Investigational Review Boards

Human Investigation Review Board Infection Control Patient Safety and Quality Pharmacy and Therapeutics... 

All investigational sites must obtain approval from their investigational review board (IRB) to conduct their portion of the trial. 

Protocols. These give the details of the types of studies that will be conducted, in which subject population, for how long, with what variables. The protocols also list the qualifications of the investigators and subinvestigators and the name and address of the investigational review board. 

Sec. 312.50 General responsibibties of sponsors Protection of Human Subjects Financial Disclosure by Clinical Investigators Institutional Review Boards (IRBs)... 

Unlike human trials. Institutional Review Boards/Independent Ethics Committees are not involved, while informed consent is only required from the owner of the trial animals. In addition to the standard items associated with human trials, aspects such as management and housing of animals, diet and disposal of trial animals and their produce should be included in the trial protocol. Studies may be blinded from the investigators in order to avoid bias in the reporting of animal observations. 

While there is no FDA involvement in such investigations, ethical considerations and institutional regulations would generally dictate that informed consent and the approval of the local institutional review board be obtained. However, due to the negligible risks involved these are likely to be a formality and will not involve extensive review or scrutiny. 

A list of names and address of chairpersons of Institutional Review Boards (IRBs) that have been asked to review the investigation... 

US Department of Health and Human Services. Food and Drug Administration. Guidance for institutional review boards and clinical investigators, 1998 update. http //www.fda.gov/oc/ohrt/irbs/faqs.html... 

After completing preclinical testing, a company files an Investigational New Drug (IND) application with the regulators (the FDA in the U.S.), so that clinical studies in man can begin. The IND shows results of all experiments to this point, a detailed proposal for the clinical study, the expected mode of action for the drug, and any side effects observed. All clinical trials will also be reviewed and approved by the Institutional Review Board (IRB) at the clinic where the trials will be run. 

Requirements of an Investigator for Institutional Review Board Research Approval... 

After 1962, still more rules were adopted to insure ironclad control from the top. The Surgeon General and Chief of the Chemical Corps were added to the decisionmaking hierarchy. Committees and Review Boards replaced individual reviewers. The Army Investigational Drug Review Board provides an insfructive example. 

The Human Use Review Office was charged with administering and coordinating activities of the Army Investigational Drug Review Board, the U.S. 

Army Medical Research and Development Command Contract Review Board and the Surgeon General s Human Use Committee and Clinical Investigation Committee, to insure uniform application of ethical standards for human research studies conducted within or sponsored by the Army Medical Department and other Army Agencies. 

Weapons, Lieutenant General Taylor reported Furthermore, the review mechanisms applied to Edgewood have been tightened over the last two years so that protocols are reviewed by the Army Investigational Dmg Review Board and Human Subjects Research Review Board and relevant Department of Defense and Food and Dmg Administration regulations are followed. ... 

Apart from a few minor differences, the FDA has adopted the ICH GCP guidelines. The contents of the FDA Code of Regulations with reference to the protection of human subjects, institutional review boards and investigational... 

Pood and Drug Administration (PDA). Recruiting study subjects. In Guidance for Institutional Review Boards and Clinical Investigators Section in Information Sheets. Rockville, MD Office of the Associated Commissioner for Health Affairs, 1998 (update)... 

The major problem for control based on material states, however, is the quality control culture that requires that parts be accepted based on adherence to a preset cycle within specified limits. Because state-based inferential control systems could theoretically come up with a new cure cycle every time, this sort of specification cannot be used with such systems. Specifications instead have to be in terms of the process plan used for the cure. The satisfactory completion of a certain cure history without alarm states would be assumed to produce an acceptable part. Once the culture was able to accept that difference for autoclave curing, production costs at the U.S. air force s McClellan AFB Logistic Center were substantially reduced [32], This type of specification could also give material review boards a head start on investigations because they would know that a part did not meet specification as well as what sorts of flaws might result from the deviation. The experience at McClellan is that there are fewer parts to review. It is even conceivable that, with improvements to sensors, much of the current postcure nondestructive evaluation used to verily the quality of parts could be incorporated into the process, building quality in rather than inspecting it in after the fact. 

Drug (IND) must be filed with the FDA (Figure 5-1). The IND includes (1) information on the composition and source of the drug, (2) chemical and manufacturing information, (3) all data from animal studies, (4) proposed clinical plans and protocols, (5) the names and credentials of physicians who will conduct the clinical trials, and (6) a compilation of the key data relevant to study the drug in man made available to investigators and their institutional review boards. 

The Food and Drug Administration relies on data that sponsors submit to decide whether a drug should be approved. To protect the rights and welfare of people in clinical trials, and to verily the quality and integrity of data submitted, the FDA s Division of Scientific Investigations (DSI) conducts inspections of clinical investigators study sites. DSI also reviews the records of institutional review boards to be sure they are fulfilling their role in patient protection. 

---