Frequently Asked Questions (FAQs)
What does BCRI stand for?
Baptist Clinical Research Institute
Where is the BCRI located?
BCRI is located at 6025 Walnut Grove Road, Suite 500, Memphis, TN 38120. The building is Medical Plaza 1 on the Baptist Memorial Hospital Memphis campus. Parking is in the main hospital parking garage, and you can enter Medical Plaza 1 via the footbridge from the 3rd level of the garage. Valet parking is also available in front of the 6025 building.
What type of Clinical Trials do BCRI and its affiliates conduct?
The Baptist Clinical Research Institute (BCRI) conducts inpatient and outpatient phase I through IV clinical trials. The BCRI has conducted and facilitated many kinds of research studies (clinical trials) since it’s opening in 1989. We have conducted over 300 studies in diverse areas, including cardiology, neurology /neurovascular surgery, endocrinology, migraine treatment, novel surgical procedures incorporating new devices, hematology, gastroenterology, and community health. Click here for information about our current studies.
What services does BCRI provide?
BCRI provides central clinical trial management which includes: contract and budget negotiation, participant consenting and screening, data collection, clinical research coordinator support, financial cost analysis, regulatory expertise, investigational pharmacy services, protocol development and study start-up support services.
Who does BCRI provide services to?
This includes, but is not limited to, clinics and physicians who would like to open their own studies, students, residents and fellows seeking to engage in research, and national and international sponsors wanting to open studies at any of the many Baptist facilities. Click here for a map of Baptist locations.
What should I do if I have a new clinical research study and request BCRI Services?
For more information on opening a research study at Baptist, please contact our Director of Clinical Research or call 901-226-0031. For additional information, you may also refer to the Baptist Institutional Review Board (IRB) webpages.
If I am utilizing BCRI Services, who do I contact for assistance with CDA’s, budgets, contracts, coverage analysis, etc. required for the study?
Please contact our Director of Clinical Research via email at Paul.Koros@bmhcc.org
What is the expected turnaround time when BCRI provides oversight from the initial study contact to study initiation?
It is our goal to complete the process in a timely manner. However, the turnaround time is contingent upon the timeliness of responses to requests for information and the availability of all required study documentation.
What kind of Human Subject Protection (HSP) training is required at Baptist?
All persons involved in the conduct or oversight of research involving human subjects must demonstrate understanding of the ethical principles and relevant regulations. In addition to on-site training, a course of training must be completed via the web-based training program Collaborative Institutional Training Initiative (CITI Program). Individual modules include, but are not limited to, Conflicts of Interest, Biomedical Responsible Conduct of Research, Good Clinical Practice, the Health Insurance Portability and Accountability Act (HIPPA), and Biomedical Research. The National Institutes of Health (NIH) Conflict of Interest Course must also be completed. For more information, please see the Baptist IRB page.
Patients/Research study participants
What is research?
Research is the best way for us to improve medical care for our patients. By conducting research, we explore treatments and address questions about the ways in which treatments are being conducted, the efficacy of current and proposed medical devices, and the effectiveness and side effects of medications. It is important to see how medical care is different from research. Medical care’s primary aim is to treat our patients to improve their health and well-being using proved and effective treatments. Research, on the other hand, tests new scientific ideas or new treatments. Research is experimental – participation in research may or may not benefit individual participants or patients.
What is a clinical trial?
Clinical trials are scientific studies in which new treatments –drugs, diagnostic or medical procedures, and other therapies – are tested to determine if they are safe and effective for use with patients. In most trials, participants receive either the best available care or a new treatment that is hoped to be better. These trials help scientists answer questions about new therapies or devices, including what diseases they should be used for, what doses are most effective, and which patients can benefit most.
All disease therapies in use today were tested and made available through the participation of hundreds of thousands of patients on clinical trials.
By law, marketing of a new drug or device cannot begin until clinical trials are conducted. All clinical trials are regulated by the FDA (Food and Drug Administration), and FDA approval is needed before any clinical trial begins.
What are the phases of a clinical trial?
Phase I trials assess the safety of a drug or device. During this type of study, the effects of the drug or device on humans is observed. Investigators also increase dosage levels and note side effects.
Phase II trials, usually fairly small, provide information about how well a new therapy works and generate information about patient safety. These studies usually focus on a specific disease or condition.
Phase III trials compare new treatments with standard ones to determine which is safer and more effective. These trials generally involve a large number of patients and often take place at several health centers all over the nation at the same time. Patients receive either the new therapy or a standard one.
Phase IV trials further evaluate the long-term effects of new FDA-approved drugs.
What is a randomized trial?
A Randomized research study compares two or more treatments or procedures. As a study participant, being randomized means that you will be assigned to a study group that receives one of the interventions by chance. In these randomized trials, one of these interventions is a control. The control may be a standard medical care, a placebo ("sugar pill"), or no intervention at all.
What is a placebo or a placebo-controlled study?
A placebo-controlled research study compares a new treatment with a placebo. Also known as a “sugar pill,” a placebo is an inactive drug or treatment that is designed to have no real effect. By using a placebo, investigators have a “control group” (those patients who receive the placebo) to compare to the group of patients who receive the actual treatment. This allows more accurate evaluation of the effects of the new treatment.
What is a registry?
A registry is a database composed of information and/or tissues obtained from patients. These registries may also be called "banks”. Registries are used for the purpose of collecting as much information as possible about a particular illness or a group of people. Some registries are very large and may include family members of people with specific illnesses. If you consent or agree to participate in a registry, it could be as simple as allowing a research study to collect tissues or blood that would normally be thrown away after surgery; or a registry could be designed to collect blood, tissue specimens, and information from your medical records for many years. A registry could have information on 100 people or it could have information on 10,000 people. It is from registries and banks that many researchers develop new ideas for new research studies.
