Consent Form

Appendix J

Informed Consent Form

Adult Consent Form

Title of Study: Evaluating Consumer Behaviors and Responses to Risk Messaging (eIRB # 10599)

Principal Investigator(s): Dr. Benjamin Chapman, [email protected], 919-515-8099

Funding Source: U.S. Department of Agriculture

What are some general things you should know about research studies?

You are being asked to take part in a research study. Your participation in this study is voluntary. You have the right to be a part of this study, to choose not to participate, and to stop participating at any time without penalty. The purpose of research studies is to gain a better understanding of a certain topic or issue. This research study is to test new packaging for a breakfast sausage product.

You are not guaranteed any personal benefits from being in this study. Research studies also may pose risks to those who participate. You may want to participate in this research because this study will generate knowledge that can help others in the future. You may not want to participate in this research because of the minimal risks associated with cooking in a kitchen.

Specific details about the research in which you are invited to participate are contained below. If you do not understand something in this form, it is your right to ask the researcher for clarification or more information. A copy of this consent form will be provided to you. If at any time you have questions about your participation, do not hesitate to contact the researcher named above or the NC State IRB office (contact information is noted below). The IRB office’s contact information is listed in the What if you have questions about your rights as a research participant? section of this form.

What is the purpose of this study?

The purpose of the study is to test new packaging for a breakfast sausage product.

Am I eligible to be a participant in this study?

There will be approximately 380 to 410 participants in this study.

In order to be a participant in this study, you must agree to be in the study and:

1. Be between the ages of 18- and 64 years of age and;

2. Have cooked a breakfast meal containing raw pork and eggs during the past 6 months;

3. Have experience cutting a watermelon, cantaloupe, or honeydew melon.

You cannot participate in this study if you do not want to be in the study or:

1. cooked or worked professionally in a food preparation setting in the past 5 years;

2. received any type of food safety training, such as ServSafe, in the past 5 years; or

3. participated in a research study related to food in the past 4 years.

What will happen if you take part in the study?

If you agree to participate in this study, you will be asked to do all of the following:

1. Enter the test kitchen, listen to the introduction, and become familiar with the test kitchen setup (e.g., location of plates, utensils, restroom). The average participant will take approximately 10 minutes to complete this part.

2. Prepare a meal while being video recorded. Meal preparation may include frying, grilling, baking, microwaving, cutting, slicing, and preparing meats and vegetables. The average participant will take approximately 90 minutes to complete meal preparation.

3. You will also be asked to take part in a short interview after preparing the meal. The interview will ask about your food preparation practices. We will use the recordings and interview findings to prepare a summary report; however, your identity will not be associated with your behaviors in any reports. The average participant will complete the interview in approximately 20 minutes.

The total amount of time that you will be participating in this study is a maximum of 120 minutes, including from the time of check in to the end of the interview.

Recording and images

If you want to participate in this research, you must agree to be audio and video recorded. If you do not agree to be audio and video recorded, you cannot participate in this research.

Risks and benefits

There are minimal risks associated with participation in this research. You will be asked to prepare one recipe in a kitchen and complete a short interview. There are minimal risks to you as a preparer of food as there are heat sources (stove, oven, countertop grill) and sharp objects that may result in cuts (knives, forks, slicers). The items and appliances are common home kitchen equipment. We anticipate that the risk of injury is the same as the risk if you were preparing food in your own home. Each study kitchen is equipped with a first aid kit and fire extinguisher. Researchers will be available just outside of the kitchen to assist in case of injury by providing the first aid kits and alerting medical staff if needed. There is no provision for free medical care for you if you are injured as a result of this study.

There are no direct benefits to your participation in the research. The indirect benefits include knowledge that may be gained that can help others.

Right to withdraw your participation

You can stop participating in this study at any time. In order to stop your participation, please let a staff member know. If you choose to withdraw your consent and stop participating, you can expect to exit the kitchen, sign out with a staff member, and receive partial compensation. If you choose to withdraw your consent and to stop participating in this research, you can expect that the researcher(s) will redact your de-identified data from their data set, securely destroy your data, and prevent future uses of your de-identified data.

Confidentiality, personal privacy, and data management

Trust is the foundation of the participant–researcher relationship. Much of that principle of trust is tied to keeping your information private and in the manner that we have described to you in this form. How we manage, protect, and share your data are the principal ways that I protect your personal privacy. Data generated about you and shared in this study will be de-identified.

