ORA News and Updates Fall 2019
In honor of the start of the new academic year, we are launching the ORA e-newsletter with helpful tips and reminders for navigating your research endeavors at MSU. We welcome all new and returning faculty and staff to campus and wish you a successful fall semester!

The Office of Regulatory Affairs is composed of several compliance units that provide regulatory oversight and/or operational management of research activities. Our mission across campus is to:

  • promote the responsible conduct of research,
  • assure compliance with federal, state, and local regulations, and university policies,
  • protect the rights and welfare of research subjects,
  • protect public health and safety, and
  • assure the objectivity and integrity of research.

Below you'll find recent updates and an overview of several services designed to assist you in your research efforts. If you should need assistance or have any questions, please contact the appropriate unit. We urge you to save this newsletter for future reference and contact information.
New Biomedical Research Building Ready to Open
MSU's new interdisciplinary science and technology building
MSU’s newest research facility, the Interdisciplinary Science and Technology Building (ISTB), will open this month and researchers from several buildings across campus will soon be moving in. Both Environmental Health & Safety and Campus Animal Resources have made preparations for supporting the new building.

ISTB will be added to the current Safety Neighborhood of the Institute for Quantitative Health Science & Engineering (IQ), Life Science Building, Research Complex-Engineering, and Clinical Center. The neighborhood safety program is designed to be a comprehensive, hands-on safety approach which facilitates communication, safety, and compliance between EHS and Michigan State University departments.

Behavioral Neuroscience, Physiology, Precision Medicine, and Reproductive and Developmental Sciences, will have wet labs and offices in the building. Campus Animal Resources will oversee the veterinary care, husbandry, animal facility and cage wash areas for the ISTB. 

This building was designed and constructed to emulate the Grand Rapids Research Center, and construction was completed in less than two years. Congratulations to all involved in this project!
Human Research Protection Program (HRPP)
Reminder: Human Subjects Research Requirements
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. Exemptions and Non-Exemptions are explained in further detail in this overview.

Use of a Single IRB for NIH Grants
For researchers who plan to submit a grant proposal to NIH, it is important to be aware of the requirement for use of a Single IRB for multi-site human subject research. All sites must rely upon a Single IRB that has been designated and agreed to by the sites. It is also important to note that the selection of Single IRB occurs at the time of grant proposal submission, not at Just In Time. Please familiarize yourself by reading the full announcement and contact MSU HRPP as early as possible, as the decision to determine which IRB will serve as the IRB of record may require discussions between institutions.

Revised Rule of the Federal Policy for the Protection of Human Subjects (Common Rule)
The U.S. Department of Health and Human Services and other federal departments and agencies have implemented a revised rule regarding human subjects (also known as the Common Rule) as of January 21, 2019. There are several significant changes that researchers should familiarize themselves with. Please read the full story or watch this workshop video to learn more.
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CAR Now Using Service Provider Billing
In July 2019, CAR began processing monthly invoicing through Service Provider Billing. This change has very little impact on researchers, but we want to notify you of the change in order to keep your fiscal officer informed. Learn more about this new billing service and the benefits using it provides.

Veterinary Services Offered by CAR
Campus Animal Resources offers a number of services to researchers including coordination of shipping/receipt of rodents from/to other institutions, veterinary consultations, vet and medical supplies, help with breeding colony management, and much more. Veterinary rounds are performed in all facilities housing animals used in research and care is provided to all animals in need of veterinary assistance. Any concerns about the health of your animals can to be sent to carvets@ora.msu.edu. Visit our website to learn more about our services and please call (517) 884-8527 for emergency animal care , 24 hours a day, 7 days a week. We are here to help!

Free Training
New personnel in your lab? Crunched on time for training? GREAT NEWS: Campus Animal Resources is here to help! We have experts available to instruct investigators and their project personnel on various procedural techniques including basic handling and restraint, to more advanced technical procedures. Classes can be scheduled online or customized requests can be emailed to cartrain@msu.edu. Our training staff is excited to collaborate with you and help your lab achieve your research goals!

IACUC Overview
The Institutional Animal Care and Use Committee reviews, oversees, and approves all MSU programs involving the care and use of all live animal activities to ensure compliance with best practice standards and regulatory requirements, A few reminders:
  • Research and other activities involving animals must obtain approval prior to the start of the project/class. Protocols are submitted through the Click System. Please allow 4-6 weeks for review.
  • The Click IACUC software has been in use since May 2018. Learning materials and tips for principal investigators are available online.
  • The IACUC is using a rolling transition to move active protocols into Click. Please plan ahead for your next protocol renewal since it will need to be submitted into the Click system.
  • If you have any questions or need assistance using Click, call the help desk at (517) 355-2000. For assistance on research design within the system, please contact IACUC@msu.edu or call (517) 432-8103.
We strongly encourage PIs to set up an appointment with the IACUC office for initial training in Click as this saves time for the PI and creates a more efficient review process.
FRIB Completes Successful Safety Audit
The Facility for Rare Isotope Beams (FRIB) recently completed a safety management system audit. The five-day visit resulted in zero non-conformance issues and was recommended by NSF-ISR for ISO 45001 standard. Learn more about FRIB and their excellent safety management results.

Revised Eyewash and Shower Safety Guidelines
In response to MIOSHA's 2018 amendments to its eyewash and safety shower interpretation guidelines, EHS has partnered with stakeholders across campus to make necessary improvements. Affected employees include those working in labs, custodial services, residential and hospitality services, infrastructure and facility planners, and others. Please read this overview for more details.

New Containment Lab Coming Soon
A new BSL-3/ABSL-3 High Containment Lab has been in the design and planning phase for the past year, and we are pleased to announce that construction is scheduled to begin in late August. The new facility will provide dedicated space for ongoing studies. Read the full story and be sure to contact the MSU BioSafety Office with any questions at 355-0153.
Conflict of Interest (COI)
All MSU faculty and academic staff are required to complete an annual disclosure of personal significant interests related to their MSU responsibilities. This is required by MSU's Conflicts of Interest, Faculty/Academic Staff Policy approved April 13, 2012.

What: Interests to be disclosed depend on the funding agency, but everyone must disclose the names of outside organizations and entities in which they have a significant financial interest, and which relate to their MSU responsibilities. Additionally, Public Health Service investigators must disclose all sponsored and reimbursed travel.

When: COI disclosure must be completed prior to the submission of a new proposal or activation of a new award when required by the funder OR annually at the latest.

How: Individuals can complete their annual disclosure by visiting their Kuali Coeus Research Administration (KCRA) home page and selecting either 'Create New/Annual Disclosure' or 'Update My COI Disclosure' (if an annual disclosure has previously been completed). 'Creating a New Or Annual Disclosure' or 'Updating a Master Disclosure'
Job Aids are available to provide individuals with step-by-step instructions.

This two minute video provides an excellent overview about the COI process.

Please contact FCOIIO@msu.edu or 517-884-7000 for questions about COI disclosures. If technical assistance is needed, please contact the Kuali Coeus Help Desk at kchelpdesk@msu.edu or 517-355-2000.
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