Biorepository consent form fact sheet

This fact sheet provides information for NHS, Health Professionals Follow-up Study (HPFS), and Growing Up Today Study (GUTS) participants with biospecimens in the Brigham and Women's Hospital (BWH) / Harvard Cohorts Biorepository.

Overview

Thank you for participating in the BWH/Harvard Cohorts Biorepository.  This fact sheet provides more information about the biorepository.   

We have provided a list of definitions of some of the terms used in the consent form and fact sheet.  This is followed by more details about what will happen to your samples and health information. 

As a participant of the Nurses’ Health Study (NHS), Health Professionals Follow-up Study (HPFS), or Growing Up Today Study (GUTS), you may be asked to provide specimens and information in the future. This may happen even if you decide not to participate in this particular collection.  As always, you may decline to be in any specimen collection or study that you don’t want to participate in.

Definitions

Biorepository

  • A “biorepository” is a collection or bank of biological samples, such as blood, urine, tissue, and DNA that are linked to health and lifestyle information, and are used for scientific research. We refer to the biorepository in the consent form as “the Biobank”.
  • In this study, you will not be asked to take any medication, receive treatment, or change your behaviors. We will just collect samples and health information for researchers to study.

DNA

  • Your specimen consists of many cells. These cells contain genetic information called DNA that is inherited from your parents. DNA provides a code that instructs the cells in our bodies to do specific things. In some cases, abnormalities in the DNA can put us at risk for certain diseases

Genes

  • Genes are parts of the DNA code that direct cells to perform certain functions. Genes contain the instructions that tell our bodies how to grow and work, and determine physical features such as hair and eye color.

Genetic variants (or mutations)

  • Genetic variants or mutations are changes in genes that can increase a person’s risk for developing diseases. 

Proteins

  • Genes are also used to make proteins. Proteins help carry out the instructions present in our genes. They do many things in the body such as keeping our skin together, protecting us from infections, digesting the foods we eat, and helping us to think.
  • Research on proteins is important in order to identify their functions and to understand how the genes that produce them are altered in disease.

Types of genetic tests

There are several types of tests that can be done; for example:

  • Single or multiple DNA markers can be studied: this is called genotyping
  • Many gene variants (mutations) can be studied to see if there is any relationship between specific genes and a particular disease: this is called genome wide association studies
  • The entire DNA genome can be studied: this is called gene sequencing.
  • Since many diseases are not just caused by one genetic variant, researchers may study many gene variants or the entire genome in order to understand the multiple genetic variants that contribute to disease. By providing a specimen, such as blood or saliva, you are enabling researchers to do these complicated tests.

Genetic research

  • Genetic research uses DNA, genes, and other health information to study the links to different types of health conditions.
  • Genetic research may explore why some people are more likely than others to get certain diseases. This type of research may also show why some people respond to certain medicines or have side effects from other medicines.
  • The long-term goals of genetic research are to learn how to better understand, prevent, diagnose or treat diseases.

Section 1.  What is the purpose of the BWH/Harvard Cohorts Biorepository?

  • The BWH/Harvard Cohorts Biorepository is a long-term research support service that is an integral part of the Nurses’ Health Study, Health Professionals Follow Up Study, and Growing Up Today Study designed to collect and manage biological specimens for use by researchers working on these studies.  These scientists are interested in using specimens and data to understand how people’s health is affected by their genes and other factors.  A person’s risk for getting a disease depends on many factors.  Your risk includes the genes you inherit from your parents as well as environmental factors.  Environmental factors include just about anything you are exposed to in your daily life – what you eat and drink, where you live and work, whether you smoke or exercise, and so on.  Scientists believe that even small differences in genes or these other factors can affect whether you get a disease or medical condition, such as asthma, heart disease, cancer, and many others.  We hope these studies will help researchers develop better ways to prevent, detect, and treat disease.

Section 2. What will happen in this study?

  • You will be asked to provide one or more biological specimens (blood, urine, saliva, stool, hair, toenails) as directed by a detailed instruction sheet.
  • You will also be asked to provide some general information from the time of collection such as what you ate or drank the day your sample was collected.
  • We will also ask you to complete a short study specific questionnaire, using a computer.  This will take between 5-15 minutes. You may skip any questions you do not want to answer.  You may save your responses, stop answering the questions, and return to complete the questionnaire later.  For example, the questionnaire may ask you about:
    • Whether you smoke cigarettes or how much you exercise.
    • The environment in which you live and work (for example, your exposure to the sun and what type of job you have)
    • Your family history (for example, whether your parents have diabetes or cancer)

Section 3.  For what types of research will my samples be used?

  • Many types of research may be done with your samples. Some studies will do genetic research to look at your DNA and genes, including an examination of genetic variants. Others may look at proteins and other factors made by your body.
  • Some genetic research looks at a small portion of your genes, while other genetic research may study all of your genes.  Research that looks at all of your genes is usually trying to find out if there is an association between a medical condition and a change in one or more genes. 
  • In order to allow researchers to share research results, agencies such as the National Institutes of Health (NIH) and others, have developed secure information banks that collect and store research data from genetic studies.  These central banks may share this information with qualified and approved researchers to do more studies.  Data provided to the central banks will not contain your name or other information that directly identifies you. There are many safeguards in place at these banks to protect your privacy.
  • Your sample may be used as a healthy control in research to study why some people have a disease that you don’t. If researchers know what causes disease, they can help find ways to prevent it in the future.
  • It is not possible for us to list every research project that may be done.  Also, we cannot predict all of the research questions that will be important in the future. As we learn more, we may use your samples and information to answer new types of research questions related to human diseases. 

