Research through clinical trials is a scientific and systematic way to look at the outcomes of a particular drug, device or other process to see how well it works, including how safe it is. There's risk in clinical trial treatment as there is in standard therapy. It's important to know that the investigators designing and conducting the research, the institutions where the research may be conducted, the sponsors of the research and the federal government are all interested in minimizing the risks to participants involved in a clinical trial.
Participating in research is a voluntary process, and you need to decide if the risk is acceptable to you or not. Be sure you understand the research and ask as many questions as you can to make an informed choice. Discuss your options with your doctor. Talk over what you have learned with your family, friends and other healthcare providers. Learn as much as you can before you decide to participate.
Contact Cape Cod Healthcare
Our Director of Research Compliance at Cape Cod Healthcare is also able to assist you and can be reached at 508-862-5812.
Contact a Research Nurse
Please contact our specially-trained research nurses to find out what clinical trials may be appropriate for your needs:
Shannon B. Antman, RN, BSN
Clinical Research Nurse, Cape Cod Healthcare
Kelcie Brown, RN, BSN
Research Nurse, Cape Cod Research Institute
CCHC Institutional Review Board
Federal regulations dictate that a group called an Institutional Review Board (IRB) must approve and oversee the research being conducted. The IRB at Cape Cod Healthcare is comprised of physicians, nurses, pharmacists, and community members. The community members are critical to an IRB to review the research from the point of view of the patient. The IRB plays a critical role in safeguarding subjects' rights and welfare during the recruitment process, informed consent process, and the conduct of the trial.
Federal Agencies Involved in Clinical Trials
These federal agencies have the primary responsibility of helping to ensure the rights and welfare of human subjects participating in the clinical research. All are under the auspices of the Department of Health and Human Services (DHHS).
- The Office for Human Research Protections (OHRP): The OHRP ensures the rights and welfare of human subjects and establishes standards for the organizations' review of research through the Institutional Review Board (IRB) process. The OHRP provides guidance and training to help IRBs. Sponsors of trials and physicians must meet the Federal requirements.
- Food and Drug Administration (FDA): The FDA regulates research in the products it oversees. In clinical trials, these products are usually a new drug or new medical device. The FDA requires evidence of drug and product safety in the form of an application process and has rules about reporting of safety issues during clinical trials.
- The Office of Good Clinical Practice: The Office of Good Clinical Practice is part of the FDA. Its mission is to establish consistency in policy. This office is charged with ensuring FDA’s protective role in clinical research, from the design of a trial through how the trial is conducted and overseen.
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