Online Informed Consent for Research Being Conducted Under the Auspices of the University of Tulsa

Physical Behavior and Health: A Prospective Cohort Study

INTRODUCTION
This research study is being conducted by Eric Wickel, PhD (primary investigator, PI) and co-investigators John Hale, PhD and Brett McKinney, PhD. This document defines the terms and conditions for being in this study.
WHY IS THIS RESEARCH STUDY BEING DONE?
This study will improve our understanding of daily physical behaviors and how they influence health. Physical behaviors are difficult to assess and interpret under free-living conditions using self-report tools. Wearable devices can improve our understanding of daily behavior and its relationship with health.
WHAT KEY INFORMATION DO I NEED TO KNOW TO HELP ME DECIDE TO PARTICIPATE IN THE STUDY?
What am I being asked to do?
If you agree to be in this study, you will be asked to:
Answer questions about yourself using an online survey tool. This will take about 5 minutes. The questions will focus on personal characteristics (such as sex, race, income, education, and occupation), health conditions (such as high blood pressure, type 2 diabetes, anxiety, and depression), and body size.
Provide your mailing address so we can send you the data collection tools.
The first data collection tool is a small device to be worn on your thigh. This device will collect information about your daily behavior. After you complete the continuous 7-day monitoring period, you will return the thigh device to the PI (Dr. Eric Wickel) using a postage-paid envelope. Detailed instructions will be provided regarding the attachment and use of the thigh device.
The second data collection tool is an at-home finger prick test. This will take about 5 minutes. This test requires you to collect a small amount of blood from your finger on a weekday (Monday – Friday). The blood sample must be collected in the morning while fasting (collect before eating breakfast) and returned the same day. A small tool, along with detailed instructions, will be provided to explain how to collect the blood sample and how to send your sample to a designated laboratory using a postage-paid envelope.
During the seven-day monitoring period, you are expected to spend less than 15 minutes completing the self-report tools and finger prick test.
Complete a 2-year follow-up study that involves an additional activity monitoring protocol and at-home finger prick test. The PI will provide updates to you regarding the follow-up study.
Any possible risks or discomforts to you?
The thigh device is small and lightweight (2.3 × 4.3 × 0.5 cm; 9 grams) and attaches to the skin’s surface using a hypoallergenic cover. Some initial discomfort may exist with the attachment of the thigh device; however, like wearing a band-aid, the novel sensation will diminish. The online survey tool will ask questions about personal characteristics, health status, thoughts of self-harm, and body size. The finger prick test may result in some short-term discomfort.
Any direct benefits for me? No.
Any paid compensation for my time?
Yes, you can receive a total of $75 by completing the study protocol. Participants completing the self-report surveys and finger prick blood test can receive partial compensation at a rate of $10 for each complete day the thigh device was worn. Partial compensation will only be provided if the thigh device is returned to the PI. Compensation (up to $75) will also be provided to you for completing the 2-year follow-up study. Partial compensation will be allocated using the same approach as outlined above. Please note, for payments over $25 the University of Tulsa requires participants to provide their name, address, and social security number to receive compensation.
What are the total number of subjects the researcher(s) will try and recruit for this study?
At least 300 participants.
How will my information and/or identity be protected?
You will be assigned an ID number that will be used in place of your name throughout the study. A master list containing your name and ID number will be stored in a designated folder on the PI’s password-protected university OneDrive account. Data obtained from the thigh device, online surveys, and finger prick test will be linked by your ID number and stored in a unique folder on the PI’s password protected university OneDrive account. Files will be accessible only to designated research personnel.
WHAT ARE THE CONDITIONS OF MY PARTICIPATION AND CAN I LEAVE THE STUDY BEFORE IT ENDS?
To participate in this research study, you must meet the age criteria (25 to 55 years), live in Oklahoma, and have access to broadband internet service and a smartphone.
Participants reporting any of the following characteristics will be excluded: pregnant; physical limitations that prevent locomotion; taking medication that increases the risk of bleeding; increased risk of fainting/loss of consciousness due to blood sample collection or fear of blood; bleeding disorder; impaired lymphatic circulation in both upper limbs; skin disorder or condition that may result in poor healing; increased risk of disease, or skin ulceration; arrhythmia, untreated hemophilia, vasovagal syncope, Raynaud’s, Scleroderma, peripheral vascular disease, or peripheral neuropathy.
Participation in this research study is voluntary. Refusal to participate will involve no penalty or loss of benefits to which you are otherwise entitled. Your participation in this study is over after you have completed the described activities. However, you can leave the study at any time, even if you have not finished, without any penalty or loss of benefits to which you are entitled.
WHAT IF I HAVE QUESTIONS ABOUT THE PRIVACY PROTECTION FROM THE INTERNET SERVICER?
Qualtrics will collect your internet responses. Please note that Qualtrics may have specific privacy policies of their own. If you have any questions or concerns, you should consult Qualtrics directly at http://www.qualtrics.com/privacy-statement/.
LetsGetChecked will be used to report results from your blood sample. Please note that LetsGetChecked may have specific privacy policies of their own. If you have questions or concerns, you should consult LetsGetChecked directly at https://www.letsgetchecked.com/privacy-policy/.
The activPAL thigh device will collect information about your daily behavior. If you have questions about their privacy and security policies, please consult activPAL directly at https://www.palt.com/privacy-policy/.
CAN MY COLLECTED INFORMATION FROM THIS STUDY BE SHARED OR USED BY OTHERS?
Once personal identifiers have been removed from the identifiable private information, the de-identified information could be used for future research studies or distributed to other investigators for future research studies without additional informed consent from you or your legally authorized representative.
HOW WILL THE RESULTS BE USED?
Data from this study will be presented at academic conferences and/or within scientific documents. The data will not include personally identifiable information.
WHO CAN ANSWER MY QUESTIONS ABOUT THIS STUDY?
You can contact Dr. Eric Wickel by email (eric-wickel@utulsa.edu) or phone (918-631-2677).
WHO CAN ANSWER QUESTIONS ABOUT MY RIGHTS AS A RESEARCH SUBJECT?
You can contact the Coordinator of Research Compliance at the University of Tulsa (researchcompliance@utulsa.edu; 918-631-3310) or Dr. Eric Wickel at eric-wickel@utulsa.edu.
PARTICIPANT’S RIGHTS
You have been given an opportunity to read and discuss the informed consent and ask questions about this study;
You have been given enough time to consider whether or not you want to participate;
You have read and understand the terms and conditions and agree to take part in this research study;
You understand your participation is voluntary and that you may stop participation at any time without penalty.