UNIVERSITY OF MICHIGAN

CONSENT TO BE PART OF A RESEARCH STUDY

 

1. KEY INFORMATION ABOUT THE RESEARCHERS AND THIS STUDY

 

Study title: Providing Mental Health Precision Treatment (PROMPT)

 

Company or agency sponsoring the study: University of Michigan

 

Principal Investigators:

Amy S. B. Bohnert, Ph.D., Associate Professor, Department of Psychiatry, University of Michigan

Srijan Sen, M.D., Ph.D., Associate Professor, Department of Psychiatry, University of Michigan

 

1.1 Key Study Information

You may be eligible to take part in a research study. This form contains important information that will

help you decide whether to join the study. Take the time to carefully review this information. You

should talk to the researchers about the study and ask them any questions you have. You may also wish

to talk to others such as your family, friends, or other doctors about joining this study. If you decide to

join the study, you will be asked to sign this form before you can start study-related activities. Before

you do, be sure you understand what the research study is about.

 

A research study is different from the regular medical care you receive from your doctor. Research

studies hope to make discoveries and learn new information about health conditions and how to treat

them. You should consider the reasons why you might want to join a research study or why it is not the

best decision for you at this time.

 

Research studies do not always offer the possibility of treating your condition. Research studies also

have different kinds of risks and risk levels, depending on the type of the study. You may also need to

think about other requirements for being in the study, such as the amount of time required. In your

decision to participate in this study, consider all of these matters carefully.

 

The purpose of this research study is to learn how we can improve current treatment to help manage

mental health. We are studying two main things in our research. First, we are studying how certain

smartphone apps can improve mental health. Second, we are studying people’s behaviors, genes, and

health information to understand how to match people with the type of mental health care that will be

the most helpful for future treatments.

 

At the beginning of the study, we will ask you to download an app to your smartphone. Through the

app, we will ask you to complete a short baseline survey. You will then be given a new Fitbit to wear

during the study. This will allow us to gather data on things like sleep and activity. We will also ask you

to submit a DNA sample via a saliva sample and have it stored in the University of Michigan Central

Biorepository.

 

For this study, you will be asked to wear a Fitbit, rate your mood every day through the study app, and will also be asked to use a mental health smartphone app. Research participants will also receive personalized feedback through the study app on topics like your activity, sleep, and mood. You may also be asked to configure your phone settings or download additional apps to allow for active and passive data collection through your smartphone. Smartphone data may be collected through the Apple Sensorkit app and/or the Effortless Assessment Research System (EARS) app.

 

You will also be asked to complete one initial and three short follow-up surveys. You can earn up to

$150 in cash, gift cards, or check and you get to keep your Fitbit once you complete the study. The

study will last about one year. Completing the study involves 1) wearing your Fitbit for one year, 2) using the mental health smartphone app regularly throughout the year, 3) completing your daily mood rating for one year, 4) completing your assigned study surveys that are assigned throughout the year, with the final survey taking place 12 months after you enroll, 5) allow for the collection of phone data, and 6) saliva donation for genetic testing and storage.

 

There can be risks associated with joining any research study. The type of risk may affect whether you

decide to join the study. For this study, some of these risks may include feelings of discomfort

answering personal questions on sensitive topics, jaw or cheek tiredness or soreness or dry mouth

associated with providing a DNA saliva sample, and loss of confidentiality. More detailed information

will be provided later in this document.

 

This study may offer some benefit to you now through the use of the smartphone apps or the health

features of the Fitbit. The study may also benefit others in the future by allowing us to improve

therapies for people with mental health conditions. More information will be provided later in this

document.

 

You can decide not to be in this study. Choosing not to participate will not affect the care you receive in

this clinic in any way. Even if you decide to join the study now, you are free to leave at any time if you

change your mind.

 

More information about this study continues in Section 2 of this document.

 

2. PURPOSE OF THIS STUDY

 

2.1 Study purpose:

This research study is being conducted to understand what patients may benefit most from mobile

health interventions as well as how best to provide clinicians with useful patient data that may help

inform future treatment decisions and improve patient outcomes.

 

3. WHO MAY PARTICIPATE IN THE STUDY

Taking part in this study is completely voluntary. You do not have to participate if you do not 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?

