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?