Office of Human Research Protections definition

Office of Human Research Protections. (OHRP) means the HHS office that oversees protection of human subjects from research risks under 45 C.F.R. Part 46 (the Common Rule).
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Office of Human Research Protections means the HHS office that oversees protection of human subjects from research risks under 45 C.F.R. Part 46 (the Common Rule).
Sample 1Sample 2

Examples of Office of Human Research Protections in a sentence

  • For more information about reporting requirements, refer to the U.S. Department of Health and Human Services’ Office of Human Research Protections website at http://www.hhs.gov/ohrp/.

  • Funds awarded to any subcontractor, subrecipient or recipient by the Department of Health and Human Services shall not be expended for research involving human subjects, and individuals shall not be enrolled in such research without an assurance by the Office of Human Research Protections http://www.hhs.gov/ohrp/about/index.html ) that the studies comply with the requirements of 45 CFR Part 46 to protect Human Research subjects.

  • Researchers must use an IRB that has been registered with the United States Department of Health and Human Services Office of Human Research Protections.

  • The Office of Human Research Protections (OHRP) recognizes that any adverse event in a trial is a potentially important occurrence because it may reflect additional risks to subjects.

  • Report non-compliance with federal regulations to the DHHS Office of Human Research Protections [OHRP].

  • If research involving human subjects is anticipated, you must hold a Federal Wide Assurance (FWA) of compliance from the Office of Human Research Protections (OHRP) prior to award.

  • The knowledge of any pending compliance inspection/visit by the FDA, DHHS Office of Human Research Protections (OHRP), or other government agency concerning this research, the issuance of Inspection Reports, FDA Form 483, warning letters or actions taken by any regulatory agencies including legal or medical actions and any instances of serious or continuing noncompliance with the regulations or requirements, must be promptly reported to the HRPO.

  • Noncompliance with respect to human research participant protection violates the LSUHSC-Shreveport Federalwide Assurance Registration (FWA) with the Office of Human Research Protections (OHRP).

  • A Federalwide Assurance (FWA) is an assurance approved for Federalwide use by the Office of Human Research Protections (OHRP) in accordance with Section 103(a) of the Common Rule (see 38 CFR 16.103(a)).

  • To others who are required by law to review the quality and safety of the research, including: U.S. government agencies, such as the Food and Drug Administration or the Office of Human Research Protections, the research sponsor or the sponsor’s representatives including but not limited to the contract research organization (CRO), or government agencies in other countries.

Related to Office of Human Research Protections

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