1. December 17, 2014 The Process of Informed Consent Amy Blakeslee, BS, CIP, CCRP HIC Lead Coordinator Yale University School of Medicine Amy Blakeslee, BS, CIP, CCRP HIC Lead Coordinator Yale University School of Medicine

2. December 17, 20142 What is the HIC? Institutional Review Board (Called HIC- Human Investigation Committee at Yale) Committee whose primary responsibility is to protect the rights and welfare of human research participants. Governed by Federal Regulations (OHRP and FDA) Also by Belmont Report (Ethical Principles of Justice, Beneficence and Respect for Persons) Institutional Review Board (Called HIC- Human Investigation Committee at Yale) Committee whose primary responsibility is to protect the rights and welfare of human research participants. Governed by Federal Regulations (OHRP and FDA) Also by Belmont Report (Ethical Principles of Justice, Beneficence and Respect for Persons)

3. December 17, 20143 What is Informed Consent? Example of Ethical Principle of Respect for Persons Not a document, but a process Starts at initial contact (e.g. recruitment) Example of Ethical Principle of Respect for Persons Not a document, but a process Starts at initial contact (e.g. recruitment)

4. December 17, 20144 Continues through study participation an informed participant is better able to adhere to the protocol and therefore provide evaluable data research staff members are obligated to share any new information related to subject’s participation (i.e. newly identified side effects, etc) Continues through study participation an informed participant is better able to adhere to the protocol and therefore provide evaluable data research staff members are obligated to share any new information related to subject’s participation (i.e. newly identified side effects, etc)

5. December 17, 20145 Informed Consent The Document Informed Consent The Document

6. December 17, 20146 All subjects must receive a copy of the ICF document for their records Many participants will refer back to it or take it to show to a loved one USE THE CORRECT (HIC approved!) VERSION NO crossing out/white out—no changes of ANY type without HIC approval All subjects must receive a copy of the ICF document for their records Many participants will refer back to it or take it to show to a loved one USE THE CORRECT (HIC approved!) VERSION NO crossing out/white out—no changes of ANY type without HIC approval

7. December 17, 20147 Written/signed consent may be waived under certain circumstances—this must be approved by HIC on a case-by-case basis Investigators must keep a copy of the signed consent document for their records (in a secure location) Written/signed consent may be waived under certain circumstances—this must be approved by HIC on a case-by-case basis Investigators must keep a copy of the signed consent document for their records (in a secure location)

8. December 17, 20148 Elements-Required by Federal Regulations and HIC policy (see Yale template handout) Involves research Explain purpose of research Expected duration of participant’s involvement Description of procedures (***In LAY terms***--see handout) Involves research Explain purpose of research Expected duration of participant’s involvement Description of procedures (***In LAY terms***--see handout)

9. December 17, 20149 Elements-Required (cont’d) Differentiate between experimental and standard procedures Description of Risks/Discomforts Description of Benefits (**Does NOT include Payments to Subjects) Disclose Alternatives Differentiate between experimental and standard procedures Description of Risks/Discomforts Description of Benefits (**Does NOT include Payments to Subjects) Disclose Alternatives

10. December 17, 201410 Elements-Required (cont’d) Confidentiality Section In Case of Injury Whom to contact with questions Voluntary Participation—free to withdraw at ANY time Confidentiality Section In Case of Injury Whom to contact with questions Voluntary Participation—free to withdraw at ANY time

11. December 17, 201411 Industry sponsored research Sponsors usually provide a template to be used; however the HIC must approve the final version and it must follow the HIC guidelines This is not a ‘contract’ between the participant and the company-both the document and process are meant to inform participants Sponsors usually provide a template to be used; however the HIC must approve the final version and it must follow the HIC guidelines This is not a ‘contract’ between the participant and the company-both the document and process are meant to inform participants

12. December 17, 201412 Informed Consent The Process Informed Consent The Process

13. December 17, 201413 Handing a participant the consent document and asking them to read and ask questions is NOT Informed Consent Verify participant knows diagnosis before proceeding with process (If a treatment study) Handing a participant the consent document and asking them to read and ask questions is NOT Informed Consent Verify participant knows diagnosis before proceeding with process (If a treatment study)

