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Mastering Informed Consent: Tips for a Smooth Process

Learn key elements, writing techniques, and tips to prevent common pitfalls in the informed consent process to ensure compliance and participant understanding.

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Mastering Informed Consent: Tips for a Smooth Process

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  1. How to Avoid Problems in the Informed Consent Process Shannon Ontiveros, MS, CIP, CIM Institutional Review Board

  2. Agenda • Required elements of consent • Additional Elements • Writing the Consent Document • Reminders to Check • Amendments • Suggestions for Assent Documents • #1 POINT

  3. Research Purpose Duration Procedures Risks/discomforts Benefits Alternatives Confidentiality Whom to contact Compensation/ treatment for research related injury Right with refuse or withdraw Required elements of consent

  4. Additional Elements • Unforeseen risks to subject (fetus) • Anticipated reasons for termination from the study by PI • Costs • Consequences of withdrawal by participant • New findings • Number of subjects

  5. Writing the Consent Document • Written in 2nd person. • Not valid unless the consenter understands the information that has been provided. • The investigator must consider subject population, type of information, and circumstances under which obtaining consent.

  6. Writing the Consent Document • Avoid technical terms • Simple sentences • Translation is required when English is not participants’ primary language

  7. Tools for Simplifying Language • SMOG • Flesch Reading Ease • Flesch-Kincaid Grade Level • Medterms.com

  8. Reminders to Check • Remove template instructions, for example [INSERT if applicable]. • Complete header with version date. • Complete all sections unless not applicable.

  9. Reminders to Check • If you are using a modification of the subject injury language, submit a copy of the contract so that the IRB can verify language.

  10. Problems Often Encountered • Parent consent forms should be written referencing “your child.” • AGE APPROPRIATE LANGUAGE! • Difficulty distinguishing between standard of care and research. • Complete alternative treatment statement, especially when the study involves “treatment.”

  11. Amendments • ALL changes to the consent document must be submitted to the IRB for review and approval, no matter how small! • Update version date when submitting for amendments.

  12. Suggestions for Assent Documents • Under Age 7 • Provide very simple script to communicate to child. • Include dissenting procedures in the parent/legal guardian consent form. • Stress voluntary participation to child. • Not typically a form requiring signature from child.

  13. Suggestions for Assent Documents • Children 7 – 12 • Very simple consent document. • Slightly more detail with regard to study procedures, etc. • Sample question/answer format. • Stress voluntary participation.

  14. Suggestions for Assent Documents • Children 13 – 17 • Federal regulations allow for child to sign form in same language as parent, however, IRB recommends simplifying as much as possible. • More detail regarding study procedures. • Would obtain signature from child. • Discuss confidentiality issues, will parents know outcomes?

  15. #1 POINT Consent is a Process!

  16. Questions?

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