How to Avoid Problems in the Informed Consent

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

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

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

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

Writing the Consent Document • Written in 2 nd 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.

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

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

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

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.

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. ”

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.

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.

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.

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?

#1 POINT Consent is a Process! Review and Discussion of Informed Consent Document Time for Questions Answers Time to discuss with Family and Friends

Questions?