Announcements

Update to Click SmartForm

September 29, 2019

An enhancement has been added to the Click™ Research Compliance System to help streamline the IRB review process. Several questions on the “HRP-503 – Template – Protocol” form that are frequently updated by researchers have been incorporated into the online Click SmartForm.

Updated HRPP Manual Sections Related to FERPA and PPRA

September 4, 2019

Several HRPP Manual sections related to research involving schools or students have been revised.

Reminder: Human Research Requirements

August 23, 2019

Michigan State University (MSU) Institutional Review Board (IRB) review and approval or an exempt determination is required for all projects that involve research or clinical investigations with human subjects conducted by faculty, staff, students, or agents of MSU before initiation of any human subject research activities.

Use of a Single IRB

August 23, 2019

For researchers who plan to submit a grant proposal to the U.S. National Institutes of Health (NIH), it is important to be aware of the NIH requirement for use of a Single Institutional Review Board (IRB) for multi-site human subject research. The Final NIH Policy on Use of a Single IRB for Multi-Site Research establishes the expectation that when a study involves multiple domestic sites conducting the same non-exempt human research protocol, a Single IRB is used. This means that rather than each site obtaining separate IRB approvals from each of their institutions, the sites must rely upon a Single IRB that has been designated and agreed to by the sites.

Revised Rule on the Federal Policy for the Protection of Human Subjects

August 22, 2019

The U.S. Department of Health and Human Services (HHS) and other federal departments and agencies have implemented a revised rule on the Federal Policy for the Protection of Human Subjects (also known as the Common Rule), effective January 21, 2019.

How to find finalized consent forms?

August 20, 2019

If applicable, use the IRB approved finalized consent (with IRB approval language indicating an effective date) to enroll subjects.

HRPP Compliance Office Spotlight

August 20, 2019

Learn more about HRPP Compliance Analysts.

De-identified left over human specimens: not research with human subjects or FDA regulated research?

August 19, 2019

Activities involving de-identified human specimens that do not require IRB approval under the Common Rule Protection of Human Subjects regulation must still receive IRB approval if the activities are subject to U.S. Food and Drug Administration (FDA) regulations.

Student Access to Click™ IRB Research Compliance During Summer Months

June 11, 2019

During the summer months, students will receive an error if trying to log into the Click system if not enrolled or they do not otherwise have access to Click (e.g. MSU employee).

Revisions to HRPP Manual 3-2 Policy Development and Approval

May 1, 2019

HRPP Manual Section 3-2, Policy Development and Approval has been updated.

Revised Common Rule

May 1, 2019

The U.S. Department of Health and Human Services (HHS) and other federal departments and agencies have implemented a revised rule on the Federal Policy for the Protection of Human Subjects (also known as the Common Rule), effective January 21, 2019.

Change in IRB Assignment Process

April 3, 2019

The MSU IRB office has recently changed its process for assigning incoming application requests.

Western IRB (WIRB) Training - May 14, 2019

Western IRB (WIRB) Training - May 14, 2019

April 3, 2019

Michigan State University’s Human Research Protection Program (HRPP) is pleased to announce that Christopher Gennai from WIRB will be conducting an on-site training with a question/answer period on Tuesday, May 14 from 12:00 P.M. – 1:30 P.M. at 4000 Collins Road, Lansing, MI 48910. The session will also be available as a webinar through Zoom.

Revised Common Rule: FAQs and Resources

April 3, 2019

New Revised Common Rule resources available: FAQs and webinar slides.

Revised Common Rule Implements January 21, 2019

January 21, 2019

The U.S. Department of Health and Human Services (HHS) and other federal departments and agencies have implemented a revised rule on the Federal Policy for the Protection of Human Subjects (also known as the Common Rule). While implementation of this rule has been delayed several times, the revised rule became effective January 21, 2019.

ACCESS TO MSU IRB LEGACY ONLINE SYSTEM EXTENDED TO FEBRUARY 1, 2019

November 25, 2018

As part of the Click™ Research Compliance System implementation, the Legacy MSU IRB Online System was replaced with Click and the MSU IRB Legacy Online System was planned to be taken offline on December 4, 2018. However, access to the MSU IRB Legacy System for researchers has been extended to February 1, 2019.

