Announcements
Social Science IRB Chair Changes
February 15, 2024
On January 1, 2024, the Social Science / Behavioral / Education Institutional Review Board (SIRB) chair transitioned from Harry McGee to Dr. Nora Rifon.
Update to HRPP Manual 8-1, Exemptions
February 5, 2024
The HRPP Manual 8-1, Exemptions provides the requirements and processes when a study may qualify as exempt from the Institutional Review Board (IRB) regulations.
MSU Winter Break
December 14, 2023
The Michigan State University Human Research Protection Program, including the Institutional Review Board and Compliance offices, will be closed for MSU’s Winter Break from December 23, 2023 through January 2, 2024.
August Click System Upgrade, Outage
July 13, 2023
Planned August upgrades to the Click system will require some system downtime.
Update to HRPP Manual 10-1, Conflict of Interest
April 7, 2023
HRPP Manual Section 10-1, Conflict of Interest has been updated.
Guidance for Human Research Studying or Impacted by Violence Experienced by the MSU Community on 2/13/2023
March 22, 2023
A webpage has been developed to provide guidance on additional steps that are being taken for human research studies that involve topics that may be distressing to participants based on the violence experienced by the MSU community on 2/13/2023.
MSU Winter Break
November 16, 2022
Beginning December 2022, the university is implementing a Winter Break at the end of the year. This year, the Winter Break will be observed from December 23 through January 2. The Winter Break will function the same as university holidays and the university will be closed. Because the university will be closed, the MSU Human Research Protection, including the Institutional Review Board (IRB) and Compliance offices will also be closed from December 23 through January 2. We will reopen at the start of business on Tuesday, January 3.
UPDATE: Click Now Available for Use After Scheduled Maintenance
October 31, 2022
UPDATE: Click Now Available for Use On Friday, October 28 at approximately 5:00 PM through Monday, October 31, the Click™ Research Compliance System experienced scheduled maintenance to correct a software issue and was unavailable to users during this time. Click is now available for use. Please report any problems to the Click Help Desk, clickhelpdesk@msu.edu; 517-355-2000.
Updates to MSU HRPP Manual Sections
October 31, 2022
As part of Michigan State University’s (MSU) reaccreditation process, sections of the MSU Human Research Protection Program (HRPP) Manual were updated. Updated HRPP Manual sections are available at: https://hrpp.msu.edu/help/manual/index.html
ORA Changes to ORRS
April 1, 2022
We are excited to announce that the name of Office of Regulatory Affairs has changed to the Office of Research Regulatory Support, ORRS.
New Click IRB Workspace Enhancement: Display of Review Level
September 1, 2021
Within the Click ™ Research Compliance System, a new enhancement has been added to the IRB main study workspace to make it easier for researchers to find the study’s review level.
Human Research Reactivation Update
June 16, 2021
Over the past year, human research that has the potential for in-person interactions with participants has been phased in using a Tiered approach. In-person interactions with human participants by MSU employees, MSU students, or agents of MSU were paused unless the activity was permitted under a Tier and a Human Research Plan for a Safe Return was approved. The university continues to adapt to changes in COVID-19 requirements and continues to move forward with processes to return to on-site work. Dr. Gage recently provided expectations for active research teams regarding research under new on-site work framework (Research Reactivation Update). This information is in follow-up to these changes.
Update: MSU Human Participant Research Expansion
May 20, 2021
Currently, restrictions to in-person interactions with human research participants by MSU employees, MSU students, or agents of MSU are in place until the activity is permitted under a Tier and a Human Research Plan for a Safe Return is approved. With recent changes to CDC guidance, State of Michigan requirements, and Michigan Department of Health and Human Services epidemic orders, we are working with the university to evaluate its impact on human research activities, including use of masks, vaccination status, and the requirement for all in-person research with participants that can be done remotely must be done remotely. While that evaluation occurs, we are moving forward to expand in-person research with participants permitted under Tier 3. The Tiers provide a phased approach for in-person interactions with research participants. Effective immediately, Human Research Plans may be submitted for research that falls within Tier 3.
Student Access to Click™ IRB Research Compliance During Summer Months
May 11, 2021
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).
Updated Pause to Human Research Involving In-Person Interactions with Research Participants in Michigan
March 8, 2021
Based on the recent Michigan Department of Health and Human Services (MDHHS) Epidemic Order, MSU is permitting the restart of human research that involves in-person interactions with research participants conducted indoors in Michigan by MSU employees, MSU students, or agents of MSU under the following circumstances: -Gatherings with no more than 25 persons, -Gatherings that occur for the purpose of medical treatment (as defined in the order), or -Gatherings for the purposes of indoor group fitness, exercise, or sports that comply with the restrictions set forth in the MDHHS Epidemic Order. All other in-person interactions with research participants conducted indoors in Michigan by MSU employees, MSU students, or agents of MSU remain paused.
