FAQs and Additional Info

Common Rule Changes

Changes to regulations governing human subjects research, as outlined in 45 CFR 46 (also known as the Common Rule) were published in the Federal Register in January, 2017. The majority of rule changes will take effect Jan 19, 2018. The amended rules are the first significant changes to these regulations since 1991.

As of Jan 4, 2018, a proposal to delay the changes is currently under review by the OMB Office of Information and Regulatory Affairs (OIRA). With the indication that OIRA is reviewing a final rule, we would hope to see a final rule implementing a delay published prior to the current January 19 effective date.

Summary of Changes

  • Effective January 19, 2018 (but that still could change!)
  • Consent forms must begin with a concise and focused presentation of the key information. The IRB will not require already-approved studies to re-consent, except when other significant changes would require re-consent.
  • Updates to the Exempt Categories:
    • (1) Research, conducted in established or commonly accepted educational settings
      • NEW: A new ineligibility criterion will be added to this interaction/intervention exemption for research that involves possible "adverse effects" on student learning of the required education content and/or on the assessment of educators
    • (2) Research that only includes interactions involving educational tests, survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) of adults (no children)
      • NEW: The scope will be expanded to include the collection of sensitive and identifiable data. However, the following is not allowed:
        • Interventions
        • Collection of biospecimens
    • NEW CATEGORY: (3) Research involving benign behavioral interventions with adult subjects (no children) if the subjects prospectively agree to the intervention and information collection
      • Benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing (e.g., online game, solve puzzles, decide how to allocate a nominal amount of cash)
      • The research may not involve deception unless prospective agreement
    • (4) Secondary research uses of identifiable private information or identifiable biospecimens
      • NEW: Prospective data review
    • (5) Research and demonstration projects that are conducted or supported by a Federal department or agency
      • NEW: A new eligibility criterion for this interaction/intervention exemption will be that the project must be published on a federal website.
    • (6) Taste and food quality evaluation and consumer acceptance studies
      • NO CHANGES
    • NEW CATEGORY: (7) Storage or maintenance of identifiable data/specimens if IRB conducts a limited review
      • Broad consent is required
    • NEW CATEGORY: (8) Secondary research for which broad consent is required if consent is obtained (documented or waived) and IRB conducts a limited review
      • Limited IRB Review is to ensure that adequate provisions are in place to protect privacy and confidentiality
      • Continuing review is no longer required for minimal risk research (expedited, limited IRB review, or any research limited to analysis of identifiable data)

    Frequently Asked Questions and Additional Information

    Frequently Asked Questions

    Investigator resources
    Help for those conducting human subjects research.

    IRB member resources
    Forms and resources for IRB members reviewing human subjects research.

    Research participant resources
    Information for those individuals participating in human subjects research.