Research

General Guidance

  • What immediate steps can researchers take?
    • Researchers must follow the DU COVID-19 guidelines that have been established for reopening research, scholarship, and creative work.  Prior to returning to campus, all individuals must obtain their Dean’s approval and complete a survey link to formally register and obtain access to campus.  Once approval is granted by your Dean, individuals will be sent the survey link.  No employee may return to campus until they have received a formal acknowledgement letter and have been granted card access to their designated location.
    • Do not come to work if you are sick.
    • Practice “social distancing” – reduce meetings, use videoconferencing, work in shifts of at most 2-3 people, keep 6 foot distances between personnel, work remotely if possible.
    • Enhance cleaning of shared instruments and surfaces (shared phones, shared lab equipment, shared benches, doorknobs). Use a disinfectant that is safe and appropriate for the item.
    • Wash hands frequently for 20 seconds
    • Practice remote working arrangements as possible.
    • View specific guidance, FAQs, and resources on the topics listed below.

Research Communications

Restarting Research Paused Due to COVID-19

  • When can PIs resume research in labs and human subjects research in person?

    Researchers may resume research once they are approved to return to campus by following the DU COVID-19 Protocols for Research, Scholarship, & Creative Work” guidance. All PIs and their research staff members must follow the DU COVID-19 guidelines that have been established for reopening research, scholarship, and creative work issued 5/11/20 through the Provost’s Office.  The University will transition through phases in accordance with state and local orders, Colorado Department of Public Health and Environment (CDPHE) and Centers for Disease Control (CDC) guidelines. At this time, only Phase I and Phase II employees have been granted access to campus by the Provosts Office.  As personnel are approved and granted access, additional requirements must be followed that includes completing a daily Personnel Symptom Monitoring Survey when you arrive on campus and when you leave, and following the policies on social distancing, PPEs, and disinfecting cleaning the lab and work sites. PIs will be responsible for ensuring that these strict safety guidelines are followed, with support as needed. Please note this is subject to change.

  • When PIs do ramp back up their research, what will they need to do and what supplies will they need?

    To safely resume research, research teams will be required to adhere to strict safety guidelines in DU COVID-19 Protocols for Research, Scholarship, & Creative Work. All PIs and research personnel must obtain approval and access to their lab or work site, and receive an acknowledgement letter before restarting any research. Once a PI has been approved to restart their research, EHS will make arrangement with Housekeeping to provide appropriate disinfectant to be used in the lab or workspace. Please note this is subject to change.

  • What can PIs be doing now to prepare for returning to their research?
    1. Contact their Dean to seek approval for returning to their building on campus. This will initiate a process for formal approval and granted access.
    2. Be in contact with your funder to determine what flexibilities are allowed.
    3. Be in contact with partnering institutions to determine if there are additional requirements that are mandated by the affiliated research facility. DU investigators must comply with that institution’s safety protocols in addition to applicable DU protocols.
    4. Consider your various active projects and determine which can be conducted remotely to continue to reduce risk (preferred), which need be conducted in labs or in-person while adhering to safety guidelines, and which should remain on pause until safety guidelines are less restrictive.
    5. Carefully review DU COVID-19 Protocols for Research, Scholarship, & Creative Work.
    6. Develop a safety protocol for projects that need to be conducted in labs or in-person in the community.
    7. Gather safety supplies needed as possible. PIs are encouraged to purchase face coverings/masks for their research staff and require participants to either wear their own face covering/masks or provide a face covering/masks to research activities. Many grants allow PPE to be charged. If PIs have insufficient funds to pay for PPE, they should contact ORSPadmin@du.edu for help acquiring supplies as available.
    8. Wait for announcements from the Provost’s Office indicating if additional restrictions will be lifted and the next phase for returning to campus has been approved.
    9. Please note this is subject to change.
  • Is in-person human subjects research allowed?

    Once a PI has received an acknowledgement letter and building access from the Provost’s office, they can restart the following forms of human subjects research.

