US Consent

 
1.  KEY INFORMATION ABOUT THE RESEARCHERS AND THIS STUDY

 

1.1 Study title: Mobile Technology to Identify Behavioral Mechanisms Linking Genetic Variation and Depression

 

1.2 Company or agency sponsoring the study: National Institutes of Health (NIH) R01 MH101459-06; Michigan Institute for Clinical and Health Research (MICHR); Fitbit

 

1.3 Principal investigator: Srijan Sen, MD, PhD, Department of Psychiatry, University of Michigan

 
2. PURPOSE OF THIS STUDY
 

2.1 Study purpose:

 

As an incoming intern, you are invited to participate in a research study designed to look at the role of stress, psychological and genetic factors in depression. If you choose to participate, you will be asked to complete an initial survey and brief follow-ups throughout your intern year, as well as provide a salivary DNA sample. Once the results are available, you will have the option to receive your raw genomic data for your own use. In addition, you will be asked to regularly wear a Fitbit Charge 3 daily mood ratings via a mobile phone app. You will have access to graphs of your mood, sleep, and step data within the app, as well as your predicted fatigue over the next 24 hours and how “shifted” your circadian clock is from normal. You may also have the opportunity to participate in group step and sleep challenges with interns in other residency programs.

3. WHO MAY PARTICIPATE IN THE STUDY

Taking part in this study is completely voluntary.  You do not have to participate if you don't want to.  You may also leave the study at any time.  If you leave the study before it is finished, there will be no penalty to you, and you will not lose any benefits to which you are otherwise entitled.

 

3.1 Who can take part in this study?

 

Incoming interns at US university and community residency programs are eligible for participation in the study.

 

3.2 How many people (subjects) are expected to take part in this study?

 

We expect approximately 1500 to 3000 subjects will take part in the study each year.

4. INFORMATION ABOUT STUDY PARTICIPATION

 

4.1 What will happen to me in this study?  

INTERN HEALTH APP AND FITBIT. If you agree to participate, we will ask you to install the Intern Health phone app and complete an initial confidential survey. After completing the initial survey, we will mail you a Fitbit Charge 3 that we will ask you to sync with your phone and wear throughout your intern year (including when you sleep). This will allow us to collect objective data on your daily activity, such as steps, sleep, and heartrate. If you already have a Fitbit or an Apple Watch that you prefer to use for the study, you may elect to receive a $50 Amazon gift certificate instead of the Fitbit. 

Surveys. In addition to the confidential survey at the beginning of the study, you will complete follow-up surveys at months 3, 6, 9 and 12 of your internship year using the Intern Health phone app. Surveys will contain questions pertaining to personality traits, stressful life events, and depression.

Daily Mood. During set-up, you will be prompted to allow the Intern Health app to send you daily notifications to collect a record of your mood. A notification will be automatically generated on your phone and will appear as follows: “On a scale of 1 to 10 what was your average mood today?” You will then respond in the app. We ask you to complete a daily rating pre-internship through the end of your internship year.

Location. In order to obtain an objective measure of your activity, we may also access the “frequent locations” data that your iPhone already collects using GPS - latitude, longitude, and time stamp. During the Intern Health Study set-up process, you will be prompted to grant the application access to read this location information from your phone. This information may also be obtained when you complete each survey via Qualtrics software. 

Dashboard. You will be able to view graphs of your mood, sleep, and step data at any time on the app dashboard. Based on this data, estimates of your predicted fatigue over the next 24 hours and how “shifted” your circadian clock is from normal will also be displayed. Additionally, you may receive periodic pop-up notifications which may contain data feedback, a relevant fact or tip, or general support throughout the year. You may also have the opportunity to participate in group exercise and sleep challenges against interns in other residency programs.

DNA SAMPLE. Over the course of the study, we would like to collect a sample of cells using a noninvasive method. We will ask that you provide two small samples of saliva for cell collection, one before intern year starts and a second sample during intern year. The samples can be collected at home and returned to investigators by mail. Your samples will be stored indefinitely or until their use is exhausted. Analysis of the samples will include genes that have been implicated in depression- these are called candidate genes. While there are currently several candidate genes of interest, investigators will also search for new candidate genes and continue to use this sample to investigate other potential genes as they arise in the future.

