Short Consent Forms: More with Less?

1. Short Consent Forms: More with Less? James Flory, BA Bioethics Fellow Department of Clinical Bioethics Warren G. Magnuson Clinical Center National Institutes of Health

2. Background • Investigators want at least two things from our consent forms: • To promote research participants’ understanding • To meet regulatory requirements

3. Disclaimer The views expressed in this presentation do not represent the views of the NIH, the United States DHHS, or any other government agency or official.

4. Consent Form Length • Oncology Phase I Consent forms at NCI have median length 6-7 pages. • This seems representative of consent forms in other areas Horng S et al. 2002

5. Too Long? • Consent forms this long or longer can give detailed information • But many people will not finish reading them • Or will be confused by the detail and complexity of what they do read

6. The Short Form • A SHORT, 2-3 page form would be more manageable • More people might read and understand it

7. Objections • Can a short form contain the information required by ethics and the law? • Must disclose all required information • Must give participants an accurate idea of what their participation will entail

8. Yes! • We have produced short forms that are 1/3 the length of the consent forms actually in use • While covering the information required by 45 CFR 46 • And receiving favorable comments from IRBs

9. What is there to gain? • Short forms should be no harder to write than the long forms in current use • We hypothesize their effect would be marginal improvements in understanding • And more significant gains in time saved and improved satisfaction for research participants

10. How to write a short form • Base form on protocol • Make sure all 8 elements required by 45 CFR 46 are there • Along with appropriate recommended elements • Express each element as concisely as possible

11. How to write a short form 1) Avoid digression 2) Avoid unnecessary background 3) Avoid boilerplate 4) Avoid repetition 5) Avoid repetition 6) Write from reader’s perspective

12. Two examples •Phase III oncology protocol: 4,126 words (11 pages)  1,319 words (3 pages) •Study of Circumcision and HIV Prevention in Rural Uganda 2,317 words (6 pages)  753 words (3 pages)

13. Specific Example • For a specific example, let’s compare how both versions of the oncology consent form address one required piece of information: • Study Purpose

14. Long Form: Study Purpose(1) • Why is this study being done? This study is being done in patients who have had surgery for colorectal cancer. It is being done to: • Find out the effectiveness of the following three different combinations of drugs in preventing the return of your colon/rectal cancer. These treatments (namely irinotecan and oxaliplatin) are considered experimental in the stage of colon cancer that you have.

15. Long Form: Study Purpose(2) • Arm A: Oxaliplatin, 5-FU, and CF • Arm B: Irinotecan (CPT-11), 5-fluorouracil (5-FU), and CF • Arm C: Treating first with Oxaliplatin, 5-FU, and CF and then treating with Irinotecan, 5-FU, and CF • See whether patients get better results in one or more of these groups. • Compare the side effects in the different groups of patients in the study

16. Long Form: Study Purpose(3) • Compare the effects of treatment on your quality of life (changes to daily routines and feelings of overall health). • See if there is any interaction between such things as your lifestyle habits, medication use or dietary patterns and the molecular markers contained within your tumor. • See if your eating habits affect the chances of getting your cancer back.

17. Long Form: Study Purpose(4) • We will look at markers in tissue or blood specimens obtained from you to determine whether these markers can be used to predict whether your tumor responds to chemotherapy or the chance that your cancer will recur. These studies are for research purposes and have not been accepted into routine medical practice. • It is not possible at this time to know whether your participation in this study will improve your chances of cure.

18. Short Form: Study Purpose • What is the purpose of this study? We are conducting this research study to compare three combinations of drugs to find out which combination best prevents your colon cancer from coming back and extends your life. We are also interested in the side effects you have from the drugs, your quality of life, and how your habits, like smoking and eating, affect your cancer.

19. That’s it!

20. What changed? • Long version was more detailed, sometimes confusingly so • “interaction between such things as your lifestyle habits, medication use or dietary patterns and the molecular markers contained within your tumor” • Goes to “how your habits, like smoking and eating, affect your cancer”

21. What changed? • Long version contained information given elsewhere in the form: • Drug names • “these treatments, namely irinotectan and oxaliplatin, are considered experimental in the stage of colon cancer that you have” • This information is repeated in the study plan section

22. What changed? • Long version went into some detail on stored tissue • The short form kept all that information in a section devoted to stored tissue

23. Brevity good? • Do we omit important details? • Could repetition actually be a good thing? • Would you do a short form differently? • Would you not do a short form at all?

