Announcements

University Outreach and Engagement Webinar: Human Subjects Research: IRB Considerations During the COVID-19 Pandemic

July 15, 2020

University Outreach and Engagement will host a webinar, Human Subjects Research: IRB Considerations During the COVID-19 Pandemic, on Tuesday, July 28. Registration now open!

Click Unavailable 7/29 at 5PM through 8/2

July 7, 2020

From Wednesday, 29 July 2020 at 5pm EST through Sunday, 2 August 2020, the Click™ Research Compliance System will experience a software upgrade and be unavailable to researchers during this time.

HIPAA and MSU Health Care, Inc.

May 26, 2020

MSU has established MSU Health Care, Inc., a non-profit corporation created to be the clinical enterprise of MSU’s College of Human Medicine, College of Nursing and College of Osteopathic Medicine. MSU Health Care's predecessor, MSU HealthTeam, will become fully integrated into MSU Health Care as of July 1, 2020. As a result of this integration, as of July 1, 2020, MSU HealthTeam medical records will be transferred to MSU Health Care, and MSU Health Care will become the responsible covered entity for the medical records and the associated protected health information (PHI). This transfer will impact the future disclosure of PHI for research purposes on or after July 1, 2020.

Click System Issues Reported

May 22, 2020

On Friday, May 22, issues with the Click™ Research Compliance System were reported. These issues have been reported to IT and the issues appear to have been resolved. If you still are experiencing issues, please log out of Click and try clearing your browser’s cookies/cache before logging in again. If you still experience difficulties, please contact the Click Help Desk at clickhelpdesk@msu.edu.

COVID-19 Restrictions

May 1, 2020

As the situation evolves, MSU continues to review and discuss when to resume research activities, including in-person participant interactions in human research studies. While MSU continues to evaluate when and how research activities may resume, all of the human research restrictions are in effect until further notice.

MSU Human Research Restrictions and Extension of the Stay Home, Stay Safe Executive Order

April 28, 2020

On April 24, 2020, Governor Whitmer issued Executive Order No. 2020-59, extending her prior “Stay Home, Stay Safe” order through May 15 at 11:59pm. Please note that the restrictions described in the March 26, 2020 email for MSU human research conducted in Michigan are now also extended through May 15, 2020 at 11:59pm.

MSU Human Research Restrictions and Extension of the Stay Home, Stay Safe Executive Order

April 13, 2020

On April 9, 2020, Governor Whitmer issued Executive Order No. 2020-42, extending her prior “Stay Home, Stay Safe” order through April 30, 2020 at 11:59pm. Please note that the restrictions described in the March 26, 2020 email for MSU human research conducted in Michigan are now also extended through April 30, 2020 at 11:59pm.

MSU Human Research Restrictions and the Stay Safe, Stay Home Executive Order

March 27, 2020

On March 23, 2020, Governor Whitmer issued Executive Order No. 2020-21, “Temporary requirement to suspend activities that are not necessary to sustain or protect life” which takes effect on March 24, 2020 at 12:01 am and continues through April 13, 2020 at 11:59 pm.

COVID-19 and New Restrictions on Human Subject Research

March 16, 2020

As the situation with the novel coronavirus continues to rapidly evolve, ensuring continued public health and safety is of greatest importance. To reduce the risk that the coronavirus poses to the health and safety of our research community and after considerable discussion and consultation, the university is placing temporary restrictions on human subject research effective immediately. These restrictions will last until Monday, May 4, and we will reevaluate this decision on an ongoing basis, sharing additional updates or modifications as more information becomes available.

HRPP and COVID-19 Information

March 12, 2020

The MSU HRPP has established a webpage with information about the impact of the novel coronavirus (COVID-19) on the HRPP and to address questions from researchers, which will be updated as we learn more and as the situation evolves.

New Single IRB Requirement for Federally Funded Research

February 19, 2020

Projects seeking funding from a federal department or agency that has adopted the Revised Common Rule for the protection of human subjects in research are now required to identify and use a single Institutional Review Board when certain criteria are met. Any institution located in the United States that is engaged in cooperative non-exempt research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States, with limited exceptions.

Use of Single IRB

October 14, 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. When a study involves multiple domestic sites conducting the same non-exempt human research protocol, a Single IRB is required.

Graduate Student Research Requirements

October 14, 2019

There are additional requirements for graduate student research at MSU. Graduate student research refers to research conducted to fulfill graduate degree requirements, i.e., preparation of master’s theses and doctoral dissertations.

Transferring Projects to MSU

October 14, 2019

If you are still engaged in human research (e.g., interacting and/or intervening with subjects, obtaining and/or analyzing private identifiable data about living individuals), this activity needs to be reviewed by an MSU IRB or a reliance agreement must be executed before you can continue your human research activities. This includes continued collaborations with a previous institution, transfer of the activities to MSU, bringing private identifiable data to MSU to analyze, etc.

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.