managing Federal Contract Performance Issues Associated with the Novel Coronavirus (COVID-19) (Posted by OSP, March 20, 2020)

OMB Guidance M-20-11 - Administrative Relief for Recipients and Applicants of Federal Financial Assistance Directly Impacted by the Novel Coronavirus (COVID-19) (March 9, 2020)

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USAMRAA Guidance - Frequently Asked Question (FAQ) about COVID-19 (Posted by OSP, March 16, 2020)

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DARPA Guidance - Frequently Asked Question (FAQ) about COVID-19 (Coronavirus) for DARPA Performers (Posted by OSP, March 19, 2020)

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Department of Health and Human Services Guidance - Preparation for Potential COVID-19 Impact on Contract and Contractor Performance (March 14, 2020)

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Department of the Air Force (Sent to Contractors, Subject to Change)

Guidance on No Cost Extensions (3/26/20) 

Potential Contract Impacts due to Coronavirus (COVID-19) (3/17/20)

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Food and Drug AdministrationFDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic (Content current as of March 18, 2020)

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SAMHSA Guidance - 

COVID-19 Information for SAMHSA Discretionary Grant Recipients (3/24/20)

Frequently Asked Questions (FAQs) Related to COVID-19 for SAMHSA Grant Recipients (3/24/20)

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The Assistant Secretary of the Navy for Research, Development and Acquisition Guidance

(Intent and Direction) Engaging the Research and Development Industrial Base during COVID-19 (3/24/20)

 

BNL Update and Guidance

Brookhaven National Laboratory released a COVID-19 letter to subcontractors and vendors that support the efforts at BNL. Click here to read the letter. 

OVPR Travel Guidance on COVID-19

UPDATED as of March 13, 2020

Under further notice, all university-related travel, regardless of funding source, is strictly prohibited except for regional travel utilizing a personal vehicle. 
Travel can increase the risks of exposure to you and the community. Government restrictions and public health measures are changing fast. If you travel, those changes may make it hard for you to return to campus and resume activities.
Exceptions to this Advisory will be rare. A request for approval of regional travel or an exception to this advisory must be approved by the employee’s immediate supervisor, Vice President and Senior Vice President or Provost.  Travel to Brookhaven National Lab and to other SBU locations does not require pre-approval. Faculty, staff and students requesting this exception must use the pre-approval form located at: 

https://www.asa.stonybrook.edu/asa/ASAForms/Department/PROC/Document/PROCF0005.

Travel undertaken without the appropriate pre-approvals will not be reimbursed and other disciplinary actions may apply. 

POSTED on March 6, 2020

In light of the unique circumstances presented by COVID-19 virus with respect to previously arranged travel reservations, OVPR offers the following guidance for travel on externally sponsored awards.

This guidance reflects current information from federal funding agencies which indicates that award recipients should continue to follow all relevant policies and procedures and to apply these practices consistently. As new information becomes available, we will disseminate to our research community.

As a reminder all travelers are strongly urged to purchase refundable airline tickets when making travel arrangements, so that if or when a trip is cancelled, the only cost incurred would be the potential cancellation fees. Unused nonrefundable airline tickets cannot be charged to sponsored awards.   

If nonrefundable tickets were purchased, every effort should be made to obtain a credit for the cancelled travel with the respective carrier. If the airline carrier agrees to a credit, and an alternate directly related travel event can utilize the credit within the active award period, the cost can be included in the travel reimbursement request for that trip.  

If travel arrangements were made through Euro Lloyd, contact them immediately to determine what options may be available through their services.

In the instance where the respective carrier will not issue a refund or when a credit cannot be used for other related research travel, Principal Investigator's should seek approval for reimbursement from the sponsor, specifically from the financial official for their sponsored award.  This approval from the sponsor should clearly articulate that the charges for the cost of tickets and/or associated fees related to the cancellation are allowable.  

If after taking each of these steps you do not have a solution, please Sheila Routh directly with the specific travel details and outline of unresolved costs.

 

Human Subject Guidance on Covid-19

Question:

Is the Institutional Review Board at Stony Brook University operating as usual?

Answer:

The Stony Brook IRB continues to meet as scheduled via videoconference. All email addresses will continue to be monitored with the same frequency as typically provided. The main office number is being monitored regularly and any messages left on the main line will be returned.

 

Question:

What is the effect on the review of new studies?

Answer:

The Human Research Protection Program will continue to receive and review new studies. For studies that are approvable, but involve in-person interactions with study subjects and do not have the potential for direct benefit, the IRB will approve the study but with a stipulation that the study cannot begin enrollment until official guidance (e.g., government) states that social distancing is no longer necessary.

 

Question:

Which human subject studies should be placed on hold during the outbreak of the COVID-19?

Answer:

For studies in which there is no direct benefit to subjects or where there is subjects travel for research purposes (and no direct benefit), studies must be paused, effective immediately or as soon as can be implemented. Procedures such as telephone contact or monitoring or remote data collection, if part of such studies, may continue. 

