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Hot Topics in Human Subjects Research

Revisions to Common Rule

In January 2017, the US Dept. of Health and Human Services and fifteen (15) other Federal Departments and Agencies issued final revisions to the Federal Policy for the Protection of Human Subjects, otherwise referred to as the 'Common Rule.'  In response to these changes, the NDSU IRB is conducting a comprehensive review of its procedures, forms, templates and guidance to ensure compliance by the effective date of January 19, 2018

This section of the website will be updated frequently as more information becomes available.

NIH Policy on Single IRB (sIRB) Review of Multi-Site Research

The National Institutes of Health (NIH) policy on the use of single Institutional Review Board (IRB) for multi-site research to establishes the expectation that a single IRB (sIRB) of record will be used in the ethical review of non-exempt human subjects research funded by the NIH that are carried out at more than on site in the United States.  This policy goes into effect for competing applications after January 25, 2018.

RESOURCES:

Revised Common Rule

  • The Secretary's Advisory Committee on Human Research Protections (SACHRP) has drafted and the Office for Human Research Protections (OHRP) has published a document titled, "A Guidance and Educational Tool for Benign Behavioral Interventions."  The document outlines questions to ask to determine if the benign behavioral intervention proposed in a research study will meet the criteria for exemption under the new Exemption Category 3 in the Revised Common Rule (effective 1/19/2018).  The document describes several examples of behavioral interventions and whether or not they would be considered exempt or non-exempt under the new common rule.
  • Requirements for Informed Consent for non-exempt research have been updated in the new common rule.  Find the Basic and Additional elements of consent on our Consent Resources page.

NDSU Resources:

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Additional Resources for Informed Consent:

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Other Related Organizations:

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International Research:

The 2016 edition of "The International Compilation of Human Subject Protections"

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Last Updated: Thursday, October 12, 2017 2:23:50 PM
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