Category Archives: Compliance Training

Review of Foreign National Restrictions on Awards – Education Session

The Vice President for Research Office will host an educational session, “Review of Foreign National Restrictions on Awards” from noon to 1:30 p.m.Wednesday, May 9th.  The session will be in the Memorial Union Alumni Lounge. Registration begins today and ends on May 8.

This session will help faculty and staff understand and address foreign national restrictions considerations when conducting research.  Topics covered will include: managing technical data, intellectual property and proprietary materials; defining and working with foreign nationals, publishing and teaching; and exporting and licensing considerations.

Register now to reserve a seat!

This workshop is sponsored by the Office of the Vice President for Research. There will be desserts and beverages provided, please bring your own lunch.

If you have questions, please contact Ramona Englund at 487-2654 or rlenglun@mtu.edu.


Effective: 1/19/2018 – Changes to the Federal Policy for the Protection of Human Subjects

Effective January 19, 2018, Read about how the Revised Common Rule will affect researchers at Michigan Tech

Dear Michigan Tech Research Community:

Final revisions to the Federal Policy for the Protection of Human Subjects (a.k.a the “Common Rule”) were issued by the Department of Health and Human Services (HHS) on January 18, 2017. The majority of changes will go into effect on January 19, 2018. Our institution will not be changing the method of processing continuing reviews at this time, and our current informed consent template has already implemented guidance for incorporating the new changes within your written consent forms.

What to expect:

Our institution asks that all research be submitted to our office for evaluation purposes.

Exemptions and Limited Review

The Compliance, Integrity, and Safety (CIS) Office announces the launch of a new human subject research submission form to be used by all researchers whether faculty, staff, or students effective January 19, 2018.

This new form will incorporate new categories and clarification of existing categories. Some exemptions may require “limited IRB review” (similar to an expedited review process). The form will ask questions to determine whether or not exemption applies or if limited review is needed. NOTE: not all research planned will be able to use this form; it is intended for use for only research qualifying under the explained exemptions, or the new Limited Review categories (example research types: benign social behavior projects, class assessment, research about a process and not someone, etc.). The form will also indicate when you do not qualify for any of the categories in which case you will need to complete and submit a Protocol Document and/or informed consent information along with other applicable documents for the study.

The new Exemption Form will be contained in the human subject library of the software tool our institution uses along with all other forms, and templates. You must be a registered user of irbnet.org to download all Forms, Templates, Samples, and Instructions.

Existing studies: those investigators who currently have ongoing human subject protocols approved before the effective date of Jan. 19, 2018, there is nothing that you need to do at this time. Your study may not be affected at all, however, if your study qualifies for any burden-reducing changes such as annual review, you may apply the new rule and request to minimize your burden at the time of your next annual review.

If you have any question, feel free to contact the Research Compliance Coordinator, Cheryl Gherna at 487-2902 or email irb@mtu.edu.

Additional information:  https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html


New Conflict of Interest Regulations

If you are thinking  of submitting a proposal to any of the Public Health Service agencies (e.g. NIH, FDA, CDC), you should consider attending the workshop being offered on Thursday, September 20, 2012.

Workshop Addresses ­­­­­­­­­­­­­­­­­­­­­­­­­­­­Conflicts of Interest and Public Health Service Projects

The Office of Compliance, Integrity, and Safety will host an educational session, “Conflicts of Interest and Public Health Service Projects” from noon to 1 p.m., Thursday, Sept. 20. The session will be in the Memorial Union, Ballroom A-2.

This session will help faculty and staff who conduct research funded by the federal Public Health Service agencies. Topics covered will include new and old regulations concerning these projects, the new process for determining and disclosing conflicts of interests, and why these changes have been implemented.

To register for this session, see Integrity, Compliance, and Safety. Registration deadline is 9:00 a.m. on Thursday, Sept. 20. If you have questions, please contact Joanne Polzien at 487-2902 or jpolzien@mtu.edu


Research Training

In compliance with federal regulations, Michigan Tech requires that all faculty, staff, and students involved in the use of human or animal subjects in research and teaching complete appropriate training. This requirement will be met by successfully completing the appropriate Collaborative Institutional Training Initiative (CITI) modules. This training will be required to be completed by January 1, 2009 by all investigators for all new IRB or IACUC applications submitted for review regardless of funding source.

For more information from the IRB committee chair, Dr. Susan Amato-Henderson and instructions for accessing the CITI site along with IRB guidelines see:

http://www.mtu.edu/research/administration/integrity-compliance/review-boards/human-subjects/human-training.html

For more information from the IACUC committee chair, Dr. Tammy Haut-Donahue and instructions for accessing the CITI site along with IACUC guidelines see:

http://www.mtu.edu/research/administration/integrity-compliance/review-boards/animal-subjects/animal-training.html

Feel free to contact either Cheryl Gherna or Joanne Polzien in the Research Integrity and Compliance Office with any questions at 487-2902, or email cagherna@mtu.edu. Our office would be happy to assist you in registering in order to complete this training.