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1. INSTRUCTIONS FOR STUDY TEAM

1.1. Please use this template to create Standard Operating Procedure for providing appropriate protections to human research participants when conducting in-person activities during a public health crisis and when community transmission of disease is moderate to significant1. Use of this SOP is consistent with UGA resumption of research and return to campus plans, Phases 1-2 during the COVID-19 pandemic and is required for any study in Level 4 according to the HRPP Toolkit Decision Tools.

1.2. This template includes samples of the elements that should be included in the SOP. Please create your own document, applicable to your specific research. You may choose sample language from the options in each section or create your own description. Remove any instructions (red font) and the HRPP logo from your document before submission.

2. DEFINITIONS 2.1. Standard Precautions assume that every person is potentially infected.

3. IDENTIFICATION OF IN-PERSON AND REMOTE PROCEDURES3.1. In this section, list all procedures that were previously approved and paused or all proposed

procedures if the submission is new research. Provide the location where each procedure will be conducted, the estimated duration for each procedure, and a separate estimate for the part of the procedure that requires close proximity, when applicable. For studies with several procedures or complex steps, consider submitting a table as a supplemental material (see Template – Study Procedures.)

3.2. PROCEDURE 1 – Demographic Questionnaire – Remote administration via Qualtrics after in-person visit is complete by home computer or by phone if participant does not have access to a computer/Internet. Duration: 10 minutes.

3.3. PROCEDURE 2 – Blood draw by venipuncture – In PI lab/facility, Building Name, Office # by PI/research assistants. Duration: 15 minutes.

1 Sustained transmission with high likelihood or confirmed exposure within communal settings and potential for rapid increase in cases. https://www.cdc.gov/coronavirus/2019-ncov/community/community-mitigation.html

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3.4. PROCEDURE 3 – Focus Group – Group of 5 individuals at local area church after services are complete. Duration: 30 minutes.

3.5. PROCEDURE 4 – MRI – BIRC facility – Duration: 1 hour total, close proximity 20 minutes.

4. SCREENING4.1. Describe specific screening procedures for reducing the potential for transmission of infection.

Eligibility screening to determine inclusion/exclusion should not be included here. The level of screening required to ensure participant safety is dependent on the targeted population and the study procedures. Use of the HRPP Template for Screening is highly recommended.

4.2. All participants will be administered screening questions to assess for fever and COVID-19 symptoms when scheduling the visit and again upon entry to the facility (or research space as applicable.)

4.3. Study staff will be placed near the facility entrance (outdoor if weather permits) to ensure that participants are screened for symptoms prior to entering the facility.

4.4. When scheduling the visit, participants will be asked to check their temperature before traveling to the facility. If a temperature indicative of fever (100.4 F or higher) is reported, the participant will be advised to seek medical care as they typically would and to reschedule the appointment for two weeks after symptoms resolve.

4.5. If the participant reports a fever (100.4 F or higher), the participant will be advised to seek medical care as they typically would and to reschedule the appointment for two weeks after symptoms resolve.

4.6. Guardians will be screened when they must accompany a child to the visit.4.7. Temperature will be checked using a no-touch thermometer. If the individual has a

temperature indicative of fever (100.4 F or higher), the participant will be advised to seek medical care as they typically would and to reschedule the appointment for two weeks after symptoms resolve.

4.8. Study staff should carefully consider personal travel plans and follow the CDC recommendations. Any non-essential travel should be minimized.

4.9. Staff will be screened daily for symptoms of illness and will be asked to return home and self- quarantine for 14 days if signs are present. Staff will be asked to check for fever at home and report a fever (100.4 F or higher).

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4.10.Staff is asked to self-quarantine if they are in contact with anyone who has tested positive for the coronavirus or if they have been around someone who is suspected of having an active coronavirus infection.

5. PERSONAL PROTECTIVE EQUIPMENT (PPE)5.1. In this section, describe the PPE or other prophylactic measures that will be used by participants

and study team members. Droplet protection should be described as cloth face covering, facemask, or respirator2, as applicable. Consider carefully if the facility is large and well-ventilated enough to propose no face covering be utilized (e.g., outdoors.)

5.2. If participant is not already wearing a cloth face covering, the study team will provide a cloth face covering or a facemask (if supplies allow.)

5.3. Participants will be given a disposable facemask upon entry to the facility. The mask is single-use only and should be disposed of following completion of the study visit.

5.4. Study staff will ensure that all participants and guardians wear a cloth face covering or facemask. Cloth face coverings will not be placed on young children under age 2.