Adult patients (age 18+) who have a scheduled adult mental health intake appointment at either
Michigan Medicine Outpatient Psychiatry or University Health Service are eligible for participation in the
study. Adult patients (age 18+) who are on the wait list or referral list for mental health care at either
Michigan Medicine Outpatient Psychiatry or University Health Service are eligible for participation in the
study. Students who are newly involved in mental health care related services or organizations at the
University of Michigan may be eligible to participate in the study. Patients must have daily access to a
smartphone to use for the study in order to be eligible.

 

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

4,500 subjects are expected to participate, with approximately 2,250 at Michigan Medicine Outpatient

Psychiatry and 2,250 at University Health Service.

 

4. INFORMATION ABOUT STUDY PARTICIPATION

 

4.1 What will happen to me in this study?

STUDY APP AND MOBILE HEALTH DEVICE: If you agree to participate in this study, we will ask you to

complete one initial (baseline) survey, three follow-up surveys, and a daily mood rating via the

MyDataHelps study app. Participants may complete active behavioral tasks in the study app at baseline. We will provide you with a Fitbit that we will ask you to sync with your smartphone and wear every day throughout the study. This will allow us to collect data on your daily activity, such as steps, sleep, and heart rate. You may use the study provided Fitbit or your own personal Apple Watch for study participation. Participation in the study will not impact your mental health care or influence your ability to receive mental health care at either Michigan Medicine Outpatient Psychiatry or University Health Service. As a way to remove potential barriers for study enrollment or engagement, you can request virtual assistance from study staff through video conference platforms.

 

• Surveys: You will be asked to complete a confidential survey at the beginning of the study and

again after 6 weeks, 18 weeks, and 12 months. These surveys will typically be completed via the

MyDataHelps study app. Surveys will contain questions about your mood, behaviors,

personality traits, and stressful life events.

• Daily Mood: During app set-up, you will be prompted to allow the study 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 similar to the following: “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 mood

rating throughout the length of your enrollment in the study.

 

Study Procedures: For this study, you will be asked to wear a Fitbit, rate your mood every day through
the study app, and will also be asked to use a mental health smartphone app. Based on your baseline
answers, you will be asked to use one of two mobile health interventions: mindfulness (Headspace) or
cognitive behavioral therapy (Silvercloud). You will be assigned to either Headspace or randomized to
either Headspace or Silvercloud. Participants cannot choose which mobile health application they are
assigned to but will be notified after their initial survey. We ask you to engage regularly with the
Headspace or Silvercloud app. Research participants will also be randomized to receive personalized
feedback through the study app on topics like your activity, sleep, and mood. You may also be asked to
configure your phone settings or download additional apps to allow for active and passive data
collection through your smartphone.

 

DATA GATHERING: If you agree to participate, we will gather active and passive data through your
smartphone, Fitbit, personally owned Apple Watch, Silvercloud, or via Headspace. Up to a year of
historical wearable device data from your personally owned devices may be uploaded to the study app
and used in analysis. Data may include general phone usage, geospatial location, screen time, app usage,
physical activity, sleep, heart rate, voice, phone orientation, phone acceleration, electrodermal activity,
speed of typing and errors, counts of nearby Bluetooth devices, social network indicators (e.g., call or
text frequency) or text input across applications on the mobile phone including SMS, social media,
searches, and emails. Words typed are stripped from their context and syntax, thus preventing the
content of any messages from being deciphered. Smartphone data maybe collected through the Apple
Sensorkit app and/or the Effortless Assessment Research System (EARS) app. The study apps do not
collect phone numbers or email addresses, photos or videos, passwords, credit card numbers, or any
other secure or personally identifying information for research data analysis purposes. We may also
collect data via your electronic health record, outcomes registries, prescription-related data accessed via
the SureScripts Health Information Network, administrative data, or other sources of health/outcomes
data stored in the University of Michigan Research Data Warehouse. As part of this study, we ask you to
agree to be re-contacted in the event that researchers would like to invite you to participate in future
studies requiring further testing, data, or feedback. You may decline any further study opportunities
without any impact on your participation or compensation in this study. We will also collect a DNA
sample as part of this study.

 

DNA SAMPLE: As part of this study, you will be asked to contribute a DNA sample to a research

biorepository called the University of Michigan Central Biorepository. You will be asked to provide a

saliva sample. Analysis of your DNA sample will contribute to the development of precision treatment

for various mental health conditions. The results of your DNA analysis will not be used as a part of your

treatment, and results will not be returned to you or your clinician(s).

