Consent Coercion Creep Patrick Herbison, MEd, CIP Assistant Director of Compliance Office of Human Research (OHR) patrick.herbison@jefferson.edu These slides contain summaries of regulations (mainly 45 CRF 46) and OHR Policies. Please follow the full regulations and policies.

Consent Regulations Common Rule – 45 CFR 46.116 and 117 Consent – What You Must Do: Obtain consent Give the subject the opportunity to read the consent form Give the subject time to consider participation Consent form must be signed and dated Give the subject a copy of the consent

Consent Regulations Common Rule – 45 CFR 46.116 and 117 Consent – What You Can’t Do: Make the subject waive their rights Release PI/Sponsor/Institution from negligence Use Coercion or Pressure the subject to participate

Coercion, or pressuring the subject to participate, can be subtle: A Print Advertisement A+ Pharmaceuticals has selected Ivyleague University to offer an invitation to people with X needed for a clinical study.

Coercion A Print Advertisement – Note the word choice. A+ Pharmaceuticals has selected Ivyleague University to offer an invitation to people with X needed for a clinical study.

Coercion A Print Advertisement – The only information needed. A+ Pharmaceuticals has selected Ivyleague University to offer an invitation to People with X needed for a clinical study.

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FDA Review of Advertising The Office of Prescription Drug Promotion (OPDP) They “ensure that the information contained in these promotional materials is not false or misleading.” NDA holders must submit advertisements, but they are rarely approved before the ad is used. https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm090142.htm In 2009, only 59 full-time employees were reportedly responsible for reviewing 71,759 industry submissions of . . . promotional material. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278148/

Consent Regulations Common Rule – 45 CFR 46.116 The 8 (13) Basic Elements that Must be in a Consent Form Explain that the study involves research Purpose of the study Duration of the subject’s participation Procedures that will be done Experimental procedures Risks Possible benefits

Consent Regulations Common Rule – 45 CFR 46.116 The 8 (13) Basic Elements that Must be in a Consent Form Alternatives to participating in the study Confidentiality (HIPAA) Compensation/Treatment in case of injury Contact info (study, injury, rights as a research subject) That participation is voluntary Subject may chose not to participate or to withdraw without penalty

Consent Regulations Common Rule – 45 CFR 46.116 The 6 Additional Elements that Frequently Apply and should also be in the Consent Form Unforeseeable risks to subject, unborn child The possibility of ending the study without the subject’s consent What will happen if the subject leaves the study early Any cost to the subject That significant new findings will be provided to the subject Number of subjects in the study

Coercion is creeping into ads, make sure it is not creeping into the consent forms and advertisements you review.

Discussing these elements provides the opportunity to avoid coercion: Study Involves Research Purpose Risks Benefits Alternatives Voluntary Participation

Element with Possible Coercion Element: Study involves research Consent Text: This study involves research. ? ? ? ? ? ? ?

Element with Less Coercion Element: Study involves research Consent Text: This is a research study. The procedures in this study are different than those you would normally have. The drug used in this study is not approved for this use. The purpose of this study is to see if the drug will work for people with your condition.

Element with Possible Coercion Element: Purpose of the Research Consent Text: This new drug is being developed as a cure for your condition.

Element with Less Coercion Element: Purpose of the Research Consent Text: This study is being done to see whether or not an experimental drug would benefit patients with your condition.

Element with Possible Coercion Element: Benefits Consent Text: There is a chance that your condition will improve. You will receive free physical exams. You will receive $500 for your participation.

Element with Possible Coercion Element: Voluntary Participation Consent Text: Your participation in this study is voluntary. 12th grade reading level

Element with Less Coercion Element: Voluntary Participation Consent Text: If you don’t want to take part in this study, you don’t have to. You can stop taking part in this study at any time. 3rd grade reading level

Take Away Consent is a presentation of the facts Take Away Consent is a presentation of the facts. It is not meant to entice people to participate. Make sure that coercion is not creeping into the consent forms you review.

Questions? Thank you!