24. Another Example • A consent form for a trial of circumcision to prevent HIV transmission in rural Africa • Risks section especially important due to concerns that participants might have a false sense of security from HIV

25. Long Form: Risks (1) Risks from being in the study: Potential risks include: risks of surgery for the men who receive circumcision risks associated with collection of interview information and of specimens for HIV and STD testing.

26. Long Form: Risks (2) Risks of surgery: The complications include:- pain, bleeding, swelling, and infections following surgery, and temporary numbness following the local anaesthesia.Complications are rare if circumcision is done properly (usually less than 2 out of 100 men experience complications).

27. Long Form: Risks (3) We will minimize these risks by having well trained doctors, ensuring that all things used for surgery and wound dressing are completely sterile, and by giving pain medicine. We will follow up participants to ensure proper wound healing, and provide care in the Kalisizo clinic or referral for free care to hospitals if needed.

28. Long Form: Risks (4) Rarely, men may get allergic symptoms such as rash, swelling or difficulty in breathing due to the pain medication the substance used to clean the skin before surgery of the immunization. We have medicines to treat this type of allergy. The medicines to control pain may make some people drowsy, dizzy and unsteady.

29. Long Form: Risks (5) Risks associated with collection of interview data and samples for HIV and STD testing:In the screening consent we described the risks associated with collection of interview data and samples that may occur at any time in this study. Do you have any questions about these risks?

30. Long Form: Risks (6) If at any time you feel you have experienced any negative effect or have been injured because you participate in the study, you can contact Dr. D. Serwadda or his representatives (named below).Please note: we do not know if circumcision reduces a man’s risk of getting HIV or STDs. Even if circumcision does

31. Long Form: Risks (7) reduce the risk, a circumcised man can still get HIV. Thus, we strongly advise you to always practice safe sex. As you know, safe sex means abstaining from sex, or only having sex with a regular spouse or partner who you know is HIV-uninfected, or using condoms whenever you have sex with a casual partner or someone whose HIV status you do not know.

32. Long Form: Risks (8) If men are HIV-infected there is a risk that they might transmit the infection to their partners, and this risk may be particularly high if intercourse is resumed before the surgical wound has healed. Therefore, it is important to abstain from sex until wound healing is complete and to always use condoms during intercourse.

33. Short Form: Risks (1) Risks: After your circumcision, you must have NO sex for 1 month, because during that one month you will have more risks of infection and transmission of HIV and other infections.

34. Short Form: Risks (2) Possible risks of circumcision are:1) There is very likely to be pain requiring medication. 2) Less likely is numbness or increased sensitivity that usually lasts only several days3) More rarely infection, pain or bleeding that will require additional treatment (2 out of 100 men) and if you have them, you will be treated or referred to a hospital.

35. Short Form: Risks (3) 4) The drug for pain or the vaccine for tetanus can both have side effects like rash and swelling, but the study has medicines to treat those side effects. The medicines for pain can also make you dizzy or drowsy. Other risks include social risks, such as embarrassment and other discovering you have HIV. This will be minimized by doing interviews in private and keeping records private.

36. Short Form: Risks (4) If you are injured you will get free treatment and transport to hospital and free hospital care, but no personal payment. A circumcision does not cure HIV or prevent you from getting or transmitting HIV. You still must engage in safe sex.

37. What Changed Here? • Again, some repetition eliminated • E.g., not necessary to give contact info in Risks, since there is a separate section of the consent form for contacts • Otherwise, level of detail is considerably reduced • Able to heavily emphasize major risk of having sex within one month of circumcision

38. Brevity good? • This discussion of risks is very important • Was there too little detail in the short form? • Or does the short form’s brevity make it easier to take in crucial points? • Concerns about safe sex may be clearer from the short version