Protocol Support Laboratory and Biospecimen Repository Facility

A biological sample is a bodily fluid – blood, saliva or urine – or tissue, such as skin or tumor, that is collected for diagnostic or research purposes. More often, biological samples are collected to help diagnose or monitor your health condition. After being used for your care, leftover materials from the samples are normally discarded or destroyed. These extra materials are sent to the Biospecimen Repository Facility for research instead of being discarded.

No. Opting in or out of donating leftover or additional biological samples will have no impact on your diagnostic tests or clinical care. You will still receive the best possible care.

When you decide to take part in this program, you allow your doctor and the team to:

• Have access to your medical file as long as the study remains in progress.
• Collect and store tissue surgically removed as part of the normal diagnostic or treatment process that would otherwise be discarded.
• Use tissue and any other samples that have been stored from your previous surgeries or biopsies.
• Collect and store a maximum of 50 mL – about 10 teaspoons – of blood during a routine visit and when your doctor decides to change your treatment.
• If needed, obtain other biological samples that can be collected by noninvasive means. These may include urine, saliva, hair, nail, excreta, placenta or other fluids or tissues.
• If you have been diagnosed with a hematological malignancy, and you are undergoing a bone marrow biopsy, up to 15 mL of additional bone marrow may be collected, while your regular procedure is being performed.
• Occasionally, place your genetic and/or genomic health information (sequencing data) in scientific databases with information from many other people. We will not include your name, address, medical record number, birth date or other information that could identify you. Researchers who want to study the information stored,  must apply to use the database.

You will not need to make any extra visits to participate in this program, and you will not receive personal results from research done on your sample, which will be stored indefinitely.

Your samples will be taken to the Biospecimen Repository Facility for processing, tracking and storage. They will be labeled with codes that do not contain any information about you and will be registered in a password-protected data system. Your samples and data may be used as soon as they are received, or they may be stored for an undetermined period to:

• Identify disease markers
  Researchers can use your sample to find better ways to treat diseases, to understand why some people develop diseases and others do not, to discover new diagnostic techniques and to learn something that might help future patients.
• Conduct genetic research
  Your sample may be used to study how genes affect health or responses to treatment. Genes are pieces of DNA that control how our cells and bodies develop and work. The DNA code is what you inherit from your parents and pass on to your children. Researchers can use several methods, including whole genome sequencing, to look at parts or all of your DNA code.
• Enhance scientific databases
  Stored genetic and/or genomic health information, or sequencing data, can help researchers speed the pace of future discoveries.
• Develop new products or treatments
  Researchers may use your samples to create new products useful for research and/or clinical treatment. For example, your sample may be used to develop cell lines – a group of cells that can live and divide indefinitely outside of the body – and those cell lines may be used to identify disease markers.

Only research requests approved by the Biospecimen and Data Release Committee are allowed to move forward. These research requests are for scientific projects conducted by Baptist Health South Florida researchers and those from universities, government agencies and private companies around the world that work on developing new tests or treatments. Some of these entities may provide funding to offset current and future costs associated with this program.

You will not receive personal results from research done with your samples. Researchers are unable to connect their research results to your name or identifying information. It can take many years for the research to be completed and to understand whether results would have been important to you as an individual.

You will not be charged or paid for donating your samples or receive any compensation, even if your samples lead to the development of a new medicine, product, test or treatment.

Research on clinical data and biological samples from people today will benefit patients in the future with new medicines, diagnostic tools and screening strategies. If you donate your biological sample, there may be no direct health benefit to you, other than the personal satisfaction of knowing that you contributed to the advancement of science and helping tomorrow’s patients.

The Biospecimen Repository Facility follows state and federal laws to protect your confidentiality. Whether you choose to share your leftover sample or donate an additional sample for research, your privacy will be protected.

We release limited information to other parties, and none of what we share includes identifying information. In fact, the Biospecimen Repository Facility only gives researchers code numbers.

Your samples will be coded as illustrated below.

