Clinical Trials

Clinical trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available.

Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study has its own rules about who can take part. Some studies need volunteers with a certain disease. Some need healthy people. Others want just men or just women.

An Institutional Review Board (IRB) reviews, monitors and approves many clinical trials. It is an independent committee of physicians, statisticians and members of the community. Its role is to make sure that the study is ethical, protect the rights and welfare of the participants and make sure that the risks are reasonable when compared to the potential benefits

In the United States, a clinical trial must have an IRB if it is studying a drug, biological product, or medical device that the Food and Drug Administration (FDA) regulates, or it is funded or carried out by the federal government.

Research Oversight at North Mississippi Health Services

Research at North Mississippi Health Services (NMHS) is overseen by a group called an Institutional Review Board.

An Institutional Review Board (IRB) is a group formally designated by an institution to review and monitor research involving humans as subjects.

NMHS has an IRB that meets monthly. The NMHS IRB members include doctors, nurses, pharmacists, social workers, a lawyer, risk manager, and community members. This group reviews the science and ethics of the research. Their objective is to assess the risks and benefits to subjects involved in the study.

The NMHS IRB has the authority to approve, require modification to, or disapprove all research activities that involve an NMHS investigator, facility, or patient group. Following initial approval, the IRB conducts periodic reviews of such research.

In most instances, in order to approve research, an IRB must determine that specified criteria have been satisfied. Among these criteria, an IRB must determine that, when appropriate, the research protocol includes "adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data."

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