Scientists in the SMaHT Project will learn about changes in our DNA that happen in different places in the body, including how these changes might build up as we age. This information will help us understand the human body and people’s risk for diseases like cancer, diabetes, and heart disease. Knowing more about these normal changes as we age will also lead to better early disease detection and treatment because understanding normal changes can help us know when changes are abnormal or risky. This project will create a much-needed resource of genetic data and tissues that will support many research studies in the future.

The SMaHT research team includes scientists from the National Institute of Health (NIH) and scientific researchers. These individuals will work together to reach the project’s goals. Researchers in the SMaHT project are organized into teams that will perform specific parts of the project. These researchers were selected and funded through a competitive process. Many of the SMaHT researchers have years of experience in genetic research and have worked on projects that set the groundwork for the SMaHT project.

We believe families everywhere will benefit from the project’s genetic and genomic discoveries, ultimately leading to new, life-saving treatments and disease prevention. Past genetic research has not always included many people from underrepresented groups, including people who identify as racial and ethnic minorities. Unfortunately, not representing people from all backgrounds and heritage can limit what populations benefit from a project. The SMaHT Network has a team of researchers focusing on the Ethical, Legal, and Social Impacts (ELSI) of tissue donation for genetic research. One of the ELSI team’s goals is to support SMaHT in representing as many people as possible in tissue samples that are collected for the project. The ELSI team will address past research gaps using a unique approach called Diversity, is.

SMaHT hopes that families everywhere will benefit from the project’s genetic discoveries, ultimately leading to new, life-saving treatments and disease prevention. Past genetic research has under-represented some groups, including racial and ethnic minorities. That under-representation can limit what populations benefit from genetic research findings. The SMaHT ELSI project is trying to address these past gaps using a unique approach called Diversity, Equity, and Inclusion 360⁰. Using this model, the ELSI team will work with many community stakeholders and create Community Advisory Boards (CABs) to help support diverse donor families as they decide whether or not to donate their loved one’s tissues to SMaHT.

The SMaHT project includes a team of researchers who are specifically interested in questions like:

• How do families decide whether or not to donate to a genetic study like SMaHT?
• How can we best support families while deciding whether to donate their loved one’s tissues for research?
• What are the best ways to support staff who meet with families to ask about donations?

Donated tissues will be physically stored in a Biobank which will preserve the samples of donated tissue from many people for use in current and future research. The Biobank will allow scientists to keep using the tissues in the future so that each donation has an even larger impact.

Scientists will analyze the donated tissues to determine the unique genetic makeup of the donor, including the non-inherited gene changes that could happen in some cells. That information will be stored in a genetic Database. The large database will create a resource of non-inherited gene changes in several tissues across many individual donors.

Most tissues will be stored at the National Disease Research Interchange (NDRI) in Philadelphia, a not-for-profit organization contracted by the National Institutes of Health. Brain tissue will be stored at the University of Maryland Brain and Tissue Bank, another not-for-profit organization contracted by the National Institutes of Health. The Biobanks are secured facilities and only approved personnel are allowed to access the biobanks.

NIH-approved researchers from academic, government, and commercial organizations worldwide may request access to the tissue samples and medical information about the donor. However, we will do everything we can to make sure that the medical information we share will not allow researchers to identify who the donors are. We will never share donors’ names or other information that we know could identify them with researchers using the tissue or data. Researchers will be subject to an approval process and must also sign an agreement to protect the privacy and confidentiality of the donor.

The project makes every effort to ensure the confidentiality of the donor and his/her blood relatives. Safeguards include the following:

• Identifying information such as donor’s name, address, date of birth, and medical record number are excluded from Databases and are also not included in the way tissues are labeled.
• No researchers using the genetic Databases or tissues in the Biobank will know the identity of the donor because the information and tissues will be labeled only with a unique code number.
• Researchers using the genetic Databases and/or tissues in the Biobank must agree to never try to discover the identity of the donor.

There are two types of databases in the project. The first database is protected, which means that only a select group of approved researchers will have access to it. The second database is public and does not include as much information about the donor. Both of the databases are anonymous and will not include donors’ names or other information that we know could identify them.

The protected database will include the donor’s full (inherited) genetic information and other anonymous information from the donor’s medical record, like health or disease history. This protected database will only be accessible to researchers who have been approved.

There will also be a public online database that is separate from the protected database. The public database will include non-inherited genetic data that is unique to each donor’s tissues or cells. Everyone can access the public database, but this database will not include any information that we know could identify the donor, like names.