Revisions to HRP-513 - Template - External IRB Request

November 14, 2018

The HRP-513 - Template - External IRB Request has been revised. A description of the changes are included below.

Training System Unavailable November 29 – December 3

November 9, 2018

As part of the implementation of the new learning management system (LMS), the training system is scheduled to be unavailable starting on Thursday, November 29 at 5:00 P.M. until Monday, December 3.

COMING SOON – Revised Rule on the Federal Policy for the Protection of Human Subjects

October 5, 2018

The U.S. Department of Health and Human Services (HHS) and 16 other federal departments and agencies are implementing a revised rule on Federal Policy for the Protection of Human Subjects (also known as the Common Rule) that is anticipated to become effective January 21, 2019.

New Learning Management System

October 5, 2018

Currently, the Human Research Protection training is accessed through the Saba Learning Management System (LMS). In November/ December 2018, there are plans to replace the Saba LMS with a new LMS, Ability.

Access to MSU Institutional Review Board Legacy Online System

October 5, 2018

IMPORTANT: If you are a researcher and have records in the MSU IRB Legacy online system that you would still like to access, you will need to obtain these records before December 4, 2018.

Updates to HRPP Manual

August 8, 2018

HRPP Manual sections have been updated to better reflect use of the Click™ Research Compliance system.

Revisions to the HRP-503 - Templates

August 7, 2018

The “HRP-503 - Template - Protocol - No Instructions” and “HRP-503 - Template - Protocol” have been revised.

New Form Required for Closure of FDA Studies Conducted under an IND or IDE

August 2, 2018

When requesting closure for studies regulated by the U.S. Food and Drug Administration (FDA) and conducted under an IND or IDE, a new form will now be required in addition to the standard closure form. The new form, “HRP-555 – Template - Appendix to the Closure Form for FDA Regulated Studies Conducted Under an IND or IDE” will be required in addition to the “HRP-528 – Template – Closure Report.”

Closure and sIRB Templates Revised

July 18, 2018

Closure and sIRB Templates Revised

Revised Human Research Protection Rule Delayed until 2019

June 17, 2018

The Final Rule delays the general compliance date of the 2018 Requirements for an additional 6-month period until January 21, 2019.

Student Access to Click™ IRB Research Compliance During Summer Months

June 11, 2018

During the summer months, students will receive an error if trying to log into the Click system if not enrolled or they do not otherwise have access to Click (e.g. MSU employee). Learn how to access Click during the summer if this applies to you.

European Union General Data Protection Regulation

June 7, 2018

On May 25, 2018, the European Union (EU) General Data Protection Regulation (GDPR) went into effect.

CITI FERPA Modules Now Available

June 7, 2018

Family Educational Rights and Privacy Act (FERPA) modules have been added to the courses available to MSU faculty, staff, and students in CITI.

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

April 18, 2018

The MSU Human Research Protection Program (HRPP) Manual 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.

New HRPP Manual Section: Use of a Single IRB

March 26, 2018

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 Single IRB (sIRB) and costs.

Federal Policy Revisions Issued

Federal Policy Revisions Issued

January 22, 2018

The federal departments are now proposing a further delay of the revisions to the "Federal Policy for the Protection of Human Subjects" until January 2019.

NIH Certificate of Confidentiality

January 16, 2018

The National Institutes of Health now provides a Certificate of Confidentiality automatically to research funded wholly or in part by the NIH for human research, including exempt research studies.

NIH Certificate of Confidentiality

NIH Certificate of Confidentiality

January 16, 2018

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.

NIH Policy on Single IRB

January 10, 2018

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).

Revised Template Consent Form Contact Information

November 24, 2017

Update your consent forms with HRPP's new address upon renewal or revision of your application...

MSU is Now a Participating Institution in SMART IRB

November 1, 2017

SMART IRB (Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform) is designed to harmonize and streamline the IRB review process for multi-site research.