    • In-person human subjects research on DU campus that follows strict safety guidelines is allowed.
    • In-person human subjects research at other research and higher education institutions that follows safety guidelines is allowed.
    • In-person human subjects off campus, including community-based organizations, who have established safety guidelines, is  allowed.
    • In-person human subjects research that involves bodily fluids, (i.e., blood draws, sputum samples, etc.) regardless of whether it takes place on or off campus, is allowed if established safety guidelines are established.
    • In-person human subjects research in participants’ homes is NOT allowed at this time.
  • Who should I contact if I have questions about safety protocols or guidelines?

    Please contact your SPARC representative or Jerry.Mauck@du.edu with questions.

  • What is the guidance for repurposing federal funding from the NSF to respond to COVID-19?

    The Foundation has issued guidance on NSF’s implementation of the Office of Management and Budget (OMB) Memorandum (M-20-20), entitled, Repurposing Existing Federal Financial Assistance Programs and Awards to Support the Emergency Response to the Novel Coronavirus (COVID-19).  NSF remains committed to working with the Administration, other federal agencies, and the research community to effectively respond to the COVID-19 national emergency.  This guidance is to implement the flexibility class exception authorized by OMB Memorandum M-20-20 that allows Federal awarding agencies to repurpose their Federal assistance awards (in whole or part) to support the COVID-19 response, as consistent with applicable laws. This will certainly help address questions that recipients may have regarding the donation of items/resources from NSF awards. 

    Any questions about the policies described in the NSF Guidance should be directed to policy@nsf.gov.  Questions specific to a particular award should be directed to the cognizant NSF Program Officer.  NSF is working to update existing FAQs and other resources to reflect NSF’s new guidance and will keep you informed on our website at: nsf.gov/coronavirus.

Research Travel

Research Costs

Proposal Submission and Award Management

Human Subject Research

  • Can I still continue to recruit participants during the COVID-19 pandemic?

    Yes, if the recruitment and ongoing data collection is done in a method that follows the current DU safety protocol, recruitment for your research project can continue as approved by the IRB.

  • Can I still interact with my research subjects?

    All research studies that were initially approved by the IRB that involves direct person-to-person interactions, with the exception of research in participants’ homes, may resume as originally approved if all research personnel and participants follow the DU safety guidelines.  If remote methods were implemented in response to the COVID-19 restriction, the IRB does not require that a formal amendment be submitted to convert back to in-person interactions.  However, if research interventions can continue remotely, it is still recommended to limit in-person interactions, if possible.

  • Are research participants allowed to come to the DU campus (i.e. lab) for research activities?

    Yes, PIs and any of the research staff who have been approved to be on campus, may contact research participants and resume research activities on the  DU campus if the DU safety guidelines are followed.  The guidelines include completing a daily Personnel Symptom Monitoring Survey when you arrive on campus and when you leave, and following the policies on social distancing, face coverings, and disinfecting cleaning the lab and work sites.  A visitor survey to monitor symptoms must be completed for each research participant visiting campus, and all visitors must follow policies on social distancing and wear a face covering/mask while on the DU campus. 

  • Do I need to submit an amendment if I modify my protocol to use an electronic format for obtaining data rather than collecting through an in-person interaction?

    No. The IRB does not require that current research participants be re-consented.  The IRB does not require an amendment application be submitted through IRBNet for this type of change. Nor does the IRB require an amendment application be submitted through IRBNet if research activities revert back to in-person interactions from using a remote format. To inform current research participants about the change in allowing in-person interaction, investigators are required to contact each participant prior to their research visit, complete a visitor symptom survey and review the DU safety guidelines. For any new projects or amendments to an IRB-approved research project, it is recommended that the PI incorporate the use of remote options as well as in-person interaction into the protocol and consents.  This change will allow investigators to utilize either method without having to modify documents later to adapt to the lessening or increase of restrictions due to the COVID-19 pandemic.

  • Can research that has does not require IRB approval and has received a Human Subjects Determination letter collect data through in-person interactions?

    In-person interactions with participants may occur if the DU research personnel have been approved to be on campus and follows the strict safety protocol regardless of whether a proposed project qualifies as human subjects research.

