VPR Announcement - Updated Guidelines for Human Subjects Research

Date: December 1, 2020
Attn: Faculty, trainees and staff registered in EHS Integrator for human subjects research
Summary: Updated Guidelines for Human Subjects Research

Dear Principal Investigator,

You are receiving this email because you are listed as the PI of an approved protocol to reactivate your human subjects research (HSR) during the pandemic. As conditions in Connecticut, nationally, and globally have recently been deteriorating, the Human Subjects Research (HSR) Committee is strengthening its guidelines so that HSR Phase 1 and 2 research can continue under Yale’s research reactivation with appropriate risk mitigation measures in place. We are therefore reaching out to the human subjects research community, asking you to review the guidance below carefully and to discuss with your research staff and trainees. Some of these recommendations are advisory, others are required. Some new human subjects research restrictions may apply to your protocol(s) and may require action on your part. These new restrictions are a consequence of increased virus prevalence, and will be reviewed regularly to determine when they can be lifted.

Travel by Out-of-State Participants to Yale (May Require Action)

Investigators must follow both State of Connecticut and Yale travel restrictions with respect to travel by research staff and by participants. Yale travel guidelines do not permit any out-of-state visitors to Yale’s campus without first quarantining. These guidelines also apply to participants in human subjects research. Exceptions to this policy can be extended if the participant is already enrolled in a clinical trial or therapeutic research protocol, or is enrolled in a longitudinal study, if subjects requiring travel cannot be substituted in the study, and if the study procedures, specimen collection, or medication distribution cannot be reasonably performed using remote methods or third-party services. Out-of-state participants must, in any event, comply with the State of Connecticut travel restrictions in place at the time of the visit.

Given these guidelines, the HSR Committee recommends that PIs not recruit out-of-state or other participants that require travel to their research protocols especially for non-therapeutic trials without a prospect of direct benefit. If your research involves out-of-state participants and they are required to travel to CT for research visits, consistent with Yale travel guidelines, then you must submit an amendment to your EHS protocol explaining how you will mitigate the additional risks associated with participant travel. This may involve pre-visit COVID testing, enhanced PPE for research staff, or other risk mitigation procedures.

To amend your existing HSR registration, see here.

Travel by Yale Investigators to Participants (New Restrictions, May Require Action)

Researchers traveling to participants for human subject data collection need to observe restrictions imposed by the State of Connecticut and those imposed by Yale and follow Yale’s travel guidelines. Out-of-state travel by researchers may require quarantine unless they choose the testing alternative upon their return (see Governor’s Executive Order 9I). When traveling, researchers must also follow general Yale health and safety guidelines, observe Yale‘s vehicle use policy, and consider enhanced protection strategies as outlined in response to the recent increase in COVID cases here.

In addition, human subject researchers are no longer allowed to travel to and perform their studies at sites not approved by EHS (for a list of EHS-approved sites, see here) and from making home visits in Connecticut and surrounding regions. This step is being taken because Yale EHS cannot adequately assess the risks to Yale faculty, research staff, and trainees associated with research at sites not approved by EHS. For travel to sites outside Connecticut and surrounding areas, please see COVID safety updates provided by the Off-Campus Research and Fieldwork Committee for research in the natural sciences and in the humanities and social sciences, and monitor COVID conditions nationally and internationally.

If your protocol involves travel to a facility not approved by EHS or a home visit in Connecticut or to another high COVID incidence location, then you must stop these visits immediately. There are a limited number of exceptions detailed below. If you believe that your research qualifies for an exception, then you must submit an amendment to your EHS protocol explaining how you will mitigate the additional risks associated with your travel before you can restart your visits. This may involve pre-visit COVID testing for staff or participants, enhanced PPE for research staff and/or participants, remote acquisition of specimens by authorized third party service providers, or other risk mitigation procedures.

Exceptions to this policy may include (1) research performed at non-Yale sites that have obtained EHS approval, (2) drop-off or pick-up of equipment, specimens, or samples that does not require physical contact, (3) the use of authorized third-party entities (e.g., Quest) that can obtain specimens at a participant’s home, (4) participant interactions that can be performed outdoors, socially distanced with appropriate PPE, and (5) where a failure to travel to a site not approved by EHS or a participant’s home would pose a health risk to that participant.

If you believe that your research meets one of these exceptions, you must submit an amendment to your HSR registration.

To amend your existing HSR registration, see here.

Aerosol Generating Procedures (Advisory)

The HSR Committee has recently published guidelines for the PPE requirements associated with research that involves the production of aerosols. If your research involves high aerosol generation (e.g., smoking/vaping, CO2 measurements, spitting, singing, bronchoscopy, endotracheal intubation, BVM ventilation, GI endoscopy, nebulized treatments, or similar procedures or activities), then you must follow these guidelines. The guidelines can be found at here

EHS can offer additional advice regarding risk mitigation if you are uncertain about your particular research activity or PPE requirement.

Testing Participants Who Must Remove Their Masks (New Restrictions)

Protocols that require the participant to remove his/her mask while interacting with investigators or other participants as part of the research procedure are no longer allowed. Investigators are advised to use remote/electronic procedures (e.g., cameras, intercoms) whenever possible if visualization of the face is required.

Exceptions for this new restriction are allowed when mask removal is unavoidable, and occurs only for a brief period, in an appropriately ventilated room audited and approved by the EHS, and with appropriate PPE for the limited research staff present. Examples of such protocols may include MRI placement/positioning or EEG probe placement under conditions reviewed by the Human Subject Research Committee. Exceptions may also be made if testing is being performed in infants or young children where mask use is not possible. Enhanced PPE and eye protection for staff is required in these situations. Please note that mask removal by a participant during interactions with an investigator is considered an aerosol generating activity and investigators who have been granted an exception must consult the guidelines linked in the section above.

EHS can offer additional advice regarding risk mitigation if you are uncertain about your particular research activity or PPE requirement.

Eye Protection (Highly Recommended)

It has been recognized that eye protection such as lab safety glasses mitigate risk of viral transmission. Yale is therefore now strongly recommending that all participant-facing researchers use eye protection throughout encounters. Eye protection can include face shields or safety goggles.

COVID Testing for Staff (Highly Recommended)

We are strongly recommending that research groups consider having participant-facing research members (particularly in studies with a high participant volume) participate in the free, voluntary twice weekly COVID testing offered by Yale or at an appropriate location off-campus. Details about testing can be found here.

Sincerely,

Michael C. Crair, Ph.D.
William Ziegler III Professor of Neuroscience
Vice Provost for Research

Eric Velazquez, M.D.
Robert W. Berliner Professor of Medicine
Co-chair, Human Subjects Research Committee

Gregory McCarthy, Ph.D.
Henry Ford II Professor of Psychology
Co-chair, Human Subjects Research Committee