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Clinical Trials at UC Davis Health
Changes to Common Rule
Changes to Common Rule
Begins January 19, 2018
The U.S. Department of Health and Human Services and 15 other federal agencies have issued a final rule to update the “Common Rule” regulations that safeguard individuals who participate in research. Key changes to existing Common Rule regulations include:
- Required additional content in informed consent documents.
- Required use of a single IRB for most multi-institution research studies.
- New options for the use of “broad consent” documents for research involving identifiable data or identifiable biospecimens.
- New categories of “exempt” human research.
- Elimination of continuing review requirements for certain human research studies.
- Required posting of consent documents for certain federally funded trials to a public website.
- Elimination of grant congruency review by the IRB.
- New criteria for limited IRB review required for certain exempt categories.
Changes to Registration and Reporting Requirements in Clinicaltrials.gov
January 18, 2017
A new Department of Health and Human Services (DHHS) regulations and National Institutes of Health (NIH) Policy have been issued addressing researchers’ obligations to register at ClinicalTrials.gov. Some of the significant changes under the new Final Rule & NIH Policy include:
- All clinical trials funded in whole or in part by NIH (including behavioral studies) are required to register and report on ClinicalTrials.gov.
- More frequent updating of data elements is required.
- Results information is required for all registered trials, including drug or device product that is not approved, licensed, or cleared by the FDA.
- The data elements required for registration and reporting have expanded.
- Increased penalties for failing to properly register and report including financial penalties and the withholding of DHHS and NIH grant funds.
New International Ethical Guidelines for Health-Related Research Involving Humans
December 2016. The International Ethical Guidelines for Biomedical Research Involving Human Subjects, sometimes informally referred to as CIOMS Guidelines, is a set of ethical principles regarding human experimentation created in 1993 by the Council for International Organizations of Medical Sciences (CIOMS) and updated in 2016. CIOMS is an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949. Updates include:
- GUIDELINE 1: SCIENTIFIC AND SOCIAL VALUE AND RESPECT FOR RIGHTS
- GUIDELINE 2: RESEARCH CONDUCTED IN LOW‑RESOURCE SETTINGS
- GUIDELINE 3: EQUITABLE DISTRIBUTION OF BENEFITS AND BURDENS IN THE SELECTION OF INDIVIDUALS AND GROUPS OF PARTICIPANTS IN RESEARCH
- GUIDELINE 4: POTENTIAL INDIVIDUAL BENEFITS AND RISKS OF RESEARCH
- GUIDELINE 5: CHOICE OF CONTROL IN CLINICAL TRIALS
- GUIDELINE 6: CARING FOR PARTICIPANTS’ HEALTH NEEDS
- GUIDELINE 7: COMMUNITY ENGAGEMENT
- GUIDELINE 8: COLLABORATIVE PARTNERSHIP AND CAPACITY-BUILDING FOR RESEARCH AND RESEARCH REVIEW
- GUIDELINE 9: INDIVIDUALS CAPABLE OF GIVING INFORMED CONSENT
- GUIDELINE 10: MODIFICATIONS AND WAIVERS OF INFORMED CONSENT
- GUIDELINE 11: COLLECTION, STORAGE AND USE OF BIOLOGICAL MATERIALS AND RELATED DATA
- GUIDELINE 12: COLLECTION, STORAGE AND USE OF DATA IN HEALTH RELATED RESEARCH
- GUIDELINE 13: REIMBURSEMENT AND COMPENSATION FOR RESEARCH PARTICIPANTS
- GUIDELINE 14: TREATMENT AND COMPENSATION FOR RESEARCH RELATED HARMS
- GUIDELINE 15: RESEARCH INVOLVING VULNERABLE PERSONS AND GROUPS
- GUIDELINE 16: RESEARCH INVOLVING ADULTS INCAPABLE OF GIVING INFORMED CONSENT
- GUIDELINE 17: RESEARCH INVOLVING CHILDREN AND ADOLESCENTS
- GUIDELINE 18: WOMEN AS RESEARCH PARTICIPANTS
- GUIDELINE 19: PREGNANT AND BREASTFEEDING WOMEN AS RESEARCH PARTICIPANTS
- GUIDELINE 20: RESEARCH IN DISASTERS AND DISEASE OUTBREAKS
- GUIDELINE 21: CLUSTER RANDOMIZED TRIALS
- GUIDELINE 22: USE OF DATA OBTAINED FROM THE ONLINE ENVIRONMENT AND DIGITAL TOOLS IN HEALTH-RELATED RESEARCH
- GUIDELINE 23: REQUIREMENTS FOR ESTABLISHING RESEARCH ETHICS COMMITTEES AND FOR THEIR REVIEW OF PROTOCOLS
- GUIDELINE 24: PUBLIC ACCOUNTABILITY FOR HEALTH-RELATED RESEARCH
- GUIDELINE 25: CONFLICTS OF INTEREST