Institutional Review Board approvals

What Research Requires Institutional Review Board Approval... 

There is a concern that blanket consent (for example, for future testing of tissue samples with genomic or metabonomic assays that are not available at the time of study recruitment) has the potential to result in abuse. It is a highly contentious issue and particularly pertinent to sample collection from children and other susceptible subpopulations. As a result, it has led to increased difficulty in obtaining institutional review board approval for some kinds of biomonitoring studies. 

Institutional review board approval of the consent or revised consents) has not been obtained. 

Bioequivalence studies do not always require the filing of an Investigational New Drug application (IND). An IND is needed always if the generic drug is without an approved innovator in the USA, is radioactive, or is a cytotoxic. However, when single-or multiple-dose studies do not exceed the approved clinical dose sizes, and when there will be retention samples available for inspection, then an IND need not be filed. An IND is needed for a multiple dose bioequivalence study, when a single-dose study has not preceded it. The usual protections for human subjects are required, and, of course, these include an Institutional Review Board approval. 

Special precautions and permissions are required to work with students under die age of 18. Institutional Review Boards must approve their involvement, and the parents of students must sign appropriate permission slips. (Refer to die section of this chapter titled Institutional Review Board Approval for more information.)... 

Section 111-C. Experiments that Require Institutional Biosafety Committee and Institutional Review Board Approvals and NIH/ORDA Registration Before Initiation... 

This section describes six categories of experiments involving recombinant DNA (i) those that require Institutional Biosafety Committee (IBC) approval, RAC review, and NIH Director approval before initiation (see Section III-A), (ii) those that require NIH/ORDA and Institutional Biosafety Committee approval before initiation (see Section III-B), (iii) those that require Institutional Biosafety Committee and Institutional Review Board approvals and NIH/ORDA registration before initiation (see Section III-C), (iv) those that require Institutional Biosafety Committee approval before initiation (see Section IIIl-D), (v) those that require Institutional Biosafety Committee notification simultaneous with initiation (see Section III-E), and (vi) those that are exempt from the NIH Guidelines (see Section III-F). ... 

Before the experiments each subject filled out a questionnaire, which was kept confidential and included patient s identification, age and gender. The tenets of the Declaration of Helsinki were followed the local Institutional Review Board approved the study and informed consent was obtained for all subjects. 

Ten healthy subjects participated in this study. Their ages ranged from 25 to 50 years old (age average and standard deviation 35.6 4.5 years old). Two were females 8 were males, 7 were Asians and 3 were Caucasians. All of them were free of any medication and didn t complain of any kinds of muscle pains at the time of the experiments. The tenets of the Declaration of Helsinki were followed the local Institutional Review Board approved the study protocols and experimental procedures. Also, informed consent was obtained for all subjects. Before the experiment each subject filled out a questionnaire, which was kept confidential and included patient s identification, age, ethnicity and gender. 

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 approval / favourable opinion of Institutional Review Board / Independent Ethics Committee of amendments... 

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. 

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. 

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. 

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

The protocol should be approved by an independent ethics committee/institutional review board prior to study start... 

A general rule is that if the intent of the activity is to contribute to the general knowledge base (e.g., large number of subjects, systematic data collection, intent to publish), the entire proposal should be submitted in writing and reviewed by the local institutional review board (IRB). These entities are committees formally designated by a research institution to review, approve, and monitor research on human subjects ( 25). 

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