Office of Responsible Research Practices
The Ohio State University

Common Rule Revisions

The resources below were developed to help the Ohio State human subjects research community understand the revisions to the Common Rule that went into effect on January 21, 2019. Please check back often as updates will be made on an ongoing basis.

What the Final Rule Changes Mean for Your Research
Overview Definitions
Continuing Review Exempt Research
Informed Consent Cooperative Research

The final rule contains several major revisions to the requirements for informed consent. The changes are specifically intended to make informed consent more meaningful so that research subjects have the necessary information to make informed decisions, as follows:

  • New requirements relating to the content, organization, and presentation of information included in the consent form and process to facilitate a prospective subject’s decision about whether to participate in research. The informed consent documents/process must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This provision further requires that this beginning portion of the informed consent must be organized and presented in a way that facilitates comprehension.
  • New basic element of informed consent
    The informed consent form and process must inform the participant that:

    • Identifiers might be removed from the data and that the non-identified data could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the representative, if this might be a possibility; or
    • The subject’s data collected as part of the research, from which identifiers are removed, would not be used or distributed for future research studies.
  • New additional elements of informed consent
    • A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit;
    • A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions;
    • When appropriate for research involving biospecimens, subjects are informed of whether the research will (if known) or might include whole genome sequencing (WGS).
  • Broad consent for the storage, maintenance, or secondary research use of identifiable private information and identifiable biospecimens; permissible only for secondary research and no other types of research. Must include an additional element that specifically addresses whole genome sequencing.
  • Waiver or alteration of informed consent:
    • If an individual was asked to consent to the storage or maintenance for secondary research use of identifiable private information or identifiable biospecimens in accordance with the proposed broad consent provisions and such individual refused to consent, the IRB would be prohibited from waiving consent for the storage, maintenance, or the secondary research use of such biospecimens or information.
    • A new waiver criterion which mandates that for research involving access to or use of identifiable private information or identifiable biospecimens, the requirements of informed consent can be waived or altered only if the research could not practicably be carried out without using such information or biospecimens in an identifiable format.
  • A new provision that allows IRBs to approve a research proposal for which investigators obtain information or biospecimens without individuals’ informed consent for the purpose of screening, recruiting, or determining the eligibility of prospective human subjects of research, provided certain conditions are met.
  • A new requirement to post to a federal website a copy of an IRB-approved version of the consent form that was used for enrollment purposes for each clinical trial conducted or supported by a federal department or agency.  The consent form is posted after recruitment closes, but no later than 90 days after the last study visit.  The primary purpose of this provision is to improve the quality of consent forms in federally funded research by assuring that they would eventually subject to public scrutiny and would provide useful models for others.