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2018 Revised Common Rule

2018 Revised Common Rule. Informed Consent (SBER). NOTE & DISCLAIMER. January 21, 2019 is both the effective date and the compliance date for the Revised Common Rule.

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2018 Revised Common Rule

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  1. 2018 Revised Common Rule Informed Consent (SBER)

  2. NOTE & DISCLAIMER • January 21, 2019 is both the effective date and the compliance date for the Revised Common Rule. • This means that applications currently submitted and awaiting review may require revision based on the revised common rule requirements.  Please be patient...

  3. TOPICS • Introduction and Background • Major Changes • Sample Consent Form

  4. ABOUT THE REGULATIONS • Common Rule – Federal regulations governing human subjects research • U.S. Department of Health and Human Services (HHS) regulations - 45 CFR 46, Subpart A “Federal Policy for the Protection of Human Subjects” • Current regulations published in 1991

  5. THE NEW REGULATIONS • The Revised Common Rule (2018 Common Rule) was published on January 19, 2017 • Effective date is January 21, 2019 • Why revised? • The revisions are intended to: • Better protect human subjects involved in research • Facilitate research • Remove ambiguity • Reduce regulatory burden

  6. MAJOR CHANGES • “Key information” at beginning of consent document • New required elements of consent • Changes to waiver criteria and documentation • “Broad consent” option

  7. ADDED BONUS • The HIPAA language is being incorporated into the consent form • There will be a new section in the revised Sample Consent Form: Confidentiality and Authorization to Use and Disclose Information for Research Purposes

  8. KEY INFORMATION • The consent form must begin with a “concise and focused presentation of the key information” that will assist subjects in deciding why they might or might not want to participate in the research. • Key information must be organized and presented in a way that facilitates comprehension. • Key information appears at the beginning of the consent form and is presented first in the consent discussion.

  9. KEY INFORMATION • The key information is information that a “reasonable person” would want to have. • Investigator is still responsible for providing more information when requested by subjects, allowing sufficient time and opportunity to discuss the research, and answering questions from subjects.

  10. KEY INFORMATION Five Factors

  11. KEY INFORMATIONConcise Summary Table [Insert applicable Concise Summary Table – see samples in separate document]

  12. DRAFT - Concise Summary for Drug/Device Study

  13. DRAFT - Concise Summary for Other Treatment or Intervention Study (No Drug/Device)

  14. DRAFT - Concise Summary for Survey & Focus Group Study

  15. FOUR NEW ELEMENTS For research that involves collection of identifiable private information or identifiable biospecimens, include a statement indicating whether: • identifiers may be removed, and • de-identified information or biospecimens may or may not be used or shared for future research

  16. DRAFT of the Revised Sample Consent

  17. FOUR NEW ELEMENTS For research involving use of biospecimens, include a statement indicating whether: • biospecimens may be used for commercial profit, and • the subject will share in that profit

  18. DRAFT of the Revised Sample Consent

  19. INFORMED CONSENT – FOUR NEW ELEMENTS For research expected to generate clinically relevant results, include a statement indicating whether: • the clinical results (including individual research results) will be returned to the subject, and • if so, under what conditions

  20. DRAFT of the Revised Sample Consent

  21. INFORMED CONSENT – FOUR NEW ELEMENTS For research involving whole genome sequencing, include a statement that the research will or might include whole genome sequencing

  22. DRAFT of the Revised Sample Consent

  23. INFORMED CONSENT – BROAD CONSENT • Broad consent is an optional, alternative consent process for use only for the storage, maintenance, and secondary use of identifiable private information or identifiable biospecimens for unspecified future research • Requires recording and tracking who has agreed to or refused consent • Requires you apply that agreement/refusal of consent to all secondary use research – waivers would no longer be allowed UAB notadopting broad consent at this time.

  24. STAY TUNED

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