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People also ask
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Is OHRP part of NIH?
The Office for Human Research Protections (OHRP) is a small office within the United States Department of Health and Human Services (DHHS), specifically the Office of the Assistant Secretary for Health in the Office of the Secretary of DHHS, that deals with ethical oversights in clinical research conducted by the ...
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Who follows the Common Rule?
The Common Rule applies to all federally funded research conducted both intra- and extramurally. The rule directs a research institution to assure the federal government that it will provide and enforce protections for human subjects of research conducted under its auspices.
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What activities are deemed not to be research under the Common Rule?
The definition of “research” has been expanded to list activities that are specifically deemed not to be research, i.e., scholarly or journalistic activities, including oral history, journalism, biography, literary criticism, legal research, and historical scholarship; public health surveillance; criminal justice or ...
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Who does the Common Rule apply to?
The Common Rule applies to certain human subjects research that is supported or conducted by a Common Rule agency. However, not all research is supported by a Common Rule agency.
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What are Common Rule laws?
The main elements of the Common Rule include: Requirements for assuring compliance by research institutions. Requirements for researchers' obtaining, waiving, and documenting informed consent. Requirements for Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping.
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What is the Common Rule in Hipaa?
Subpart A, also known as the Common Rule, provides a robust set of protections for research subjects; subparts B, C, and D provide additional protections for certain populations in research; and subpart E provides requirements for IRB registration. The Common Rule, subpart A, was revised in recent years.
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Is OHRP approved for federalwide assurance?
FWAs also are approved by the OHRP for federalwide use, which means that other federal departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) may rely on the FWA for the research that they conduct or support.
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What is OHRP primarily concerned with?
The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).
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