 

• You may complete a saliva collection kit in person or we will mail the kit to you, where you will self-collect saliva by spitting in a coded tube and return the sample in a pre-addressed, stamped envelope with no personal identifiers.

• More information about the University of Michigan Central Biorepository, including risks and protection information, will be provided in a separate consent.

​

Because this research receives funding from the National Institutes of Health (NIH), if you return a saliva
sample we will submit your genomic information to a public repository approved by NIH. NIH is a
national research agency and is part of the federal government. 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.

 

YOUR REGULAR HEALTHCARE: Choosing not to participate in this research study will not affect the care

you receive in this clinic in any way.

 

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

Your participation will require approximately 25-40 minutes to complete the initial survey, set up your

study app and Fitbit, and provide a DNA sample. The mood rating will require less than one minute each

day. Each of the three follow-up surveys will require approximately 20 minutes to complete. If you are

assigned to a group receiving access to a mental health app, your engagement time may vary depending

on the program and your desire for utilization (e.g., 5-60 minutes weekly). We may send you reminders

via email, text message, phone, or mail to complete the surveys, submit a DNA sample, regularly wear

your Fitbit, or submit daily mood ratings.

 

4.3 When will my participation in the study be over?

Your active participation in the study will last approximately 1 year. In addition to your active

participation, we will collect information from your medical records after your participation. If you have been given access to a mental health app as part of the study, your free access to the app will end after your 1 year of active participation. If you wish to continue use of one of the mental health apps used in the study, you will be responsible for accessing and paying any associated fees with the app on your own.

 

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

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. Your sensor data (e.g., Fitbit/own personal Apple Watch) and survey
responses may be shared with Michigan Medicine health care providers and may be included as part of
your regular medical records. Additionally, there may be situations where we share information with
your care providers to determine your study eligibility or confirm that ongoing participation is consistent
with your care plan. This information could be included in your regular medical record.

The information we collect from you, including your biospecimens, may be stripped of identifiers. This
means that any information that would identify you, like name, address, or phone number, would be
removed. This information may then be used for future research studies or distributed to another
researcher for future research studies without additional informed consent.

 

5. INFORMATION ABOUT STUDY 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?

• Less common risks (1% - 10% of patients) are:

  • There is a risk of psychological discomfort or stress resulting from answering study survey

questions. You may skip any question that is distressing, seek clarification of questions with

research staff, or terminate participation without penalty at any time. Research staff will be

trained to discuss any issues or concerns with you and may assist in arranging medical or

psychiatric help, including emergency treatment, if necessary.

• There is a risk of psychological discomfort or stress resulting from answering study survey

questions about suicidality, including if study staff needs to engage you in further discussion

(risk assessment) about these questions. Research staff will be trained to have these

discussions with you, conduct assessments, and provide resources or arrange for medical or

psychiatric help, including emergency treatment, if necessary. In order to ensure your

safety, there is the possibility for breach of confidentiality if research staff or investigators

determine that you are at significant risk of harm to yourself or others or if there is mention

of child or adult abuse.

 

There is also the risk of psychological discomfort by study participants from wearing a
fitness tracker if they have an untreated eating disorder. Any participant becoming
distressed while wearing a fitness tracker will be encouraged to stop wearing the fitness
tracker and connect with their treatment provider and the PROMPT study team.

 

• Rare risks (less than 1% of patients) are:

  • There is a rare risk of minor skin irritation on your wrist as a result of wearing a Fitbit. There

are no other known or expected risks from use of these devices. Researchers will minimize

this risk by having bands available that are shorter or longer than the standard band size, as

well as alternate material device bands if you have reactions to fluorocarbon-based

synthetic rubber bands.

• Related to collection and storage of your DNA sample: There is a rare likelihood of risk

related to breach of confidentiality related to storage of your DNA sample. Your DNA will be

stored in a coded manner and will be linked to other data only by anonymous participant ID

number, so as to minimize risk of breach of confidentiality. There is also a rare risk of jaw

and cheek tiredness, soreness, and pain, as well as dry mouth associated with producing a

DNA saliva sample.

