1. Informed Consent Betty Wilson, CIP, MS Senior Compliance Manager MU IRB Lori Wilcox, EdD Director of Academic Compliance, Corporate Compliance

2. Overview  Developing the Consent  Elements  Types of consents  When each is applicable  Special Populations  Who can obtain consent  Re-consenting  The process  Patient Advocate  Resources

3. Developing the Consent Use the template http://research.missouri.edu/irb/researcher_resources  Work with your Sponsor  Call the IRB  Work with the Patient Advocate in Corporate Compliance

4. Elements  Study involves research, purpose, duration of participation, a description of the procedures to be followed, and identification of any procedures which are experimental  Reasonably foreseeable risks  Benefits  Alternative procedures or treatment  Confidentiality  Compensation/treatments for injuries  Contact information for questions  Voluntary participation/no penalty or loss of benefits

5. Additional Elements (if applicable)  Unforeseeable risks for embryo or fetus  When a subject’s participation may be terminated  Additional cost of participation  Consequences of early withdrawl  Disclosure of significant new findings  Number of subjects

6. Considerations Consent matches the Protocol and Application:  Risks  Study tests/procedures  Windows  Number of subjects Clarity on Investigational Articles Payment/Treatment is NOT a Benefit

7. Additional Considerations Clinicaltrials.gov requirement  Check with sponsor or Corporate Compliance  Add if study will be registered Modify the signature lines to fit the study Two parent - two places to sign AND date Consider the population  Font size  Terminology Consider recruitment

8. Additional Considerations More than One Type of Consent  Written  Waiver of Documentation  Waiver of Consent More than One Consent  Screening  Study  Different phases  Different arms doing different tests

9. Considerations When Applicable: Place In Medical Record (copy) PowerTrials (on and off) Keep the Original! Record retention Do NOT add extra requirements (initial and/or date when not required)

10. IRB Application Describe what you are doing: Multiple steps More than one type of consent Screening: Be clear regarding what data is kept –not shared Screening logs Consent Starts with Recruitment

11. Types of consents  Written Consent  Subject is informed and makes a choice  Consent is documented with signature and date  Waiver of Documentation of Consent  Subject is informed and makes a choice  No signature  Waiver of Consent  Subject does not know about the study

12. Written Consent  Subject signs and dates  Subject receives a copy of the consent  The consent may be required to be placed in the medical record  The person obtaining consent should sign and date  Has the required elements of consent

13. Waiver of Documentation  Consent without signature and date  Minimal risk & Outside of research written consent is not required or  The principal risk of the study is breach of confidentiality and the only link between the subject and the research study is the consent document (*cannot be FDA regulated).

14. When? Survey Studies Telephone screening Studies where the risk is the Breach and the Breach potentially puts the person at risk Illegal behavior Domestic Violence Potentially Damaging to the subject’s reputation

15. Waiver/Alteration of Consent  Minimal risk  Does not adversely affect the rights and welfare  Could not practicably be carried out without the waiver  Whenever appropriate, the subjects will be provided with additional pertinent information after participation

16. When? Complete Waiver:  Screening the record for inclusion/exclusion criteria  Retrospective Chart Review Alteration:  Deception study

17. Special Populations Minors Incompetent Subjects Subjects that cannot read/write English Visually Impaired Non-English Speaking

18. Assent (Minors)  Child category:  404 and 405 (1 parent permission)  406 and 407 (2 parent permission*)  Child assent  Waiver of documentation  Written assent  Waiver of assent (45 CFR 46.408 or 45 CFR 46.116)  Consent when 18! *both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child

19. Assent (Incompetent)  Legally Authorized Representative (LAR)  Temporary (consent when competent)

20. Guidance: http://research.missouri.edu/irb/files/consentin g_subjects_who_do_not_read.pdf Subjects Who Do Not Read, Speak or Understand English

21. Illiterate  Impartial witness observe the consent process (contact the Research Participant Advocate)  Consent materials should be presented orally  Sufficient time for questions  Subjects marks with an X  witness signs and dates attests consent information was accurately explained and that the subject apparently understood the information, and informed consent was given freely

22. Visually Impaired: Large Font Legally Blind  Impartial Witness

23. Recruiting Specific Population/High likelihood  Translated documents  Interpreter Occasional  Short-form IRB APPROVAL  Process  Population Non-English Speaking

24. Consenting Personnel  Greater than Minimal Risk, medical treatment study which would require consent was obtained by a licensed physician outside the scope of research, must have a physician obtain consent for research (i.e.. medical or surgical intervention and dispensation of investigational or prescription drugs).  Greater than Minimal Risk, non-medical treatment studies, consent may be obtained by the non-physician PI or other qualified, active member of the study personnel.  For all other types of research, such as minimal risk studies, consent must be obtained by a qualified, active member of the study personnel.

25. Consent Roles Authorized Participate in the Process Non-Consenting

26. Consenting Personnel  All Key Personnel must be listed on the study  Authorized  Participate in the process  Non-consenting

27. IRB Approval to enroll the population! The current Approved Consent is utilized! The Correct Person is Obtaining Consent

28. Amendments How the change impacts Currently Enrolled Subjects Revise the Consent Consent Addendum:  Not a Complete Consent  Addresses the Change

29. Re-consent Any change that may affect participation  New tests, procedures, surveys  New risks  New conflicts New Risk Information: Stop Enrollment Timeliness = change/information Next visit Call Notify IRB when complete

30. PI Responsibilities Correct Consent Qualified Consenting Personnel Consent is Documented as Required Re-Consent Occurs as Required Subject Understands Subject Receives a Copy

31. Consent is a Process  Starts with recruitment and screening and continues past the close of the study  Real-time checks and balances  Transparency and a complete understanding increase retention, compliance, and validity  Be aware of the information on each page, check dates, initials, & signatures  Document this process as well

32. Role of Corporate Compliance  Research Participant Advocate is a partner throughout the process  Reviews consent in conjunction with IRB application  Please provide RPA contact information within consent document  Available to observe consents for new personnel, special populations, new studies, in conjunction with reviews

33. Compliance, cont.  Ensure consent appropriately discusses potential cost to participant  Can be a partner to discuss problems or issues with recruitment  Will be auditing the consent process for initial and ongoing during the life of the study  In person and surveys of past participants

34. Questions? IRB: 882-3181 Compliance: 882-8957