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

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 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.

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 POINTConsent is a

Process!Time for Questions

Answers

Time to discuss with

Family and Friends

Review and Discussionof Informed Consent

Document

Questions?