Table 3 Sentences commonly highlighted as reassuring^a

WHY IS THIS PROJECT BEING DONE?

 Researchers will use the stored materials in future studies on health and disease. Through such studies, they hope to find new ways to detect, treat, and maybe prevent or cure health problems.

WHO IS DOING THIS PROJECT?

 There is a Steering Committee to watch over the project and make sure we are doing things the right way. This includes researchers, doctors, lawyers, ethics experts, and government officials. It also includes patients and members of the public to help speak for people who take part.

WHAT WILL YOU ASK ME TO DO?

We will get a blood sample from you.

  We will use a needle to draw about 3 tablespoons of blood from your arm.

WHAT WILL YOU DO WITH MY SAMPLE AND INFORMATION?

We will store all the samples and information in a central place.^*

  We will store your sample and information, along with those from all the other people who take part, at a secure location in Norfolk, Virginia. There will be many layers and kinds of safeguards to help keep the materials safe.

We will not give researchers anything that directly identifies you.^*

  When we store the materials, we will remove names and other identifiers. We will replace them with code numbers.

  Only a few project staff can see the list, and they sign a pledge to keep it secret.

  People who study the samples and information will not know who you are. We will give them materials labeled with only the code numbers.

Researchers will do many kinds of studies to learn about health and disease.^*

  • What causes people to be healthy or have a disease?

  • Why do diseases and treatments affect people differently?

  • How do basic biology, lifestyle, and environment work together to affect health?

  Some of the studies may lead to new products, such as drugs or tests for diseases.

Researchers will have two ways to access the stored materials.

  We will put some information in a public database that anyone can look at. This database will not contain names or other direct identifiers. Further, it will not allow anyone to see information about just one person. It will only show information at a group level (for instance, for the group of people in the Million American Study who have heart disease).

  We will also make a scientific database. Like the public one, this database will not contain names or other direct identifiers.

  Access to the scientific database will be strictly controlled. Researchers who want to use it must first complete ethics training. Then they must apply to do their specific study. An Access Committee will review each request. If a study is approved, the researcher must sign a pledge to use the materials only for that study. They also promise to keep the materials secure and not try to figure out who you are.

ARE THERE ANY BENEFITS?

 The main reason you may want to join is to help researchers learn things that could improve health care for people in the future.

WHAT ARE THE RISKS AND HOW WILL I BE PROTECTED?

Someone could identify you.

  Your privacy is very important to us and we will make every effort to protect it. We will keep everything in a secure place and label it only with a code. We will not give out anything that tells who you are. Nobody will know just from looking at the databases that the information belongs to you.

  We will follow federal rules designed to make sure only the right people see your data. These include limiting and tracking who has access, as well as passwords, encryption, and other safeguards. We will tell you if someone sees the data who was not supposed to.

The stored materials could be used for studies you do not like.

  The goal of the Million American Study is to make discoveries that improve health for everyone.

  You can learn about the studies being done on the Million American Study web site [URL].

  You have the right to leave the project at any time (see the part below, “What are my options?”).

Your sample and information could be of interest for reasons other than research.

  Federal laws also make it illegal for most employers to use your genetic information against you.

  There are federal laws that require us to refuse to give out information that identifies you, even if ordered to by a court or judge, without your okay. Still, we must follow laws that require us to report certain things to state officials.

The stored materials could suggest information about your family.^*

[Concluding paragraphs of Risks & Protections section]

  The federal laws we described protect you no matter where you live.

  We will tell you if we learn of anything that might change your decision to take part.

ARE THERE ANY COSTS OR PAYMENTS?

 Some research may lead to new products, such as drugs or tests for diseases.

WILL I GET THE RESULTS OF STUDIES ON MY SAMPLE AND INFORMATION?

 There is a small chance that researchers could find something that might be very important to your health or medical care right now. At the end of this form, you can tell us whether you want us to try to contact you if this happens.

Getting results may affect your privacy risks.

  We will not give information to insurance companies.

WHAT ARE MY OPTIONS?

 Taking part in the Million American Study is your choice. You can choose to join or not. If you decide to join, you can change your mind at any time.