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Institutional Review Board (IRB)

The Institutional Review Board is a board, committee or other group formally designated by an institution to review, to approve the initiation of, and to conduct continuing review of biomedical research involving the participation of human subjects in accordance with Food and Drug Administration (FDA) and Office of Human Research Protection (OHRP) regulations.

The Institutional Review Board of Rex Healthcare was established by the Medical Staff Executive Committee to oversee the participation of human subjects involved in research studies and the IRB is charged to protect the rights and welfare of these subjects.

Through this process the IRB ensures the following:

  • Safeguards are provided to protect the rights and welfare of subjects
  • Risks to the subjects do not outweigh benefits or knowledge gained through the study
  • Selection of subjects is fair and equitable
  • Each subject gives informed consent prior to participation according to the regulations governing human subject research
  • Adequate evaluation of the data occurs to ensure the ongoing safety of subjects
  • Provisions are in place to protect the privacy of subjects and confidentiality of data collected

Research that involves the participation of human subjects cannot commence until it has been reviewed and approved by the IRB.

The IRB Administrative Coordinator will try to provide any additional information that you may request. Please feel free to call (919) 784-2237 or contact us through e-mail at IRB@rexhealth.com.

Resources

Rex Healthcare and its affiliated physicians are dedicated to providing the best in health services by bringing together compassionate care and leading edge technology. Through clinical trials, we can actively contribute to improvements made in medical science.

A clinical trial is a test or study of a drug or medical device in people. These tests are done to see if the product is safe and effective for use. Doctors and other health professionals run tests according to strict rules set by the Food and Drug Administration (FDA). The FDA sets these rules to make sure the participants who agree to be in the studies are treated as safely as possible.

Current medical therapies and technologies are constantly being evaluated for areas of improvement. These potential advances in medical science are dependent on clinical trials. The results from clinical trials provide vital information towards determining whether the new advances are safe and effective prior to being placed on the market. Feedback received from the participants who volunteer is crucial to understanding how the therapy works in people of different ages, races and genders.

Both Oncology and Heart & Vascular diagnostic trials are underway at Rex Healthcare:

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