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JAMIA HAMDARD IRB MEETING REPORT Free essay! Download now

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JAMIA HAMDARD IRB MEETING REPORT

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JAMIA HAMDARD IRB MEETING REPORT essay previewJAMIA HAMDARD IRB MEETING REPORT essay previewJAMIA HAMDARD IRB MEETING REPORT essay preview

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JAMIA HAMDARD IRB MEETING REPORT

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JAMIA HAMDARD
IRB MEETING REPORT



INSTITUTIONAL REVIEW BOARD (IRB)

Aninstitutional review board(IRB), also known as anindependent ethics committee(IEC) orethical review board(ERB), is acommitteethat has been formally designated to approve, monitor, and reviewbiomedicalandbehavioralresearchinvolvinghumanswith the aim to protect the rights and welfare of theresearch subjects. In theUnited States, theFood and Drug Administration(FDA) andDepartment of Health and Human Services(specificallyOffice for Human Research Protections) regulations have empowered IRBs to approve, require modifications in planned research prior to approval, or disapprove research. An IRB performs critical oversight functions for research conducted on human subjects that arescientific,ethical, andregulatory.


IRB FUNCTIONS AND OPERATION
In order to fulfill the requirements of these regulations, each IRB shall:
(a) Follow written procedures:
For conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution;
For determining which projects require review more often than annually and which projects need verification from sources other than the investigator that no material changes have occurred since previous IRB review;
For ensuring prompt reporting to the IRB of changes in research activity; and
For ensuring that changes in approved research, during the period for which IRB approval has already been given may not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the human subjects.

(b) Follow written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the Food and Drug Administration of:
(1) Any unanticipated problems involving risks to human subjects or others;
(2) Any instance of serious or continuing noncompliance with these regulations or the requirements or determinations of the IRB; or
(3) Any suspension or termination of IRB approval.

(c) Except when an expedited review procedure is used, review proposed research at convened meetings at which a majority of the members of the IRB are present including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved it shall receive the approval of a majority of those members present at the meeting.

CRITERIA FOR IRB APPROVAL OF RESEARCH
(a) In order to approve research covered by these regulations the IRB shall determine that all of the following requirements are satisfied:
Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge that may be expected to result. In evaluating risks and benefits, the IRB should consider only those ...

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