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This is the online protocol submission and review system for the Institutional Review Board (IRB) at Wake Forest University. eIRB provides a collaboration workspace for the IRB and the Human Subjects Research community and is the location for IRB review activities.  Principal Investigators and their study teams can initiate new study applications, make amendments to existing studies, submit continuing review applications and report safety events through this site.

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NEW Information 4/30/2020

COVID-I9 Research Changes

WAKE FOREST SCHOOL OF MEDICINE COVID-19 RESPONSE: GUIDE FOR SAFE RE-START OF

RESEARCH ACTIVITIES

Overall Goals

Re-start research activities while continuing to protect the health and safety of our employees, students,

patients, and community.

Address the unique circumstances and challenges of the many different research environments at the

medical center.

Identify and implement creative COVID-19 research strategies, encouraging new research in this field.

Encourage continued social distancing and limit on-site activity to only that which is necessary,

identifying creative approaches to completing work remotely without compromising study integrity.

Position each Department/Center/Institute to develop an operational plan that addresses all criteria

within this document. These plans will be shared with Research Leadership for review and filing. Contact your Chair for details with you own area.

Clinical Research

Wake Forest School of Medicine clinical research programs will be permitted to re-start on June

1, 2020 under the following conditions and standards. This guidance will remain in place until

further notice.

Conditions that must be met and/or maintained to engage in research:

o No current Shelter in Place Orders (State & Local)

o Continued guidance from experts in the field that we are not putting our employees, students,

patients, and/or community at undue risk through the conduct of research.

o Adequate supplies of PPE for clinical, research, and education enterprises

o COVID-19 evaluation processes in place for employees and research participants

o Ability to implement and maintain strategies to reduce potential COVID-19 transmission in the

workplace.

Ramp-up Standards:

o Effective Tuesday, May 26, 2020, Departments/Centers/Institutes with clinical research teams

will be permitted to allow a maximum of 10% of their workforce back on site to plan and prepare

for the June 1, 2020 re-start.

o During the week of May 26, 2020, activity must be limited to planning, cleaning, and preparing

for the upcoming research start-up, but not the actual conduct of clinical research studies.

o The Clinical Research Unit, Translational Imaging Program, and other Research Cores will not

initiate new activities during the week of May 26, 2020. They too should be using this time to

conduct preparatory work in advance of the June 1, 2020 re-start.

Personnel Standards:

o All research faculty and staff must adhere to the mask wearing standards set forth by the

institution. With this, masks must be worn at all times while on campus with the exception of

breaks that allow for social distancing or instances when an individual is working alone in an

office. In any shared environment, masks must be worn at all times.

o All research faculty and staff are required to stay home if they are sick with no exceptions. In

addition, we ask that all faculty and staff self-administer the following screening questions daily:

§ Have you had a fever, cough, or shortness of breath in the last 7 days?

§ Have you had vomiting or diarrhea in the last 7 days?

§ Have you had contact with someone who was diagnosed to have COVID-19?

o If any faculty or staff answer positively to these questions or report illness, refer them to

Employee Health to determine next steps. In addition, if a COVID-19 positive individual is

known to have entered or worked in the office or lab, notify Employee Health. The area may

have to be temporarily closed for cleaning and disinfection.

o Limit the number of staff on-site to the absolute minimum possible, identifying strategies for how

essential activities can be done with a smaller staff footprint at any one time.

o Identify activities that can be performed with reduced face-to-face interaction:

§ Limit the number of meetings and when possible, use remote collaboration tools (phone,

video), even for those on site and in the same office/building.

§ If you must meet in person, limit attendance in conference rooms to a maximum of 50%

occupancy.

§ Encourage employees to use phones and email to ask each other routine questions or

obtain service versus in-person discussions.

o Do not permit children or volunteers to be on site at any time.

Research Site Standards:

o Environmental Services and our contracted cleaning companies have initiated protocols to

increase cleaning standards across all research buildings with a particular focus on increased

cleaning frequency of high touch areas in common spaces.

o With the above said, research teams must create and/or update Standard Operating

Procedures, putting in extra measures to ensure a clean and appropriate environment for staff.

Please note that the heterogeneity of our research programs will require a heterogeneous

response. These items cannot be dictated centrally, so please carefully consider the needs of

your teams, including re-evaluation of guidelines for cleaning, PPE use, and handwashing. In

addition, please provide guidance to your teams regarding areas and activities that are

appropriate for standard issue cloth masks as compared to areas or activities requiring a higher

level of PPE (surgical masks, N95 masks, etc.).

o Identify high-touch locations and equipment specific to environment. Locations and equipment

with a high frequency of handling and contact represent a higher probability of viral loading in

the work area and should be disinfected on a routine basis.

o Be vigilant with supplies coming into research areas. Without knowing where these items

originated or who has handled them, it is best practice to disinfect everything that is received.

