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 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.
Effective October 12, 2020, 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.
Effective July 16, 2020, the Office of Research Compliance is providing additional guidance regarding human subject research. This guidance applies to all ongoing and new research studies (including exempt research) as well as activities that have been/will be deemed Not Human Subjects Research conducted by Stony Brook University personnel.
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.
Human Subject research that continued after the guidance to ramp down research in March must meet the requirements outlined in these guidelines. 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 10/12/20)
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 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. Additionally, studies with no direct benefit that involve aerosol-generating procedures are not allowed at this time.
Participation from subjects with any conditions predisposing them to more severe COVID19 disease is not allowed at this time. Please see the Center for Disease Control (CDC) for updated information on these conditions for updated information on these conditions. However, subjects with conditions predisposing them to COVID-19 may participate in studies with no direct benefit in which their only participation would be an additional procedure when that same procedure is already being done for clinical purposes (i.e. blood draw at the same time that blood is already being drawn for clinical purposes).
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
- 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, Reportable New Information (RNI) application must be submitted to the IRB Office.
- Collect contact information from subjects in the event that contact tracing is needed. Principal Investigators, Department Chairs, and study team members should not discuss or share any protected health information on behalf of study subjects and are not responsible for conducting contact tracing. Subjects who notify study teams regarding exposure to COVID-19 or actual symptoms of the disease, will be directed to call the Health Information Line (HIL) at 631-632-5000. An individual from the Health Information Line will interview the subject and determine who may have been in close contact with them during their time on and off campus. If the Principal Investigator or study team members have been in close contact with the subject, they will also need to contact the Health Information Line.
- Request that subjects contact the study team if they develop symptoms of COVID-19 within 14 days of the study visit or if the study subject finds that he or she had been exposed to someone with COVID-19 at the time of the study visit.
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