COVID-19 Research & Information

Human Subjects Research Plan

Temporary Guidelines for PIs Conducting In-Person Human Subjects Research

These guidelines are designed to help principal investigators (PIs) develop specific plans for conducting  in-person human subjects research (HSR) and transitioning between levels of safety at the appropriate time, as approved and communicated by University leadership. These guidelines include review and approval of a Human Subjects Research Plan by a new HSR Restart Review Committee prior to proceeding with IRB or IBC review. These guidelines apply to on-campus research as well as research conducted off-campus; research at off-campus locations must follow both that location’s guidelines and UND guidelines. The goal is to conduct HSR in a manner that protects our community and allows HSR to move forward as an important part of our research mission. In order to best meet that goal, the process should be careful and deliberate, and should align with guidance provided by the Office of the Vice President for Research, the Pandemic Planning Team, the Dean of the appropriate School(s), the Institutional Review Board, the Institutional Biosafety Committee (when applicable), and federal, state, and local requirements. 

Because of the rapidly-evolving understanding about the factors that affect transmission of the COVID-19 virus, please be aware that in the future there may be a need to pause, scale back, or wind down on-campus research and scholarly activities in response to new information about COVID-19, new outbreaks or changes in the capacity of our communities to respond. Research that has received approval to ramp back up may in the future have to ramp back down.

Key Principles

Principle 1. Protect the overall health and safety of our human research subjects and our UND community.

Principle 2. Resume research activities in alignment with the UND campus response to COVID-19. In-person human subjects research will restart depending on ability to ensure safety of research teams and research participants. See Healthy Hawks Restart for information. While the three levels of Healthy Hawks provide useful general guideposts, each level will encompass a range from more restrictive to less restrictive as conditions evolve; see Human Subjects Research Plan Template: Specific Instructions (below).

Principle 3. Comply with ethical and legal requirements, as well as guidelines imposed by the sponsors of funded research.

Principle 4: Students have the right to decline to return to in-person research without fear of retaliation or retribution.  Students who feel pressure or coercion to engage in in-person research that makes them concerned for their own health and safety should first report the situation to their academic college Dean, then to the Office of the Vice President for Research. Graduate students should also report to the School of Graduate Studies Dean.

Principle 5:  The risks and benefits of the research participation should be weighed for each individual participant, considering the nature of the research participation and any COVID-19 risk factors particular to the participant.  Research participants should participate only if the risk/benefit profile is favorable: as the health and safety of research participants are the paramount concerns, the health and safety potential benefits of research participation must outweigh the potential risks to the participant’s health and safety, as determined by application of these and IRB safety guidelines in the approval and screening process.

Principle 6: Enhanced planning is required to reduce the risk of exposure to COVID-19.

 Key Guidelines

• HSR that can be done remotely is already permitted. All research that can be done remotely should continue to be done remotely.
• All research meetings that can be conducted remotely should be conducted remotely.
• In-person, face-to-face HSR is subject to a planning and approval process.
• In-person research participation may only proceed if all of the following are true:
  • The participant’s individualized risk of developing severe coronavirus infection has been assessed, weighed against the reasons for the research participation, and found to be reasonable.
  • The participant and research staff have been screened for symptoms per UND policy.
  • Appropriate precautions have been taken to optimize the safety of the participant and research staff during the participation, in accordance with updated guidance from UND and, as applicable, the IRB.
  • Research teams are conducting activities remotely whenever possible.
• Physical distancing is critical. Physical distancing should be maintained to the extent that it is safe for the participant. In some cases, direct contact may be unavoidable (e.g., in collecting samples).  In those situations, the coordinator/researcher should wear additional PPE as indicated for the activity.
  • Direct contact should be avoided or minimized as much as possible.
  • The number of people in a room should be minimized, in alignment with UND guidance on COVID-19 resistant room capacities.
  • Time of interaction should be minimized.
• The presence of research participants and research staff in clinical and research spaces needs to be minimized and considered in the context of other participants and staff in the area and must conform to UND guidelines.
• For on-campus research, the research team and the research participants must wear appropriate personal protective equipment (PPE), with specific requirements dependent on the nature of the research. At a minimum, both research staff and participants should wear face coverings during all in-person visits. If the participant does not have PPE, it is expected that they will be provided PPE at the visit. In the event that a research participant refuses to wear appropriate PPE as mandated by UND guidelines, that participant can no longer take part in the research.
• For research at an off-campus site, the research team will wear appropriate PPE, as defined by UND guidelines, while subjects may follow guidelines at the site only if the participant presence at the site is not primarily because of the research. In other words, if the research involves participants who would otherwise be in a given location, outside the research, the participants must follow the site guidelines.
• Researchers will communicate with any relevant shared services or facilities offices to ensure that they have capacity and are willing and able to provide services and to manage scheduling appropriately.
• Before any research activities occur, both participants and research staff must be screened for symptoms or risk of COVID infection before engaging in in-person HSR. No one should participate or come to campus if they are symptomatic. Participants should be pre-screened by phone or online means to the extent possible the day before their participation and again upon arrival.
• All study personnel (faculty, research staff, post-doctoral scholars and graduate students) should receive appropriate training regarding proper research participant screening (e.g., masking protocols).
• Signs should be posted regarding symptoms, hand washing, physical distancing, and masking.