Non-Exempt Studies with No Expiration
February 17, 2021
One of the major changes to the revised regulations for human research protection was removal of the requirement to conduct annual review (no expiration date) for some non-exempt studies. While annual review is not required for these studies, there are still continuing IRB responsibilities such as submission of modifications, reportable events, and closure of the study once it is complete. Once a year, principal investigators will receive an email reminder of these responsibilities for non-exempt studies approved by the MSU IRB with no expiration.
SAVE THE DATE: Clinical Research Education Series and Training (CREST) - 4/13 at Noon
February 15, 2021
Save the date! The Human Research Protection Program (HRPP) has scheduled a Clinical Research Education Series and Training (CREST) meeting on April 13th, 2021 from 12:00pm-1:00pm. This will be a virtual event and the Zoom link will be posted along with an agenda closer to the meeting date. This meeting is designed to be an opportunity for study coordinators, clinical research administrators and all people who provide clinical research support to share questions/concerns and obtain information from the HRPP.
Updated Pause to Human Research Involving In-Person Interactions with Research Participants in Michigan
February 11, 2021
Based on the recent Michigan Department of Health and Human Services (MDHHS) Epidemic Order, MSU is permitting the restart of human research that involves in-person interactions with research participants conducted indoors in Michigan by MSU employees, MSU students, or agents of MSU under the following circumstances: Gatherings with no more than 10 persons from no more than 2 households are gathered, Gatherings that occur for the purpose of medical treatment (as defined in the order), or Gatherings for the purposes of indoor group fitness, exercise, or sports that comply with the restrictions set forth in the MDHHS Epidemic Order. All other in-person interactions with research participants conducted indoors in Michigan by MSU employees, MSU students, or agents of MSU remain paused. Investigators impacted by the change will be contacted individually to determine whether each paused study may restart.
Pause to Human Research Involving In-Person Interactions with Research Participants in Michigan Extended
January 13, 2021
Based on the recent Michigan Department of Health and Human Services (MDHHS) Emergency Order, MSU is continuing to pause human research that involves in-person interactions with research participants conducted indoors in Michigan by MSU employees, MSU students, or agents of MSU, with the exception of gatherings that occur for the purpose of medical treatment (as defined in the order) or for the purposes of indoor group fitness, exercise, or non-contact sports that comply with the restrictions set forth in the MDHHS Emergency Order. This pause has been extended and is now in effect through January 31, 2021 at 11:59 PM.
Pause to Human Research Involving In-Person Interactions with Research Participants in Michigan Extended
December 18, 2020
Based on the recent Michigan Department of Health and Human Services Emergency Order, MSU is continuing to pause human research that involves in-person interactions with research participants conducted indoors in Michigan by MSU employees, MSU students, or agents of MSU, with the exception of gatherings that occur for the purpose of medical treatment (as defined in the order). This pause has been extended and is now in effect through January 15, 2021 at 11:59 PM.
Pause to Human Research Involving In-Person Interactions with Research Participants in Michigan Extended
December 8, 2020
Based on the recent Michigan Department of Health and Human Services Emergency Order, MSU is continuing to pause human research that involves in-person interactions with research participants conducted indoors in Michigan by MSU employees, MSU students, or agents of MSU, with the exception of gatherings that occur for the purpose of medical treatment (as defined in the order). This pause has been extended and is now in effect through December 20, 2020 at 11:59 PM.
Pause to Human Research Involving In-Person Interactions with Research Participants in Michigan
November 30, 2020
Based on the recent Michigan Department of Health and Human Services Emergency Order, MSU is pausing human research that involves in-person interactions with research participants conducted indoors in Michigan by MSU employees, MSU students, or agents of MSU, with the exception of gatherings that occur for the purpose of medical treatment (as defined in the order). Currently, this pause is in effect through December 8, 2020 at 11:59 PM.
Changes to GCP Training
November 30, 2020
Because Good Clinical Practice (GCP) training requires completion of refresher training, the set-up of GCP training is being modified in the Ability training system.
Compliance Office Remote Monitoring
November 30, 2020
During the COVID 19 pandemic the Compliance office has replaced on-site monitoring with remote monitoring and will conduct routine remote site visits for all full board initial applications that have enrolled subjects and a sample of ongoing expedited projects.
Tier 0 Research Restart
November 30, 2020
Approval of a Human Research Plan for a Safe Return form is required for any potential in-person interactions with research participants conducted by MSU individuals (e.g. faculty, staff, students, agents), including all studies in Tier 0.
External IRB Requests
October 29, 2020
For employees, students or agents of MSU who will be collaborating with external (non-MSU) investigators who wish to obtain IRB approval from an external (non-MSU) IRB, an external IRB request must first be submitted in Click to the MSU HRPP for review and determination before engaging in research with human subjects.
Biomedical IRB Chair Changes
October 21, 2020
After many years of dedicated service, Dr. Ashir Kumar has retired as the Biomedical and Health Institutional Review Board (BIRB) chair.
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 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.
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.
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
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.
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.
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.”
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
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
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.