 

You will have the option to receive your raw, uninterpreted genomic data. Raw genomic data will be contained in a securely encrypted computer file.

 

Because this research receives funding from the National Institutes of Health (NIH), we will submit your genomic information to a public repository approved by NIH. We will label your genomic information with a code, instead of your name or other information that people could use to directly identify you. Even so, there is a possibility that when your genomic information is combined with other information available to researchers, either now or in the future, they may be able to identify a group you belong to (like an ethnic group or a disease population) or, less likely, you personally. NIH prohibits people from trying to identify individuals whose genomic information is in an NIH-designated repository.

Researchers will have controlled access to your specific genomic information. Controlled access means that researchers will need approval from NIH in order to obtain genomic information from the repository.

 

If you allow us to put your genomic information in the repository, you can change your mind later and ask us to remove it. Keep in mind, however, that we cannot take back information that other researchers have already obtained from the repository.

4.2 How much of my time will be needed to take part in this study? 

 

Participation will require approximately 20-25 minutes to complete the initial survey, set up your Fitbit or Apple Watch, and provide your salivary DNA sample. The mood rating will require less than one minute each day. Subsequent surveys will take approximately 1-5 minutes to complete.

 

4.3 When will my participation in the study be over?

 

Your participation will last approximately 1 year. After that time, we may ask you to complete a brief survey on an annual basis thereafter.

We understand that you will be very busy with the demands of internship over the next year and may not have time to participate in this study. If this becomes the case, you can discontinue your participation in this study at any time. If you have agreed to participate but do not complete the surveys, submit a saliva sample, or regularly wear your Fitbit or Apple Watch and submit daily mood ratings, we will send a reminder via email or app notification. To discontinue participation you may email the study contact.

4.4 What will happen with my information and/or biospecimens used in this study?

 

Your biospecimens and collected information may be shared with the NIH.

 

With appropriate permissions, your samples and collected information may also be shared with other researchers, here, around the world, and with companies.

 

Your identifiable private information or identifiable biospecimens may be stripped of identifiers and used for future research studies or distributed to another researcher for future research studies without additional informed consent.

5.  INFORMATION ABOUT RISKS AND BENEFITS

 

5.1 What risks will I face by taking part in the study?  What will the researchers do to protect me against these risks?

There will be a substantial time lag between when we collect and analyze the data provided in the surveys. Therefore, we will not be able to act in a timely manner on any personal information you provide to us. If in the process of completing the survey or other tasks, or anytime throughout your intern year, you feel your require medical, psychiatric or other attention we would advise you to please obtain it locally. You will be provided with general information about depression as well as a list of resources for mental health counseling and treatment in your area upon completing each survey.

In rare cases, minor skin irritation may occur on the wrist as a result of wearing a Fitbit or Apple Watch. There are no other known or expected risks from Fitbit or Apple Watch use.

The technology and protocols we use for genotyping are suitable for genetic research, not for clinical genetic testing. Our genotype lab is not FDA-approved or CLIA-certified. Although we do everything we can to ensure high quality standards in sample handling and data generation, unexpected things can happen and we might not be able to detect some errors. 

Please exercise great caution if you attempt to interpret your genes, or when sharing your results and asking someone else to interpret your genes. There is always the possibility of learning something unexpected about you or your family.

For example:

  • Some individuals may discover through their genes that they were adopted, or their biological parent(s) or sibling(s) may not be who they believed them to be.

  • Some individuals may discover they are at heightened (or lowered) risk for some disease(s).

  • Diagnosing a health condition, typically requires not just a CLIA-certified genetic analysis but also a full assessment of your health, including non-genetic factors.

 

We store your genotype files on secure, HIPAA compliant University of Michigan servers and will provide you access to your data using an encrypted data sharing system (if requested). However, your files may become less secure when stored on your computer.

 

Additionally, there may be a risk of loss to confidentiality or privacy.  See Section 9 of this document for more information on how the study team will protect your confidentiality and privacy.

