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

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! Time for Questions Answers Time to discuss with Family and Friends Review and Discussion of Informed Consent Document

22. Questions?