- All research projects must be approved before investigators may begin any aspect of their project.
- All UM-Flint research projects must be submitted through an electronic software program known as the eResearch Regulatory Management System (http://www.eresearch.umich.edu/).
- All research in which a UM-Flint faculty or staff member or student or other trainee is the principal investigator and all research using UM-Flint facilities or private information should be reviewed and, if approved, monitored, by IRB-Flint.
- Occasionally, given the nature of the research or location of subject recruitment, a project may require review by a University of Michigan IRB other than IRB-Flint. Investigators who believe this situation may apply to their project must contact IRB-Flint before submitting an application.
AAHRPP Reaccredititation is currently underway
Changes to Federal Regulations are Proposed
On September 8, 2015, a Notice of Proposed Rule Making (NPRM) entitled “Human Subjects Research Protections: Enhancing Protection for Research Subjects and Reducing Bur-den, Delay, and Ambiguity for Investigators” was published by the Office of Human Research Protections (OHRP) in the Federal Register https://www.federalregister.gov/articles/2015/09/08/2015-21756/federal-policy-for-the-protection-of-human-subjects
The NPRM is the next step in a process initiated by the Advance Notice of Proposed Rule Making, which was published in 2011. Public comment is sought on the proposed changes, the most significant of which pertain to informed consent requirements for future use of bio-specimens and personally identifiable data, as well as calibration of IRB review so that it is proportional to the potential risks associated with a study. If implemented, some studies that currently require IRB review would become exempt and others considered exempt would become “excluded”, or not regulated, and therefore would not require IRB review.
The Office for Human Research Protections has developed six short webinars help the public better understand the proposals.
6 Topics Covered:
Overview of the NPRM
Exclusions and Exemptions
IRB Review and Operations
Research with Biospecimens
Secondary Research Use of Data
To WATCH NOW, go to: http://www.hhs.gov/ohrp/education/training/nprmwebinars.html
The OHRP summary of the proposed Common Rule revisions can be found at http://www.hhs.gov/ohrp/humansubjects/regulations/nprm2015summary.html
OHRP will accept public comments on the NPRM until December 7, 2015. Researchers are encouraged to submit their comments.
Exemption #2a expands the definition of federal Exemption #2 to minimal risk research with adults that involves a non-invasive intervention followed by data collection via survey, interview (including focus groups) or observation.