5.5. Study staff will wear a facemask during all procedures that require close proximity. 5.6. Study staff will wear a surgical or N95 mask (as available) during the study visit. Those who will

be doing procedures with direct participant contact such as blood draws will also be encouraged to wear a disposable gown (if available), and goggles or face shield.3

5.7. Study staff will wear lab coats during all procedures. Lab coats will be laundered daily.

6. HAND HYGEINE

2 Cloth face covering: Textile (cloth) covers that are intended to keep the person wearing one from spreading respiratory secretions when talking, sneezing, or coughing. They are not PPE.Facemask: Facemasks are PPE and are often referred to as surgical masks or procedure masks. Respirator: A respirator is a personal protective device that is worn on the face, covers at least the nose and mouth, and is used to reduce the wearer’s risk of inhaling hazardous airborne particles (including dust particles and infectious agents), gases, or vapors. 3 CDC recommends use of eye protection is recommended in areas with moderate to substantial community transmission. For areas with minimal to no community transmission, eye protection is considered optional https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control.html

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6.1. In this section, be sure to describe procedures for participants and study team. Handwashing is the preferred method but use of hand sanitizer can also be proposed.

6.2. Participants and guardians will be instructed to wash hands when they arrive and before they leave, but hand sanitizer will be provided as an alternative (if available).

6.3. Participants and study staff will be provided with alcohol-based hand rub (with 60-95% alcohol), tissues, and no-touch receptacles for disposal. Visual alerts will be posted to provide instructions about hand hygiene and cough etiquette.

6.4. Study staff will wash hands with soap and water for 20 seconds before and after any contact with the participant.

6.5. Study staff will wear single-use gloves when applying sensors to participant’s leg. Immediately after applying sensors, gloves will be removed and disposed of, and the staff member will wash hands with soap and water for 20 seconds.

6.6. During the study visit, study staff will avoid unnecessary touching of surfaces in close proximity to the participant to prevent both contamination of clean hands from environmental surfaces and transmission of pathogens from contaminated hands to surfaces.

6.7. Study staff will wash hands with soap and water before having direct contact with patients, after contact with blood, body fluids or excretions, after contact with a patient’s intact skin (e.g., when taking a pulse or blood pressure), after contact with inanimate objects (including equipment) in close proximity to the participant, and after removing gloves.

6.8. Study staff will wear disposable gloves or reusable utility gloves for cleaning commonly touched surfaces and equipment and will immediately dispose of used gloves after doffing.

7. SOCIAL DISTANCING7.1. Social distancing refers not just to the distance between participants and researchers but to the

allowable number of people (group size) in an enclosed area. This section should describe procedures should consider appropriate measures to enforce/facilitate social distancing. Procedures that require close proximity between individuals (< 6ft. between individuals) should be identified and the duration specified. The number of participants and number of researchers present for a procedure should be described.

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7.2. Only one participant will be scheduled per visit timeslot. Two study team members will be present during the treadmill protocol to ensure participant safety but only one study team member will be present during all other procedures to reduce potential exposure.

7.3. Participants will be asked to wait in a personal vehicle until their appointment time, if possible. Participants without vehicles will be advised to wait outside if conditions permit. If not, they may be allowed in the building if safe to do so, but they will be asked to sit at least 6 feet away from the entrance and other individuals. Seating will be arranged to facilitate social distancing.

7.4. Participants will be instructed to arrive alone. When guardians accompany children or adults who require legally authorized representatives, guardians will be asked to wait in a designated area designed to facilitate social distancing.

8. FACILITY8.1. In this section, describe how the research space is set up to ensure protections, limit group size,

restrict unnecessary traffic, and improve/ensure adequate air-flow.8.2. Points of entry to the facility will be limited to prevent unnecessary traffic and to control the

number of individuals in the area. 8.3. Doors to the research space will be kept open to prevent unnecessary contact between

individuals and surfaces. 8.4. Windows in the research space will be opened to improve ventilation.8.5. No touch waste receptacles with lids will be utilized for disposable PPE and other trash.

9. CLEANING AND DISINFECTING9.1. In this section, describe measures taken by study staff for routine and targeted cleaning of

environmental surfaces as indicated by the level of contact. It is understood that some areas are routinely cleaned and disinfected by UGA FMD; however, to adequately protect researchers and participants, additional cleaning/disinfecting may be required. Cleaning/disinfecting is expected prior to participants entering the space and/or touching objects or equipment with bare skin. It is not sufficient to clean after a participant leaves since others with access to the space (e.g., other study team members) may touch the surface/equipment between participants. Look here for the list of EPA recommended cleaners and disinfectants.

