This guidance supersedes guidance dated June 15, 2020, April 9, 2020 and March 26, 2020
July 16, 2020: Guidance for Researchers Conducting Human Subject Research
(Revised on May 6 ,2021, March 5, 2021, November 13, 2020, October 12, 2020, August
4, 2020 and July 23, 2020)
This guidance applies to all research involving human subjects on campus and has been developed in conjunction with the School of Medicine Vice Dean for Research.
This guidance applies to both on-site and off-site research. Off-site research must be conducted with the same safety measures that are used in on-site research. The Principal Investigator is responsible for ensuring that all research conducted off-site follows the instructions contained within this guidance document.
Research with human subjects can proceed only to the extent that it can be performed safely. Investigators must account for safeguards for study personnel and subjects in restarting research activities, and these safeguards must be included in the Principal Investigator Laboratory Operation Plan. Stony Brook University research faculty and staff must continue to comply with executive orders and health authority guidance from national, state, local, and University authorities to protect the safety of research subjects, caregivers, students, staff, visitors (i.e., monitors, vendors, etc.), and faculty.
The approach outlined here is based on continuing to establish physical distancing requirements for various research spaces, requiring the use of personal protective equipment (PPE), and sound hygienic practices, such as recommended hand washing/use of hand gel, and routine sanitizing of work areas and self-health checks prior to coming to work. Staff and research subjects should also avoid gathering in areas that do not allow a distance of 6 feet between persons.
Under no circumstances should safety be sacrificed due to lack of adequate PPE.
NOTE: Plan in advance for PPE supply issues and the availability of other necessary supplies when evaluating on-site clinical and non-clinical research.
Unless otherwise noted, any research activities that include on-site visits are expected to follow the guidance outlined below.
Informing All Study Participants of COVID19 Risk
Subjects must be informed of the added risk of participating in in-person research during the COVID-19 pandemic with universal language for all studies. However, it is not required for the language to be added to the consent form. The universal language must be posted in the research space where subjects visit. Individuals must also be given a copy of the information and the opportunity to read the information prior to participation.
Studies with Direct Benefit to Research Subjects
On-going and newly submitted studies in which there is likelihood of direct benefit to the research subject, and/or serious or immediate harm could be caused to the subject if the research were stopped, should continue, with appropriate safeguards. These direct benefit therapeutic studies that require on-site enrollment may enroll new subjects on-site if there is a direct benefit to the study subject. On-site study visits may also occur based on staff availability, required PPE and the ability to maintain required social distancing measures among staff.
Studies with Moderate Direct Benefit to Research Subjects
On-going and newly submitted studies in which there is likelihood of some benefit to the research subject, and/or some risk could be caused to the subject if the research were stopped, should continue, with appropriate safeguards. On-site enrollment may occur if there is a moderate benefit to the study subject. Study visits may occur on-site based on staff availability, required PPE and the ability to maintain required social distancing measures among staff.
Studies with No Direct Benefit to Research Subjects
(Section Last Updated 5/6/21)
Ongoing and newly submitted studies in which it has been determined that there is no direct benefit to subjects and includes direct interaction are allowable as of this date , except as noted below , with provisions of staff availability, appropriate use of PPE and the ability to maintain required social distancing measures among staff.
- Studies with no direct benefit that invovle direct interaction with subjects who cannot be masked or shielded during all close contact procedures are not allowed at this time.
- Studies with no direct benefit that involve aerosol-generating procedures are not allowed at this time.
- Participation by a subject with any conditions that can increase the subject's likelihood of a severe illness from COVID19 disease is not allowed at this time unless the subject has been fully vaccinated. Fully vaccinated means that the subject is two weeks past either the two-dose vaccination series or the one shot (single does) vaccine. Subjects must bring their vaccination card to their in-person research study visits for verification purposes. Please see the Center for Disease Control (CDC) for updated information on these conditions for updated information on these conditions.
Researchers with requests that are outside the current guidelines for research in which there is no direct benefit to subjects should contact Rebecca Dahl at the Office of Research Compliance (rebecca,firstname.lastname@example.org). The Office of Research Compliance will provide additional expertise that can range from an administrative review to consultation with the Institutional Review Board. This process will include the consideration of any additional risks and ensure that safety measures are put into place for the protection of subjects.
NOTE: Researchers must maintain and follow all approved Principal Investigator Laboratory Operation Plans and be prepared to return to remote activities on short notice if this becomes necessary.
Additional Considerations for Human Subject Research
A. Safety Practices
- Sanitize research areas and equipment between subject engagements (e.g., wipe down tabletops, chairs, computer keyboard/mouse, tablets, pens, body sensor devices, study measurement devices).
- Utilize gloves when contact with the subject is required to conduct the research; ask the subject to bring a pen to sign the consent form.
- Wear surgical/procedural masks while working on-site, including when in contact with research subjects and/or staff.
- Research subjects and caregivers must wear either a surgical/procedural mask or a cloth mask/face covering throughout the visit, except when removal of the mask/covering is necessary (e.g., during a physical exam or other research procedure, or when eating/drinking/taking medication).