 

Additionally, there may be a risk of loss to your confidentiality or privacy. See Section 9 of this

document for more information on how the study team will protect your confidentiality and privacy.

Your health information may be discussed with your mental health team to determine initial study

eligibility or to ensure that ongoing involvement in study is consistent with your treatment needs.

 

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, even when the researchers are careful to avoid them. Please tell the researchers listed in

Section 10 about any problems that you have during this study. You should also tell your regular

doctors.

 

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. Some subjects may see improvement in their mental health

symptoms and overall well-being as a result of utilizing mobile health apps. Subjects may also

experience benefits on health or well-being from the health and fitness features of the Fitbit. Possible

benefits of the research for society or future patients with mental health conditions include better

understanding of key predictors of treatment response for patients with mental health conditions,

which may lead to changes in clinical practice and improvements in the quality of care.

 

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. There may be other ways of treating your condition. These

include engaging in outpatient mental health care as part of standard treatment, seeking care via your

standard health care provider, or utilizing apps or mobile health devices independently to seek potential

benefits. Your other 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?

We do not expect that you would 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 billing for this study. There may be an indirect cost to participate in this study

because some of the data collected for this study and transmitted to the study team will need to be

covered by your smartphone’s data plan. By signing this form, 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 to use during your study participation and you may keep this device once you

have completed the study. You will receive $20 in cash, gift card, or check for completing the initial

survey, $20 in cash, gift card, or check for completing the first follow-up survey, $40 in cash, gift card, or

check for completing the second follow-up survey, and $50 in cash, gift card, or check for completing the

third follow-up survey. Whether you receive cash, gift card, or check will be determined by the study

team, and you will receive your payment by mail or in person.

 

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

The companies whose products may be studied include Fitbit, Apple, Headspace, Ksana Health, and CareEvolution.

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 AND AUTHORIZATION TO RELEASE YOUR PROTECTED

HEALTH INFORMATION

The information below describes how the confidentiality of your research records will be protected in

this study, and any sub-studies described in this document.

 

9.1 How will the researchers protect my information?

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. Phone

data collected through Apple SensorKit will not be shared with third parties, the data will only be used

by authorized researchers, and the data will only be retained until end of the study. As described in

section 4.4, “Your sensor data (Fitbit/Apple Watch) and survey responses may be shared with Michigan

Medicine health care providers and may be included as part of your regular medical records.

Additionally, there may be situations where we share information with your care providers to determine

your study eligibility or confirm that ongoing participation is consistent with your care plan. This

information could be included in your regular medical records.”

 

The companies that may be collaborating with this study to provide the devices and apps used for data

collection include Fitbit, Apple, Headspace, and CareEvolution, and Ksana Health. Fitbit, Apple,

Ksana Health and Headspace will receive the routine information that these companies typically

collect as part of usual account creation, mobile health device use, or smartphone/app use. Beyond this

routine collected data, Fitbit, Apple, and Headspace will receive no further study related data. Prior to account creation and consenting to this study, you should be sure to review the

privacy policies and terms for Fitbit, Apple, Headspace, and Ksana Health to ensure you are

comfortable with their data use and sharing practices. CareEvolution is the developer of the

MyDataHelps study app. Any information that you provide in the MyDataHelps study app falls under

the app’s privacy policy. Data shared with the MyDataHelps app may be shared with CareEvolution, so

you should also be sure to review the MyDataHelps privacy policy and terms to make sure you are

comfortable with the data use and sharing practices before signing this consent and authorization.

 

This study 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 SPONSOR 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 child abuse and neglect, adult abuse and neglect, or harm to self or others.

The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you have

consented to in this informed consent document.

 

In order to ensure your and others’ safety, there is the possibility for breach of confidentiality if research

staff or investigators determine that you are at significant risk of harm to yourself or others or if there is

mention of child or adult abuse. This may include informing your health care provider (e.g., your

University of Michigan primary care provider or mental health provider) or the appropriate crisis

services or reporting agency (e.g., Child Protective Services) if you disclose any of the aforementioned

items within your study data.

