Research

General Guidance

  • What immediate steps can researchers take?
    • Under “Safer at Home” orders, researchers 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.  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

  • Is in-person human subjects research allowed?

    Once a PI has received an individual email letting them know they have building access and an acknowledgement letter to post outside their lab/workspace, they can restart the following forms of in-person 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 off campus (aside from at other research and higher education institutions), including in participants’ homes or in community-based organizations, is temporarily paused and restricted.

    In-person human subjects research that involves bodily fluids, regardless of whether it takes place on or off campus, is temporarily paused and restricted. Please note this is subject to change.

    Once a PI has submitted a safety protocol and received an acknowledgement letter from ORSP, 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 off campus (aside from at other research and higher education institutions), including in participants’ homes or in community-based organizations, is temporarily paused and restricted.

    In-person human subjects research that involves bodily fluids, regardless of whether it takes place on or off campus, is temporarily paused and restricted. Please note this is subject to change.

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

    Under “Safer at Home” orders, researchers may resume research once they are approved to return to campus by following the DU COVID-19 Protocols for Research, Scholarship, & Creative Work While Under “Safer at Home” 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 (CDPHE) and Centers for Disease Control (CDC) guidelines. At this time, only essential employees have been granted access to campus by the Provosts Office but Phase II steps have begun to review and process additional personnel access into labs and work spaces.  As personnel are approved and granted access, additional requirements must be followed that includes completing a daily Personnel Symptom Monitoring Survey 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 for restarting research, scholarship and creative work on campus. 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. Please note this is subject to change.

  • What can PIs be doing now to prepare for returning to their research?
    1. Be in contact with your funder to determine what flexibilities are allowed.
    2. 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.
    3. 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.
    4. Contact your Dean to determine if they will approve your request to be conducting work on campus.
    5. Carefully review safety guidelines restarting research/scholarship/creative work on campus.
    6. Once ORSP sends you a link (upon Dean approval), complete information to formally request access to campus.
    7. Gather safety supplies needed as possible. PIs are encouraged to purchase face coverings/masks for their research staff and to encourage participants to wear their own face covering/masks to research activities whenever possible. 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.
  • 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.

COVID-19 Research

  • I’m interested in COVID-19-related research. What do I need to know?

    DU has established an internal review committee to assess the risk/benefit of proposed COVID-related research and projects on campus. PIs making requests to carry out this work must be faculty members at DU; students who want to do work must have their advisor submit a request on their behalf. The faculty PI making the request is responsible, upon approval, for assuring safety precautions are carried out on campus.

    If you are interested in conducting COVID-related research or projects (e.g., creating products such as masks, shields, hand sanitizer or other materials) on campus please submit the following information to Kimberly.bender@du.edu with a CC to your dean and chair:

    1. The aim of the proposed work
    2. How the proposed work aligns with governmental research needs and definitions of essential research – including the potential impact or benefit of the work being carried out
    3. What efforts will be taken to assure the research is conducted safely (i.e., how the work will adhere to social distancing policy of maintaining 6 feet between individuals and no more than 2-3 individuals in at one time, how schedules will be staggered, how individuals will acquire masks to wear while in the work space (PPE if available), and how hygiene/cleaning practices will be followed) while on campus
    4. Clarification of what actions can be taken at home rather than in the lab whenever possible
    5. What evidence exists that any products developed will be safe/comply with standards (if applicable)
    6. Plans for submitting the proposal to relevant internal regulatory bodies (IRB, IBC, IACUC) where applicable
    7. What funding will be used to conduct the proposed work

    These requests will be sent to the internal review committee who will make recommendations (within 2-3 days as possible) to the provost’s office regarding whether the work should be approved.

  • 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 does not require in-person, face-to-face interaction, recruitment for your research project can continue.

  • Can I still interact with my research subjects?

    All research studies that currently require direct person-to-person interactions, but do not offer direct therapeutic (drug or device) benefit to research participants must immediately pause new enrollment and discontinue in-person interactions unless study procedures can be modified to use alternative methods of gathering study data (e.g., telephone interviews, email, etc.). Studies involving no direct person-to-person interactions with participants may continue (e.g., remote or online contact).

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

    When the “Safer at Home” orders are in place and the PI and any of the research staff have been approved to be on campus, limited in-person interaction may occur. 

    In-person human subjects research that involves bodily fluids, regardless of whether it takes place on or off campus, is temporarily paused and restricted. Please note this is subject to change.

  • 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. 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 Participant Letter templatefor guidance. For any new amendments to a 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 tightening 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?

    During the “Safer at Home” orders, 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 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 Participant Letter templatefor guidance.

  • 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 of restrictions due to the COVID-19 pandemic.

  • Which studies or study procedures must be paused?
    • In-person human subjects research that involves bodily fluids, regardless of whether it takes place on or off campus, is temporarily paused and restricted.
    • In-person human subjects research that takes place in individuals’ homes or in the community (aside from institutions) is paused and restricted.
    • Please note this is subject to change.
  • Which studies may continue?

    Once a PI has submitted a safety protocol and received an acknowledgement letter from ORSP, 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.
    • Studies which offer direct therapeutic benefit (FDA-related drug or device studies) to participants.
    • Studies conducted electronically or via telephone or involving secondary data analysis may continue.
  • Are these simply guidelines or true restrictions?

    The temporary restrictions involving in-person human subjects research that involves bodily fluids or in-person data collection in the community or in individuals’ homes must be followed.

  • How will the pause in research impact studies conducted outside of a DU setting, both domestic and international?
    1. Once a PI has submitted a request and received approval, building access, and an acknowledgement letter from ORSP, 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.
    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. All other domestic studies involving person-to-person interactions must be paused, unless research procedures are modified to eliminate face-to-face interactions with participants.
    3. All other 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 must monitor the changing COVID-19 situation.
    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. 
  • Should social-behavioral and observational studies be paused?

    Once a PI has submitted a request to return to work and received approval, building access and an acknowledgement letter from ORSP, 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 that involves bodily fluids, regardless of whether it takes place on or off campus, is temporarily paused and restricted. Please note this is subject to change.
  • 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?

    In-person human subjects research that involves bodily fluids, regardless of whether it takes place on or off campus, is temporarily paused and 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 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.  The PI will be requested to modify the protocol to comply with the current restrictions or it will be transferred to a database until the COVID-19 restrictions are removed. For additional information you may contact the IRB at IRBAdmin@du.edu for assistance.

  • 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?

    Under “Safer at Home” orders, researchers, including undergraduates 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.

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