Section 4.  Will I get results of research done using my samples?

  • You may receive a newsletter or other information that will tell you about the research discoveries from the study. This newsletter will not identify you or describe any of your personal results. You should not expect to receive personal results from this research.  Researchers will study samples and information from many people; it will take many years before they know if the results have any meaning.  Most of the findings that come from studying your sample will not be relevant to your personal health. There is a small chance that researchers could find something that might be important to your health.  If this happens, we may contact you to find out if you would like to learn more. However, even if we find something important to your health, we cannot guarantee that you will be contacted.

Section 5.  What are the benefits to me? Will I be paid for my samples?

  • While there is no direct benefit to patients for participating in this project, your participation could help us better understand, treat, and even prevent diseases that affect your loved ones, your future generations, as well as the larger community. Your samples and information will help further progress of the NHS, HPFS, and GUTS research studies.

Section 6.  What are the costs to me to take part in the research tissue bank?

  • There are no costs to you to participate in this study.

Section 7.  How are my samples and health information stored in the biorepository?

  • Our biorepository staff will assign your sample a code number and store it in a locked freezer or locked cabinet. We will not keep your name of other information that could identify you with your sample. 
  • We will use the code number to connect your sample to your health information that is stored in a computer database.  The computer database is protected, and only select staff at our research facility have been granted a password to access the information.

Section 8.  Which researchers can use my samples and health information stored in the biorepository?

  • Your samples and associated data may be made available to researchers at the Harvard T.H. Chan School of Public Health and Brigham and Women's Hospital (BWH) and our academic research collaborators.  Very rarely, your samples may be shared with for profit companies collaborating with Harvard Chan School of Public Health or BWH researchers on a specific project. Your samples will never be sold. When providing samples to researchers, the biorepository will provide limited information such that you cannot be identified. 
  • In order to access samples from the biorepository, all researchers must submit a project plan to the biorepository advisory board.  In addition, projects approved by the advisory board, must then be reviewed and gain approval from the Partners Ethics Board (Institutional Review Board, IRB).  The IRB is a group of people who independently review and watch over all research studies involving people.  The IRB follows state and federal laws and codes of ethics to make sure that the rights and welfare of people taking part in research studies are protected.  In order to allow researchers to share research results, agencies such as the National Institutes of Health (NIH) have developed secure data banks that collect and store data from genetic studies. These central banks may store results from research done using your samples and information. The central banks may share information with qualified and approved researchers to do more studies. Results shared with the central banks will not contain information that directly identifies you. There are many safeguards in place at these banks to protect your privacy.

Section 9.  How long will the biorepository keep my samples and information?

  • We will store your samples and information indefinitely

Section 10.  Can I stop allowing my samples and information to be stored and used for research?

  • Yes.  You can withdraw your permission at any time. If you do, your samples will be destroyed.  However, it will not be possible to destroy samples and information that have already been given to researchers.  If you decide in the future to withdraw your permission for use of these samples, please contact the Biorepository staff via email at nhsgwas@channing.harvard.edu, or in writing addressed to BWH/Harvard Cohorts Biorepository, 181 Longwood Ave, Boston, MA 02115. 

Section 11.  What are the risks to me?

  • The main risk of allowing us to use your samples and health information for research is a potential loss of privacy. We protect your privacy by coding your samples and information.
  • There is a risk that information about taking part in genetic research may influence insurance companies and/or employers regarding your health and life insurance.
  • We do not think that there will be further risks to your privacy by sharing your whole genome information with other researchers; however we cannot predict how genetic information will be used in the future.
  • There is a very small risk of bruising or infection from drawing blood similar to what might occur from a routine blood draw that you get for your doctor.

Section 12.  How will you protect my privacy? Do you share my identifiable health information?

  • All of your identifiable health information is private under federal law. However, there are certain cases where we may need to release your information to organizations such as federal and state agencies and audit committees that oversee research. We do not release any information stored in the repository to insurance companies.
  • The main risk of your participation in this research is a loss of privacy.  By sharing your personal information with researchers, it is possible that someone could find out private information about you.  However there are many safeguards in place to protect your privacy. These include assigning codes to your samples and information, requiring ethics board approval for researchers and staff, and an oversight committee.
  • Research results that are provided to central banks also have many procedures to protect your privacy and confidentiality.  While we think that there are only minimal risks associated with sharing research results, we cannot predict how this information might be used in the future.
  • Your privacy is very important to us and we will use many safety measures to protect your privacy.  However, in spite of all of the safety measures that we will use, we cannot guarantee that your identity will never become known.  Although your genetic information is unique to you, you do share some genetic information with your children, parents, brothers, sisters, and other blood relatives.  Therefore, it may be possible that genetic information from them could be used to help identify you.  Also, it may be possible that genetic information from you could be used to help identify them. 
  • Collaborating with researchers. The Partners Institutional Review Board (IRB) is certified to approve all researchers who will want to use samples and health information for their studies. The IRB ethics board independently reviews and watches over all research studies involving people. The board follows state and federal laws and codes of ethics to make sure that the rights and welfare of people taking part in research studies are protected.

Contact information

  • If you have any questions before you sign this consent form or after you join the study, you can contact the Biorepository staff at [617-525-8628] from Monday - Friday 9a – 5p.  You can also email us anytime at consent.questions@partners.org
  • The person in charge of the BWH/Harvard Cohorts Biorepository is Shelley Tworoger.