Office of Research Federally Funded Research - Office of Research

Federally Funded Research

If you receive a federal grant to conduct human subject research, you are obligated to comply with the applicable regulations of the funding department or agency.  The Common Rule found at 45 CFR 46 is the regulation that most funding sources follow.  The Common Rule provides the definitions, exemptions and procedures an institution receiving the funds must follow.

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The New Common Rule

The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). Starting January 21, 2019, all new research receiving federal funding must comply with the New Rule.

Effective July 19, 2018, UC Davis IRB Administration is adopting 3 burden reducing provisions for research that comply with the New Rule, these include:

  • Updated definition of “research,” which deems certain activities not to be research
  • Elimination of grant application review by the IRB Administration
  • No annual review for studies that qualify for expedited review

 

What is needed to comply with the New Rule?

  • The research consent form must comply with the new rule. Visit the IRB Forms page to find consent form templates that comply with the 2018 Common Rule.
  • Researchers requesting a waiver of consent for access to or use of private identifiable information or identifiable biospecimens must explain why the research cannot practicably be conducted without the use of identifiers.
  • At some time in the future, single-IRB review must be used for multisite research.

 

What are the impacts of the 3 burden reducing provisions?

When submitting a new study between July 19, 2018 and January 21, 2019

  • If the study is considered Not Human Subjects Research (HSR) under the New Rule definition, the IRB will issue a Not HSR determination.
  • If study documents are compliant with the New Common Rule and the study qualifies for expedited review, IRB approval of the research will not expire and there will be no requirement for continuing review.
  • If study documents are compliant with the New Common Rule, grant applications will not need to be submitted for IRB review.

 

When am I required to comply with the New Rule?

New Projects

New federally-funded research reviewed between July 19, 2018 and January 21, 2019, has the option to comply with either the Old (pre-2018) Rule or the New  Rule. The IRB Administration recommends investigators comply with the New Rule if submitting studies during this period. Starting January 21, 2019, all new federally funded research must comply with the New Rule.

Existing Projects

The revisions to the Common Rule will have no effect on most existing research. All existing research may continue uninterrupted and must follow the old rule (the rule in effect before 2018.)

Investigators must continue to submit continuing review/progress reports before the administrative due date, as is the current practice. During the continuing review process, the IRB will determine if the research complies with the new rule. If the research qualifies for expedited review and complies with the new rule, no expiration date will be issued.

If an investigator wants the IRB to apply the new rule to existing research that is not due for continuing review, s/he may submit a modification to the IRB. If the study is open to enrollment or requires access to private identifiable data or specimens changes will be required to comply with the new rule.  To modify a study to comply with the new rule researchers must:

  • Update consent forms to comply with the new rule or
  • Request a waiver of consent for access or use of private identifiable information or biospecimens by explaining why the research cannot practicably be conducted using anonymous or coded data or specimens

 

Additional changes are expected to take effect on January 21, 2019.

  • New exemption categories and clarification about existing categories
  • Some exempt research will require limited IRB review
  • Clinical trials must post one IRB-approved informed consent form to a publicly available Federal website within 60 days of study completion
  • Single IRB review is required for multi-site federally funded research conducted in the US
  • “Broad Consent” requirements for secondary research

 

Additional Information

Even when continuing review is not required, investigators remain responsible for submitting all modifications to research, reporting all necessary information to the IRB, and closing the project with the IRB when the human subjects research is complete.

Posting of clinical trials consent forms

This revised Rule requires one consent form to be posted on a publicly available federal website for any clinical trial conducted or supported by a Common Rule department or agency.  The consent form must be posted no later than 60 days after the last study visit by any subject. The consent form must have been used in enrolling participants in order to satisfy this new provision. The compliance date for this provision is January 21, 2019.

At this time, two publicly available federal websites have been identified to satisfy the consent form posting requirement: ClinicalTrials.gov and a docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021). HHS and other Common Rule departments and agencies are developing instructions and other materials providing more information to the regulated community about this posting requirement.

Additional federal websites satisfying the revised Common Rule’s clinical trial consent form posting requirement might be identified in the future.

What is “Broad Consent?”

The term “Broad Consent” as defined by the New Rule applies to consent for storage and secondary research of identifiable private information or biospecimens. This concept must be implemented on an institutional level and requires tracking of individuals who decline to provide consent. Because there is no guidance from OHRP and because of the implications of tracking individuals who do not provide consent and excluding their data from all future research, UC Davis is not pursuing broad consent at this time.  Investigators can continue to use biospecimens that are coded or to seek a waiver of consent for use of biospecimens with identifiers retained consistent with current practices.

What about the requirement for single-IRB review of multisite studies?

The New Rule states that federally funded studies where the same protocol will be conducted at more than one domestic site must use a single IRB.  The single IRB provision does not take effect until January 20, 2020. UC Davis researchers do not need to comply with this provision at this time unless the study is funded by the NIH. Additional information about NIH single IRB requirements can be found here.

What about FDA-regulated research?

The Common Rule regulations are separate from FDA regulations. The FDA regulations have NOT changed. The FDA still requires annual continuing review for FDA-regulated studies, even those FDA-regulated studies involving only minimal risk.

What if my research does not receive federal funding?

Studies that do not receive federal funds are not required to comply with the new rule. Existing research may continue uninterrupted for the current approval period. New projects that do not receive federal funding may use consent templates that comply with the new rule but are not required to do so.