On January 19, 2017 the U.S. Department of Health and Human Services along with 15 other federal departments and agencies published in the Federal Register a final rule revising the Federal Policy for the Protection of Human Subjects, otherwise known as the Common Rule.

The revised Common Rule (hereinafter referred to as the 2018 Requirements) went into effect on January 21, 2019 except for the cooperative research requirements that did not become effective until January 20, 2020.

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Code of Federal Regulations Title 45 Part 46.101(a) states that the 2018 Requirements apply “to all research involving human subjects conducted, supported, or otherwise subject to regulations by any Federal department or agency that takes appropriate action to make the policy applicable to such research”. However, institutions are given the flexibility to voluntarily extend the 2018 Requirements to all research activities, regardless of funding.

To assure that all research subjects are equally protected and to maintain continuity for the review and oversight of research, GBMC applies the 2018 Requirements to all research, regardless of funding; therefore, all proposed research, regardless of funding, to be conducted at GBMC HealthCare, Inc. or its subsidiaries, must be submitted to and undergo GBMC IRB review prior to initiation.

Code of Federal Regulations Title 45 Part 46.101(l)(3) further allows institutions to determine whether to apply the new 2018 Requirements to ongoing research initially approved or exempted prior to January 21, 2019. In response to this, GBMC has made the following determinations:

1. All research projects initially approved or determined to be exempt by the GBMC IRB prior to January 21, 2019 shall continue to be subject to and comply with the pre-2018 Requirements in accordance with 45 CFR 46.101(l)(3).
2. All research projects initially approved or determined to be exempt by the GBMC IRB on or after January 21, 2019 shall be subject to and comply with the 2018 Requirements in accordance with 45 CFR 46.101(l)(4).

To make a distinction between research projects that fall under the pre-2018 Requirements vs. research projects that fall under the 2018 Requirements, the GBMC IRB has put into practice two standard operating policy and procedure manuals:

1. Pre-2018 Requirements manual for all research projects initially approved or determined to be exempt prior to January 21, 2019
2. 2018 Requirements manual for all research projects initially approved or determined to be exempt on or after January 21, 2019

These two manuals are accessible below:

PRE-2018 REQUIREMENTS MANUAL 2018 REQUIREMENTS MANUAL

The Food and Drug Administration (FDA) regulations remain unchanged, and the GBMC IRB reviews all research under the FDA regulations as they apply.