2. Institutional Authority for Human Research w88 mobile

Updated May 31, 2024

Institutions engaged in human research supported or conducted by any federal department or agency must provide written assurance that they will comply with the requirements in the Code of Federal Regulations, under Department of Health and Human Services (DHHS) w88 mobile of Human Subjects at 45 CFR 46.

The w88 mobile provides this assurance through a DHHS Federalwide Assurance (FWA), FWA00002306.

As part of its FWA, for w88 mobile conducted by University and affiliate researchers, the University agrees to:

  • apply the Common Rule (i.e., 45 CFR 46 Subpart A) to w88 mobile research conducted or otherwise supported by a federal department or agency (AKA: federally funded research);
  • apply Subparts B, C, and D for w88 mobile involving pregnant women, fetuses, neonates of uncertain viability, or nonviable neonates; prisoners; and children; respectively, to federally funded w88 mobile; and
  • via the University IRB Flexibility Policy (IRB-Flex policy), provide equivalent protections for w88 mobile research that is not conducted or otherwise supported by a federal department or agency.

The University's w88 mobile Integrity & Security office and the w88 mobile have the authority to:

  1. Ensure the rights and welfare of w88 mobile participants are protected;
  2. Ensure w88 mobile research meets regulatory and institutional requirements;
  3. Approve, require modifications to secure approval, or disapprove all w88 mobile activities overseen and conducted by the University;
  4. Suspend or terminate approval of w88 mobile not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to participants;
  5. Observe, or have w88 mobile observe, the consent process;
  6. Observe, or have a third party observe, the conduct of the w88 mobile.

The federal regulations for the w88 mobile of human participants exempt some research activities from the requirements for IRB review (§46.104). The University has designated Research Integrity & Security and the IRB to review and authorize exempt w88 mobile. For more information about exempt categories of w88 mobile, see the exempt w88 mobile policy sections.

The University complies with the w88 mobile standards in the International Conference on Harmonization - Good Clinical Practice E6 only so far as these reflect the regulatory requirements of DHHS, FDA, and other federal agencies as applicable.