Office of the Institutional Review Board

Common Rule Changes

Revisions to the Common Rule, the primary rule governing human subjects research, go into effect on January 21, 2019.

 

This page provides a summary of key changes that affect study teams and informs how the UTHSA IRB plans to implement these changes.

 

Studies approved after January 21, 2019 will be governed by the new rule. A case-by-case decision will be made for studies altered after January 21, 2019 regarding whether the study should be transitioned to the new rule requirements.

 

Overview of Main Changes

Click on the links below to expand/collapse the content.

 

New & Revised Definitions of Key Terms New & Revised Definitions of Key Terms
  • Research (Revised): Includes activities no longer deemed to be research.
  • Human subject (Revised): Includes use of information or biospecimens through intervention or interaction with a subject and using, studying, or analyzing the information or biospecimens OR using, studying, analyzing or generating identifiable private information or identifiable biospecimens.
  • Individuals with Impaired Decision-Making Ability (Revised): The final rule removes pregnant women as an example of populations that are potentially vulnerable to coercion or undue influence.
  • Benign behavioral interventions (New): 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.
Updates include changes to policies and forms for non-research/non-regulated research and the non-human research. Glossary terms will be revised to include the new and revised terms.

 

 

New & Revised Categories of Exempt Research New & Revised Categories of Exempt Research
  • Exemption 1 – restrictions now include the condition that research is not likely to have adverse impacts on students learning, required educational content, or assessment of educators who provide instruction.
  • Exemption 2 – the category was expanded to include visual or auditory recording as research methods and Limited IRB Review where identifiable information is collected.
  • Exemption 3 – this is a new category requiring Limited IRB Review for benign behavioral research with adults where identifiable information is collected.
  • Exemption 4 – the category has been expanded and added a new component. This category covers research use of identifiable private information or identifiable biospecimens that are publically available or information/biospecimens recorded by an investigator which renders the information/biospecimens de-identified. Includes prospective collection. Research is conducted by, or on behalf of, a Federal agency using data collected or generated by the government for non-research purposes, and the information is protected by federal privacy standards.
  • Exemption 5 – this category has been expanded to allow research supported by a federal agency. Research has to be designed to study, evaluate, improve, or otherwise examine public benefit or service programs.
  • Exemption 6 – No Change
  • Exemptions 7 & 8 will not be used at this time.
The Exempt Research Policy and Procedure and Form B-3 will be updated to reflect these changes.

 

 

Eliminating Continuing Review for Certain Minimal Risk Research Eliminating Continuing Review for Certain Minimal Risk Research
  • Continuing review not required for:
    • Research eligible for expedited review (unless required by the Expedited Reviewer)
    • Research that has had limited IRB review
    • Research that has completed all interventions and is now limited to analyzing data (even if the information/biospecimens are identifiable)
    • Research that has completed all interventions and is now limited to accessing follow-up clinical data from clinical care
UTHSA institutional review (brief project update) will be required every 3 years.

Continuing review will still be required for FDA-regulated unless the FDA harmonizes with the revised Common Rule. UTHSA IRB and Institutional policies will be updated to incorporate these changes.

IRB determination letters will indicate whether or not continuing review is required (at initial review or during continuing review).

 

 

Key Informed Consent Revisions Key Informed Consent Revisions
  • New Process – Concise Summary of Key Information Presented Before “Body” of Consent
    • Must provide information a reasonable person would want to have
    • Emphasize the need to get essential information to prospective subjects
    • Organize document to provide sufficient detail but also facilitate understanding
    • Present Key Information First
  • New Basic and Additional Elements to serve as notice about:
    • Whether information and biospecimens collected as part of the current research might be stripped of identifiers and used for future research;
    • A subject’s biospecimens, even if identifiers removed, may be used for commercial profit and whether the subject will or will not share in the commercial profit.
    • Whether clinically relevant research results, including individual results, will be disclosed to subjects, and if so, under what conditions.
    • Whether the research including biospecimens will or might include whole genome sequencing
  • Changes to Waiver Criteria for Informed Consent
    • Applies to research with identifiable private information or identifiable biospecimens
    • IRB must determine that the research could not practicably be carried out without using the information/biospecimens in an identifiable form
  • Exception to consent requirement for screening and recruitment
    • IRB not required to waive consent for investigators to record identifiable private information for screening, recruiting, and determining eligibility
  • 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 clinical trials conducted or supported by a federal department or agency.
The UTHSA IRB will revise the informed consent policy as well as IRB consent templates (Forms D, D-1, E, E-1) to incorporate the required elements. Posting of consent forms will be a requirement for UTHSA institutional activation.

 

 

More information regarding the Revised Common Rule implementation will be discussed at the IRB Forum on Thursday, November 29, 2018 at 3:00 pm (MED 409L).

 

The IRB and OCR websites will be revised to reflect new and revised forms and processes prior to the effective date of January 21, 2019.