Informed Consent

Types of Informed Consent

Screening Enrollment Off-site visits Specimen storage In depth interviews/focus groups

Informed Consent Tools Fact Sheets Ring use instructions/Important information sheet IC Booklet Pelvic model and sample ring IC Coversheet IC Comprehension Checklist Visual aids Table top flipchart

Activity Split into two groups.

Whichever team can identify the IC tool first gets a point.

For an additional point, the winning team has a chance to describe the contents/purpose of the tool and give one example of how they might use it in the informed consent session. If they do not get this part correct, the other team has a chance to get the point.

Team with the most points at the end wins.

Critical Components

Setting free of

coercion

The Informed Consent ProcessDiscuss study,

risk/benefits, etc.

Read or allow participant to read the ICF

Assess understanding and willingness

Allow time for understanding

Allow time for understanding

Document Provide/review informed consent booklet

Encourage Questions

ICF Topics

YOUR PARTICIPATION IS VOLUNTARY

PURPOSE OF THE STUDY

STUDY PRODUCTS

STUDY GROUPS

WHAT DO I HAVE TO DO IF

I DECIDE TO TAKE PART IN THE ASPIRE

STUDY?

RISKS AND/OR DISCOMFORTS

BENEFITS

 PREGNANCY

 NEW INFORMATION

 WHY YOU MAY STOP TAKING THE

STUDY DRUG EARLY OR BE

WITHDRAWN FROM THE STUDY

WITHOUT YOUR CONSENT

 ALTERNATIVES TO

PARTICIPATION

 COSTS TO YOU

 REIMBURSEMENT

CONFIDENTIALITY

RESEARCH-RELATED INJURY

YOUR RIGHTS AS A RESEARCH

PARTICIPANT/ VOLUNTEER

PROBLEMS OR QUESTIONS

CONSENT FOR STORAGE AND

FUTURE TESTING OF SPECIMENS

CONSENT FOR OFF-SITE VISITS

Practice With a partner, practice conducting the

informed consent.

“A” Session counselor should start at “Informed Consent” section.

“B” Session counselor should start at “Study Groups” section.

Debrief

How did the mock sessions go? What questions or concerns do you have

about facilitating the IC process?

QA/QC Procedures

How will your site ensure all the correct forms are administered and completed?

What if ICFs go to version 2.0? What systems are in place?