Consent for Blood Draw

NSAL: National Survey of American Life

UNIVERSITY OF MICHIGAN

CONSENT FOR A BLOOD DRAW, BLOOD STORAGE, AND/OR PHARMACY AND LABORATORY TEST RESULTS RECORDS MATCHING

Sponsor:        National Institutes of Health

As part of the National Survey of American Life 25-Year Follow-Up, we are inviting you to take part in several optional parts of the data collection. The additional parts of the data collection are a blood draw, and gathering your past pharmacy and laboratory test results. If you say “yes” to the blood draw, we will also ask you if you are willing to allow the study to store some of your blood for future research. This form contains information that will help you decide whether to participate in the additional parts of the study.

Things you should know

  • These parts of the data collection are optional. You can still be in the study if you say no to some or all of these parts of the data collection.
  • The purpose of the blood draw is to give the study researchers additional information about your health. The researchers will be able to measure markers in your blood that can give us insight into the aging process.
    • If you agree to provide a blood sample, a phlebotomist will visit your home or other quiet location to collect a small sample of blood. This appointment will take less than 20 minutes.
    • There is a small risk that the blood draw might result in bruising or momentary discomfort.
    • There is also a small risk that you will feel worried if the clinical lab results we send you raise concerns about your health.
    • We will ask you for permission to store your blood for future research. This is also optional. You can say yes to the blood draw to help this study, but no to storage for future studies.
  • If you give us permission, we will access your pharmacy records and clinical lab test results for the last seven years. This will allow us to better understand your health. You can still participate in the blood draw if you do not agree to share pharmacy or other lab test information.
  • There is only one direct benefit to you. You will be provided with some of the results from your blood draw, which you can share with your doctor to help you better understand your own health.

Taking part in this blood draw and/or granting us permission to access your pharmacy and laboratory test records is entirely voluntary. You do not have to participate and you can stop at any time. Read this entire form and ask questions before deciding whether to take part in these additional parts of the data collection.

Purpose of this part of the study

The purpose of our study is to understand how factors such as social support, mental health and wellbeing, physical health conditions, neighborhood environments, and stressful life events relate to the risk of dementia and other health and functional challenges as people age. With the results from the blood draw, pharmacy and past laboratory test results, we can understand even more about bodies as they age and the factors that are linked to different health outcomes.

What participation involves

What will happen during the blood draw? A professional phlebotomist will arrange to visit

your home or other agreed-upon location to collect the blood sample at a day and time that is convenient for you. The total amount of blood collected will be approximately 40 mL, which is about 2 to 3 tablespoons.

After your blood has been analyzed, we will share some of your blood test results with you in a letter, including:

Hemoglobin A1c and glucose, which are measures of diabetes risk Cholesterol and triglycerides, which are measures of heart disease risk

Your blood sample will also be used to measure proteins in the blood that are related to inflammation, brain health, and changes that can occur with aging. These measurements are for research purposes only and will not be shared with you.

We also ask for your permission to store any remaining blood samples so they may be used in future research related to health and aging. Results from these future research studies will not be shared with you. This choice is optional, and you may decline without any penalty or impact on your participation in this study.

How much of my time will be needed to take part in the blood draw? The blood draw appointment should take about 20 minutes.

What will happen if I grant permission to share my past pharmacy and clinical lab results with the study (part of my protected health information)? Instead of asking detailed questions about your medications, we are requesting permission to access your prescription records and lab test results from the past 7 years, as provided by ExamOne-Quest Diagnostics. This will help us better understand your health. We will use these records only for research and will not share them with any businesses or use them for other purposes. This choice is optional, and you may decline without any penalty or impact on your participation in this study.

Information about study risks and benefits

What risks will I face by taking part in the blood draw? What will the researchers do to protect me against these risks? If you agree to provide a blood sample, possible risks include brief discomfort and/or bruising at the needle site. Your blood will be drawn by a trained and experienced professional, and they will make sure you are feeling alright both before and after the blood draw. Some people may feel worried or upset if the clinical lab results they receive raise concerns about their health. We encourage you to share your results with your doctor or nurse when they arrive in the mail so they can discuss them with you.

Your blood sample will contain some of your DNA, which we will ask your permission to store for future genetic testing. Genetic testing is a way for scientists to look at your DNA, which is like the instruction manual that tells your body how to work. Researchers use genetic information to learn more about how the body works and how to improve health for everyone in the future.

Because everyone’s DNA is unique, there is a possibility that, in the future, someone could identify you using only your DNA sequence, even though this is not possible currently. If you grant permission for storing your DNA, only the NSAL research team will have access to your sample, and it will not be shared with any other researchers or groups.

