Announcements

UPDATE: Implementation Delayed - Revisions to the Federal Policy for the Protection of Human Subjects

UPDATE: The U.S. Department of Health and Human Services and 15 other federal departments and agencies have announced an Interim Final Rule (IFR) that delays by six months the effective date and general compliance date of the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule) originally published in the Federal Register on January 19, 2017 (82 FR 7149).  Most provisions in the revised Common Rule were scheduled to go into effect on...more


New HRPP Manual Section: Use of a Single IRB

The Final NIH Policy on Use of a Single IRB for Multi-Site Research establishes the expectation that all domestic sites participating in multi-site studies involving non-exempt human subjects research funded by NIH will use a single Institutional Review Board (sIRB) (NOT-OD-16-094). The new HRPP Manual Section, 2-2-F-iii, Use of a Single IRB (U.S. Department of Health and Human Services, National Institutes of Health), provides MSU requirements related to the selection of the sIRB and costs....more


NIH Certificate of Confidentiality

The National Institutes of Health provides a Certificate of Confidentiality automatically to research funded wholly or in part by the NIH for human research, including exempt research studies. As a result, upon award, the study is automatically issued a Certificate of Confidentiality from NIH and the NIH Policy for Issuing Certificates of Confidentiality applies to the study. For more information about Certificates of Confidentiality, please visit the MSU HRPP website: https://hrpp.msu.edu/nih-...more


Revised: HRPP Manual Section 2-4, ICH GCP E6(R2)

The MSU Human Research Protection Program (HRPP) Manual Section 2-4, International Conference on Harmonization Good Clinical Practice E6 (R2), has been revised to incorporate reference to the integrated addendum (R2) to ICH GCP E6. The section has also been simplified, referencing the ICH GCP E6(R2). For the revised HRPP Manual Section, please visit https://hrpp.msu.edu/msu-hrpp-manual-section-2-4...more


Revised Template Consent Form Contact Information

As a result of the new MSU HRPP office location, template consent form contact information has been updated to the following: If you have questions or concerns about your role and rights as a research participant, would like to obtain information or offer input, or would like to register a complaint about this study, you may contact, anonymously if you wish, the Michigan State University’s Human Research Protection Program at 517-355-2180, Fax 517-432-4503, or e-mail irb@msu.edu or regular mail...more


NIH Policy on Single IRB

The Final NIH Policy on Use of a Single IRB for Multi-Site Research establishes the expectation that all domestic sites participating in multi-site studies involving non-exempt human subjects research funded by NIH will use a single Institutional Review Board (sIRB). This policy applies to: NIH-funded Non-exempt human subject research Multi-site where each site will conduct the same protocol Domestic sites Supported through grants, cooperative agreements, contracts, or NIH intramural Research...more


NIH Policy on Clinical Trial-Specific Funding Opportunities

For due dates on or after January 25, 2018, NIH will require that all applications involving one or more clinical trials be submitted through a Funding Opportunity Announcement (FOA) specifically designed for clinical trials. Applications/proposals involving clinical trials with due dates on or after January 25, 2018 must be submitted to an FOA or request for proposal (RFP) that explicitly states it will accept clinical trials. After January 25, 2018, NIH will no longer accept clinical trial...more


March 8 at 12PM - Click Maintenance

On Thursday, March 8 at approximately 12:00 P.M., Click IRB will become unavailable for maintenance. The system may be unavailable for an hour. Individuals will not be able to log into Click IRB until the maintenance is complete. 3/8/2018...more


March 6 at 7PM - Click Scheduled Maintenance

On Tuesday, March 6 at approximately 7:00 P.M., Click IRB will become unavailable for scheduled maintenance. The system may be unavailable for several hours. Individuals will not be able to log into Click IRB until the scheduled maintenance is complete. 2/27/2018...more


SMART IRB

MSU is Now a Participating Institution in SMART IRB! SMART IRB (Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform) is funded by NIH and is designed to harmonize and streamline the IRB review process for multi-site research. It allows institutions to minimize duplicate IRB review while maintaining appropriate oversight and is in line with the Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research. MSU is now a participating...more