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