Revisions to Common Rule
Common Rule v. Final Rule
OHRP has released a revised Common Rule (45 CFR 46) and it will go into effect on January 21, 2019. Researchers will notice changes to the HRPP website, policies and procedures, and Cayuse IRB template.
This is a summary of the changes to the Common Rule (45 CFR 46) and the major impacts it will have on researchers. Researchers should become familiar with the revised document.
Implementation of Final Rule | |
Pre January 19, 2019 | Post January 19, 2019 |
Referred to as Common Rule | Referred to as Final Rule |
IRBs must follow one set of regulations.
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All research approved on or before Friday, January 18, 2019 will be reviewed and required to follow the Common Rule regulations. | All research approved on or after Saturday, January 19, 2019 will be reviewed and required to follow the Final Rule regulations. |
Researchers should continue to submit research team changes, modifications, renewals and incidents for any study that has received IRB approval prior to January 19, 2019. |
Cayuse IRB Logistics | |
IRB reviewers will not be reviewing submissions or approving IRBs during this transition. December 17, 2018 – January 28, 2019. |
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Common Rule | Final Rule |
Researchers that submit an IRB on the old template between December 4, 2018 – March 1, 2019 will be contacted by HRPP staff requesting that a new IRB be submitted on the new template.
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The new Cayuse IRB template was launched on Friday, December 7, 2018. The new template follows the Final Rule.
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IRBs that are unsubmitted on the old Cayuse IRB template will be administratively withdrawn on March 1, 2019.
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Transitioning IRBs from Common Rule to Final Rule |
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Applicability of the Final Rule based on Funding Source | ||
Funding | Common Rule - existing research approved or exempted before Jan. 19, 2019 | Final Rule - approved or exempted on or after Jan. 19, 2019 |
FDA Regulated | Transition is not applicable. | Research must continue to follow FDA Regulations: 21 CFR Part 50 and Part 56. |
Federal Research (except DOJ) |
There will be no transition of already approved research to the revised Common Rule. Federal research approved prior to Jan. 19, 2019 will remain under the Common Rule: 45 CFR 46 (2009) | All federally funded research must follow the revised 2018 Final Rule (Jan. 19, 2019). |
DOJ Research | Transition is not applicable. | DOJ research must continue to follow the Common Rule 45 CFR 46 (2009) until DOJ becomes signatory to the revised rule. |
SUMMARY of CHANGES |
Exempt Categories |
REVIEW PROCESS
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UNCHANGED
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REVISED
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REMOVED
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ADDED
** Consultation with the HRPP Director or IRB Chairs is required before completing IRB application for Exempt Category 7 and 8. Requesting more guidance from OHRP. |
Renewal/Continuing Review | |
Renewals are conducted at least once a year until the research has been completed and the IRB protocol has been closed. | |
Common Rule |
Final Rule |
Renewals Required
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Renewals Required
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HRPP Administrative Check-In
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HRPP Administrative Check-In
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** Researchers are still obligated to submit/report modifications, incidents, and study completion no matter the review type. IRBs that remain active are subject to audit by the IRB. |
Consent Process & Form |
RE-ORGANIZATION of CONSENT INFORMATION
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ADDITION of REQUIRED ELEMENT of CONSENT
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ADDITION of ADDITIONAL ELEMENTS of CONSENT
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WAIVER of CONSENT An IRB may approve a research proposal in which a researcher will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective participants without the informed consent of the prospective participant or the participant's legally authorized representative, if either of the following conditions are met:
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WAIVER of WRITTEN CONSENT
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ELECTRONIC SIGNATURES
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BROAD CONSENT (Exempt Categories 7 & 8)
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Cooperative Research |
Mandates the use of a Single IRB for federally funded cooperative research.
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Human Research Protection Program
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Address
Texas Tech University, 2500 Broadway, Box 41075 Lubbock, TX 79409 -
Phone
806.742.2064 -
Email
hrpp@ttu.edu