Research

UPDATE

Fully vaccinated DU personnel and students may now conduct research and field work, including within private facilities and homes. These individuals must take reasonable precautions including wearing face coverings. These frequently asked questions will be updated soon.

General Guidance

Research Communications

Pausing Research

  • What if I can’t pause my research because my sponsor and the study protocol has established specific timelines and requirements and my funding may be jeopardized due to this pause in research?

    If the funding for your research will be jeopardized due to this temporary, 2-week pause, please notify your dean or chair, to determine whether your research meets the criteria for an appeal and a waiver can be issued to continue your research during this period of time.

    If your study protocol dictates that certain measures or tests be performed at certain time periods and if not conducted would jeopardize the integrity of the study design or results, please contact your dean or chair to determine whether your research meets the criteria for an appeal and a waiver can be issued to continue your research during this period of time.

  • If my human subjects research is temporarily paused due to the DU COVID-19 requirement, do I need to notify the IRB?

    If your IRB-approved protocol has been paused to conduct any on-campus interactions with unaffiliated research participants during this temporary pause in research, the DU IRB does NOT need to be notified. The DU IRB must be notified if a research participant experiences an increased risk or unanticipated problem due to this temporary pause through the submission of a Reportable New Information (RNI) Report.

  • If my human subjects research is paused, how long do you anticipate this time period to last?

    To de-densify the campus and lower the potential exposure to COVID-19, DU has implemented a pause in research for protocols that involve bringing unaffiliated persons to campus for non-essential research procedures or interactions during the Orange Alert Level. This temporary pause in research began Monday, October 26, and does not currently have an end date. The University will re-evaluate biweekly and decisions will be made based upon city and state mandates. Any announcement for an extension of this research pause will be sent the Friday of each week.

  • If there is an outbreak on campus and a pause in research is issued, will research be paused indefinitely?

    If an outbreak occurs on campus, the COVID-19 Response Team (CRT), in coordination with the Chancellor and Provost, will implement response protocols based on state and local guidance and current campus information, and will make decisions on whether to revert back to a stricter safety precautions for the campus.  If a stricter phase is implemented additional safeguards and restrictions will need to be incorporated into current research protocols and activities. Researchers that need to be on campus to continue their work should make sure they are identified having a Phase II Covid access. This can be done by logging in to MyDU. To make changes to your phase, follow the instructions below:

    • Log on to MyDU
    • Click Employee tab
    • On left side, click Return to Campus Status
    • You should see your Phase, a box for details (which contains a letter with your Phase) and then a link to Request or Change Access. Click link.
  • If my research involves recruiting and enrolling DU students, staff or faculty on campus, does my research need to be paused?

    For IRB-approved protocols that involve the enrollment of DU students, staff or faculty who are current research participants, and who have obtained Phase III access and observe all additional safety measures per DU COVID-19 Protocol issued by the Provost’s Office, research may continue as approved. 

    If the research involves potential participants who are not affiliated with DU, any intervention that occurs on the DU campus must be temporarily paused. If a research project meets the criteria for an appeal, a waiver may be granted by their Dean or Chair. Even if investigators follow the current COVID-19 safety precautions, all unaffiliated individuals must not participate in any in-person interactions if conducted on the DU campus during the Orange Alert Level period unless a waiver has been issued.

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 and the DU COVID-19 Campus Access protocol. 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. 

  • 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 and the DU COVID-19 Campus Access protocol. All PIs and research personnel must obtain re-approval and access to their lab or work site, and receive an acknowledgement letter before resuming any research. Once a PI has been approved to resume their research during the Orange Alert Level, 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 resuming their research during the Orange Alert Level during the Winter break?
    1. Contact their Dean to seek approval for returning to their building on campus during the Winter break. This will initiate a process for formal approval and grant campus access.
    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. Carefully review DU COVID-19 Protocols for Research, Scholarship, & Creative Work.
    5. Develop a safety protocol for projects that need to be conducted in labs or in-person in the community.
    6. 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.
    7. 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.
    8. Please note this is subject to change.
  • Is in-person human subjects research allowed?

    Once a PI has received their Dean’s approval, and building access for on-campus research has been re-issued from the Provost’s office, they can resume 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, must obtain a Dean’s approval to resume any research with research participants.  Once Dean approval is received, campus access will be issued per the DU COVID-19 Protocols for Campus Access. 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 have been have implemented in response to the COVID-19 restriction, the IRB does not require that a formal amendment be submitted. However, the IRB requires that any research in-person interventions that are approved to occur on campus, the DU COVID-19 Protocols for Research, Scholarship, & Creative Work must be incorporated into the research protocol and submitted as an amendment.

  • 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.

  • 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 obtained approval from their Dean and have been granted clearance per the COVID-19 Protocols for Campus Access, regardless of whether a proposed project qualifies as human subjects research.

  • 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?

    Any research activities involving in-person interaction must obtain a Dean’s approval to continue and all research employees must obtain campus access per the COVID-19 Protocols for Campus Access issued by the Provost’s Office.

  • Which studies may continue?

    All research studies that were initially approved by the IRB that involves direct person-to-person interactions, must obtain a Dean’s approval to resume any research with research participants. Once Dean approval is received, campus access must be issued per the DU COVID-19 Protocols for Campus Access if research will resume on campus. With the exception of research in participants’ homes, research may resume as originally approved if all research personnel and participants obtain their Dean’s approval and follow all of the DU safety guidelines. 

    • 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 all of the 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.
  • 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. 

     

  • 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 to the current COVID-19 Alert Level restrictions. 

    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

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?

    To accommodate reduced laboratory density, researchers can plan to:

    • Occupy labs at 50% capacity and 6ft social distancing.
    • Develop staggered schedules
  • 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