EMU Research

Revised Common Rule Guidance

What is the Common Rule?

The Common Rule is the set of federal regulations, designed to protect human subjects in research, that are promulgated by the Office for Human Research Protections (OHRP) in the Department of Health and Human Services (DHHS). The regulations are called the Common Rule because 15 other federal agencies have signed onto the DHHS regulations. The Common Rule can be found in the Code of Federal Regulations at 45 CFR 46. EMU applies the Common Rule to all human subject research, regardless of funding, unless the funding source has different human subject regulations or the project comes under another agency's jurisdiction. In those cases, the appropriate organization's regulations would be applied.

Why was the Common Rule revised?

The Common Rule was originally published in 1991 after 10 years of development. It has persisted for over 25 years, and in that time, technology and research methods have outpaced regulation. OHRP saw a need to update the Common Rule to account for recent changes in research methodology, technology, an increase in collaborative research, differing risks in social/behavioral/educational research vs. biomedical research, and scandals in human subject research.

What are the major changes in the Revised Common Rule?

The Revised Common Rule introduces some major changes to existing human subject regulation. Key changes that are likely to affect EMU researchers follow.

Changes to Definitions:

The definition of Research is clarified to purposely exclude journalistic endeavors, oral histories, historical scholarship, and data collection for professional, non-research purposes (e.g., public health surveillance, criminal justice activities, and national security purposes).
The definition of Human Subject is changed to include identifiable biological specimens.
The definition of Clinical Trial was expanded to harmonize with the definition used by the National Institutes of Health.

Changes to Informed Consent:

Consent process must begin with a brief summary of essential information that a reasonable person would want to know before agreeing to participate in research.
Consent forms must organize information in such a way to facilitate comprehension.
Consent forms must disclose whether or not research data, including biological specimens, may be used in unspecified future research.
If applicable, consent forms must disclose the following:
For federally-supported clinical trials only, one version of the consent form must be posted after recruitment closes on a publicly available federal website that has yet to be determined.

Changes to Exempt review:

Benign behavioral interventions will now be eligible for Exempt review provided specified safeguards are in place.
More research involving collection of identifiable and sensitive information may be eligible for Exemption with a Limited IRB Review of data privacy and confidentiality protections.
Secondary data analysis of both retrospective and prospective data will be eligible for Exempt review.

Changes to Continuing Review:

Expedited research will no longer require Continuing Review.

Changes to review of cooperative research:

Research conducted by investigators at multiple research sites must rely on a single IRB of record (sIRB). This provision has a different implementation date of January 20, 2020, however, EMU plans to implement sIRB review as much as possible beginning on January 21, 2019.

What does this mean for my research approved after January 21, 2019?

All human subject research approved on or after January 21, 2019, regardless of submission date, will be reviewed in accordance with the Revised Common Rule.

What does this mean for my research approved before January 21, 2019?

Research approved according to current (pre-2018) regulation will continue as approved. Research determined Exempt prior to January 21, 2019 will continue to be Exempt.

The EMU Human Subjects Review Committee decided that all pre-2018 studies that require continuing review will be re-reviewed according to the Revised Common Rule at continuing review time. That is, if a study was approved on December 1, 2018, its approval expires November 30, 2019. For the November 30, 2019 continuing review, this study will be re-reviewed according to the Revised Common Rule. As such, its status may be changed to Exempt if the research methods fall under one of the new Exempt categories. Likewise, if it is reviewed under Expedited procedures, there will be no future continuing review.

How will this affect me and my research?

These changes will affect human subject research in profound ways. The goal is to reduce investigator and administrative burden overall. Specifically, it means that more of the human subject research conducted at EMU will qualify for Exempt review, which has a shorter turn-around time than full review. It also means that fewer studies will require annual continuing review. As with any change, there will be an adjustment period, but the hope is that the burden of regulatory compliance decreases under the Revised Common Rule.

What assistance is EMU providing for the transition to the Revised Common Rule?

There is additional guidance at the end of this page. In addition, the rest of the human subjects website will be revised prior to January 12, 2018 to account for the changes in the Revised Common Rule, the Cayuse IRB application will be revised to account for the changes in regulation, and the consent form templates and samples will be revised.

The Office of Research Compliance will continue to hold office hours on Mondays, Tuesdays, and Thursdays from 1 to 2 pm and by appointment. If you have any questions or concerns, contact the Research Compliance Officer at 734-487-3090 or [email protected].

Additional resources about the Revised Common Rule