This guidance is superseded by guidance dated July 16, 2020.
June 15, 2020: Further Updated Guidance for Researchers Conducting Human Subject Research during Covid-19
In response to the COVID-19 outbreak, the Office of Research Compliance is providing guidance for research activities, effective June 15, 2020 and continuing until further notice.
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 June 15, 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.
Clinical research can proceed only to the extent that it can be performed safely. 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, 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 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:
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 benefit to the study subject. These studies may be initiated with on-site contact based on staff availability, required PPE and ability to maintain required social distancing measures among staff. On-site study visits may also occur based on staff availability, required PPE and the ability to maintain required social distancing measures among staff.
Moderate Direct Benefit to Research Subjects - On-going and newly submitted studies in which participation by subjects may result in a direct benefit and would, if stopped (for those subjects already enrolled), pose some risk to the research subject. 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.
No Direct Benefit to Research Subjects – Ongoing and newly submitted studies in which it has been determined that there is no direct benefit to subjects. The target date for expansion of research that does not provide direct benefit to subjects, but requires direct contact with subjects is highly dependent on ongoing updates to federal, state, local, and institutional policies related to physical distancing and allowed activities and based on continuous monitoring of the guidelines. Staff involved in data collection and studies where contact is not required, should continue to work remotely to minimize the number of staff in research buildings and offices at any time.
NOTE: Researchers must maintain plans and be prepared to return to remote activities on short notice if this becomes necessary.
In order for research employees to return to on-site work, the following practices must be in place:
- Maximizing opportunities for remote work is critical and should remain in use for the foreseeable future.
- Meetings with sponsors/CROs/vendors and collaborators should continue to be conducted virtually until local, state, institutional and facility restrictions are lifted.
- 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.
In addition to Stony Brook University requirements for safety of staff and study subjects, the following must occur:
- Investigators should minimize the number of research staff in procedure rooms in order to limit exposure and use of PPE.
- 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 a consent form.
- All research personnel must 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).
- Research related activities should be conducted by a minimum number of necessary people, with time limitations in accordance with the institutional plan for staff 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.).
Research office/clinic visits (Additional Guidance Where Appropriate):
- For outpatient research visits conducted
- Research personnel should contact subjects within 24 hours prior to the visit.
- Research staff should verbally confirm and document that the subject is well, and explain the procedures on campus for screening.
- The subject must be informed that they will be required to wear a mask throughout the visit.
- Upon arrival, research subjects will be asked about symptoms consistent with COVID-19.
- In healthcare facilities where this screening is conducted for everyone who enters the building, research personnel do not need to repeat the screening.
- Research subjects should not bring guests to the visit.
- Children and adults who require assistance may have one caregiver.
- If a caregiver is required to be present, the caregiver must also be screened prior to the visit as outlined above.
- Throughout the study visit, including during the screening process, research personnel should follow physical distancing guidelines (i.e., 6 feet of physical distancing), except as necessary to complete required procedures.
NOTE: If the facility in which the research occurs has stricter restrictions than outlined above, the facility guidance must be followed.