Institutional review board is a committee established for protecting the rights and welfare of (subjects)humans who participate in research activities according to federal regulations.
The major role of IRB is to follow the policy for protecting and ensure the rights of the human subjects who are used in research. It has the full authority to approve, regulate and disapprove any research activity involving human subjects.
The key responsibilities of IRB include:
Expertise: For performing review activities each committee will have the appropriate proficiency which is necessary to review the specific research activities come for approval.The committee should have knowledge about the subject populations involved in research along with risk benefit ratio of the subjects and their consents. They also should verify the consent document and check its truthfulness & acceptability to provide full protection to human subjects in research.
Communication: The IRB will provide the researcher and his institution with written document about the approval or disapproval and the reasons for approval or reasons for disapproval. They also provide room for the researcher to provide his point of view by writing or in person.
Criteria for approval: IRB will determine whether the policies and rules are satisfied by aproving the research activity
Convened meetings: IRB conducts meetings regularly and also during presence of majority of the members. It conducts polls , and the majority votes decide whether the appropriate level of research can continue or any changes should be included in research program. This meetings often are conducted via audio or video conferences .
Review: Reviews are conducted by IRB even in between research activity to assure the protection of the human subjects.
Minutes of meeting: The meetings conducted should be reviewed and summarised . Name of the attendees , the decision taken, affiliation, capacity of members, risk benefit ratio, significant / non significant risks , key information discussed, the opinions of all members, attendance , waiver of consent for particular population should be noted .
HIPAA privacy review: IRB is accountable for following the HIPAA privacy review. Accordingly IRB should review individual authorization forms for use and donot disclose the protected health information of subjects.
Monitoring and record keeping : IRB documents and safeguard the welfare of the human subjects going to be used in research activity. The research study is monitored and revised according to policy and guidelines of FDA and HIPAA.
Thus these are the major responsibilities of IRB.
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