Human Subjects Protection
Over 40 years ago, the now infamous Tuskegee Syphilis Study became public, leading to the establishment of laws protecting human subjects involved in research. But can something like Tuskegee happen again?
Join us as we have an open forum with UM-Flint’s Institutional Review Board to discuss federal regulations and the precautions taken to protect human subjects. 12:30 – 1:30 pm in the Office of Research, 530 FH. Refreshments will be provided.
A few important reminders regarding Human Subjects Research:
Please visit the Human Subjects Website: http://www.umflint.edu/humansubjects for more information or contact the [email protected]
Please join us in welcoming Mary Mandeville, UM-Flint’s new Research Compliance Specialist. Mary is responsible for assisting the campus community with issues regarding Human Subjects protection. Mary also serves as the campus contact for training and administration of the eResearch Regulatory Management system and will work closely with Marianne McGrath, Ph.D., chair of the Institutional Review Board.
Mary holds an MBA from Eastern Michigan University, a Masters degree from Kansas State University, with undergraduate work at Michigan State and additional certification from The University of Michigan.
Most recently Mary served as Project Director/Program Manager for a federally funded, multi-site nursing research project for the University of Illinois at Chicago & The University of Michigan. Previous to this assignment she was affiliated with the Senate Advisory Committee on University Affairs at the University of Michigan in Ann Arbor.
Welcome to the team Mary!
After more than 8 years with UM-Flint including the last 3 with the Institutional Review Board, Sally Conley, IRB Core Support Staff, has accepted a new position with the Internal Revenue Service. Sally’s last day was Thursday, June 18.
Human subjects research review will continue as usual and any questions should be directed to John Callewaert, [email protected], 810-762-3383. We hope to post the vacancy as soon as possible and have the position filled later this summer.
A new version of eResearch (2.0), the web-based regulatory management system that centralizes the review and approval process for human subjects research applications, is scheduled to go live March 1. Please be advised that due to the upgrade, it is anticipated that the system will be down February 27-March 1.
The new system will be particularly helpful for exempt and not-regulated projects – reducing the number of questions by as many as 60. More information on the new system and training dates will be sent soon.
From The University Record:
The Association for the Accreditation of Human Research Protection Programs has granted full accreditation to U-M, one of 15 institutions to receive the group’s endorsement this year.
The AAHRPP in a non-profit organization that works with universities, hospitals and other institutions that conduct biomedical, behavioral and social sciences research involving human participants. The group accredits institutions that demonstrate they provide participant safeguards beyond the threshold of state and federal requirements.
To date, 107 institutions have earned AAHRPP accreditation. The latest endorsements were announced March 20 in Washington, D.C.
Congratulations to all involved, especially UM-Flint’s IRB!