  • Do I need to re-consent current research participants if the method to collect data is changed from in-person interactions to “remote” options?

    No. The IRB does not require that current research participants be re-consented.  The IRB does not require an amendment application be submitted through IRBNet for these type of changes. To inform current research participants about the change in method for collecting data, the IRB requires that investigators contact research participants by phone prior to scheduling any in-person visits on campus or in the community, complete a visitor symptom survey for each research participant (within 2 hours prior to their arrival on campus) and review the DU safety guidelines (at a minimum). Currently, no in-home research visits are allowed.

  • Do I need to modify my current consent if I will continue to recruit new research participants and plan to change the method to collect data from in-person interaction to “remote” options?

    Yes. The IRB must review and approve any changes in the project procedures and they must be reflected in the research consent when administered to new research participants. An amendment application must be submitted through IRBNet along with a tracked and clean copy of the informed consent document. For any new amendments to a research project, the IRB recommends that the PI incorporate the use of remote options as well as in-person interaction into the protocol and consents.  This change will allow investigators to utilize either method without having to modify documents later to adapt to the lessening or increase of restrictions due to the COVID-19 pandemic.

  • Which studies or study procedures must be paused?
    • No in-home visits conducted for research purposes are allowed. This restriction is reviewed weekly and is subject to change.
  • Which studies may continue?

    Once a PI has been approved to be on campus and received an acknowledgement letter, they can restart the following forms of human subjects research.

    • In-person human subjects research on DU campus that follows strict safety guidelines is allowed.
    • In-person human subjects research at other research and higher education institutions that follows safety guidelines is allowed. Other institutions may have their own guidelines for restarting research, and PIs should develop plans that meet both institutions’ guidelines (or the more restrictive policy) as they prepare to restart their work.
    • In-person human subjects research at other community-based organizations that have their own established safety guidelines. In the event that an organization’s guidelines are less restrictive than DU’s guidelines, DU researchers must follow DU’s safety guidelines.
    • In-person human subjects research that involves collection of bodily fluids as long as that research does not occur in participants’ homes.
    • Studies conducted electronically or via telephone or involving secondary data analysis may continue.
  • Are these simply guidelines or true restrictions?

    Any research involving in-person interaction, including interventions that involve bodily fluids, are allowed if the DU safety guidelines are followed.  In-home visits are currently not allowed. 

  • How will the pause in research impact studies conducted outside of a DU setting, both domestic and international?
    1. Once a PI has received an acknowledgement letter from the Provost’s office, they can restart the following forms of human subjects research.
    • In-person human subjects research on DU campus that follows strict safety guidelines is allowed.
    • In-person human subjects research at other research and higher education institutions or at community-based organizations that follows safety guidelines is allowed. Other institutions may have their own guidelines for restarting research, and PIs should develop plans that meet both institutions’ guidelines (or the more restrictive policy) as they prepare to restart their work.
    1. If a study is deemed to have potential direct therapeutic benefit (FDA-regulated drug or device) to individual subjects, the study may continue.
    2. Domestic studies involving person-to-person interactions in participants’ homes must be paused, unless research procedures are modified to eliminate face-to-face interactions with participants.
    3. Research in international settings must be paused or modified as described below:
    • For projects where an international collaborator is responsible for the direct interaction/intervention with participants, or where DU and international researcher are conducting such interactions together, the local COVID-19 situation must be considered. The study team should seek guidance from the local IRB or research ethics review board regarding the continuation of the research and share this information with the DU IRB. In areas with high-risk for COVID-19, projects involving person-to-person contact should be paused or use modified procedures to eliminate the need for person-to-person contact.  Investigators (faculty, staff and students) must obtain travel clearance through Enterprise Risk Management before research projects will be reviewed by the IRB.
    1. For projects where DU researchers, such as anthropologists, are already in country and actively involved in person-to-person subject interactions independently, the research must be paused and procedures modified to eliminate person-to-person interactions and conform to the local COVID-19 restrictions. 
  • Should social-behavioral and observational studies be paused?

