JAMIA HAMDARD IRB MEETING REPORT Free essay! Download now
Home > GCSE > Business studies > JAMIA HAMDARD IRB MEETING REPORT
JAMIA HAMDARD IRB MEETING REPORT
You can download this essay for free. All you need to do is register and submit at least one of your essays to us.
Or you can purchase this essay for just $2 instantly without registering
Downloads to date:
| Words: 1155 | Submitted: 31-Mar-2011
92.4% | Number of pages: 6 | Filetype: Word .doc
This is what the first 3 pages of the essay look like
DescriptionJAMIA HAMDARD IRB MEETING REPORT
IRB MEETING REPORT
INSTITUTIONAL REVIEW BOARD (IRB)
An institutional review board (IRB), also known as an independent ethics committee (IEC) or ethical review board (ERB), is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the research subjects. 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 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 are scientific, ethical, and regulatory.
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 ...
Download this essay in full now!
Just upload at one of your essays to our database and instantly download your selection! Registration takes seconds
Comments and reviews
Reviews are written by members who have downloaded the essay
No comments yet. If you download the essay you can review it afterwards.