9.2. COMMONLY TOUCHED SURFACES

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9.3. Doorknobs, conference table surface, and chair arms will be routinely cleaned and disinfected before the first participant enters and at the end of the work day. When more than 5 participant visits are scheduled for one day, additional cleaning and disinfecting will be done after every third participant. EPA registered disinfectants for SARS-CoV-2 will be used in accordance with manufacturer’s instructions

9.4. EQUIPMENT/SHARED OBJECTS9.4.1.For the procedures that require the participant's bare skin or uncovered head to come in

contact with the object, surface, or piece of equipment, cleaning and disinfection with EPA registered disinfectants for SARS-CoV-2 will be conducted prior to each participant use in accordance with manufacturer’s instructions

9.4.2.Non-porous surfaces used during a visit will be cleaned with EPA registered disinfectants for SARS-CoV-2, Cavi-Wipes, virucidal bleach solutions or wipes, or an isopropyl alcohol mixture of at least 70% alcohol before each participant visit.

9.4.3. The phlebotomy tray and chair, countertop, and stool will be cleaned and disinfected using EPA recommended materials prior to each participant visit.

9.4.4.Study staff will clean their individual work stations/terminals following a visit to prevent cross-contamination. The desk and computer keyboard/mouse (any multi-use electronic equipment) used by the participant during the visit will be cleaned prior to the next participant use to prevent contamination.

9.4.5.Any reusable PPE will be cleaned, decontaminated, and maintained after and between uses.

10. CONSENT PROCESS10.1.In this section, describe the consent process. The consent process can be conducted in-person

but may be facilitated so that the time the process takes is reduced by providing materials by text or email prior to the scheduled visit and/or by going over elements and answering questions by phone. The process may also be conducted remotely, further reducing participant burden and risk by phone, text, email, Skype, Zoom, or other technology. Where signature is sought, consider options such as the participant signing and sending a picture of the signed document or a scan, if possible.

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10.2.Prior to in-person testing, consent materials including the addendum pertaining to risk due to COVID will be emailed to the participants. The researcher will review the consent information with the participant over the phone prior to the scheduled testing sessions and answer any questions that they may have. When the participant arrives in the lab, after screening and hand hygiene, they will sign the forms.

10.3.During initial contact, an email address will be obtained so that the consent materials can be sent for review. The participant will be instructed to call with any questions and to electronically sign or to print and sign the document. If necessary, instructions for signing the document using a mobile phone, picture app, or other method will be provided. The participant will be asked to take a picture of the signed document (or screenshot) and email or text it to the researcher. An appointment for the testing visit will be scheduled when the signed consent has been received.

11. RISK AND BENEFIT ASSESSMENT11.1.Risk for in-person activities associated with COVID-19 transmission/infection should be

described in this section. While it is understood that COVID-19 infection risk is not research-related, the participant will be having contact for research-purposes with the study team and may be visiting facilities which they would not normally do. Particularly for studies that do not have potential direct benefits for the participants, the risks of these additional contacts should be assessed and mitigated. The benefit of doing the procedure, to the outcomes of the study, should also be assessed.

11.2.The researcher must have brief but direct contact with the participant’s body to complete some assessments (e.g., to measure height and waist circumference.) Protections for the procedures include additional PPE as described herein. These measurements are important outcomes for the scientific question pertaining to effect of the exercise intervention.

12. TRAINING12.1. The Principal investigator is expected to describe the process 12.2.The PI will ensure all study team members have knowledge of and adhere to the campus

Research Resumption Requirements and the project Research Resumption Plan (RRP).

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12.3.Participants and guests will be provided with information about the project and/or facility policy for facemasks/face covering, areas designated for waiting or research activities, hand hygiene, social distancing, and limiting surfaces touched.

12.4.The PI will educate and train study stuff on cleaning and disinfection procedures so they are followed consistently and correctly.

12.5.The PI will educate and train all study staff on appropriate use of PPE and prevention of contamination of clothing, skin, and the environment during the process of removing such equipment.

12.6.The PI will educate and train all study staff when to use PPE, what PPE is necessary, how to properly don, use, and doff PPE in a manner to prevent self-contamination, how to properly dispose of or disinfect and maintain PPE, and the limitations of PPE.

13. MATERIALS13.1. Procedure Table: XXXXX 13.2. CHECKLIST: XXXXX 13.3. Decision Tree: XXXXX

Revision History:06/15/2020: REV0 New Document