Institutional Review Board

Under US regulations, each institution conducting research with human subjects must have its own IRB. These perform the same functions as the Independent Ethics Committees in Europe, and should contain at least five members, one of which should be independent of the institution. There should be available a mixture of scientific and non-scientific expertise capable of assessing research proposals from legal, ethical and scientific perspectives. The IRB must grant written authorisation to the investigator before a study can commence. They are also responsible for on-going reviews of research, and must report to the FDA  

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

Form ApproveO OMB Ns. DSIO-OOIA. Expiration Dale May31, 2009 See OMB Stateineni an fievefse. 

NOTE No dfug may be shipped or clinical investigaiion begun until an IND for that invastigalion is in elfect (21 CFR 312.40). 

LIST NUMBERS OF ALL INVESTIGATIONAL NEW DRUG APPLICATIONS 21 CFR Pan 312), NEW DRUG OR ANTIBIOTIC APPLICATIONS (S CFR Part 3U). DRUG MASTER FILES (2i CFR Pan 314.420A AND PRODUCT LICENSE APPLICATIONS 21 CFR Part 601) REFERRED TO IN THIS APPLICATION. 

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Once the FDA receive the initial submission, an IND reference number is assigned. The application is then passed on to the appropriate review centre either the Center for Drug Evaluation and Research (CDER), or the Center for Biologies Evaluation and Research (CBER). Various experts will then review the submitted documents, the purpose being to ensure that the safety of subjects is not compromised and, in the case of Phase II and III studies, that the quality of study design is scientifically adequate. The FDA are allowed 30 days to complete the initial review, after which the study can commence, provided that it has been approved by an Institutional Review Board (IRB). 

Dated, documented approvai / favourabie opinion of Institutional Review Board / Independent Ethics Committee... 

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... 

Data collected at each participating site must be stored in a read-only format at that site for future reference. The Institutional Review Board (IRB) at each participating site requires that the site retain its local database after trial closeout. Data retention can be achieved in various ways. However the method should ensure that (1) participating sites are not be able to modify retained data (2) data are presented in a way that allows sites to easily locate any data form for any subject at any trial visit and (3) the site PI is solely responsible for the retained data. 

When conducting a clinical trial, the well-being of the study subjects is primary. Subjects must be treated fairly and with respect. The two primary methods of ensuring fair treatment of study subjects are review of the study protocol by an Institutional Review Board (IRB) or Ethics Committee and... 

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... 

K Dickersin, YI Min, CL Meinert. Factors influencing publication of research results. Follow-up of applications submitted to two institutional review boards. JAMA 267 374-378, 1992. 

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. 

DNA array-CGFI data were provided by Sandy DeVries at Dr. Fredric Waldman s Lab at UCSF. RNA extraction experiments were technically performed by Cheng Liu and Kelly Smith. Both studies were supported by NUT grant 1 R33 CA103455. Use of human tissues has been exempted under 45 CFR 46.101 (b) and was approved by the Institutional Review Board (IRB 009071) at USC. 

IP —inositol-1,4,.5-trisphosphate IRB—institutional review board IV—int r a veno us (ly)... 

Insurance Portability and Accountability Act (HIPAA). Therefore, it is not necessary, under HIPAA, to obtain authorization for their use and disclosure. Nevertheless, institutional review boards (IRBs) may well require additional measures, especially for the prospective collection of new samples and information. In addition, even without individual identifiers, if there are group identifiers, such as race and ethnicity, there is the potential for group-based stigma and other harms (see chapters by Foster and Greely, this volume). 

Institutional conflicts of interest, 24 371 Institutional Review Board (IRB), 16 698 Instrument accuracy, in process control, 20 679... 

Subjects were primarily young female adults, undergraduate and graduate students at the University of Nebraska. All were assumed to be in good health and received medical clearance for participation prior to the start of each study from the University of Nebraska Division of Student Health Services. The project was approved by the University of Nebraska Institutional Review Board Involving the Protection of Human Subjects. 

Focus of the development process for a new pharmaceutical is an essential aspect of success, but is also difficult to maintain. Clinical research units generally desire to pursue as many or as broad claims as possible for a new agent, and frequently also apply pressure for the development of multiple forms for administration by different routes. These forces must be resisted because they vastly increase the work involved in safety assessment, and they may also produce results (in one route) that cloud evaluation [and impede Institutional Review Board (IRB) and regulatory approval] of the route of main interest. 

An Institutional Review Board (IRB) and an Institutional Biosafety Committee (IBC) must approve each gene therapy clinical trial before it can be carried out. An IRB is a committee of scientific and medical advisors and consumers that reviews all research within an institution. An IBC is a group that reviews and approves an institution s potentially hazardous research studies. Multiple levels of evaluation and oversight ensure that safety concerns are a top priority in the planning and carrying out of gene therapy research. 

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