 

As with any research study, there may be additional risks that are unknown or unexpected.

 

5.2 What happens if I get hurt, become sick, or have other problems as a result of this research?

 

The researchers have taken steps to minimize the risks of this study. Even so, you may still have problems or side effects, even when the researchers are careful to avoid them. Please tell the researchers listed in Section 10 about any injuries, side effects, or other problems that you have during this study.

 

5.3 If I take part in this study, can I also participate in other studies?

 

Being in more than one research study at the same time, or even at different times, may increase the risks to you. It may also affect the results of the studies. You should not take part in more than one study without approval from the researchers involved in each study.

 

5.4 How could I benefit if I take part in this study? How could others benefit?

 

You may not receive any personal benefits from being in this study. However, others may benefit from the knowledge gained from this study.

 

5.5 Will the researchers tell me if they learn of new information that could change my willingness to stay in this study?

 

Yes, the researchers will tell you if they learn of important new information that may change your willingness to stay in this study. If new information is provided to you after you have joined the study, it is possible that you may be asked to sign a new consent form that includes the new information.

6.  ALTERNATIVES TO PARTICIPATING IN THE STUDY

 

6.1 If I decide not to take part in this study, what other options do I have?

 

Your participation is completely voluntary. The alternative is not to participate in the study, in which case there will be no penalty.

 
7.  ENDING THE STUDY

 

7.1 If I want to stop participating in the study, what should I do?

 

You are free to leave the study at any time. If you leave the study before it is finished, there will be no penalty to you. You will not lose any benefits to which you may otherwise be entitled.  If you choose to tell the researchers why you are leaving the study, your reasons for leaving may be kept as part of the study record. If you decide to leave the study before it is finished, please tell one of the persons listed in Section 10 “Contact Information”.

 

7.2 Could there be any harm to me if I decide to leave the study before it is finished? 

 

You will not experience any harm for leaving the study.

 

7.3 Could the researchers take me out of the study even if I want to continue to participate?

 

Yes. There are many reasons why the researchers may need to end your participation in the study. Some examples are:

 

  • The researcher believes that it is not in your best interest to stay in the study.

  • You become ineligible to participate.

  • Your condition changes and you need treatment that is not allowed while you are taking part in the study.

  • You do not follow instructions from the researchers.

  • The study is suspended or canceled.

 
8.  FINANCIAL INFORMATION

 

8.1 Who will pay for the costs of the study? Will I or my health plan be billed for any costs of the study?  

 

There are no costs or billings for this study. By consenting to participate in this study, you do not give up your right to seek payment if you are harmed as a result of being in this study.

 

8.2 Will I be paid or given anything for taking part in this study?

 

You will receive a Fitbit Charge 3 after completing the initial survey. If you already have a Fitbit or Apple watch you prefer to use for the study, you will receive a $50 Amazon card instead. You will also receive $80 in Amazon gift certificates throughout the year ($20 following each quarterly survey), contingent upon continued Fitbit or Apple Watch use (including when you sleep), regular mood score submission, and quarterly follow-up survey completion. At the conclusion of the study, participants may keep their Fitbits for personal use.

 

If you decide to participate in the annual survey, you will receive a $25 gift certificate to Amazon.

Research can lead to new discoveries, such as new tests, drugs, or devices. Researchers, their organizations, and other entities, including companies, may potentially benefit from the use of the data or discoveries. You will not have rights to these discoveries or any proceeds from them.

8.3 Who could profit or financially benefit from the study results?

 

The company whose product is being studied: Fitbit

 

Research can lead to new discoveries, such as new tests, drugs, or devices. Researchers, their organizations, and other entities, including companies, may potentially benefit from the use of the data or discoveries. You will not have rights to these discoveries or any proceeds from them.

 
9. CONFIDENTIALITY OF SUBJECT RECORDS
 

The information below describes how your privacy and the confidentiality of your research records will be protected in this study.

 

9.1 How will the researchers protect my privacy?

 

Your survey data and all other information collected through your phone, as well as your DNA sample, will be coded with a unique non-decodable identifier so that all information provided by you will remain confidential. All identifying information will be stored and secured separately from your survey and phone data and DNA sample and will only be accessible to essential study personnel. All data is transferred directly from your phone and stored in a secure and HIPAA compliant environment.