De-identified. De-identified data are information that at one time could directly identify you, but I have recorded this data so that your identity is separated from the data. I do not have a master list with your code and real name that connects your information to the research data. When the research concludes, there will be no way your real identity will be linked to the published data.

To help maximize the benefits of your participation in this project, by further contributing to science and our community, your de-identified information will be stored for future research and may be shared with other people without additional consent from you.

Compensation

For participating in this study, you will receive a $75 gift card to Target or Wal-Mart and a free gift. If you withdraw from the study before its completion, you will receive partial compensation: the $75 gift card.

Emergency medical treatment

If you are hurt or injured during the study session, the researcher will contact the University’s emergency medical services at 1.919.515.3333 for necessary care or call 911. There is no provision for compensation or free medical care for you if you are injured as a result of this study.

Sponsorship and Funding

This research is funded by the U.S. Department of Agriculture’s (USDA). This means that the sponsor is paying the research team for completing the research. The researchers do not, however, have a direct financial interest with the sponsor or in the final results of the study.

What if you have questions about this study?

If you have questions at any time about the study itself or the procedures implemented in this study, you may contact the researcher: Dr. Benjamin Chapman of NCSU, [email protected], 919-515-8099.

What if you have questions about your rights as a research participant?

If you feel you have not been treated according to the descriptions in this form or your rights as a participant in research have been violated during the course of this project, you may contact the NC State IRB (Institutional Review Board) Office. An IRB office helps participants if they have any issues regarding research activities. You can contact the NC State IRB Office via email at [email protected] or via phone at 919-515-8754.

Consent To Participate

By signing this consent form, I am affirming that I have read and understand the above information. All of the questions that I had about this research have been answered. I have chosen to participate in this study with the understanding that I may stop participating at any time without penalty or loss of benefits to which I am otherwise entitled. I am aware that I may revoke my consent at any time.

Participant’s printed name _____________________________________________

Participant’s signature ___________________________ Date _________________

Investigator’s signature __________________________ Date _________________

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 0583-0169 and the expiration date is XX/XX/XXXX. The time required to complete this information collection is estimated to average 10 minutes 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.

Informed Consent Addendum

Research During COVID-19 Pandemic

These research activities are 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. This has been affirmed through daily researcher screenings and attestations.

The sanitation and cleaning measures in place during all study activities include the following steps. At the beginning of each day, all counter and stove surfaces, refrigerator handle and shelves, trash can lids, sinks, and sink faucets 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) for one round: the researcher will spray surfaces listed above, let the spray sit for 60 seconds, then wiped down with a paper towel. Refrigerator and cabinets (including handles) will be clean and sanitized with Clorox Disinfecting Wipes, enough to be wet for four minutes. After each observation, the researcher will follow this cleaning and disinfecting procedure. The entry (main) door handle and the handles of all test kitchens and the observation room will also be wiped down, with enough to be wet for four minutes. Meal preparation items (knives, utensils, plates, etc.) will be cleaned and sanitized in the dishwasher. Any meal prep item that cannot be loaded into the dishwasher will be cleaned and disinfected using either Clorox spray, let sit for 60 seconds then wiped down with a paper towel or wiped with a Clorox Disinfecting Wipe, enough to be wet for four minutes after each observation.

The personal protective equipment that the researchers will use includes wearing disposable or reusable face masks. If researchers are wearing reusable face masks, he/she will be required to wash the mask overnight before using again. Disposable masks will be available to the researchers and located in the observation room.

As a participant, you will be provided with a disposable face mask as personal protective equipment and you must wear it while participating in this research.

Participants, Please Initial

• ________ I have not knowingly interacted with someone who has been diagnosed or demonstrated symptoms of COVID-19

• ________ I do not have any symptoms of COVID-19 such as cough, fever, shortness of breath, chills, muscle pain, sore throat, new loss of taste or smell.

• ________I agree to follow all safety and sanitation procedures while participating in this study including wearing appropriate personal protective equipment.

• ________I understand that in order to take part in this research, while I am a participant in this study I must allow my name and information about those I interacted with to be recorded for contact tracing purposes should an issue arise regarding COVID-19 infection or transmission.

• _I understand that if I am vaccinated, it is possible that my participation in this research, even with all the precautions in place, may still expose the people in my life to COVID-19 and they may be at risk for severe illness if they are not also vaccinated.

I have read the above information and have had the opportunity to ask questions and have them answered. I understand my responsibility related to COVID-19 and the risks associated with being in this study as a result. I agree to participate in this research.

_____________________________________________________

Participant Printed Name, Signature, and Date