IRB Role In Biomedical Research

1.
An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB) formally designated to approve, monitor, and review human involved biomedical and behavior research. They frequently conduct some form of risk benefit analysis in an effort to determine whether or not research should be done. By reviewing research protocols and related materials IRBs is to protecting human from physical or psychological harm. In the United States, the Food and Drug Administration (FDA) and Department of Health and Human Services (specifically Office for Human Research Protections) regulations have authorized IRBs to approve or modifications in planned research prior to approval,

or disapprove research. IRBs are responsible for critical oversight functions for research conducted on human subjects that are "scientific," "ethical," and "regulatory."
a.

Yes, IRB role in clinical trial is mandatory as per 21 CFR 56.106.In the regulations (21 CFR 56.102(g)), an IRB is defined as “any board, committee or other group formally designated by an institution to review, approve the initiation of and conduct periodic review of biomedical research involving human subjects. The primary purpose of such review is to assure the protection of the rights and welfare of the human subjects. An IRB is a committee that formally reviews and approves a trial before it can start with the primary goal of protecting human subjects of research. The regulatory responsibilities of IRBs are found primarily in 21 CFR 56 (Institutional Review Boards as per following:
• Follow regulations regarding IRB organization and personnel.
• Follow written procedures for conducting initial trial and continuing review of research and reporting those findings to the investigator, giving priority to the project review first and more often, ensuring that no changed have been made before approved by IRB except where necessary to eliminate apparent immediate hazards to human subjects.
• Notify investigators in writing of its decision to approve or disapprove the proposed research, or of any modifications required to secure

approval.
http://www.centerwatch.com/pdfs/s11604_ch4.pdf
b.
(21 CFR 56.102(g)), (45 CFR 46.115(b).
Reference:
Institute of Medicine (US) Committee on the Role of Institutional Review Boards in Health Services Research Data Privacy Protection. Protecting Data Privacy in Health Services Research. Washington (DC): National Academies Press (US); 2000. 4, Best Practices for IRB or Other Review Board Oversight of Health Services Research Not Necessarily Subject to Federal Regulations. Available from: http://www.ncbi.nlm.nih.gov/books/NBK222806/
3.
A record is any information preserved in a fixed medium, whether on paper, electronically or other format.

The IRB Office is responsible for maintaining records related to the functions and activities of the IRB. The IRB Office maintains a database of IRB committee members identified by name; earned degree(s); indications of experience such as board certifications, licenses, etc. [Federal Policy §___.103].
In accordance with the Common Rule and FDA regulations (45 CFR 46.115(b) and 21 CFR 56.115(b)), IRB records are retained for at least three years after the completion of the research, either electronically or as hard copy. In accordance with federal HIPAA privacy regulations, IRB records containing protected health information (PHI) are retained for at least six years after the completion of the research. Other documents, such as meeting agendas and agenda lists and meeting minutes and minute’s lists for the current IRB year are maintained in the office of the IRB Manager. In addition to the written IRB procedures and membership lists required by the Assurance process such documentation must include copies of all research proposals reviewed, minutes of IRB meetings, records of continuing review activities, copies of all correspondence between the IRB and investigators, and statements of significant new findings provided to subjects (as required by Federal Policy §___.116(b)(5)). Actions taken by the IRB; the vote on actions taken (including the number of members voting for,

against, and abstaining); the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution [Federal Policy §___.115 (a) (2)]. All records must be accessible for inspection and copying by authorized representatives of the department or agency supporting or conducting the research at reasonable times and in a reasonable manner [Federal Policy §___.115 (b)].
IRB protocol records include protocol submissions, approved protocol documents (e.g., protocol application, recruitment materials, assessment instruments, and consent forms); all relevant correspondence between the IRB and investigators; and documentation of IRB review (e.g., reviewer checklists, file notes).