 

Your biological samples contain genetic information about you. The Genetic Information

Nondiscrimination Act (GINA) is a federal law that prohibits certain kinds of discrimination on the basis

of genetic information. You will learn more about GINA in the separate University of Michigan

Biorepository informed consent document that you will reference after this consent form, “Document of

Consent to Donate to a University of Michigan Biorepository and Authorization to Release Protected

Health Information” and its accompanying information sheet. For your knowledge, 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

 

A description of this clinical trial will be available on http://www.clinicaltrials.gov/, as required by U.S.

Law. This Web site will not include information that can identify you. At most, the Web site will include

a summary of the results. You can search this Web site at any time.

 

9.2 What protected health information (PHI) about me could be seen by the researchers or by other

people? Why? Who might see it?

Signing 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.

 

Medical information and billing records are protected by the privacy regulations of the federal Health

Insurance Portability and Accountability Act of 1996 (HIPAA). This type of information is called

protected health information (PHI). PHI about you may be obtained from any hospital, doctor, and

other health care provider involved in your care, including:

 

• Hospital/doctor's office records, including test results (X-rays, blood tests, urine tests, etc.)

• Mental health care records (except psychotherapy notes not kept with your medical records)

• Alcohol/substance abuse treatment records

• HIV/AIDS status

• Sexually transmitted disease and/or other communicable disease status

• Genetic counseling/genetic testing records

• Health plan/health insurance records

• All records relating to your condition, the treatment you have received, and your response to

the treatment

• Billing information

• Demographic information

• Personal identifiers

• Other information

 

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.

• Information about your study participation may be included in your regular UMHS medical
  record.

• University, Food and Drug Administration (FDA) and/or other government officials, auditors,

and/or the IRB 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

  • Learn more about side effects

  • 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 finance
  department will need your name and address for tax reporting purposes. In a calendar year if: 1)
  your payments total greater than $400 for this study or 2) if you receive payments of greater
  than $400 for being in more than one study, the University of Michigan finance department will
  also require your Social Security Number or Taxpayer Identification Number for tax reporting
  purposes. If you do not wish to provide your Social Security Number or Taxpayer Identification
  Number, you may continue to participate in research studies, but you will not be able to receive
  payment for the remainder of the calendar year.

• Federal or State law may require the study team to give information to government agencies.

For example, to prevent harm to you or others, or for public health reasons.

 

The results of this study could be published in an article or presented at a scientific meeting, 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 cancel my permission to use

my PHI?

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 canceled your permission 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

 

As long as your information is kept within the University of Michigan Health System, it is protected by

the Health System’s privacy policies. For more information about these policies, ask for a copy of the

University of Michigan “Notice of Privacy Practices”. This information is also available on the web at

http://www.uofmhealth.org/patient+and+visitor+guide/hipaa. Note that once your information has

been shared with others as described under Question 9.2, it may no longer be protected by the privacy

regulations of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA).

 

9.4 When does my permission to use my PHI expire?

Your permission expires at the end of the overall PROMPT 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). If you withdraw your permission, you may no longer be eligible to participate in

this study. More information about your PHI use as part of donating a DNA saliva sample to the

University of Michigan Central Biorepository will be provided in a separate consent.

 

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: 2800 Plymouth Road, Ann Arbor, MI 48109

Telephone: (734) 395-8319

 

Principal Investigator: Amy Bohnert, PhD

Mailing Address: 2800 Plymouth Road, Ann Arbor, MI 48109

Telephone: (734) 845-3638

 

PROMPT Team Research Office

Mailing Address: 2800 Plymouth Road, Ann Arbor MI 48109

Telephone: (734) 539-5100

 

You may also express a question or 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 (For International Studies, include the appropriate calling codes.)

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.

​

12.1 What is meant by the storage, future research use, and sharing of study participants’ medical
information and leftover samples (sometimes referred to as biospecimens) taken from me?

Individual researchers, the University of Michigan, and companies that design and sponsor studies often
want to keep subjects’ medical information and leftover samples such as blood, tissue, saliva, and cells
to use in future research. These future research uses take different basic forms, which are described
below. The medical information and leftover samples may also be shared with other researchers so that
they can use it in their studies.

The purpose of storing, using, and sharing participants’ medical information and leftover samples is to
promote more research that might lead to useful medical discoveries.

In some cases, researchers need your consent to store, use, and share your medical information and
leftover samples; in other cases, they can store, use and/or share it without your consent. Whether or
not researchers need your consent depends on if the stored information and samples would still be
identifiable as yours or whether the researchers would first remove all information connecting them
back to you.