    No, once a PI has been approved and received an acknowledgement letter, they can restart the following forms of human subjects research.

    • In-person human subjects research on DU campus that follows strict safety guidelines is allowed.
    • In-person human subjects research at other research and higher education institutions that follows safety guidelines is allowed. Other institutions may have their own guidelines for restarting research, and PIs should develop plans that meet both institutions’ guidelines (or the more restrictive policy) as they prepare to restart their work.
    • In-person human subjects research at community-based organizations and agencies if strict safety guidelines are followed.  Community based organizations may have their own safety guidelines, and PIs must conform to their guidelines and policies that meet both institution’s safety guidelines (or the more restrictive policy).

    If research will be conducted off campus at a community-based organization or at a higher education institution, the PI should submit an IRB amendment through IRBNet, along with that organization or institution’s safety guidelines. The PI will be required to comply with the current DU safety guidelines and the organization or institution’s safety guidelines or policy (or the more restrictive).

    • In-person human subjects research that involves bodily fluids, regardless of whether it takes place on or off campus, that follows strict safety guidelines is allowed.
  • Temporary halt to study enrollment. What do I do?

    This does NOT need to be reported to the DU IRB unless the study hold is initiated at the request of an external funding agency or the study’s Data & Safety Monitoring group (if there is one).

  • May we continue to collect data and follow up with subjects by telephone when in-person data collection has been paused?

    Yes.

  • May we continue conducting telephone screening of potential subjects?

    Yes.

  • May we conduct home visits to collect data in studies with no potential therapeutic direct benefit (FDA-regulated drug or device) to participants?
    • No, in-home visits are currently restricted.  Please note this is subject to change.
  • Is an amendment necessary if I wish to change the mode of data collection for my exempt study?

    No. The IRB does not require an amendment to change from face-to-face to phone or electronic data collection.

  • Do we need approval from the IRB for communications to study subjects explaining the pause in activities?

    No. The IRB does not require an amendment application be submitted through IRBNet for this type of change. To inform current research participants about a temporary pause in activities, the IRB requests that Principal Investigators distribute a Participant Letter template to all active research participants.

  • If I am pausing study procedures on a project reviewed by an external IRB of record, must I notify that IRB?

    Yes, as soon as feasible, for their awareness. The IRB of Record may require review/approval prior to resumption of study procedures.

  • I am interested in conducting research with infectious SARS-CoV-2 (causative agent of COVID-19). What should I do?

    Both IRB and IBC approval may be necessary prior to initiating any studies related to COVID-19.  Refer to the CDC link for additional guidance. 

     

  • Do I need to submit an amendment if I modify my protocol to use an electronic format for obtaining data rather than collecting through an in-person interaction?

    No. The IRB does not require an amendment application be submitted through IRBNet for this type of change. To inform current research participants about the change in method for collecting data, the IRB requests that Principal Investigators distribute a participant letter to all active research participants. Please refer to the attached Participant Letter template for guidance.

  • Is the DU IRB operating as usual and still processing IRB submissions?

    Yes, the DU IRB staff is currently reviewing and processing IRB submissions submitted through IRBNet. However, during the initial review of a project, the IRB will assess whether the project has modified the study design to accommodate the current COVID-19 restrictions. 

    If research will be conducted off campus at a community-based organization or at a higher education institution, the PI should submit an IRB amendment through IRBNet, along with that organization or institution’s safety guidelines. The PI will be required to comply with the current DU safety guidelines and the organization or institution’s safety guidelines or policy (or the more restrictive).

  • If I have a question about my research, who should I contact at the IRB?

    Due to the COVID-19 pandemic, the IRB staff are working remotely but are responding to emails sent to the IRBAdmin@du.edu account. Please submit your questions to this email account and an IRB staff member will respond within 24 – 48 hours.

Research Involving Animals

Undergraduate Student Research

  • Under COVID-19 precautions, should undergraduates conducting research for credit be allowed to continue working in the lab?