One of the risks of participating in this study is a loss of confidentiality. This risk of this happening is rare. In order to protect your confidentiality, your name will be removed from all of your blood draw data and will be replaced with a study ID number. If you give permission to access your past pharmacy and clinical data, these will also be given a study ID number. All information that could identify you, such as your name and address, will be stored separately from your study data. All data is stored and transmitted in a secured, encrypted form to help protect your privacy (see Protecting and Sharing Research Information for more details about how we protect your information).

How could I benefit if I take part in the blood draw? How could others benefit? We will provide you with results from your blood draw that may help you and your doctor understand your health. Others may benefit from your participation because it will provide us with important information about the factors that contribute to risk and resilience for Alzheimer’s disease and health conditions related to aging. The knowledge gained from this study can help scientists understand these processes, and may lead to changes to regulations and approaches that may allow people to experience healthier aging in the future.

Ending the study

If I want to stop participating in the blood draw what should I do? If you decide not to participate in the blood draw, there will be no penalty to you. You can withdraw from the blood draw and still stay in the study, or you can withdraw from the entire study at any time. You will not lose any benefits to which you may otherwise be entitled and you will not lose any financial payments received. If you decide not to participate in the blood draw, please tell one of the people listed at the end of this form. If your blood specimen has not yet been analyzed when you tell us you want to withdraw, it will be removed from the study and destroyed. You can choose to remove your blood from storage at any time, however any results from blood tests already conducted cannot be withdrawn. If you choose to tell the researchers why you are withdrawing from the blood draw, your reasons may be kept as part of the study record.

Financial information 

Will I be paid or given anything for taking part in this study? As a token of our appreciation for your time, you will receive $50 for participating in the blood draw. You will be paid by the interviewer upon the completion of the interview.

Will I need to pay anything to be part of the blood draw? There is no cost to you for participating in the blood draw.

Protecting and sharing research information, biospecimens and protected health information

How will the researchers protect my information? We plan to publish the study results, but will not include any information that could identify you. Your privacy will be protected, and your research records will remain confidential. We use strict methods to protect your data and identity. Identifying information, such as your name and address, will be stored separately from your study data and kept confidential. All information will be kept on secure, encrypted University of Michigan servers. Your data will be labelled with a study ID number, and only researchers can link this number to your identity. The laboratories that analyze and store the blood samples will only use a barcode ID number to identify them, and your name and contact information will not be shared with them.

Certificate of Confidentiality. In addition to everything we will do to protect your confidentiality, this study holds a Certificate of Confidentiality from the National Institutes of Health. This means that we cannot release or use information, documents, or samples that may identify you in any action or suit except as described below. This protection includes federal, state, or local civil, criminal, administrative, legislative, or other legal proceedings. An example of a situation in which the Certificate would apply would be a court subpoena for research records.  There are some important things that you need to know:

  • The Certificate does not stop reporting or information-sharing that you agreed to in this consent document. For example, we may share information with appropriate authorities if we think you may harm yourself or others.  We may also share your information with other researchers.
  • The Certificate does not stop reporting that federal, state, or local laws require. Some examples are laws that require reporting of child or elder abuse.
  • The Certificate cannot be used to stop a sponsoring United States federal or state government agency from checking records or evaluating programs.
  • The Certificate of Confidentiality does not stop you from personally releasing information about your involvement in this research if you wish.
  • More information about Certificates of Confidentiality and the protections they provide is available online at https://grants.nih.gov/policy/humansubjects/coc.htm

Genetic Information Nondiscrimination Act (GINA). GINA is a federal law that generally prevents health insurance companies, group health plans, and most employers from discriminating based on your genetic information. Under GINA, health insurers and group health plans cannot request or use your genetic information from this research to determine coverage or premiums. Under GINA, employers with 15 or more employees cannot use your genetic information from this research for hiring, firing, promotion, or employment terms. GINA does not apply to life, disability, or long-term care insurance. GINA does not apply to the US Military (Tricare), VA, Indian Health Service, or federal employees, but these groups have similar anti-discrimination protections.

Who will have access to my records? If you consent to the blood draw, we will share your name and contact information with ExamOne-Quest Diagnostics in order for them to schedule your blood draw and arrange for a phlebotomist to connect with you.  Additionally, if you consent to sharing your pharmacy and clinical lab records, we will share your name and address with staff from ExamOne-Quest Diagnostics who will collect these records.

There are reasons why information about you may be used or seen by the researchers or others during or after this study. For example, University, government officials, study sponsors or funders, auditors, and/or the Institutional Review Board may need the information to make sure that the study is done in a safe and proper manner.

