Important Research Update: Clinical and Field-Based Research-July 2020

July 2, 2020

Dear RBHS Faculty,

It’s already been a month since Dr. David Kimball’s Office of Research and Economic Development (ORED) announced the phased Rutgers ‘Return to Research’ plan on May 29th.

Since then, your research deans have been working tirelessly, processing surveys and managing logistics, to assure the safe return of our researchers which, in Phase 2, pertained primarily to those involved in wet-lab research. 

This memo provides updates on the ORED plan for research return to work including: (A) Phase 2, so far primarily for wet laboratory research, and (B) ongoing ramp-up for the elective return of on-site clinical and field-based human subjects research: 

(A) We are happy to report that, in the past two-plus weeks, over 1,900 researchers across Rutgers have been tested for coronavirus (and another 1,100 tests are being processed).  Of those tested to date, approximately 0.4% of all virus tests have produced positive results. It is essential to remember that safety is paramount in all efforts to return to on-site research work. Key safety measures include the wearing of face coverings at all times while outside your home and the practice of safe distancing. Please emphasize these mandatory measures to your research team members who are permitted to return to on-site work. Failure to comply with these requirements could place others at risk and result in a surge in COVID-19 cases, in addition to leading to another ramp-down of research. Notably, we will have no choice but to revoke the privilege of on-site work from those not abiding by essential safety measures in the workplace. Should you have any safety concerns or concerns regarding research support services or building maintenance not being provided, please contact your research dean or unit director. 

We are still in Phase 2, but, as it pertains to the specific schools/units, faculty will be hearing from their research dean or unit director about the initiation of Phase 3.  If you have not already done so, and would like to be considered for return to on-site wet-lab research, please complete the ORED Return To Research survey and contact your unit director.

(B) There are new ORED guidelines for clinical and field-based research that were released on June 29th which contain important information and required protocols for the return of research involving human subjects.  In collaboration with their department chairs and deans, faculty must develop strategies specific to their research that ensure the highest possible compliance with the requirements of these guidelines.  Strategies to resume in-person clinical and field-based human subjects research should include, prior to initiation of research:

• Instructions that are communicated to all persons involved in the research including information on acquisition of face coverings and their use, the use of disinfectants, physical distancing, and the reporting of symptoms and any adverse incidents;
• Schedules to help stagger work assignments and work locations to allow for appropriate physical distancing;
• Specified workspaces, when possible, to minimize direct contact between staff or contact with materials or surfaces touched by others;
• Contingency plans if one or more personnel become sick or is no longer willing to work onsite;
• Graduate students may participate in research consistent with these guidelines; 
• Undergraduates are not permitted on campus and no student should be required or pressured to participate in on-campus research during the COVID-19 pandemic. 

If you would like to resume your in-person clinical and field-based human subjects research, you should proceed as follows:

1. If you have not already done so, please complete the ORED Return To Research survey. While there are some questions that may not apply to you, please complete all sections as this survey provides critical links to generate next steps in the approval process (please disregard the June 5, 2020 deadline on first page of survey).
2. During the week of July 6-10, discuss your proposed plans for return of clinical or field-based human subjects research with your chair and research dean (or unit director). Phases 2 and 3 of the return to on-site work are elective, and any work that can be done remotely should continue in that manner. 
3. Research involving human subjects must comply with the requirements of Institutional Review Board (IRB) and any special COVID-19-specific guidelines issued by the IRB. Depending on the nature of the research, IRB approval of amended protocols may be required. ORED has developed a quick and easy-to-use Human Subjects Determination Tool to aid you in determining whether your study requires IRB review.
4. Investigators who are approved by their research dean (or unit director) to ramp-up their in-person clinical and field research activities will then be contacted by ORED to arrange for virus testing. 
5. An email notification from ORED will contain a code that links you to delivery of the RUCDR saliva test kit for SARS-CoV-2 via the telemedicine provider (Vault Health) and a link to the mandatory safety training. The time from initiation of the telemedicine link to receiving tests results will be completed within approximately 7 days.
6. If your test result is negative for virus, you will be invited to return to on-site work. If you test positive for the virus, you will not be allowed to return to work and Occupational Health will follow up with you to inform you when you may retake the test, and when you may return to work. 

Thank you very much in advance for working with your units on this important effort, and for your patience during the ramp-down that we know has negatively impacted research across RBHS (and nationally). We look forward to working with you to continue recovery from the impact of the pandemic on research activities.

Happy July 4th weekend and best wishes,

Adrienne Ettinger
Chief of Staff for Research, RBHS

Kathleen Scotto 
Vice Chancellor for Research and Research Training, RBHS

Bishr Omary
Senior Vice Chancellor for Academic Affairs and Research, RBHS