Announcements

Revisions to the Federal Policy for the Protection of Human Subjects

In January 2017, final revisions to the Federal Policy for the Protection of Human Subjects were issued by the U.S. Department of Health and Human Services and 15 other federal agencies. Major changes include: New requirements regarding information that must be given to prospective research subjects as part of the informed consent process Allows the use of broad consent (i.e., seeking prospective consent to unspecified future research) from a subject for storage, maintenance, and secondary...more


New HRPP Office Location!

On Thursday, April 27, 2017, the Human Research Protection Program office will move to a new location at 4000 Collins Rd., Lansing, MI. The move is part of a larger relocation of the Office of Regulatory Affairs and its units to Collins Rd. The HRPP office will be closed on Thursday, April 27 during the move. While phone numbers will remain the same, the lines will be transferred during the move and as a result, will be down for some duration on April 27. For emergencies during this time of...more


New GCP Training Requirement for NIH-Funded Clinical Trials

The National Institutes of Health (NIH) “Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials” establishes the expectation that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2). At MSU, such individuals are required to complete either the CITI...more


Revision to HRPP Manual

The MSU Human Research Protection Program (HRPP) Manual Section 9-2, "Noncompliance," has been revised to add a statement that the Principal Investigator is responsible for supervising all research staff and is held accountable for their actions and/or omissions and to revise the definitions of “noncompliance” and “continuing noncompliance” and add a definition of “serious noncompliance." Additional changes include updating "human research liaison" to "HRPP compliance analyst" and updating...more


Register NOW! Viewing Information in KC

The registration for Viewing Information in KC eCourse is now available. This eCourse is suggested for Faculty and Department/College Research Administrators, however it is available to all users. To register please complete the request access to Viewing Information in KC You will be notified via email once the request has been processed ...more


NIH Online Clinical Research Training

It's not too late to grab a great opportunity to learn clinical research from the experts at NIH. Once again, MSU is serving as remote host for NIH's Introduction to the Principles and Practice of Clinical esearch (IPPCR) course.  Who: Physicians, scientists, medical students, nurses, public health professionals, and all other health professionals planning a career in clinical research will benefit. Topics: A comprehensive range of topics and speakers are offered each month. See the IPPCR...more


New Process for Initial Applications

A common message from researchers who completed the IRB feedback surveys, sent after an initial application is approved, was that they find signing and returning the Signature Page or PI Assurance difficult to do, especially when travelling.  Therefore, as a result of the feedback, we are beginning a new process. When a new initial application is submitted, we will send the Principal Investigator (PI) responsibilities by email to the project’s PI.  The PI will then provide...more


Updates to the HRPP Manual

Included below are additional summaries and links to updated sections of the HRPP Manual. To view the previous announcement about changes to the HRPP Manual, please visit http://hrpp.msu.edu/announcement/updates-hrpp-manual Section 7-8-A, Clinical Research Billing Compliance Coverage Analysis Removal of an “Abbreviated Coverage Analysis” Clarified that PIs are required to use the Billing Grid for Coverage Analysis for qualifying clinical trials Updated section titled “Qualifying Trials”...more


New Clinical Research Billing Compliance Process

The Human Research Protection Program (HRPP) Compliance Office has implemented prospective coverage analysis and post approval monitoring as part of the clinical research billing compliance program. Any new IRB projects that are subject to billing compliance requirements submitted on or after May 2, 2016 will be required to have clinical research billing compliance review. For more information, please see HRPP Manual Section 7-8, Clinical Research Billing Compliance and HRPP Manual Section 7-8-...more


Updates to Certain Federal Department Sections of the HRPP Manual

Included below are additional summaries and links to updated sections of the HRPP Manual. To view the previous announcement about changes to the HRPP Manual, please visit http://hrpp.msu.edu/announcement/updates-hrpp-manual Section 2-2-A, U.S. Department of Defense Changed from “ensuring that all additional DoD and/or Department of Navy requirements . . . are met” to “ensuring that all additional DoD and/or specific component requirements (e.g. Army, Navy, Air Force) . . . are met” Added that...more