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

2. 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

3. 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

4. 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.

5. 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.

6. 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.

9. =

10. 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.
In 2009, only 59 full-time employees were reportedly responsible for reviewing 71,759 industry submissions of promotional material.

11. 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

12. 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

13. 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

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

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

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

17. 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.

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

19. 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.

20. 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.

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

22. 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

23. 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.

24. Questions? Thank you!