If the unit where the research activity will take place has an approved plan, a PI may simply reference that appropriate policies are in place.

Recommendations for Planning Process

Before proceeding, investigators should take the following steps to re-assess if it is feasible to achieve the study’s scientific goals and ensure the safety of research participants and staff within the constraints of the current environment:

1. Review each research visit and activity against the study’s main scientific objectives, and determine (a) if it is necessary to perform; and (b) if it can be performed remotely.

   Research visits/procedures will be considered necessary if they offer the potential to provide direct benefit to participants (e.g. treatment for active medical condition), if they provide important safety monitoring of study treatments/procedures, or if they help to preserve the study’s scientific integrity.  Even within a visit, avoiding unnecessary procedures/activities can enhance participant safety, support institutional physical distancing, and help accommodate staffing limitations.

2. For in-person visits, map out what clinical areas or research units the participant will visit.

   For on-campus research or, when off-campus, if researchers are coordinating the research interaction with participants or the interaction is primarily because of the research design, investigators should understand that, beyond University policy, additional policies in place in clinical care areas and research units are likely to affect the participant flow through the visit.  Many areas will be working with modified hours, staffing, and/or other constraints to optimize physical distancing, hygiene and overall safety. Research teams should confirm in advance that all needed units/cores and personnel will actually be open and available to accommodate the participant at the desired time.  Research teams should understand where the participant will wait during various parts of the visit, and have a plan to ensure that the participant can efficiently complete all research activities in the shortest time possible, with minimal in-person contact. If research team members need to flow through public spaces or shared research areas, this should also be mapped out. All teams that utilize public spaces or shared research spaces should develop clear communication with the managers of those spaces and follow their guidance in addressing logistical issues, avoiding interference with workflow, and accommodating the volume of studies in a time of reduced resource availability. Obtain agreement that the study activities will not negatively impact the other activities in those spaces. The approved guidelines for use of those spaces must be followed.

3.  Pro-actively identify and address additional barriers that may preclude protocol execution in a manner that optimizes safety and achieves the main scientific objectives.

   Potential barriers will vary by study type, but some examples are:

   • Study procedures that require PPE that is not available, or not available in sufficient quantity, for research use.
   • Any aerosol-generating procedures that would prompt considerations of the increased risk and PPE usage.
   • Unexpected density of public spaces or research areas.
   • Off-site safety measures not properly followed by study participants

4. Confirm that the research team will be able to meet all of its regulatory responsibilities.

   Research teams should confirm that all protocol-defined safety monitoring, adverse event reporting, and investigational accountability can occur.  If the protocol requires any study procedures to be performed by study-credentialed individuals or staff with special expertise, their availability and willingness to perform their designated roles should be confirmed.

5. Communicate the modified study plan to all team members and regulatory bodies.

   It is the responsibility of each investigator to develop an organized plan for modified study conduct, and to communicate that plan to ensure that the study is conducted appropriately, with maximum attention to the safety of study participants and staff.  Communication with research team members will allow potential issues not previously considered to be identified and addressed before the plan is finalized (ideally) or at least before the participant’s arrival. 