    Researchers, including undergraduates, must follow the DU COVID-19 guidelines that have been established for reopening research, scholarship, and creative work.  Prior to returning to campus, all undergraduate students must work with their Principal Investigator or Faculty Advisor and obtain their Dean’s approval and then complete a survey to register and obtain access to campus.  Once approval is granted by your Dean, individuals will be sent the survey link. No employee may return to campus until they have received a formal acknowledgment letter and have been granted card access to their designated location.  Each building on campus has been assigned a COVID-19 building manager to coordinate schedules and monitor the number of employees that are allowed in the building at one time per CDPHE policy.

Graduate Student Research

Faculty Advisors

  • I am a faculty advisor to a graduate student who is trying to complete their research. What advise can I provide if the research lab is not operational?

    We ask all faculty to work with students to accommodate their particular situations, while helping each student continue their research path under the current circumstances. Currently, only essential personnel are allowed on campus and in research labs. 

    Under “Safer at Home” orders, researchers, including graduates students must follow the DU COVID-19 guidelines that have been established for reopening research, scholarship, and creative work issued 5/11/20.  Prior to returning to campus, all individuals must obtain their Dean’s approval and complete a survey link to formally register and obtain access to campus.  Once approval is granted by your Dean, individuals will be sent the survey link.  No employee may return to campus until they have received a formal acknowledgement letter and have been granted card access to their designated location.

    Remember that research and scholarship involves many activities that can occur remotely, including literature reviews, experimental design, data analysis, use of digitized archives and other online research and data collections, video and phone interviews, and writing. We ask all faculty to work with graduate students to allow flexibility with regard to where research is performed.

Research Facilities/Laboratory Safety

  • What can I do to prepare my laboratory research area?

    Update your Contingency Plan to include the following:

    1.        Identify procedures and processes that require regular personnel attention (e.g., cell culture maintenance, animal studies, human subjects contacts).

    2.       Assess and prioritize critical laboratory research activities.

    Level 1:  Work can be conducted remotely

    Level 2:  Work can be delayed or stopped, but requires onsite presence to continue (e.g., non-essential lab experiments)

    Level 3:  Long-term experiments and activities that would generate significant financial and data loss if not completed

    Level 4:  Essential activities that must continue (e.g., vivarium, human samples that cannot be recovered, maintenance of liquid nitrogen freezers)

    3.       Identify any research experiments that can be ramped down, curtailed or delayed.

    4.       Identify essential personnel able to safely perform essential activities and submit requests to the Provost Office.

    5.       Ensure you have access to contact information for your critical staff.

    6.       Consider documenting critical step-by-step instructions.

    7.       Review emergency procedures with researchers and staff. Ensure your door signage is up to date.

    8.       Maintain a sufficient inventory of critical supplies that may be impacted by global shipping delays.

    9.       Ensure that high-risk materials (radioactive, biohazards, chemicals) are secured and freezers are labeled with emergency contact information.

    10.   All waste should be secured.

  • Are there any restrictions regarding how many individuals can be in a research laboratory space?

    The DU campus is currently closed and no social gatherings are allowed. The University does not allow more than 3 – 4 essential personnel in a research laboratory space. 

    To accommodate reduced laboratory density, researchers can plan to:

    • Shift activities to computational work, data analysis, literature reviews. Writing, experimental design, etc.
    • Develop staggered schedules
  • Now that classes are being delivered remotely in alternative formats – and not meeting in person – are research laboratories and facilities still open and operational?

    Only essential research laboratories and facilities remain open.  All lab personnel, including students, must be classified as essential and must be approved by the Provost Office.

  • Should researcher expect shortage of Personal Protective Equipment (PPE), such as N95s and gloves that are often used in laboratory spaces?

    Research laboratory managers and PIs should anticipate a PPE shortage, and limit the number of essential personnel entering lab spaces that require donning and doffing of PPE (masks, gowns, face shields, etc.) for critical lab functions. This is especially important for users of N95 masks because these items are being prioritized for the healthcare industry. Please contact EH&S to discuss options available if shortages do occur.

Research Involving Recombinant DNA and Biological or Chemical Hazards