procedures COVID

Appendix I:

COVID-19 Procedures

Participant Population Description and Screening

• The target population for this study is participants who are between the ages of 18 and 64 who have prepared raw or cooked meat or poultry products within the last 30 days. Because the focus of this study is on the home consumer, the target population excludes people with previous work experience within the last 5 years in the food or healthcare industry, in market research, advertising, or public relations; or those who have worked for FDA, CDC, or USDA. People who have participated in a research discussion in the last 6 months, who do not consent to audio- and video- recording, and cannot read or write in English are also excluded.

• The COVID-19 screener questions will be integrated into the initial project screener. Eligible participants will receive a phone call to confirm their participation. During this phone call, participants will be reminded of “day of” screening procedures. The participant will receive a confirmation email with date/time, driving directions, cleaning and sanitizing procedures and precautions including mandatory use of face coverings, and another reminder of “day of” screening procedures.

• When the participant arrives at the facility, the facility host will greet participant at the door and administer the “day of” screening tool. If participant is eligible, the host will direct participant to the waiting area. If the participant is not eligible, participant will receive the message stating the following: “Please contact your medical provider to discuss your needs and report your symptoms.”

Research Procedures Employed that May Increase Risk to Participants

• As part of the study, participants will be handling mock food packages or food recall templates the project team has handed out. Each participant will have their own package or template to hold and look at. In between focus groups, the moderator will sanitize each food package and discard the templates, providing new templates to new participants.

• The COVID-19 information collected as part of the initial screening and day of surveys are not subject to HIPAA and will not be used as part of the research. The information in this file will not be shared with RTI or FSIS.

Informed Consent Plan, Reviewing the COVID-19 Addendum, and Participant Tracking

• The informed consent form with COVID-19 addendum will be made available to the participant prior to arrival via a hyperlink in conformation email. Upon arrival and, if deemed eligible based on ‘day of’ screener survey, the participant will be provided a paper copy of the consent form to read. The researcher will specifically review the COVID-19 addendum and answer any questions. The participant will also be provided a copy of the consent form to take home.

• At the beginning of each focus group, the moderator will be screened for and asked to sign, time, and date to confirm the following: 1) I have not knowingly interacted with someone who has been diagnosed or demonstrated symptoms of COVID-19 within the past 2 weeks and 2) I do not have any symptoms of COVID-19 such as cough, fever, shortness of breath, chills, muscle pain, new loss of taste or smell. These daily forms will be scanned and stored on the project share and will be maintained throughout data collection, then shredded and disposed of two weeks after the end of data collection.

Facility Use and Physical Distancing Plan

• Physical Distancing and Changes to Space: Waiting room chairs and chairs in the observation/conference room will be spaced at least six feet apart.

• Scheduling: Participants will be scheduled so that focus group times do not overlap. This will ensure social distancing between participants and provide enough time in between groups for cleaning, sanitizing, and setting up for the next group.

Personal Protective Equipment (PPE)

• The moderator will wear a disposable face masks, which will be disposed of and replaced before the next day of focus groups.

• Participants will be required to wear face coverings. If they do not have one, one will be provided.

Cleaning and Sanitization

• Facility Conference/Observation Room: Before the first focus group, all tables, chairs and other surfaces, will be sanitized using Clorox Clean-Up Cleaner and Bleach Spray (which is on EPA’s List N, Disinfectants for use against SARS-CoV-2). The researcher will spray surfaces listed above, let the spray sit for 30 seconds, then wipe down with a paper towel. After each

group, the researcher will follow this cleaning and disinfecting procedure, but for three rounds of cleaning and sanitizing. The entry door of the room will remain open while participants are getting checked-in/situated. In between groups, the door handle will be wiped down three times after each group. Mock food packages will be cleaned and sanitized between focus groups using a Clorox wipe three times after each focus group. All cleaning and sanitizing procedures are part of the study design and the responsibility of the researcher.

• Observation Room: Hand sanitizer will also be provided in the observation/conference room. Hand sanitizer will be available at all times, but researchers will use it in between focus groups and as needed.

• Personal Hygiene Expectations for Researchers: All researchers will wash hands following CDC guidelines:

  • Before each focus group

  • At the end of each group

  • After using the restroom

  • Before and after eating

  • After blowing nose, coughing, or sneezing

• Personal Hygiene Expectations for Participants: Before beginning the focus group, participants will be reminded to wear a face covering for the duration of the event. If any participant arrives without a face covering, one will be provided. Researchers will also remind each participant to maintain distancing of at least six feet when interacting with any research team member.

• Communication Regarding Hygiene and Cleaning and Sanitizing: Researchers will communicate cleaning and sanitizing procedures in the following ways:

  • Once a participant is deemed eligible after the initial screening, the facility staff will send an email to participants a few days prior to their scheduled group. This email will contain relevant study information (date, time, and driving directions), but also the following information regarding COVID-19: “This research study is taking place during the COVID-19 pandemic. The researchers involved in this study have no symptoms of COVID-19 and have not knowingly interacted with anyone demonstrating symptoms or diagnosed as COVID-19 positive. In addition, researchers will be cleaning and sanitizing surfaces including materials you may use or touch prior to your arrival. Researchers will be wearing face masks at all times during your scheduled focus group. As a participant, you must wear a face covering while participating in this research. You are welcome to wear your own face covering, or one will be provided for you. Please do not attend the focus group if:

    • You knowingly interacted with someone who has been diagnosed or demonstrated symptoms of COVID-19.

    • You have any symptoms of COVID-19 such as cough, fever, shortness of breath, chills, muscle pain, or new loss of taste or smell.

    • You do not agree to follow all of the safety and sanitation procedures while participating in this study including wearing the appropriate personal protective equipment (face mask).

  • On the day of the focus group, researchers will also remind participants of the cleaning and sanitizing procedures that have taken place prior to their arrival as well as remind participants to social distance whenever possible and wear a face covering throughout the focus group.

Reporting COVID-19 Cases

• This research project does not generate any information that diagnoses COVID-19.

• If participants self-report symptoms and/or contact with COVID-19 positive individuals during the “day of” screener we will suggest they seek medical advice and inform the RTI Infectious Disease Response Team.

• If any research staff tests positive for COVID-19, or if a health care provider diagnoses any staff member as presumed positive for COVID-19, the researcher should notify the RTI project coordinator and principal investigator. The project coordinator or principal investigator will then contact the RTI Infectious Disease Response Team for guidance regarding the next steps for continued research.

Weighing of Risks and Benefits of This Research

Due to the procedures involved in this study, the risk of contracting COVID-19 is minimal. Additionally, because of screening of both participants and members of the research team plus social distancing and the use of protective personal equipment, the risk of person to person infection is low. The benefit of this research is greater than the risks because this research: 1) helps to better understand consumer food handling behaviors at home; 2) promotes more effective messaging

regarding safe food handling in the home environment; and 3) seeks to reduce the incidence of food borne illness through such messaging.

According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0583-0xxx and the expiration date is 0x/xx/20xx. The time required to complete this information collection is estimated to average 1.5 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.