Writing Better Consent Forms

1. Writing Better Consent Forms Rick Wagner Associate Director Human Research Protection Program Richard.Wagner@ucsf.edu www.research.ucsf.edu/chr

2. Why Consent Forms? • Ethics: • Participants must give voluntary consent for research participation • To be voluntary, consent must be informed • Ethical and regulatory standards: • Written information, signed consent • As part of in-person discussion

3. The Ideal and the Real • An ideal consent process • but really… • An ideal consent form • but really…

4. Goals • Understand the purpose(s) of consent forms • Consider competing priorities • Increase awareness of resources available to help write consent forms • Review and practice writing techniques for clarity and readability

5. Who Reads Consent Forms and What Are Their Concerns?

6. Who Reads Consent Forms and What Are Their Concerns 2?

7. 8 Required Elements of Consent(45 CFR 46) (21 CFR 50) • a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental; • a description of any reasonably foreseeable risks or discomforts to the subject; • a description of any benefits to the subject or to others which may reasonably be expected from the research; • a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

8. 8 Required Elements of Consent (continued) • a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; • for research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained; • an explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and • a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.”

9. 6 Additional Elementsto be added when appropriate • a statement that the particular treatment or procedures may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable; • anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent; • any additional costs to the subject that may result from participation in the research; • the consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject; • a statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and • the approximate number of subjects involved in the study.

10. What Resources Are Available for Writing Consent Forms?

11. What Resources Are Available for Writing Consent Forms? - 2

12. CHR WebsiteConsent Guidance • Consent Guidelines • Consent Form Standards - Section by Section Discussion • Waiver of Consent vs. Signed Consent • Informed Consent for Research Subjects Who Do Not Read, Speak, or Understand English • Surrogate Consent • HIPAA Consent Form Guidance • Sample Consent and Assent Forms / Annotated Outlines(Revised January 2008) • Standard Wording for Consent Forms Used in Letters to PIs(to be revised)

13. Sample Consent and Assent Forms • Biomedical •Biomedical - Cancer •Social or Behavioral •One-time Survey(NEW January 2008) •Simple Blood Draw •Biological Specimens •Consent to Be Contacted For Future Research(HIPAA Compliant)      •Humanitarian Use Device (NEW September 2007)

14. Sample Consent and AssentForms •Assent #1 - For children 7 - 12 (Simple)    •Assent #2 - For more complex study, more mature children     •Assent #3 - For adolescents 13 – 17 •Alternative Lay Language for Medical Terms in Consent Forms

15. More CHR Consent Guidance •VAMC 10-1086 Consent Form •Certificates of Confidentiality •Research Using Human Biological Specimens •Guidelines for Payment of Research Subjects •Consent Form and Review Checklist(to be revised) •Guidelines on Vulnerable Subject Populations

16. And still more CHR Consent Guidance •  Treatment and Compensation for Injury StatementBackground and UCSF Policy  • Experimental Subject's Bill of Rights Amharic/Ethiopian, German, Russian, Arabic, Hebrew, Spanish, Burmese, Hmong, Tagalog, Cambodian, Japanese, Thai, Chinese, Korean, Turkish, English, Laotian, Ukranian, Farsi, Portuguese, Vietnamese, French • Lay Language Resources for Preparing Consent Forms Alternative Lay Language for Medical Terms in Consent Forms, Glossary of Lay Terms, MedicineNet.com •Translation Services

17. UCSF Wording Required • Treatment and Compensation for Injury • “Consent” section • Bill of Rights (“you have been given…”) • HIPAA (“You will be asked to sign a separate form authorizing…”) • Voluntary • If you wish to participate… • Person Obtaining Consent • Dated signature lines

18. Principles of Good Writing For Consent Forms • Everyday vocabulary • Short Sentences • Direct Address (you/we) • Focus on what’s most important • Avoid Repetition • Short Paragraphs • Format for easy reading and reference

19. Everyday Vocabulary • The purpose of this study is to determine the nature and characteristics of immune cells and tumor cells in patients treated with concomitant cisplatin-based chemotherapy regimens and high-dose radiotherapy. • We want to study people who will get both chemotherapy and radiation. We want to see what the treatment does to their tumors and their immune system.

20. Everyday Vocabulary Continued • Determine the nature and characteristics • Concomitant • The following concomitant medications are excluded: • Chemotherapy regimen • High-dose radiotherapy

21. More Everyday Vocabulary • Baseline visit • Dose titration • Efficacious • Prone • Chronic • Instrument

22. Limits on Everyday Language

23. The Goal • A consent form that conveys essential information as clearly and briefly as possible • 8th-grade reading level • Think of your grandparents or great grandparents reading the form

24. Short Sentences • It has been explained to you that you have a cancerous lesion requiring surgical removal, and that because surgery alone may fail to completely eliminate all cancerous cells, you are being asked to participate in a randomized study to compare surgery alone to surgery plus concurrent radiation treatment. • You have a tumor that needs to be cut out in an operation. We may miss some of the cancer when we try to cut it out. We want to see if we can use radiation to kill any leftover cancer. We don’t know if radiation will help, so only half of the people in the study will get radiation.

25. Direct Address/Grammatical Person • Participants will be asked to respond to a quality-of-life questionnaire at days 8, 15, 22, 29 and 35.

26. Direct Address/Grammatical Person • I understand that study participants will be required to attend clinic visits during weeks 4, 8, and 12 to return completed diaries and undergo additional blood draws to test blood lipids and enzymes.

27. Focus on What’s Most Important (Don’t Overload) • If the screening tests show you qualify for the study, the anti-cancer drug therapy on this study will be divided into the following treatment phases: Induction, Consolidation, Interim Maintenance I, Delayed Intensification I, Interim Maintenance II (for Slow Early Responder (SER) patients only), Delayed Intensification II (for SER patients only), and Maintenance.

28. Avoid unnecessary repetition • In the discussion of procedures, be sure to avoid unnecessary repetition. • In the discussion of risks, be sure to avoid unnecessary repetition. • In the discussion of benefits, be sure to avoid unnecessary repetition. • In the discussion of confidentiality, be sure to avoid unnecessary repetition.

29. Use Short Paragraphs • You have a tumor that needs to be cut out in an operation. • We may miss some of the cancer when we try to cut it out. We want to see if we can use radiation to kill any leftover cancer. • We don’t know if radiation will help, so only half of the people in the study will get radiation.

30. Practice Sentence 1 • I understand that by choosing to enroll in this study participants will not be excluded from other prescribed or over-the-counter treatments for their condition, except for other non-steroidal anti-inflamatories (NSAIDs).

31. Practice Sentence 2 • The purpose of this Phase IIA study is to assess whether QA101, with or without I-680-N, at different dose levels injected intramuscularly or subcutaneously, is safe and well-tolerated in patients with late Stage III pancreatic carcinoma.

32. Summary • Use Resources • Start with CHR samples • Keep It Simple • Everyday vocabulary • Short sentences and paragraphs • Use CHR recommended wording…especially if sponsor’s or group’s wording is twice as long and twice as legalistic • Check CHR website for special consent problems and special subject groups