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Appendix

University of North Carolina at Chapel Hill Consent to Participate in a Research Study Adult Participants

Consent Form Version Date: ___02/22/2019___ IRB Study # 18-3286

Title of Study: Design, implement, and evaluate a new remote web-based visualization system for the clinical examination and treatment of skin lesions. Evaluate system's performance base on feedback

Principal Investigator: Nick Wang

Principal Investigator Department: School of Information and Library Science Principal Investigator Phone number: (919)-593-1493

Principal Investigator Email Address: [email protected] Faculty Advisor: David Gotz

Faculty Advisor Contact Information: (919) 962-3435

Concise Summary

The purpose of this study is to test out and evaluate the functionalities in the Progression- System. The information we learn by doing this study may help us to evaluate and enhance the system during future endeavors.

Participants in this study will be given a short introduction of the system of what it does, and what the general structure is, then participants will be asked to perform several tasks on the system within certain time limit. An interview questionnaire will be given to participants to fill out after the tasks are finished or time limit runs out. During the interview process, the device screen and audio will be recorded for data collection. The data collected will not be labeled with any personal information of the participant. There is a very little chance of the collected data being compromised. However, it is virtually impossible to trace back to any of the participants with the collected data. If you are interested in learning more about this study, please continue to read below.

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

You are being asked to take part in a research study. To join the study is voluntary. You may choose not to participate, or you may withdraw your consent to be in the study, for any reason, without penalty.

Research studies are designed to obtain new knowledge. This new information may help people in the future. You may not receive any direct benefit from being in the research study. There also may be risks to being in research studies.

Details about this study are discussed below. It is important that you understand this information so that you can make an informed choice about being in this research study. You will be given a copy of this consent form. You should ask the researchers named above, or staff members who may assist them, any questions you have about this study at any time.

What is the purpose of this study?

The purpose of this research study is to evaluate the developed web system. The system is a web-based visualization and management system developed to facilitate skin lesion data processing and analysis. This semi-structured interview intends to collect data and feedback from participants to provide insights for evaluating and improving the system.

Are there any reasons you should not be in this study?

You will not be able to participate this study if you do not wish to have your interview screen and audio recorded.

How many people will take part in this study?

There will be approximately 5 people in this research study.

How long will your part in this study last?

You will have to participate the one-time interview for approximately 30 minutes. There will be no further requirement for participation of this study. However, you are welcome to reach out to us with questions and suggestions for the study.

The raw data collected during the study will be deleted after the analysis is complete. What will happen if you take part in the study?

Overall design:

o Participant read through and sign consent letter o System introduction by interviewer

o Interviewer present a page of several tasks to participant o Participant perform tasks on the system accordingly o Task complete/time up, participant complete questionnaire What are the possible benefits from being in this study?

Research is designed to benefit society by gaining new knowledge. You will not benefit personally from being in this research study.

What are the possible risks or discomforts involved from being in this study? There may be uncommon or previously unknown risks. You should report any problems to the researcher.

What if we learn about new findings or information during the study?

You will be given any new information gained during the course of the study that might affect your willingness to continue your participation.

How will information about you be protected?

Participants will not be identified in any report or publication about this study. We may use de-identified data and/or specimens from this study in future research without additional consent.

Although every effort will be made to keep research records private, there may be

times when federal or state law requires the disclosure of such records, including personal information. This is very unlikely, but if disclosure is ever required, UNC-Chapel Hill will take steps allowable by law to protect the privacy of personal information. In some cases, your information in this research study could be reviewed by representatives of the University, research sponsors, or government agencies (for example, the FDA) for purposes such as quality control or safety.

• All information will remain strictly confidential. The descriptions and findings may be used to help improve the Progression System.

• At no time will your name or any other identification be used. Your responses to the questionnaire will be stored offline in a password protected device, associated with an ID number.

• Only the researcher will have access to that data through password protection.

• After the conclusion of the study, the data will be permanently removed from those servers.

• Your mouse movements, typing, and voice will be recorded by QuickTime recording software on the computer you will use during the study. Your face or image will not be recorded. The audio recordings will only be used to reference during the analysis phase of the study, but the team may use direct quotes or screen capture from your participation if they are relevant to the area of study and could not be used to identify you.

Check the line that best matches your choice: _____ OK to record me during the study _____ Not OK to record me during the study

What will happen if you are injured by this research?

All research involves a chance that something bad might happen to you. This may include the risk of personal injury. In spite of all safety measures, you might develop a reaction or injury from being in this study. If such problems occur, the researchers will help you get medical care, but any costs for the medical care will be billed to you and/or your insurance company. The University of North Carolina at Chapel Hill has not set aside funds to pay you for any such reactions or injuries, or for the related medical care. You do not give up any of your legal rights by signing this form.

What if you want to stop before your part in the study is complete?

You can withdraw from this study at any time, without penalty. The investigators also have the right to stop your participation at any time. This could be because you have had an unexpected reaction, or have failed to follow instructions, or because the entire study has been stopped.

Will you receive anything for being in this study?

You will be receiving a $10 Amazon gift card for taking part in this study. Any payment provided for participation in this study may be subject to applicable tax withholding obligations.

Will it cost you anything to be in this study? It will not cost you anything to be in this study. What if you are a UNC employee?

Taking part in this research is not a part of your University duties, and refusing will not affect your job. You will not be offered or receive any special job-related consideration if you take part in this research.

What if you have questions about this study?

You have the right to ask, and have answered, any questions you may have about this research. If you have questions about the study (including payments), complaints, concerns, or if a research-related injury occurs, you should contact the researchers listed on the first page of this form.

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

All research on human volunteers is reviewed by a committee that works to protect your rights and welfare. If you have questions or concerns about your rights as a research subject, or if you would like to obtain information or offer input, you may contact the Institutional Review Board at 919-966-3113 or by email to [email protected].

Participant’s Agreement:

I have read the information provided above. I have asked all the questions I have at this time. I voluntarily agree to participate in this research study.

______________________________________________________ Signature of Research Participant

____________________ Date

______________________________________________________ Printed Name of Research Participant

______________________________________________________ Signature of Research Team Member Obtaining Consent

____________________ Date

______________________________________________________ Printed Name of Research Team Member Obtaining Consent