14. December 17, 201414 Should be a discussion which covers what is contained in the document Try to keep it short (people will tune out at a certain point) Tailor presentation to audience. You may want to think about your most unsophisticated relative—what would you like them to know if THEY were the participant Don’t assume people know jargon/acronyms Try to keep it short (people will tune out at a certain point) Tailor presentation to audience. You may want to think about your most unsophisticated relative—what would you like them to know if THEY were the participant Don’t assume people know jargon/acronyms

15. December 17, 201415 Participants should be given ample time to consider options, ask questions and be allowed to take the information home to consider options Pay attention to verbal and non- verbal cues both by YOU and by the person Participants should be given ample time to consider options, ask questions and be allowed to take the information home to consider options Pay attention to verbal and non- verbal cues both by YOU and by the person

16. December 17, 201416 Verify person understands information presented Consider giving a ‘quiz’ after explaining study and before participant signs

17. December 17, 201417 Consent Addendums Very useful when new information has been identified Used to provide currently enrolled subjects about new information (side effects, etc) The Committees seem to be moving toward requiring an addendum HIC has developed a template, available on our website Very useful when new information has been identified Used to provide currently enrolled subjects about new information (side effects, etc) The Committees seem to be moving toward requiring an addendum HIC has developed a template, available on our website

18. December 17, 201418 Special Populations

19. December 17, 201419 Minors Under 18 cannot sign Consent form (Unless pregnant female consenting for research related to pregnancy or on fetus OR under 18 parent consenting for research on child) Minors sign an assent form (should have separate assents for different age ranges eg- 7-12, 13-17) Parents sign permission form Child declining participation trumps parent agreeing unless HIC determines child assent not required Under 18 cannot sign Consent form (Unless pregnant female consenting for research related to pregnancy or on fetus OR under 18 parent consenting for research on child) Minors sign an assent form (should have separate assents for different age ranges eg- 7-12, 13-17) Parents sign permission form Child declining participation trumps parent agreeing unless HIC determines child assent not required

20. December 17, 201420 Non-English According to regulations, the document MUST be in a language understandable to the participant and must contain the same elements as English version—can be a ‘short form’ Consent should be obtained by someone fluent in the participant’s language. This should NOT be a family member According to regulations, the document MUST be in a language understandable to the participant and must contain the same elements as English version—can be a ‘short form’ Consent should be obtained by someone fluent in the participant’s language. This should NOT be a family member

21. December 17, 201421 Non-English (cont’d) Finalize the English version before having it translated. Talk to the translator. All translators listed on the HIC website must meet certain criteria. Finalize the English version before having it translated. Talk to the translator. All translators listed on the HIC website must meet certain criteria.

22. December 17, 201422 Decisionally Impaired May be cognitively impaired, unconscious, mentally disabled, temporarily impaired Informed Consent discussion should happen with next of kin/surrogate OR legally authorized representative When possible, participant’s assent should also be obtained—may be after the research related activities have occurred in the case of participants who are temporarily impaired May be cognitively impaired, unconscious, mentally disabled, temporarily impaired Informed Consent discussion should happen with next of kin/surrogate OR legally authorized representative When possible, participant’s assent should also be obtained—may be after the research related activities have occurred in the case of participants who are temporarily impaired

23. December 17, 201423 And now a word about HIPAA….

24. December 17, 201424 HIPAA RAF (Research Authorization Form) IS NOT a consent form authorization to use and release Protected Health Information for research purposes records to those entities listed on the RAF Consider using a Compound consent form which incorporates HIPAA language into consent form HIPAA RAF (Research Authorization Form) IS NOT a consent form authorization to use and release Protected Health Information for research purposes records to those entities listed on the RAF Consider using a Compound consent form which incorporates HIPAA language into consent form

25. December 17, 201425 Questions? HIC website: http://info.med.yale.edu/hic/ http://info.med.yale.edu/hic/ OHRP website: http://www.hhs.gov/ohrp/ http://www.hhs.gov/ohrp/ FDA website http://www.fda.gov/ HIC 785-4688 HIC website: http://info.med.yale.edu/hic/ http://info.med.yale.edu/hic/ OHRP website: http://www.hhs.gov/ohrp/ http://www.hhs.gov/ohrp/ FDA website http://www.fda.gov/ HIC 785-4688