On January 21, 2019 the Final Rule to update the current regulations at 45 CFR 46, Subpart A - "Federal Policy for the Protection of Human Subjects" (the Common Rule) will be effective.
Substantive revisions were made to the regulations to “modernize, strengthen, and make more effective” (HHS 2017) the current system of oversight that has been the federal Common Rule since 1991. The revisions are intended to:
- Better protect human subjects involved in research
- Facilitate research
- Remove ambiguity
- Reduce regulatory burden
Impact on Researchers
- Increased number of research categories approved under Exempt review
- Continuing review no longer necessary for most non-exempt research activities
- New Consent Process requirements
The RIT review process will continue as it is currently with some modifications to existing forms and some researchers may be required to submit additional information. The updated HSRO website will be online January 21, 2019 and the HSRO will assist researchers with the transition during the next few months.
To get started please go to “Submitting your Proposal”. You will find general information about submitting human subjects research activities as well as criteria for approval and guidance for conducting your research.
To submit your research activity for review:
- Send an electronic version of the Form A and all supporting materials to firstname.lastname@example.org AND,
- Provide a signed hard copy of the Form A and all supporting materials to the Human Subjects Research Office, located on the 2nd floor of the University Services Center, Suite 2400. Review WILL NOT begin until the signed hard copy is received.
Questions regarding Forms and the status and submission of new and continuing research protocols should be directed to the Human Subjects Research Office at HSRO@rit.edu.
Questions regarding research activities, determining whether an activity requires review by the IRB, and training should be directed to:
Heather Foti, MPH
Office location Bldg 17, Office 3619, Mezzanine level
Ph: (585) 475-7673
Fax: (585) 475-7990
Mailing address: ALL IRB related materials should be sent to (or dropped off at) the HSRO at
Human Subjects Research Office (HSRO) Bldg 87, 2nd Floor Administrative Services Building/Innovation Center, Suite 2400