Informed Consent Process and Federal Regulations That Must Be Met to Waive Informed Consent

1. Informed Consent Process and Federal Regulations That Must Be Met to Waive Informed Consent Open Library June 4, 2004 Tracey Craddock Regulatory Compliance Manager Office of the IRB University of Alabama at Birmingham

2. Informed Consent Process Code of Federal Regulations: 45 CFR 46.116 – General Requirements for Informed Consent 45 CFR 46.117 – Documentation of Informed Consent 21 CFR 50.20 – Consent Requirements of the FDA Regulations

3. Informed Consent Process • Consent Form Process Question on the Human Subjects Protocol  a. If the time period between informing the subject and soliciting a decision is less than 24 hours, describe the time sequence considered and the reasons why the 24-hour minimum is neither feasible nor practical.  b. Describe how participants will be "recruited."  c. Please explain how consent will be obtained.  d. Will more project-specific instruments be used in the consenting process?

4. Informed Consent Process • If the time period between informing the subject and soliciting a decision is less than 24 hours, describe the time sequence considered and the reasons why the 24-hour minimum is neither feasible nor practical.

5. Informed Consent Process • How will participants be "recruited?” Recruitment materials such as brochures, advertisements, etc. should be submitted

6. Informed Consent Process • How will consent be obtained? • WHO? • PI, SC • WHERE? • At UAB, Off campus • WHEN? • Timeframe

7. Informed Consent Process • Will more project-specific instruments be used in the consenting process? • Patient information sheets • Video

8. Persons Obtaining Informed Consent • List on the Human Subjects Protocol all personnel who will be conducting the consent discussion and obtaining consent from participants • Include a Signature Line on the consent form for “Person Obtaining Informed Consent (if other than investigator)”

9. Persons Obtaining Informed Consent • All individuals who will be obtaining informed consent must complete an initial, approved training course on human subjects protection and must update their training annually • Check the IRB website at www.uab.edu/irb/training for information regarding training requirements

10. Persons Obtaining Informed Consent • To add or delete individuals from the list of persons obtaining informed consent • amendment to the IRB • Investigator’s Progress Report at the time of renewal • Keep the IRB promptly notified of any changes to the persons obtaining informed consent

11. Waiving Informed Consent • To request a waiver of informed consent, you must address the federal regulations found in 45 CFR 46.116 (d) (1-4) and provide this information in the Human Subjects Protocol

12. Waiving Informed Consent 45 CFR 46.116 (d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:

13. Waiving Informed Consent • The research involves no more than minimal risk to the subjects; • The waiver or alteration will not adversely affect the rights and welfare of the subjects; • The research could not practicably be carried out without the waiver or alteration; and • Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

14. Waiving Informed Consent 45 CFR 46.117 (c) • An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:

15. Waiving Informed Consent • That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern; or

16. Waiving Informed Consent • That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is not normally required outside of the research context. • In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

17. Waiving Informed Consent • Other requirements may apply for research involving children referred to in 45 CFR 46.408

18. Waiving Patient Authorization Human Subjects Protocol HIPAA Questions • A waiver must be approved by the IRB if Protected Health Information from a covered entity is to be used in research without the patients' authorization

19. Waiving Patient Authorization • If you are requesting a partial waiver of patient authorization (required if personal health information is to be used in recruitment processes), you must submit a Partial Waiver of Authorization to Use PHI in Recruiting • If you are requesting a waiver of patient authorization, you must submit a Request for Waiver of Patient Authorization to use PHI in Research. • These forms can be found on the IRB website at www.uab.edu/irb/hipaa.