Guidance for Human Subject Research

Modifications in study procedures and study conduct need to be approved by the IRB. When submitting a modification to the IRB to revise study procedures in response to COVID-19, rather than add specific procedures for conducting in-person visits, include the following statement:  “To ensure appropriate safety precautions when conducting in-person study procedures, the process for conducting in-person visits outlined in the Guidance for Human Subject Research will be followed.”

Physical or in-person study visits should be replaced with phone or video sessions where possible. This may include using electronic consent for enrollment.

All study personnel who will have direct contact with study participants are required to take a daily health screening survey before reporting to work. This is mandatory to protect our research personnel and subjects. Any study personnel with symptoms should not report to work. Faculty and staff who are diagnosed with COVID-19 must report this to Human Resources, while students must report their diagnosis to Student Health Services.

All subjects, and support persons, who will have an in-person visit should be screened for symptoms of COVID-19. While the process for screening depends on facility layout and staffing, the general steps include:

• Pre-screen study subjects, and their support person(s).  Before the study visit telephone the study subject to discuss COVID-19 and provide them information about what we are doing to protect them (see script below).  Ask the subject and their support person to check their temperature and gather information about COVID-19 symptoms the day prior to their visit. They may not have a thermometer, and this should not preclude a study visit.  If they don’t have a thermometer, ask if they feel as if they have had a fever.
• Advise study subjects to check their temperature again at home before leaving for their research study visit (if they have a thermometer) for a fever (T > 100.4°F). Study subjects with a fever should have their study visit rescheduled.  Advise them they should put on a cloth face covering, regardless of symptoms, before leaving their home.
• Post alerts such as signs and posters at study site entrances and in strategic places around the facility with instructions for subjects with fever or symptoms of respiratory infection to go home and contact their healthcare provider.
• Instruct subjects to notify the study coordinator before arriving if they have fever (T > 100.4°F) or symptoms of COVID-19. If they have symptoms, they should go home and contact a healthcare provider.  You should postpone the study visit until they are symptom free for 14 days.
• Protect: If the study subject and the subject’s support person(s) arrive and are not already wearing a cloth face covering, provide a face mask.  If possible, there should be a barrier (plexiglass) between the study staff and the study subject.
• Screen all study subjects and their support persons on arrival.  Determine if they have a fever (T > 100.4°F) or symptoms of COVID-19, including cough or shortness of breath, sore throat, fever, muscle aches, headache, new loss of taste or smell, repeated or shaking chills.  Individuals who have COVID-19 symptoms should see their healthcare provider. For more seriously ill subjects, consider sending them to the Emergency Room if appropriate (subject very short of breath, confused, unable to stand up, for example).   

Field Work (Off-Site) Study Subject Visits

• Pre-screen all study subjects, and their support person(s).
• Defer study procedures or observations with any individual(s) symptomatic for COVID-19.
• Social Distance – Maintain social distancing from all study subjects during the study activities.
• Protect study staff and subjects. You must wear appropriate PPE, and your study subjects must mask during the visit.
• When studies are IRB-approved to conduct study in off-site locations, it is important that these visits follow similar guidelines with respect to subject pre-screening, masking, use of PPE, and social distancing.

Masking
All research subjects who arrive without a mask will need to be provided one.

Physical/Social Distancing
Research subject interviews or contact with research staff must adhere to physical distancing guidelines. Subjects should be seen in areas that allow 6 feet of separation at all times, except when contact is necessary to complete study procedures, for example physical examinations or other study procedures that require contact.

Hand washing/sanitizing
All areas where study subject visits will take place should have hand sanitizer available in the area.

Cleaning Research Subject Rooms and Equipment
Cleaning rooms and equipment that have been in contact with study subjects should occur immediately after the study visit is completed. Standard masking/face covering rules still apply.

Study Subject Contact
You should make sure research staff members who are screening study subjects remain six feet away from the subject until screening determines they are symptom-free and do not have a fever (by subject report or active temperature monitoring).

Screening staff should wear a face mask but do not need to wear PPE if they are separated from study subjects by a physical barrier such as a glass or plastic window. Screening staff should make these interactions as brief as possible by limiting the interaction to screening questions only.

If a staff member must be within six feet of a study subject, they should use appropriate PPE, including a face mask, gloves and eye protection. Cloth face coverings are not considered PPE and should not be worn by the study team member when PPE is indicated.

I can certainly understand your concerns—this is a worrisome situation, and we’re all trying to decide what the best way is to keep ourselves and our families safe. I’d like to share what SUNY-Potsdam is doing to make sure you stay as safe as possible while participating in research studies here.

All study investigators, coordinators, nurses and staff in our research areas are wearing masks, and we’ll also provide a mask to you and anyone who comes with when you arrive, if you don’t have one.

We also require all our employees to screen themselves for symptoms daily before they come into work, and we’ll screen you for symptoms the day of your visit.

We are following meticulous infection control practices, including disinfection, wearing gloves, and hand washing.

We are limiting the number of visitors accompanying people for their study visits and have rearranged and/or removed furniture in our waiting areas to enforce strict social distancing practices.

We’re also being careful about who we ask to come for in-person study visits, and when possible are using telephone or video conferencing to reduce the number of study subjects coming to our research areas at the same time.

We know that COVID-19 will be in our community for many months.  We appreciate your continued participation in our study.  Please ask if there is anything you are concerned about.