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Informed Consent Waivers and Alterations: Guidelines for the UH Biomedical IRB

Informed Consent Waivers and Alterations: Guidelines for the UH Biomedical IRB. Nancy R. King, MPA, MEd April 20, 2011. Purpose of this Presentation. Describe federal regulations applicable to IRB approval of: Waivers of Informed Consent,

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Informed Consent Waivers and Alterations: Guidelines for the UH Biomedical IRB

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  1. Informed Consent Waivers and Alterations:Guidelines for the UH Biomedical IRB Nancy R. King, MPA, MEd April 20, 2011

  2. Purpose of this Presentation • Describe federal regulations applicable to IRB approval of: • Waivers of Informed Consent, • Waivers or alterations of the federally-required elements of the consent form, and • Waivers of the federal requirement to require documentation of informed consent. • Does not address waivers in Emergency Use situations.

  3. General Informed Consent Requirements • For non-exempt human subjects research that is approved under an expedited review process or by the convened IRB, the IRB is required to approve: • A process to assure the full and voluntary informed consent of all study participants or their legally authorized representative, and • A consent form(s) that contains all of the required elements (see handout).

  4. Unless… • The study qualifies for and the IRB: • Waives the requirement for informed consent, • Approves a consent procedure that does not include all required consent form elements, • Approves a consent procedure that alters any of the required consent form elements, and • Waives the requirement that the PI obtain a signed consent form.

  5. Waiving Informed Consent • To waive informed consent or to waive or alter any of the required consent form elements, the IRB must find and document that: • The research involves no more than minimal risk to the subjects (see handout), • The waiver will not adversely affect the rights and welfare of the subjects, • The research could not practicably be carried out without the waiver, and • Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

  6. Waiving the Signature • To waive the requirement that the PI obtain a signed consent form, the IRB must find and document that: • The research is determined to be minimal risk and involves no procedure for which written consent is normally required outside of the research context; or • 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. In this case, each subject will be asked whether s/he wants any link between him/her and the research to be removed and his/her wishes will govern.

  7. When the Signature is Waived • When the IRB waives the requirement for the PI to obtain documentation of informed consent (e.g., the signature of the participant or legally authorized representative on the consent form)… • …the PI is still expected to obtain full and voluntary informed consent from all participants. • The IRB will typically approve a written statement about the research, that includes the usual consent form elements, to be given to participants.

  8. Examples • From the IRB Member Handbook: • Research involving deception, which rarely applies to research reviewed by the Biomedical IRB. • Review of medical records and collection of usual information pre- and post-surgery (seen as minimal risk with no affect on the participants medical care). • Use of biological materials that were collected for a prior study under which participants consented to use of their samples for future research.

  9. Procedurally, What Should the IRB Do? • When the IRB approves a waiver (or alteration), the motion to approve the study should include a motion to approve: • A waiver of informed consent, or • A waiver (or alteration) of the required elements of the consent form, or • A waiver of the requirement to obtain a signature on the consent form. • Such motions should be documented in the meeting minutes.

  10. Documenting Waiver Criteria • Documentation that the study met the waiver criteria can be accomplished by: • IRB members, who complete the Protocol Review Checklist (page 6) or • Human Studies Program staff, who complete the Staff Screening Checklist. • Documentation will be maintained in the study file.

  11. When these Rules Apply • These rules apply for research approved: • Under an expedited review procedure, and • By the convened IRB. _____ • There are comparable rules that apply to the authorizations required under the HIPAA Privacy Rule.

  12. Questions?

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