Safeguards for Clinical Trial Patients

Both standard and clinical trial treatments include risks, side effects, as well as benefits. Strict guidelines are in place to protect the rights and welfare of patients participating in clinical trials. Governmental agencies such as the Office of Human Research Protections (OHRP) and the FDA provide safety oversight of clinical trials.

Institutional Review Board
Prior to opening most research trials, an Institutional Review Board (IRB) must approve the conduct of research. Institutional Review Boards consists of experts such as scientists, doctors, non-scientists, and community members. The IRB members review the trial to ensure it is designed to minimize risks as much as possible, and that these risks are reasonable when compared to the possible benefits of the research. Members also evaluate if research treatment is at least as good as, or even better than, the current standard of treatment. Patient consent forms (consent to enroll in trial) are also reviewed for accuracy, completeness, and ease of understanding. Once approved, the IRB continues to monitor the ongoing research.

Principal Investigator
In addition to IRB oversight, each trial is assigned a Principal Investigator (PI). The PI, usually a physician, is ultimately responsible for all research activities related to the trial. He and his research staff work closely to ensure safety and compliance with guidelines.

Sponsor
All research has a Sponsor. The Sponsor may be a government agency like the National Institutions of Health (NIH), a University or Medical College, an individual person, or a pharmaceutical company. The PI and the Sponsor work closely together to ensure research is conducted within guidelines while continuing to monitor for safety and benefit to the patient.

HIPPA
To protect your privacy, information collected during a study will be confidential. Only those directly involved with the conduct of the study will have access to your medical records. The Sponsor (or Sponsor’s representatives), designated representatives from the IRB, the FDA, or other drug regulatory authorities may review information from the study that contains your identity. Any such review will be confidential and will not be made publicly available. For data collection, you will be identified by a unique Subject number and your identity will not be revealed except for the purposes described above, in the event of a medical emergency, or if required by law.