What is a protocol?
Every research study must have a protocol. A protocol is a document which outlines and explains the procedures and rules the research team will follow while conducting the study. A few questions answered in the protocol follow:
- Why is it important to study this research question?
- What is the study timeline?
- What are the possible risks and benefits of this research?
- Who are the investigators, co-investigators, and other personnel involved in the study?
- What methods will be used to analyze the data?
Who monitors the conduct of protocols?
Many different teams of people, including sponsors, investigators, nurses, statisticians, and regulatory bodies, closely monitor the progress of a research study. If any of these have a concern about how the study is being conducted, the study is stopped and investigated. Before a study is even begun, an Institutional Review Board (IRB) reviews every detail of a proposed research study to protect the people who will take part in the study.
How can I participate in a clinical trial?
Each research study is different and addresses very specific questions. By law, researchers follow strict rules when choosing research subjects. Even if you have the disease or condition being studied, other factors not related to that condition, such as age, medications you are taking, and other health issues may prevent you from qualifying to participate in a study.
There are several ways you can learn about a study which is recruiting patients. Your doctor may ask if you are interested in a study. You can also look for studies through websites or support groups.
It is important to note that you must first agree to take part in a research study … your doctor will not include you in research without your knowledge. You can also agree to take place in a study at first, but you always have the option to drop out of the study. You are always welcome to ask questions about participating to your doctor, or to another doctor who is not part of the research team.
What is informed consent?
Informed consent is a process that helps you learn about the research study. It describes the purpose, procedures, benefits, risks, discomforts and precautions of the study. It also describes the alternative treatments/procedures that are available to you and your rights to withdraw from the study at any time.
You will have ample time to make your decision – ask the research team questions about the study, talk it over with your doctor, and make sure you are comfortable with all aspects of the study. If you decide to participate, you will sign an "informed consent form." The informed consent process continues throughout the study – you can withdraw participation at any time, and researchers are required to share any new information learned with you.
Finally, the study informed consent form will describe any costs to you in detail. Make sure that you understand everything about your participation in the study, including any costs, before you sign the consent form.
What are my rights as a research participant?
It is your right to refuse to take place in research. It is your right to drop out of a study at any time. It is your right to be kept up-to-date when new information is learned. It is your right to ask questions and have them answered respectfully and quickly.
It is your responsibility to stay informed while you participant in a study, and to ask questions and express concerns about anything you don’t understand. Most importantly, you keep all of your legal rights during the entire research trial.
What should I consider before agreeing to participate?
There are several reasons people choose to take part in research studies. By participating in a study, you may benefit from a new treatment that you would not have access to otherwise. Clinical trials are how medical science advances; by taking place, you would be helping researchers improve treatments for the future.
Some reasons why you might not take part in a study are that the experimental treatment might not work for you or have unexpected side effects, your health insurance might not pay for research procedures, and you may not have time or transportation to travel to the research office and back multiple times.
When deciding whether to participate, always ask questions if anything is unclear to you, and always make sure you are comfortable with the answers you are given.
Will it cost me anything to take part in a research study?
In some cases, taking part will not cost you (or your insurance company) anything. In other studies, the research team may bill your insurance company for drugs, devices, and services they provide.
The study may include tests and procedures that are conducted for the research study only, as well as tests and procedures that are conducted as part of your routine medical care (meaning you would receive this care whether or not you are in the research study). The study Sponsor may pay for some tests and procedures, but not all. Your insurance company may deny charges they determine are related to the research study, making you responsible to pay. There is never a guarantee that you won’t have some financial responsibility for costs relating to a research study.
Investigators are required to discuss any costs to you in detail in the informed consent form. Make sure that all of the information in the consent form, including details about costs, is clear to you, and if not, ask the research team to explain.
How am I protected from injury in a study or a trial?
The main purpose of the informed consent process is to give you the information you need to decide whether or not to participate in a study or trial. This process protects you from injury by informing you honestly about any potential risks. The informed consent form will also tell you how to inform the investigator if you have any problems or concerns. You should always feel comfortable speaking to any member of the research team if you have questions or issues at any point in the study.
Do research participants get paid?
Occasionally, participants are compensated for their participation in a trial. Rarely is this payment enough to encourage participation for profit. Usually, if a patient is paid at all, it is an amount that will cover expenses resulting from participation in the trial, such as reimbursement for parking fees and meals. Some studies do not offer compensation at all. If you have questions, be sure to ask the research team during the informed consent process.
What happens when the study is over?
Researchers will analyze the data collected from all participants. Findings may be presented at scientific meetings and published in medical journals. Data is also shared with governmental agencies that approve new drugs, treatments and devices. Specific details about your case will never be discussed in a way that identifies you as a participant. The new treatment may receive final FDA approval, or it may be determined that the new treatment is not an improvement over current treatments, or that further research is needed.
What is HIPAA?
The Health Insurance Portability and Accountability Act (HIPPA) of 1996 established the “Privacy Rule” to protect patients’ personal health information. This Federal regulation ensures that your medical and health information is protected and not shared with others without your permission.
How does HIPAA apply to research?
Sometimes, a research team may need to create new health data about you or review your medical records during the study. HIPPA makes sure that the researcher asks for your authorization to access your personal health information before he or she does so. During the informed consent process, you should be advised of what type of health information will be created or viewed, and you should ask any questions if anything is unclear.
Have a question about the BCRI or about clinical trials that was not covered here?
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