1 / 12

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,

ping
Télécharger la présentation

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

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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?

More Related