Fitbit is providing the Fitbit Charge 3 devices used for data collection in this study. We will provide Fitbit with your daily mood data, but we will not link any of your identifiable information to this data. Furthermore, Fitbit has agreed not to connect the data we provide with the personally identifying information that they already collect through the normal use of the Fitbit.

This research is covered by a Certificate of Confidentiality from the National Institutes of Health. The researchers with this Certificate may not disclose or use information, documents, or biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a court subpoena, unless you have consented for this use. Information, documents, or biospecimens protected by this Certificate cannot be disclosed to anyone else who is not connected with the research except, if there is a federal, state, or local law that requires disclosure (such as to report child abuse or communicable diseases but not for federal, state, or local civil, criminal, administrative, legislative, or other proceedings, see below); if you have consented to the disclosure, including for your medical treatment; or if it is used for other scientific research, as allowed by federal regulations protecting research subjects.

 

The Certificate cannot be used to refuse a request for information from personnel of the United States federal or state government agency sponsoring the project that is needed for auditing or program evaluation by the NIH which is funding this project or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA).  You should understand that a Certificate of Confidentiality does not prevent you from voluntarily releasing information about yourself or your involvement in this research. If you want your research information released to an insurer, medical care provider, or any other person not connected with the research, you must provide consent to allow the researchers to release it.

 

The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, state, or local law of harm to self or others, or for public health reasons. The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you have consented to in this informed consent document.

We store your genotype files on secure servers at the University of Michigan. If you request to download your raw genomic data, the files will be temporarily pushed to a private location on MiShare, a HIPAA compliant system for securely encrypting and transferring files containing ePHI, research data, and other sensitive information. A MiShare user account will be set up for you. You will then be provided with log-in credentials to access and download your encrypted data package. Your files will automatically be deleted if not accessed within 5 days.

 

The federal Genetic Information Nondiscrimination Act (GINA) generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. This law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance. Under this law:

  • Health insurance companies and group health plans may not request your genetic information that we get from this research.

  • Health insurance companies and group health plans may not use your genetic information when making decisions regarding your eligibility or premiums.

  • Employers with 15 or more employees may not use your genetic information that we get from this research when making a decision to hire, promote, or fire you or when setting the terms of your employment.

 

GINA does not apply to the following groups, however these groups have policies in place that provide similar protections against discrimination:

  • Members of the US Military receiving care through Tricare

  • Veterans receiving care through the Veteran’s Administration (VA)

  • The Indian Health Service

  • Federal employees receiving care through the Federal Employees Health Benefits Plans

 

9.2 What information about me could be seen by the researchers or by other people?  Why?  Who might see it?

 

Providing your consent electronically at the end of this form gives the researchers your permission to obtain, use, and share information about you for this study, and is required in order for you to take part in the study. 

 

There are many reasons why information about you may be used or seen by the researchers or others during or after this study.

 

Examples include:

 

  • The researchers may need the information to make sure you can take part in the study. 

  • University, Food and Drug Administration (FDA), and/or other government officials may need the information to make sure that the study is done in a safe and proper manner.  

  • Study sponsors or funders, or safety monitors or committees, may need the information to:

    • Make sure the study is done safely and properly

    • Analyze the results of the study

  • The researchers may need to use the information to create a databank of information about your condition or its treatment.

  • If you receive any payments for taking part in this study, the University of Michigan accounting department may need your name, address, social security number, payment amount, and related information for tax reporting purposes.

 

The results of this study could be published in an article, but would not include any information that would let others know who you are.

 

9.3 What happens to information about me after the study is over or if I leave the study before it is finished?

 

As a rule, the researchers will not continue to use or disclose information about you, but will keep it secure until it is destroyed.  Sometimes, it may be necessary for information about you to continue to be used or disclosed, even after you have left the study or the study is over. 

 

Examples of reasons for this include:

 

  • To avoid losing study results that have already included your information 

  • To provide limited information for research, education, or other activities  (This information would not include your name, social security number, or anything else that could let others know who you are.) 

