MD Anderson Cancer Center

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Institutional Review Board

MD Anderson - Orlando maintains an Institutional Review Board (IRB), which reviews all oncology research trials being conducted at MD Anderson- Orlando and Orlando Health. The IRB is a group of voting members including physicians, nurses, pharmacists, clergy, and community volunteers dedicated to ensuring patient safety, patient rights, and ethical and quality research practices.

The IRB is regulated by the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Office for Human Research Protections (OHRP) and the State of Florida to comply with federal regulations 45 CFR 46, 21 CFR 50, FDA guidelines and state of Florida regulations to monitor research conducted under its authority. The MD Anderson Cancer Center Orlando Institutional Review Board is registered with the federal government.

IRB Responsibilities

  • To make sure that investigators are qualified to do the research
  • To determine if a study has scientific value and is ethical
  • To determine that a worthwhile study does not subject people to unnecessary risks
  • To monitor the research team
  • To make changes to a project or stop it if the project is not working as predicted
  • To watch out for any unexpected problems To make sure that participants are protected

Before the Trial - the Approval Process

Before a proposed research study can begin enrolling people, the investigator in charge of the trial must submit a detailed application to the IRB. Often details of the trial have already been reviewed on the national level by the National Institutes of Health (NIH). The IRB carefully reviews the application with patients' best interests in mind to ensure that:

Investigators (physicians or other persons who are in charge of a study or who can enroll patients) are qualified or licensed by the state of Florida, have the needed expertise in oncology, and have completed NIH or other comparable certification in the protection of human subjects.

  • Risks to participants are minimized as much as possible, through sound research design and the use of procedures that are not unnecessarily risky.
  • Risks are reasonable in relation to the anticipated benefits and the importance of the knowledge that may result.
  • Participants will be selected fairly.
  • Investigators will explain the study plus give the participant a written copy of the informed consent form which has been previously reviewed by the IRB.
  • Steps have been taken for monitoring the data collected to ensure the safety of participants as the trial progresses.
  • Steps have been taken to protect the privacy of participants and the confidentiality of data collected during the study.

Based on these factors, the IRB either approves or disapproves the clinical trial. In some cases, the IRB may state certain changes the investigator must make before the study can be approved. Once approved, the IRB must review the progress of the trial at least annually depending on the degree of risk.

During the Trial - the Monitoring Process

Some research studies, particularly National Cancer Institute/National Institutes of Health studies, may involve participants worldwide. Local, national and international reports of participant health problems are reviewed at each monthly IRB meeting. The IRB examines whether the health problems were possibly caused by the treatment or drug. The IRB makes changes to the informed consent form as needed to alert future participants of additional possible health risks. The IRB regularly reviews Data Safety Monitoring Board reports, which are compiled from statistics obtained from the many sites involved in the study. It is the IRB's responsibility to ensure that participants are kept up-to-date on any new information that may impact their decision to remain enrolled in the trial.

Based on a progress report, at least once a year the IRB decides whether or not the project should continue as described in the original research plan. The IRB can decide to suspend or terminate approval of the clinical trial if the investigator is not following set requirements, or if the study appears to be causing unexpected serious harm to participants.

Some research studies, particularly National Cancer Institute/National Institutes of Health studies, may involve participants worldwide. Local, national and international reports of participant health problems are reviewed at each monthly IRB meeting. The IRB examines whether the health problems were possibly caused by the treatment or drug. The IRB makes changes to the informed consent form as needed to alert future participants of additional possible health risks. The IRB regularly reviews Data Safety Monitoring Board reports, which are compiled from statistics obtained from the many sites involved in the study. It is the IRB's responsibility to ensure that participants are kept up-to-date on any new information that may impact their decision to remain enrolled in the trial.

Based on a progress report, at least once a year the IRB decides whether or not the project should continue as described in the original research plan. The IRB can decide to suspend or terminate approval of the clinical trial if the investigator is not following set requirements, or if the study appears to be causing unexpected serious harm to participants.

Quality Assurance Monitoring

The National Cancer Institute (NCI) conducts on-site monitoring/audits, of the procedures, documents, and data pertaining to a trial at a particular institution. Auditors review IRB Policies and Procedures; informed consent requirements; shipping, storage and use of drugs; and individual patient cases. Audits are also done by companies which make new drugs used in some research trials, the FDA if the trial involves new drugs/devices or unapproved uses for these drugs/devices, and the OHRP which reviews patient safety.

Ending the Trial Early - Protecting Patients


In an ideal world, all clinical trials would run exactly as planned from beginning to end. Of course, that is not always the case, and sometimes there are reasons to stop a trial early. If participants are having unexpected and/or severe side effects, or there is clear evidence that the risks are outweighing the benefits, then the IRB has the authority to stop a trial.

MD Anderson - Orlando IRB Contact Information
For questions or further information, contact our IRB coordinator by telephone at 321.843.1412 or 800.648.3800 ext. 31412 or at the following address:

MD Anderson Cancer Center Orlando Institutional Review Board
1400 S. Orange Ave.
Orlando, FL 32806