Pre-Visit Screening Standards:

o Administer screening questions via phone or video 24 hours in advance of all on-site visits.

o Ask participants:

§ Have you had a fever, cough, or shortness of breath in the last 7 days?

§ Have you had vomiting or diarrhea in the last 7 days?

§ Have you had contact with someone who was diagnosed to have COVID-19?

o If the participant responds negatively to all questions, they may proceed with scheduled visit. If

they report an issue, refer them to their primary care physician and/or to one of our respiratory

assessment clinics. They can call 336-713-7775 and they will receive a phone visit to help

determine if they need to be seen or evaluated for COVID-19.

On-Site Visit Standards:

o Mask all participants prior to entering clinical research environments.

o Take each participants temperature upon entry into clinical research environments. If the

participant is found to have a temperature of 100 degrees or greater, discontinue the visit and

refer them to their primary care physician and/or to one of our respiratory assessment clinics.

They can call 336-713-7775 and they will receive a phone visit to help determine if they need to

be seen or evaluated for COVID-19.

o Upon completion of the temperature check, prior to research visit start, administer the following

screening questions:

§ Have you had a fever, cough, or shortness of breath in the last 7 days?

§ Have you had vomiting or diarrhea in the last 7 days?

§ Have you had contact with someone who was diagnosed to have COVID-19?

o If the participant responds negatively to all questions, they may proceed with scheduled visit. If

they report an issue, refer them to their primary care physician and/or to one of our respiratory

assessment clinics. They can call 336-713-7775 and they will receive a phone visit to help

determine if they need to be seen or evaluated for COVID-19.

o Carefully adhere to all cleaning, PPE, and handwashing protocols to protect both the research

staff and our participants. Examples include:

§ Wipe down tables, chairs, beds, writing utensils, keyboards, tablets, equipment, and

other surfaces prior to the participants arrival.

§ Use hand sanitizer at the start of every visit.

§ At the end of every visit, wipe everything down again wearing gloves and wash hands.

Other Research Faculty & Staff

Other research faculty and staff, such as non-patient facing investigators/staff, non-lab-based

investigators/staff, and research administration personnel, while essential to our research

mission, often have the opportunity to contribute significantly while working remotely. Thus,

we ask that all departments, centers, and institutes develop a plan that allows these individuals

to continue working remotely through at least July 1, 2020 with the possibility for extension.

In advance of this date, if it is absolutely essential that other research personnel be on site, we

ask that you adhere to the following personnel standards:

o All research faculty and staff must adhere to the mask wearing standards set forth by the

institution. With this, masks must be worn at all times while on campus with the exception of

breaks that allow for social distancing or instances when an individual is working alone in an

office. In any shared environment, masks must be worn at all times.

o Environmental Services and our contracted cleaning companies have initiated protocols to

increase cleaning standards across all research buildings with a particular focus on increased

cleaning frequency of high touch areas in common spaces. That said, teams must create

and/or update Standard Operating Procedures, putting in extra measures to ensure a clean and

appropriate environment for staff.

o All research faculty and staff are required to stay home if they are sick with no exceptions. In

addition, we ask that all faculty and staff self-administer the following screening questions daily:

§ Have you had a fever, cough, or shortness of breath in the last 7 days?

§ Have you had vomiting or diarrhea in the last 7 days?

§ Have you had contact with someone who was diagnosed to have COVID-19?

o If any faculty or staff answer positively to these questions or report illness, refer them to

Employee Health to determine next steps. In addition, if a COVID-19 positive individual is

known to have entered or worked in the office or lab, notify Employee Health. The area may

have to be temporarily closed for cleaning and disinfection.

o Limit the number of faculty and staff on-site to the absolute minimum possible, identifying

strategies for how essential activities can be done with a smaller footprint at any one time.

o Identify activities that can be performed with reduced face-to-face interaction:

§ Limit the number of meetings and when possible, use remote collaboration tools (phone,

video), even for those on site and in the same office/building.

§ Encourage employees to use phones and email to ask each other routine questions or

obtain service versus in-person discussions.

§ If you must meet in person, limit attendance in conference rooms to a maximum of 50%

occupancy.

o Do not permit children or volunteers to be on site at any time.