  • To help University and government officials make sure that the study was conducted properly

 

9.4 When does my permission expire?  

 

Your permission expires at the end of the study, unless you cancel it sooner. You may cancel your permission at any time by writing to the researchers listed in Section 10 “Contact Information” (below).

 

9.5 Warranty

 

THE PARTICIPANT ACKNOWLEDGES THE APPLICATION “Intern Health Study” IS NOT AVAILABLE TO THE GENERAL PUBLIC AND IS INTENDED FOR TESTING PURPOSES ONLY.   Michigan hereby grants Participant a non-transferable, non-exclusive right to (i) install the Application on his/her personal device and use the Application as part of the Study for the duration of the Study or (ii) use the Device and Application as part of the Study for the duration of the Study.

 

Participant acknowledges that the APPLICATION has not been approved or reviewed by the U.S. Food and Drug Administration or by any other U.S. or ex-U.S. agency.  The APPLICATION is not a substitute for professional medical advice, diagnosis or treatment.

  

THE APPLICATION AND ANY REVISIONS THEREOF IS PROVIDED "AS IS" AND WITHOUT ANY WARRANTY, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

 

The Participant agrees to treat the APPLICATION as proprietary and confidential information of Michigan, whether or not the APPLICATION, or any portion thereof, are copyrighted.  The Participant agrees to safeguard the APPLICATION AND DEVICES to the same extent and in the same manner that it safeguards its own proprietary and confidential information, but no less than in a reasonable manner. 

 

Upon completion of this Study, the Participant agrees to promptly return all DEVICES to Michigan or remove APPLICATION from Participant’s personal device and certify in writing that all such DEVICES have been returned to Michigan or that APPLICATION removed from Participant’s personal device

 
10. CONTACT INFORMATION

 

10.1 Who can I contact about this study?

 

Please contact the researchers listed below to:

 

  • Obtain more information about the study

  • Ask a question about the study procedures or treatments

  • Talk about study-related costs to you or your health plan 

  • Report an illness, injury, or other problem (you may also need to tell your regular doctors)

  • Leave the study before it is finished

  • Express a concern about the study

 

Principal Investigator: Srijan Sen MD, PhD

Mailing Address: 205 Zina Pitcher Place, Ann Arbor, MI  48109

Telephone: (734)395-8319

Email: Srijan@umich.edu

 

You may also express a concern about a study by contacting the Institutional Review Board listed below.

 

University of Michigan Medical School Institutional Review Board (IRBMED)

2800 Plymouth Road

Building 520, Room 3214

Ann Arbor, MI 48109-2800

Telephone: 734-763-4768

Fax: 734-763-1234

e-mail: irbmed@umich.edu

 

If you are concerned about a possible violation of your privacy or concerned about a study you may contact the University of Michigan Health System Compliance Help Line at 1-866-990-0111.

 

When you call or write about a concern, please provide as much information as possible, including the name of the researcher, the IRBMED number (at the top of this form), and details about the problem.  This will help University officials to look into your concern.  When reporting a concern, you do not have to give your name unless you want to.

 

CONSENT

 

By submitting your response below, you are agreeing to participate in this research.

 

I would like to participate in the Intern Health Study:

 

(option to answer “Yes” or “No”)

[If "Yes" secondary consent option below is shown]

 

NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) HUMAN GENETICS INITIATIVE

 

The NIMH Human Genetics Initiative is creating a “repository” or “bank” of DNA samples. The purpose of the bank is to help researchers identify genes that make it more likely a person will develop a mental illness. If you give additional consent to participate in the NIMH Human Genetics Initiative, then after the study team has exhausted all planned Intern Health Study analyses, your de-identified DNA sample and mental health information will be forwarded to NIMH for storage in the bank. NIMH will make de-identified mental health information and DNA available to other researchers. Any use of these materials would first be reviewed and approved by NIMH. You may participate in the Intern Health Study without consenting to your sample being forwarded to the NIMH 

repository. 

 

I would like to participate in the NIMH Human Genetics Initiative:

 

(option to answer “Yes” or “No”)