   The research team should pro-actively plan how to avoid missed assessments and maximize data capture within the protocol’s time windows.

   See IRB guidance on what changes can be reported at continuing review, versus require protocol modification. The FDA has stated that for many changes (e.g. visit schedules, missed assessments, patient status changes), documentation of the COVID-19 related reason on the case report forms and research record should occur.

6. Review each participant’s individualized level of risk in attending the research visit.

   Participants must be provided with information regarding the current COVID-19 epidemic and how best to reduce their risk of infection. The participant’s individualized risk of developing severe coronavirus infection has been assessed, weighed against the reasons for the research visit, and found to be reasonable. In making this determination, investigators should consider, when applicable, (a) input from qualified individuals (e.g., physician-investigator or, a health care professional who knows the participant); (b) the individual participant’s risk for severe complications of COVID-19 as determined by age and known co-morbidities; and (c) the potential benefits to the participant and others. The CDC has updated guidance on high risk populations.

Human Subjects Research Plan Template

• HSR Plan Template
• HSR Screening

HSR Screening

Section 1: Temperature and Self-assessment Screening for Researchers and HSR Participants

1. Have you traveled outside of the country in the past 14 days?
2. Have you crossed state lines via public transportation (airline, train, or bus) in the past 14 days?
3. Do you have a fever ≥100.4°F?
4. Do you have any of the common symptoms of COVID-19: fever and cough, sometimes difficulty breathing, more rarely sore throat, body aches, headache, chills, diarrhea, nausea/vomiting, and runny nose?
5. Are you considered a “close contact” to a person who has been diagnosed with COVID-19 or has been under investigation for COVID-19 in the last 14 days?

A close contact is defined as being within 6 feet of a COVID-19 case for a period of time greater than 15 minutes within the past 48 hours or someone who was directly coughed or sneezed on.

If your answer is YES to Questions 1 or 2, then you cannot participate in the research until you comply with North Dakota Department of Health recommendations regarding international travel or travel across state lines. If you live in another state with Department of Health guidelines that differ from those of the ND Department of Health, you should defer to and follow whichever state guidelines are the more stringent/restrictive. The researcher should work with their supervisor to determine what protocols to follow before approving participation at a future date. Follow the North Dakota recommendations.

If your answer is YES to Questions 3, 4, or 5, you may not participate in the research. Researcher should contact their supervisor if this screening was done in person.

If you feel you have symptoms of COVID-19, contact Altru’s 24/7 Coronavirus Screening Hotline (701-800-6358).

Section 2: High-Risk Populations

1. Are you at higher risk for severe illness based on CDC guidelines (see below) or for any other reason?

2. Are you considered a “close contact” with anyone who would be considered to be at high risk of poor outcomes from COVID-19? A close contact is defined as being within 6 feet of a COVID-19 case for a period of time greater than 15 minutes with the past 48 hours or someone who was directly coughed or sneezed on.

According to the CDC, an individual participant would be considered to be at high risk of poor outcomes from COVID-19 if they meet any of the following:

• People 65 years and older
• People who live in a nursing home or long-term care facility
• People of all ages with underlying medical conditions, particularly if not well controlled, including:
  • People with chronic lung disease or moderate to severe asthma
  • People who have serious heart conditions
  • People who are immunocompromised
    • Many conditions can cause a person to be immunocompromised, including cancer treatment, smoking, bone marrow or organ transplantation, immune deficiencies, poorly controlled HIV or AIDS, and prolonged use of corticosteroids and other immune weakening medications
  • People with severe obesity (body mass index [BMI] of 40 or higher)
  • People with diabetes
  • People with chronic kidney disease undergoing dialysis
  • People with liver disease

Generally speaking, research participants identified as high-risk according to the criteria above should be excluded from the research.  If, however, the PI has research-based reasons for wanting to include those identified as high-risk, and the high-risk participants also express interest in continuing their participation in full awareness of the high risks to their health, the PI should articulate a rationale and additional safety protocols for inclusion of high-risk participants. This rationale will then be evaluated by the HSR Restart Review Committee and IRB.