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


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


Now Available: Reliance Application to Request Review by a Non-MSU IRB

The Reliance Application to Request Review by a Non-MSU IRB is now available on the MSU HRPP website. Previously, investigators would obtain this application by email from the IRB office. MSU may choose to rely on another institution for IRB review and approval after a determination is made that it is appropriate under the particular circumstances.  If MSU is the primary awardee of a grant and MSU is a site for the research, typically the MSU IRB will need to conduct its own review of the...more


Updates Related to Reliance on Commercial Institutional Review Boards

The MSU Human Research Protection Program (HRPP) Manual Section 1-4, “Reliance on Commercial Institutional Review Boards” has been revised to permit additional flexibility when use of a commercial IRB is proposed. Changes include: Changed from commercial IRB review being automatically excluded if the project involves certain types of research to requiring additional consideration if the project involves certain types of research Addition to allow MSU to rely upon a commercial IRB when the...more


MSU Participating in FDP Exempt “Wizard” Demonstration

Michigan State University is excited to announce its participation in a demonstration, run by the Federal Demonstration Partnership (FDP) of an electronic “wizard” that is designed to allow investigators to “self-determine” if their human subject research project meets the federal definitions of exempt.  Each institution participating in the demonstration utilizes the electronic “wizard” for 50-100 projects that have received an exempt determination and 50-100 projects that received an...more