QI Program Fall Series

1. QI Program Fall Series Case Studies: The Informed Consent Process BWH October 4, 2007 MGH October 17, 2007

2. Case Studies: The Informed Consent Process For full text/content of cases presented, please contact Julie Kaberry: jkaberry@partners.org 1.617.424.4138

3. Informed Consent: The Process Informed consent is a process ~ Both a written process and communication process that starts before the research is initiated and continues throughout the duration of the study. Your role is to ensure that the subject adequately understands the information and after considering the information, has arrived at a decision to participate without coercion or undue influence.

4. Informed Consent: Common Challenges • Providing an environment where the subject is not intimidated or influenced by others • Assessing a subject’s level of understanding and determining competency • Ensuring proper documentation of the consent process

5. Informed Consent: Reality Use the PHRC informed consent policies, but view the big picture? • Is the subject alert and physically able to read the consent form in its entirety? • Is English the subject’s primary language? • Is the subject under any pressure (from family, lack of medical insurance, terminal illness) to participate in the research? • Is there time for the subject to ask questions and get answers before participation? • Is the Principal Investigator available? • What does to IRB approved protocol say about the consent process?

6. Case #1: Surrogate Consent • Mr. Sullivan is awake and alert during initial discussion • Wife leads discussion and answers questions • Mr. Sullivan verbally agrees to participate but does not sign consent form at that time • Consent is left overnight for subject consideration • Mr. Sullivan physically unable to sign consent form the next morning (off to the OR) • Mrs. Sullivan signs for her husband

7. Case #1: Discussion Points • Can Mrs. Sullivan consent for her husband? • What could Christine have done once she realized Mr. Sullivan was unable to provide consent? • Should Mr. Sullivan’s prior verbal consent weigh into Christine’s decision? • What about the physical environment is notable? • What ‘next steps’ should Christine can take to ensure proper documentation of the consent process for this subject? • Anything done well in this scenario?

8. Case #2: Non-English Speaking • Mr. Evangeliou is a new patient whose primary language is Greek • Mr. Evangeliou and his family are excited to have an appointment with Dr. Duggan • The family is serving as his “voice” and interpreting during the clinic visit • Using the family to translate, Dr. Duggan touches on important aspects of the study • Emma begins collecting study data • Procedures include a home-grown questionnaire

9. Case #2: Discussion Points • Should the Evangeliou children translate for their father? • Who and/or what is missing from this consent process? • Is their anything coercive about this environment? • What role (think coercion) can Emma play to assist in this process?

10. Case #3: Documentation of Informed Consent • Consent is to be obtained by licensed MD only • Research team knows these subjects well • Coordinators consent subjects but do not sign the consent form (to comply with PHRC policy) • Subjects are asked if they wish to speak with PI, and most subjects decline • The PI or co-investigator provides their signature on the consent form • Study is amended and requires subject re-consent

11. Case #3: Discussion Points • Does the licensed MD signature on the consent form comply with the PHRC policy? What does the signature represent? • Can the coordinator re-consent the subjects and sign (seeing as they spoke with them about the study initially and the modification is not investigational drug related)? • Anything done well in this scenario?

12. Case #4: Documentation of Informed Consent • Subjects are aged 18-25 and do not live on college campuses/dorms • Study is of sensitive nature (sexual habits) • Majority of subjects are not taking their consent form copy with them as required • The copy not taken by the subject is being filed with the original

13. Case #4: Discussion Points • Why might the subject not want to take a copy of their consent form? • Should the study site keep the copy on file if the subject refuses? • What if anything can the study site do in preparation for the QI Review? • What reporting to the IRB is required to correct this issue? • What is a ‘next step’ to rectify the problem?

14. In the Hot Seat It’s been an uneventful day and then you are faced with the following. What do you do? 1. You are enrolling minors (aged 12-16) in a questionnaire study looking at attitudes/behaviors concerning drug and alcohol use. The IRB asked you to obtain parental consent. A potential subject arrives without a parent and informs you that she is 14 and pregnant. Pregnancy is not an exclusion criterion, but by Massachusetts state law the subject is an emancipated minor and can consent for herself. Or can she?

15. In the Hot Seat It’s been an uneventful day and then you are faced with the following. What do you do? 2. You are unpacking from a recent office move and notice that you seemed to have misplaced one of your study binders. It is the binder in which you were filing all original signed/dated subject consent forms.

16. In the Hot Seat It’s been an uneventful day and then you are faced with the following. What do you do? 3. The co-investigator you are working with has consented several subjects for a study. It is your responsibility to call and remind them of the MRI for which they are scheduled as part of participation. When speaking with subjects, the majority seemed confused, stating things such as “What MRI” and “I do not recall that being part of this study”.