For several years, global biotech CSL has taken a leading role in educating communities about medical research trials with a goal of increasing participation, especially among diverse populations.
We know diversity matters in clinical trials. In fact, we created a video to explain why it’s so important. As a company that’s driven by its promise to patients, we’re committed to energetically researching new potential treatments that can improve the lives of patients who live with rare and serious diseases.
On November 3, CSL is partnering with CliniSpan Health in North Carolina to offer a Community Health Summit in the Raleigh-Durham area.
REGISTER TO ATTEND THIS FREE EVENT
Speakers will include Veronica Suarez, Executive Director of CSL R&D Portfolio and Program Management.
We know people often have questions about how clinical trials work. Here are three Q&As about modern research and how it’s now designed to empower participants and give them control over the process.
Some people say being in a medical research trials is like being a guinea pig. Is that true?
Clinical trials are part of a long, careful process, which may take many years to complete. Before people get involved, researchers do a lot of work to learn more about potential treatments. By the time drugs or potential treatments move into the clinical research process where their effectiveness and safety are evaluated in people, they’ve already been tested by doctors in the lab and studied in animals. The U.S. Food and Drug Administration, as well as an Institutional Review Board, must approve the study’s outline and design. This review is designed to protect research participants by weighing potential benefits against possible risks.
What has changed since the Tuskegee Institute’s ethical abuses that lasted for decades? Is it risky for minority patients to participate in clinical research?
Past ethical abuses made many people skeptical about participating in clinical research. In the United States, the Tuskegee Institute violated the rights of and mistreated minority research participants from 1932 – 1972. But a lot has changed since then. Nowadays, research institutions must follow strict rules to protect and safeguard the rights of all study participants. For example, they must provide information about the clinical study and set expectations of any risks prior to anyone’s agreement to participate. This part of the process is called informed consent. Additionally, study participants have the right to leave a clinical study at any time for any reason.
If I participate in a clinical study, will my personal health data be shared without my consent?
All clinical researchers are required under the Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration to follow a set of national standards to protect personal health information of study participants. This congressional mandate is called the Health Insurance Portability and Accountability Act (HIPAA), and it keeps a study participant’s identifiable health information private and unable to be shared without consent. This includes information on a study participant’s medical chart, any test results and potential billing information for medical services.
Sometimes researchers may wish to use lab results or genetic data in the future to answer additional questions in the follow-up phase; however, they cannot use these results without consent from the study participant. If you are considering participating in a trial, information about how your data will be protected will be shared during the informed consent phase of the process.