A list of names and corresponding code numbers is kept separate from coded samples and data. Only authorized staff from the Biospecimen Repository Facility have access to this list. The samples are kept in locked storage containers located inside locked laboratory rooms containing sensors and monitors, all of which is within a building protected by security guards. All data is kept secure on password-protected computers with a secure firewall.

The Biospecimen Repository Facility also follows the Genetic Information Nondiscrimination Act (GINA), a federal law designed to protect your privacy. GINA makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information.

We are well aware that in this era of sophisticated computerization and the associated reliance upon electronic health records, the greatest risk to you is the potential release of information from your health records. That is precisely why we’ve taken many steps to prevent this from happening. Nevertheless, there is a small chance that someone could obtain information connecting the sample to you.

Another risk is that information about your ancestry, ethnic group or other people with your disease might be identified and connected with your sample. There is also a small chance of accidental release of information from your health records. Currently, only large state and federal agencies have the ability to identify individuals based on a complete DNA profile. We can’t predict how future technology might affect confidentiality. Some people may have moral, religious or cultural concerns about some kinds of research.

If you agree to participate in this program, you are free to change your mind. Your withdrawal will not affect any standard medical care or benefits to which you are otherwise entitled.

If you decide to withdraw, contact us at 786-527-8835. You may also contact any of the Biospecimen Repository Facility coordinators in person. We will ask you to fill out a “Withdrawal from BRF Request Form,” documenting your decision to withdraw. If you provide this information verbally, we will note your decision in our files. Data and analyses already derived from your samples will continue to be used. No additional samples will be collected.

If you would like to speak with someone about your rights as a participant in a research study or about ethical issues with a research study, you may contact the Baptist Health Institutional Review Board (IRB) by phone at 786-527-9280. If you want to learn more about tissue research with banked specimens, the NCI website has an information sheet called “Providing Your Tissue for Research: What You Need to Know.”

We understand that, as an investigator in the rapidly expanding genomic and personalized medicine landscape, you have probably encountered obstacles to obtaining high-quality, properly annotated and genetically diverse biospecimens for research purposes.

Since their inception, the Protocol Support Laboratory and Biospecimen Repository Facility have been staffed and equipped to address each of these challenges. First, its location in one of the most ethnically diverse populations in the continental United States provides researchers with specimens that are also genetically diverse. Second, biospecimens are collected using an IRB-approved protocol and processed in a CAP-accredited facility. Finally, real-time chain of custody, tracking of pre-analytical variables and management of your request is performed using a robust Laboratory Information Management System to ensure that your expectations are met.

Working closely with Baptist Hospital’s Pathology division, our technical staff oversees the chain of custody for biospecimens from the operating room or interventional radiology suite to Pathology and coordinates services that require strict adherence to detailed protocols. These include:

• Grossing of tissue samples
• Tissue processing, embedding, and slide preparation
• H&E and special staining
• Archived tissue identification and retrieval
• Pathologist consultation

Working closely with clinical coordinators, nurses and physicians, the  technical staffs of the Protocol Support Laboratory and Biospecimen Repository Facility coordinate services that require strict adherence to detailed protocols. These include:

• Research Protocol Feasibility Assessment (Start-Up and Activation)
• Kits management
• Biospecimen collection, including blood, bone marrow, urine, saliva, stool and others required by research protocols
• Biospecimen processing of plasma, serum, buffy coat, peripheral blood, mononuclear cells isolation and other processing techniques as required
• Biopsy and surgical tissue procurement
• Fresh tissue snap freezing
• Short- and long-term biospecimen storage at RT, 4oC, -20oC, -80oC and -150oC
• Archived tissue requests
• De-identification of biospecimens and pathology reports
• Distribution of biospecimens to central and research laboratories
• Chain of custody – tracking of collection, processing, storage and shipment events 
• Development of correlative science plans for investigator-initiated trials
• Identification of preservation and storage methods aligned with downstream analytical platforms
• Laboratory manual preparation
• Pathologist slide review, including tumor content and quality control analysis