Studies in which there is direct benefit to subjects may continue. If possible, these studies should be performed remotely. This would include the collection of safety data (based on the ability to detect potential adverse events). It is suggested that laboratory tests or imaging needed for safety monitoring occur at local laboratories or clinics.

 

Question:
Do I need to contact the industry sponsor if my research activities are placed on hold?
Answer:
Yes. If it is determined that your study will be placed on hold. However,  trials with investigational treatments, including drugs and devices, that provide the potential for direct benefit should continue.

 

Question:
What do I need to do to place my study on hold?
Answer:
Submit an amendment indicating which study components should be placed on hold and which will remain open. Provide a short statement of the risks and benefits in light of the COVID-19 epidemic.  The IRB will review each response and make a determination.

 

Question:
Can I continue to collect data and follow-up information from subjects by telephone when in-person data collection has been placed on hold?
Answer:
Yes. Once the amendment is approved for the change in data collection (through an IRB amendment) you can continue to collect information from subjects. NOTE: You do not need to modify your protocol in order to hold visits remotely or to change the schedule if the study is exempt or if the IRB protocol does not specifically describe whether the visit would be in person or remote, or give specifics about visit schedule.

 

Question:
Can I continue to collect data from home visits?
Answer:
If there is no benefit to the subjects, you should not collect data from a home visit. If there is another way for the subject to participate in the study, pursue those avenues (i.e., phone visits, email)

 

Question:
Do I need IRB approval to let my study subjects know that the study has been placed on hold?
Answer:
No. An amendment is not needed for this activity.

 

Question:
How do subjects need to be notified of visit cancellations and changes?
Answer:
When a study visit needs to be cancelled or changed to a phone call or on-line encounter, the subject should be told the reason and that they will be contacted again when the in-person visit can be rescheduled. These messages to subjects do not require IRB approval.

 

Question:
Will the IRB provide language that we can use in contacting our subjects?
Answer:
“Due to the potential or perceived risks of COVID-19, Stony Brook University has to place this study on hold. This study will continue to contact you and regular data collection activities may resume when the risk of COVID-19 has passed.”

 

Question:
Do I need to register modifications with ClinicalTrials.gov?
Answer:
Some studies registered at the federal site ClinicalTrials.gov are modifying their research procedures to include testing for SARS-CoV-2 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 with 30 days after IRB approval of the modification.

 

Question:
I am conducting an FDA-regulated study. I hold the IND or IDE. Do I need to notify the FDA if I place my study on hold?
Answer:
Yes. The FDA will need to be notified.

 

Question:
Is the Institutional Review Board at Stony Brook University operating as usual?
Answer:
The Stony Brook IRB continues to meet as scheduled via videoconference. All email addresses will continue to be monitored with the same frequency as typically provided.  The main office number is being monitored regularly and any messages left on the main line will be returned.

 

Question:
What is the effect on the review of new studies?
Answer:
The Human Research Protection Program will continue to receive and review new studies. For studies that are approvable, but involve in-person interactions with study subjects and do not have the potential for direct benefit, the IRB will approve the study but with a stipulation that the study cannot begin enrollment until official guidance (e.g., government) states that social distancing is no longer necessary.

 

Question:
Which human subject studies should be placed on hold during the outbreak of the COVID-19?
Answer:
For studies in which there is no direct benefit to subjects or where there is subjects travel for research purposes (and no direct benefit), studies must be paused, effective immediately or as soon as can be implemented. Procedures such as telephone contact or monitoring or remote data collection, if part of such studies, may continue. Studies in which there is direct benefit to subjects may continue. If possible, these studies should be performed remotely. This would include the collection of safety data (based on the ability to detect potential adverse events). It is suggested that laboratory tests or imaging needed for safety monitoring occur at local laboratories or clinics.

Question:
When do I need to report protocol deviations to the Institutional Review Board (IRB)?
Answer:
Protocol deviations do not need to be reported to the IRB unless they impose an increase risk of harm to participants or adversely affect the integrity of the data. As a reminder, a protocol deviation is something that applies to one individual.
·        Example: A subject is not able to travel for an in-person visit because of self-quarantine. This is a minor deviation and does not need to be reported to the IRB unless it impacts the risk to the participant.
·        Example: A subject has self-reported or documented symptoms compatible with COVID-19 infection 24 hours prior to dosing or at the time of dosing. The Principal Investigator will determine whether or not the subject will not receive the study drug. This situation is considered a protocol deviation as it could impact subject risk. This deviation needs to be reported to the IRB.
·        Example: A subjects’ insurance does not cover monthly laboratory testing, subjects with normal laboratory values skip the laboratory testing at the discretion of the Principal Investigator, in order to limit contact. This is a protocol deviation as it could impact subject safety and data integrity and is reportable to the IRB.
·        Example: In order to minimize contact between study staff and subjects at the time of home visits, body measurements and vitals are not be documented. This will not be considered a deviation as it does not impact subject safety or data integrity and does not need to be reported to the IRB.
·        Example: Final diagnostic testing (e.g., MRI, biopsies, etc.) is postponed based on COVID-19 precautions. This is a protocol deviation as it impacts subject safety and is reportable to the IRB.

 

 

 

 

 

 

      

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