12.2 Types of storage, future research use, and sharing in this study

For purposes of this research study, your collected private information and any biospecimens will be
shared with the study sponsor, NIMH, its collaborators, and associated research partners.

With appropriate institutional and regulatory permissions, your collected private information and
identifiable biospecimens could be used for future research with other researchers and companies,
including those in other countries, with or without your consent.

In addition, after identifiers are removed from your private information and any biospecimens, the
information and biospecimens could be used for future research studies by U-M and shared with other
researchers or companies, including those in other countries, without your additional informed consent.

In most instances of storage, use, and sharing of subject data, subjects may, after consenting to storage,
use, and/or sharing, later change their minds and rescind their consent to this activity. Keep in mind,
too, that in cases where giving us your permission to store, use, or share your information is necessary
in order for you to participate in this study, changing your mind later and withdrawing your consent to
that storage, use, or sharing may mean that you can no longer take part in the study, and we may
remove you unless your participation has already ended.

NIH data management and sharing (DMS) policy

This study receives funding from the National Institutes of Health (NIH). NIH requires us to develop a
plan regarding how we may share some information about you with other researchers so that they can
use it in their studies. Their research may be similar to this study or may be completely different. Once
we have shared information about you with other researchers, we will not be able to get it back.

Although we will do our best to protect your information, both during storage and when sharing it with
others, it’s possible that unauthorized people might gain access to your information.

We will remove all details from your information that identify you individually and assign it a random
code before sharing it with other researchers. Once we have removed and destroyed those identifying
details, it will be impossible for others to know the information came from you. Researchers who wish
to access your information must obtain permission to access your information.

You will not find out the results or directly benefit from future research utilizing your information.
Sharing your information may contribute to research that helps others in the future. Permitting us to
store and share your information is a condition of participating in this study. If you do not want us to
share your information with other researchers, you should not take part in this study.

NIH genomic data sharing (GDS) policy

As part of this study, we will collect and store information about your genes. The DNA contained in your
genes holds the instructions that your body uses to grow and function. Your genes are responsible for
your physical features such as eye color, blood type, and how your body breaks down medications.
Genes can also be responsible for some medical conditions.

Genomic information relates to the structure and function of all of the genetic material in the body.

We will submit your genomic information to a repository managed by the University of Michigan and
federal government to be used for scientific purposes. A repository contains information from many
people.

Researchers all over the world can take information from the repository and use it in their studies. Their
studies may be similar to this one or may be completely different (NIH, GWAS, etc.).

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. NIH is a national research agency
and is part of the federal government.

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.

Collection and use of your biospecimens and/or information for future research

We will also keep some of your identifiable biospecimen and medical information collected in the main
study, so that it may be studied in future research. The future research may be similar to this study or
may be completely different.

This storage and use of your biospecimen and medical information is a necessary condition of your
participation in this study. If you do not wish to allow us to store, use, and share your medical
information in the future, you should not take part in this study.

We will use your biospecimen and medical information for future research. Even if you give us
permission now to keep some of your biospecimen and medical information, you can change your mind
later and ask us to destroy it. If you do change your mind, you cannot continue participating in the
study. We will do our best to get your information and specimens back from the other researchers
we’ve shared them with. However, there may be times we cannot. For example, if we are unable to tell
which information and specimens came from you, we will not be able to get them back. Additionally,
any information that has been added to your medical record cannot be deleted. Also, keep in mind that
once we have analyzed your biospecimen, we may not be able to take the information out of our
research study.

We may share your specimen and medical information with other researchers, so that they can use it in
their research. Their research may be similar to this study or may be completely different. Once we have
shared your specimen and medical information with other researchers, we will not be able to get it
back.

Although we will do our best to protect your information and specimens, both during storage and when
sharing them with others, it’s possible that someone may be able to identify you from them. It’s also
possible that unauthorized people might gain access your information and/or specimens. To try to
minimize both of these risks, we will assign your information and specimens a random code before
sharing them with other researchers. University of Michigan will securely store the code key that links
your coded information and specimens to you. Future use of your identifiable data and/or specimens
will be conducted in compliance with applicable regulatory requirements. You will not find out the
results or directly benefit from future research on your specimen. Sharing your information and
specimens may contribute to research that helps others in the future.