If you consent to allow us to access your past pharmacy and clinical lab records, you are allowing any pharmacy or pharmacy benefit manager to share your prescription drug records with our study team. You are also allowing ExamOne-Quest Diagnostics to share your clinical lab test results with our study team. This information will be used only for research purposes.  All of your pharmacy and laboratory information will be stored securely and listed under a study ID number.

What will happen to the blood samples collected in this study? We will analyze your blood samples to test for markers of cardiovascular, metabolic, immune, and brain health. If you consent, some of your blood will be stored securely in a laboratory at the University of Michigan for future research. These samples will have an ID barcode, and the laboratory will not know your name or any other identifying information.

Will my blood samples be used for future research? We are asking for your permission to store your blood sample for analyzing in the future. Medical science is moving forward all the time, and we may be able to learn more from your blood sample in the future. This future research may be similar to this study or completely different. We will not ask for your additional informed consent for these studies. Even in future research, we will not share information that could be combined to identify you.

Will my results or blood sample be shared with others? We plan to share the information collected in this study, including from the blood test results, in a secure data repository so that other researchers can do additional research. All the information we share in this repository will not contain your name or any other information that can identify you.

Your blood sample, past pharmacy records, and past clinical lab records will not be shared with anyone outside the study team.

Contact information 

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
  • Leave the study before it is finished
  • Express a concern about the study

Principal Investigator:    Briana Mezuk

Email:                         [email protected]

Phone:                            734-615-9204

Study Coordinator:         Ask for the NSAL project

Email:                             [email protected]

Phone:                            800-759-7947

If you have questions about your rights as a research participant, or wish to obtain information, ask questions or discuss any concerns about this study with someone other than the researcher(s), please contact the following:

University of Michigan

Health Sciences and Behavioral Sciences Institutional Review Board (IRB-HSBS) 2800 Plymouth Road

Building 520, Room 2144 Ann Arbor, MI 48109-2800

Telephone: 734-936-0933 or toll free (866) 936-0933

Fax: 734-936-1852

E-mail: [email protected]

You can also contact the University of Michigan Compliance Hotline at 1-866-990-0111

Consent to Participate in the Blood Draw

I agree to have my blood drawn and analyzed as part of the NSAL.   YES_____  NO_____

Printed Participant Legal Name

 

 

 

Date

Signature

 

Consent for Storage of Blood Sample for Unspecified Future Research Purposes

This project includes the option to allow the study team to store your blood sample for use in future research, including possible genetic research. If you do not agree for your blood sample to be kept, you may still participate in the study.

I agree to allow the NSAL team to store my blood sample for future research. YES                                                                                                                                               NO _____

Printed Participant Legal Name

 

 

 

Date

Signature

 

Interest in Receiving Additional Blood Results in the Future 

Your blood sample will also be used to measure proteins that researchers believe are related to brain health. Testing for these proteins is new and therefore it’s not currently clear that they provide meaningful clinical information that you could share with your doctor. However, because science is rapidly developing, they may have clinical value in the future.  If the study team determines that these protein measures have clinical value at some point in the future, do you want us to contact you about that update?  YES              NO_____

Consent to Share Pharmacy and Lab Records (Protected Health Information available from ExamOne-Quest Diagnostics)

  • If you sign this statement,
    • You are allowing any pharmacy or pharmacy benefit manager (companies that handle prescription drug benefits for health insurance companies) to share your pharmacy records with our study team.
    • You are allowing ExamOne-Quest Diagnostics to share your clinical lab test results with our study team.
  • The health information to be used for this research includes: your prescription drug records and/or your clinical lab test results.
  • The health information listed above may be used by and/or released to: study researchers and study staff.
  • Your pharmacy and ExamOne-Quest Diagnostics are required by law to protect your health information. By signing this document, you authorize ExamOne-Quest Diagnostics and your pharmacy to use and/or release your health information for this research. Those persons who receive your health information may not be required by Federal privacy laws (such as the Privacy Rule) to protect it and may share your information with others without your additional permission, if permitted by laws governing them.
  • You may make a request to the study team to receive a copy of your own records.
  • Unless revoked earlier, this authorization will be valid for twenty-four (24) months after the date it is signed.
  • You can revoke this authorization at any time by giving written notice to the National Survey of American Life. Revoking this authorization will not negatively impact you or your ability to participate in other parts of the study. Please be aware we may not be able to remove your data from data that has already been used or shared.
  • If you do not agree to share either your pharmacy records, lab records, or both, you may still participate in the study.

I agree to share my past pharmacy records with the NSAL team. YES _____  NO _____

I agree to share my past laboratory records with the NSAL team. YES _____  NO_____

Printed Participant Legal Name

 

 

 

Date

Signature