Impacts of COVID-19 on Human Subjects Research

With the university moving to continuity of operations and the declaration by federal agencies that the COVID-19 situation has been declared a pandemic, the Office of Human Research (OHR) strongly urges investigators to take steps to decrease the likelihood that they will put themselves, members of their study teams, or their study participants at risk of becoming infected with or transmitting the 2019 Novel Coronavirus. Principal investigators (PIs) and their study teams should carefully consider their research protocols in light of the rapidly evolving environment, while being mindful of university and sponsor guidelines.

The GW IRB always encourages investigators to take such steps as necessary to eliminate apparent additional risks or immediate hazards to participants or GW personnel. Researchers may need to pause their studies or modify their studies to remove or limit in person contact. Changes that are necessary to eliminate apparent immediate hazards to study subjects may be made immediately. Please follow OHR’s guidance on changes to research during the COVID-19 pandemic. Please note that there is separate guidance for modifications to non-clinical (social/behavioral/educational/observational) research and clinical research linked below.

Eliminating immediate hazards may include actions that reduce potential exposure to COVID-19, or to continue to provide medically necessary care (including study drug) to participants who have been placed in isolation or quarantine because of suspected or known exposure.

At the current time, any research team that has not yet begun research activities should ensure that doing so will not jeopardize the health and safety of members of the research team or participants.

Below are guidelines to follow with respect to overall planning and data collection activities.

Jump to "Resuming Human Subjects Research: Phase 1"

Establish Formal Plans

All investigators engaging in human subjects research should develop concrete and actionable plans for:

  • continuing or halting data collection;
  • regularly communicating with the study team, study sites, participants and their caregivers to ensure everyone is operating under the procedures recommended by the university; and
  • managing data in the event the university and/or campuses are closed for research purposes.

As part of their planning, investigators and study teams should revisit data collection procedures as well as the extent to which or circumstances under which data collection should be brought to a halt, either temporarily or permanently.

Consider Making Adjustments

Adjustments will be study-specific and will depend on any number of factors including procedures, populations, resources and timelines.

  • Screening study participants or potential participants for their travel histories within the last 14 days and flu-like symptoms.
  • Avoid or minimize bringing groups of people together for data collection activities (e.g., focus groups, whole group interventions).
  • Moving face-to-face data collections (e.g., interviews, surveys administered in person, some forms of observation) to telephone or online (e.g. WebEx or Zoom) formats.
  • Follow recommended guidelines for reducing exposure and, if prudent, pause study activities.
  • Decreasing the number of protocol-mandated in-person study visits to healthcare facilities.
  • Replacing protocol-mandated visits to healthcare facilities with home visits or telemedicine, allowing blood draws at remote or commercial laboratories.
  • Shipping investigational products directly to research participants.
  • Determine whether it is necessary to completely suspend research activities and if so, pause the research until the situation changes.

Investigators may choose to alter research procedures to remove in-person interactions, if possible. Please see additional guidance issued by the GW IRB for making such modifications to clinical research as well as social/behavioral/educational research in order to protect research participants and staff during COVID-19. Note that there is separate guidance for non-clinical (social/behavioral/educational/observational) research and clinical research.

Modification of Research Studies

In an effort to protect research participants, research team members, and the GW community from risk of COVID-19, as well as to support access to clinical research which may provide essential support and care to participants and to ensure their safety, the GW Institutional Review Board (IRB) is issuing updated guidance on research with human subjects during the COVID-19 pandemic.

This guidance is designed to help GW investigators and study staff manage their research studies and protocols during the COVID-19 pandemic while ensuring participant and research personnel safety, as well as maintaining scientific integrity and regulatory compliance as much as possible. This guidance is not intended to represent official regulatory policy and may be updated as necessary or superseded by directives from local and national agencies. This guidance is temporary and will apply only during the COVID-19 pandemic. It is not meant to persist beyond the pandemic.

Modification of Non-clinical (Social/Behavioral/Educational/Observational) Research

Modification of Clinical Research

Halting Enrollment into Non-essential Studies Involving In-person Interaction with Participants

A primary consideration of ethical HSR is consideration of the risk-benefit ratio of the research and research procedures. Evolving information about COVID-19 introduces concerns about risks to participants from face-to face interactions. In order to more fully protect GW research participants, staff and the larger GW community, The Office of Human Research (OHR) has recommended that recruitment and enrollment into non-essential HSR that involves in-person interactions with participants be halted.

  • Non-essential HSR is research without direct clinical or therapeutic benefit to participants.
  • Essential HSR is research that provides direct clinical or therapeutic benefit to participants.
  • In-person interactions are defined as situations in which research staff and participants are in the same room and within 6 feet of each other. This type of interaction increases the possibility of physical contact and common exposure to germs (e.g., via sneezing, coughing) that can lead to COVID-19 transmission. As such, non-essential in-person HSR increases risk of harm for participants, without providing a clear benefit to participants.

Enrollment of new participants into non-essential HSR involving in-person interactions between study participants and study personnel should be paused during the local COVID-19 outbreak and reopened only in accordance with university, department, and local/national health authority requirements. This pause in enrollment does not need to be reported to the GW Institutional Review Board (IRB).

Please refer to the "Resuming Human Subjects Research: Phase 1" section below for a phased re-opening plan for non-essential research that involves in-person interactions. The OHR website will be updated with new information as the institution enters subsequent phases.

Resuming Human Subjects Research: Phase 1

For the foreseeable future, the novel coronavirus that causes COVID-19 will be circulating on campus and in the community. COVID-19 remains a risk until effective treatments and vaccines are widely available. COVID-19 represents a new risk to research participants. Therefore, all GW researchers performing research with human subjects must inform research participants of the risks of COVID-19 that might be encountered due to the research, and take appropriate steps to mitigate these risks.

The following guidance is provided to assist researchers in resuming approved human subjects research during Phase 1 of GW's research reopening:

Communicate with OHR as Necessary

If you must modify study procedures immediately in order to protect researchers and/or study participants, you may implement changes without prior IRB approval, but may need to report such action to the IRB via iRIS as soon as possible.

Please follow OHR’s guidance on changes to research during the COVID-19 pandemic linked at the end of the section above. Note that there is separate guidance for non-clinical (social/behavioral/educational/observational) research and clinical research.

If you must temporarily suspend research due to concerns about participant safety, you should submit this suspension as Promptly Reportable Information in iRIS as soon as possible.

If you decide to voluntarily suspend study activities, but that decision is not immediately related to participant safety and there is no increased risk to human subjects from that suspension, then the IRB does not need to be notified.

You may implement procedures to ask research participants about questions related to recent travel, contacts, and current symptoms prior to study. You do NOT need IRB approval to incorporate those questions into your study visit scheduling.

Requesting Rush Review

The Office of Human Research (OHR) is experiencing a larger-than-normal volume of submissions and modifications as a result of the COVID-19 pandemic. As a result, investigators can expect 4-6 weeks for review of any type of submission once it has been assigned to an analyst.

At this time, the GW IRB and OHR staff are prioritizing review of essential HSR and HSR focusing on COVID-19. For new studies focusing on COVID-19, please include the term COVID in the study title, and follow the process for requesting rush review.

Contacting OHR/Requesting Consultations

We realize that this is a challenging time for you and for our communities. Please feel free to contact OHR at any time if you have any questions or concerns.

OHR staff are available for consultation. Please see the Contact Us section of the GW OHR website for more information.

IRB submission volume is likely to be high at this time due to increased questions and modifications related to COVID-19. Please plan accordingly and contact OHR for urgent issues.

Additional Information

Please refer to these useful sites for more guidance: