Informed Consent and HIPAA Authorization Form (IRB# 828252)

Informed Consent and HIPAA Authorization Form (IRB# 828252)

Title of the research study: Smartphone application use and health

Invitation to participate
You are being asked to take part in a research study. This is not a form of treatment or therapy. It is not supposed to detect a disease or find something wrong. Your participation is voluntary, which means you can choose whether or not to participate. If you decide to participate or not to participate there will be no loss of benefits to which you are otherwise entitled. Before you make a decision you will need to know the purpose of the study, the possible risks and benefits of being in the study, and what you will have to do if you decide to participate. All this information is included in this form. Please read it carefully.
If you do not understand what you are reading, do not sign it. Please ask the researcher to explain anything you do not understand, including any language contained in this form. If you decide to participate, you will be asked to sign this form and a copy will be given to you.

You must be 18 years or older to participate.

What is the purpose of the study?
The purpose of this study is to learn more about how people interact with smartphone applications and how this may affect aspects of their health.

How long will I be in the study? How many other people will be in the study?
Participation in the study consists of an online survey and brief phone call (<10 min), as well as two appointments, which will each be 30 minutes long. Following the online survey, you will attend an in-person study appointment at least one week later, and the second in-person appointment 1 week after the first. This is a total time of participation of approximately one month. You will be one of approximately 200 people in the study.

Where will the study take place?
The study will take place at the Richards Medical Laboratories at the University of Pennsylvania (3700 Hamilton Walk). 

What will I be asked to do?
If you decide to participate, one of Dr. Falk’s associates will describe the procedure in detail to you. You will be asked to download one of two possible smartphone applications and to use the app for one week, which may involve responding to questions that the app prompts you to answer. You will also be asked to allow the researchers to access the step count information that your iPhone collects. Finally, you will answer several surveys on the online Qualtrics platform. This will involve sitting in front of a standard computer and pressing keys in order to answer questions. If you feel tired during the testing, we will take short breaks to let you rest.

What are the risks?
There are minimal risks associated with participating in the study. The testing may be an inconvenience and cause tiredness. If you are tired or uncomfortable, you may stop the experiment at any time for whatever the reason.
There may also be a risk of unintentional breach of confidentiality about your information provided in the surveys you complete in this study. We will make every effort to prevent this from happening. Identifying information such as your name will be removed from all surveys and other information we collect, and replaced with a unique study ID code.

How will I benefit from the study?
You will receive no direct benefits from participation in this study. We hope that your participation may benefit other people and further science by helping us to understand how technology like smartphone applications can influence the decisions people make.

What happens if I do not choose to join the research study? Can I leave the study before it ends?
Participation in this study is completely voluntary. You may refuse to participate or withdraw at any time without penalty. If you are a Penn student or employee, nonparticipation or withdrawal will not affect your grades or in any way impact your standing at the university.

When is the study over? 
The study ends after all participants have completed their study appointments. The investigator reserves the right to terminate your participation in the study at any time without your consent if:

• The investigator feels it is best for your safety and/or health (you will be informed of the reasons why).

• You have not followed study instructions.

•  The investigator and the Office of Regulatory Affairs at the University of Pennsylvania can stop the study at any time. 

How will confidentiality be maintained and my privacy be protected?
We will do our best to make sure that the personal information obtained during the course of this research study will be kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and or personal information will not be used.
The following procedures are used to protect your information:
Separation of data and identifiable information: Each participants’ data will be stored separately from any identifying information and coded with a unique study ID. This ID will be linked to participant identity only within an encrypted, password-protected local database running on a secure host device maintained by highly trained Annenberg IT staff. In addition, there will be one password-protected spreadsheet saved in a secure PennBox folder linking participant IDs to names and contact information.
Subject identifiers: The researchers will retain subject identifiers for a period of 10 years. After this 10th year of storage, the identifiers will be destroyed. 

Electronic data: All survey and behavioral data will be stored in secure PennBox folders which are only accessible by approved study team members, except for a study log which includes information about data quality and task completion and will be stored on Google Drive. The Google account will only be made accessible to approved study staff. All of this data will be stripped of any identifiable information as described above. 

LiveActive!: Smartphone application: Some participants will be asked to download the LiveActive! Application, which was designed by the experimenters. The app will save information (step count, participant answers to questions within the app) to a file on the participant’s phone. Participants have the option to turn off data sharing within the app at any time. Experimenters will also enter the participant’s study ID into the app; this will be the only link to identifying the participant’s information. An installation UUID is generated when the user installs the app on their phone, and experimenters will record this UUID and participant ID in a password-protected file stored on a password-protected storage system. There is no other personally identifiable information stored in this file. This file will sync with Apple’s iCloud via CloudKit, which Apple encrypts. Data will be removed from Cloud storage at the conclusion of the study and stored on password-protected systems approved by the University of Pennsylvania (e.g., PennBox). Only members of the research team will have access to this data.

WeirdFacts 1000!: Smartphone application: Some participants will be asked to download the WeirdFacts 1000! Application, which is publicly accessible and disseminated in the iTunes store. This app will save no personally identifying information. 

Health application: The Health application is installed by default on all iPhones. Participants will be asked to turn on fitness tracking within this app, and to download the last 2 weeks of information (1 week prior and 1 week after the first study appointment) at the final appointment. Participants will be guided through the download of this data, and it will be saved with only the participant’s study ID and not their name. This file will be password-protected and stored on a password-protected storage system.   
Qualtrics: Online survey data will be collected through Qualtrics and does not include identifiable or sensitive information. The data will remain on the Qualtrics server and be shared with approved study personnel until data collection is complete. Upon completion of data collection for this protocol, the data will be downloaded and stored in a secure PennBox folder  which is only accessible by approved members of our research group. At this time, all participant data will be deleted from Qualtrics. Qualtrics provides numerous privacy and confidentiality advantages. All surveys are security encrypted using 128 bit SSL technology. The Qualtrics survey program will utilize computer IP addresses to prevent multiple survey responses from the same individual; however, these IP addresses will not be available to or accessed by any of the investigators. 
Staff: All study staff are highly trained in the data security and subject privacy issues

Will I have to pay for anything?
There will be no cost to you associated with participation in this study.
Will I be compensated for participating in the study?
You will be paid $10 for each in person appointment, for a total of $20 if you complete both appointments. 

What information about me may be collected, used or shared with others?
The only identifiable information we will collect about you is your name, phone number, email address, birthdate, and street address. We will collect data from your smartphone about the number of steps you take per day, but this will not be directly linked to your name. We will also collect demographic information not linked directly to your name, such as age, gender, socioeconomic status, and education. 

Why is my information being used?
Your information is used by the research team to contact you during the study. Your information, results of tests and procedures are used to conduct and oversee the research. 

Who, outside of the study team, might receive my information?
– The Office of Human Research Protections- The study data and safety monitoring board
The Principal investigator or study staff will inform you if there are any additions to the list above during your active participation in the study. Any additions will be subject ot University of Pennsylvania procedures developed to protect your privacy.
Who may use and share information about me?
The research team at the Annenberg School for Communication at the University of Pennsylvania includes the following individuals who may use or share your information for this research study:- Emily Falk, Ph.D. (Principal Investigator)- Nicole Cooper, Ph.D. (Postdoctoral Fellow)- Yoona Kang (Postdoctoral Fellow)- Alexandra Paul (Research Coordinator)- Melis Cakar (Research Coordinator)- Kamilla Yunusova (Research Assistant)

How long may the School of Medicine use or disclose my personal health information?  
Your authorization for use of your personal health information for this specific study does not expire. 
Your information may be held in a research database.  However, the study team may not re-use or re-disclose information collected in this study for a purpose other than this study unless:- You have given written authorization – The University of Pennsylvania’s Institutional Review Board grants permission- As permitted by law 

Can I change my mind about giving permission for use of my information?
Yes. You may withdraw or take away your permission to use and disclose your health information at any time. You do this by sending written notice to the investigator for the study.  If you withdraw your permission, you will not be able to stay in this study. 

Who can I call with questions, complaints or if I’m concerned about my rights as a research subject?
If you have any questions, we strongly encourage and expect you to ask. If you have any additional questions later, you can contact the study coordinator, Alexandra Paul, at 215-573-9901. We will be happy to answer your questions.
For further information or questions about your rights as a research participant, you may contact the Institutional Review Board at the University of Pennsylvania by telephoning 215-573-2540.

 

Principal Investigator

Dr. Emily Falk

Annenberg School for Communication

University of Pennsylvania

3620 Walnut St. Philadelphia, PA 19104

(215) 573-1974

falk@asc.upenn.edu

 

 

 

Emergency Contact

Alexandra Paul

Annenberg School for Communication

University of Pennsylvania

3620 Walnut St. Philadelphia, PA 19104

apaul@falklab.org 

215-573-9901