- Pre-screening of subjects before or upon arrival is required in order to identify possible symptoms of COVID-19 and plans for administering the pre-screening should be described in the Principal Investigator Laboratory Operation Plan .
B. Research Activities
- Maximizing opportunities for remote research is critical and should remain in use for the foreseeable future. Research visits with subjects should be conducted virtually wherever permitted by study protocol or other sponsor guidance until local, state, and institutional restrictions are lifted.
- Restructure visits to combine/consolidate procedures or series of procedures to minimize participant travel and exposure and so that those at higher risk of severe illness from COVID-19 are seen at a later, safer date.
- Meetings with sponsors/CROs/vendors/monitors and collaborators should continue to be conducted virtually and are subject to New York state quarantine restrictions. If monitoring visits are essential, the monitor must abide by Stony Brook requirements which can be found here.
- Investigators should minimize the number of research staff in research areas in order to limit exposure to study subjects.
- Research related activities should be conducted with time limitations in accordance with the Principal Investigator Laboratory Operation Plan for staff and subject safety.
- All research areas must eliminate traditional waiting and common seating areas and utilize nontraditional alternatives (e.g., call ahead registration, waiting in car until called, taking the subject directly to the research room, etc.).
- If safer for subjects, consider whether clinical research procedures (e.g., MRI, blood draws, etc.) could/should take place in clinics or laboratories closer to the participant’s homes, rather than coming to the SBU campus or a major hospital for these procedures.
- If subjects or their companions do not have masks or hand sanitizer at home, consider sending a mask to the participant and/or companion to wear in-transit to the research facility.
- Discuss how subjects and if applicable their companions, will travel to the study visit and the safest method to do so (e.g., personal car, taxi, uber, etc.). If possible, provide transportation or arrange transportation and payment of transportation for the subject.
D. Continued Vigilance - REVISED MARCH 5, 2021
Please continually review Stony Brook University campus policy for guidance on exposure to the coronavirus. You can review this information here . Per campus policy, all SBU personnel who test positive for COVID-19 or may have been exposed to someone who tested positive for COVID-19 should call the Coronavirus Hotline at 631-638-1320 for further instructions regarding contact tracing and return to work.
Information from the Center for Disease Control (CDC) website can inform you about when you can be around others after you had covid-19 (or been exposed to someone who tests positive for COVID-19) . This information can be found here .
- Please see below for additional guidance on subject and study team member exposure to the coronavirus.
What to do if a study team member tests positive for COVID-19 or has been exposed to someone who tests positive for COVID-19:
The study team member should contact the Principal Investigator of the study to report the positive COVID-19 test or the exposure to an individual with COVID-19. The Principal Investigator then alerts the other study team members of their possible exposure. They in turn should have a COVID-19 test performed in order to ascertain their status as well as prevent additional exposure to others.
What to do if a study team member has tested positive to COVID-19 (or has been exposed to someone who tests positive for COVID-19) and exposes a subject:
The subject should be made aware of the exposure. The Principal Investigator should notify the subject and request that the subject be tested in order to ascertain their status as well as prevent additional exposure to others.
What to do if a subject tests positive for COVID-19 (or has been exposed to someone who tests positive to COVID-19) and subsequently exposes study personnel:
The subject should contact the Principal Investigator of the study to report the positive COVID-19 test or the exposure. The Principal Investigator then alerts the study team members of their possible exposure. Those study team members who have been exposed should have a COVID-19 test performed in order to ascertain their status as well as prevent exposure to others.
What to do if one of several subjects participating in the study at the same time reports a positive COVID-19 test (or exposure to someone who tested positive for COVID-19) after in-person study participation:
On occasion, multiple subjects may be asked to participate in a study simultaneously. Despite precautionary measures, one of the subjects may report a positive COVID-19 test or exposure to someone who tested positive for COVID-19. The subject should notify the Principal Investigator of the study to report the positive test or exposure. The Principal Investigator then alerts the other subjects of their possible exposure and encourages these individuals to have a COVID-19 test performed.
What to do if the Principal Investigator tests positive for COVID-19 or has been exposed to someone who tests positive for COVID-19:
If the Principal Investigator tests positive for COVID-19 or learns that he or she has been exposed to someone who tests positive for COVID-19, the Principal Investigator should alert study team members and subjects as previously described. To prevent delays in this important step intended to minimize additional cases of exposure, the Principal Investigator should designate other study team members who could complete study tasks or procedures if he or she becomes unable to do so.
Study teams should create a notification plan in the event that a staff member or research subject develops COVID-19 and research subjects or others may have been exposed as a result of their participation in the research. In this circumstance, a Reportable New Information (RNI) application must also be submitted to the IRB Office.
NOTE: If the facility in which the research occurs has stricter restrictions than outlined above, the facility guidance must be followed.
Please direct questions to the Office for Research Compliance at ORC_OVPR@stonybrook.edu