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2018 Revised Common Rule
On January 21, 2019, regulations governing human subjects changed. Major changes include:
- New exemption categories and refinement of existing exemptions, including:
- Research involving benign behavioral interventions that meets certain conditions may be exempt;
- Some research involving use of identifiable secondary information or biospecimens may be exempt when its use is governed by specific confidentiality protections (e.g., HIPAA);
- Surveys and interviews with adults where identifiable sensitive information is collected may be exempt when adequate privacy and confidentiality protections are in place;
- The exemption related to research involving normal educational practices now requires consideration of its effects on students’ education and assessment of educators.
Note: Some exempt research is subject to “limited IRB review”, which is similar to an expedited review process.
- Annual continuing review is no longer required for most minimal-risk research, including research where remaining activities are limited to data analysis.
- Informed consent changes
- New focus on how consent forms are written and how information is presented to participants to facilitate understanding;
- New requirement to inform participants of whether data may be used for purposes other than the current study;
- New requirements to inform participants about potential for biospecimens to be used for commercial profit, whether the research involves whole genome sequencing, and whether clinically relevant results may be returned;
- Obtaining consent prior to screening/assessing eligibility is not required under certain conditions;
- For clinical trials, one IRB-approved informed consent form used to enroll subjects must be posted on a publicly available Federal website within certain timelines.
2018 Common Rule Changes--Summary Documents
- Changes to Continuing Review Requirements -- Summary
- Changes to Exempt Research -- Summary
- Changes to Informed Consent -- Summary
- Changes to Research Definition -- Summary
- Clinical Trials -- Summary
New research proposals reviewed on or after January 21, 2019 will be reviewed in accordance with the 2018 Common Rule and/or applicable FDA or other Agency regulations.
Research approved prior to January 21, 2019 (i.e., “ongoing research”) may either:
- Continue to operate in accordance with the Pre-2018 Common Rule for the life of the study (until closure); OR
- Be transitioned to the 2018 Common Rule.
Upon submission of an action (continuing review or modification), the study will be assessed on a case-by-case basis for determination of whether the project should be formally transitioned to the 2018 Common Rule. Note that transition to the 2018 Common Rule may require protocol modifications, such as changes to the informed consent form.
More details about these changes and the ISU IRB’s plans for transition can be found here.
For more information, you may email Jen Ensley Gorshe at email@example.com.
July 27, 2017: Status of Final Rule Revisions
July 27, 2017: Overview of Final Rule Revisions
July 27, 2017: New and Revised Definitions
July 27, 2017: Overview of Informed Consent Changes
January 17, 2018: Interim Final Rule Delays Common Rule Revisions
April 20, 2018: NPRM Released by HHS and 16 Other Agencies
June 18, 2018: HHS Releases Final Rule to Delay Revised Common Rule