1. WRITING CONSENT FORMS FOR RESEARCH SUBJECTS Research Administration & Development

2. WHO IS THE FH REB ? Meets TCPS & Health Canada quorum requirements Co-Chairs/Primary Reviewers: Dr. Allan Belzberg [SMH] Dr. Marc Foulkes [RCH] Primary Reviewers: Dr. Bob Gillies [Pharmacy] Dr. Michael Vince [RCH lab] Dr. Arthur Friesen [RCH Cardiologist]

3. WHO IS THE FH REB ? Ethicist: Prof. Lindsay Meredith [SFU] Statistician: Michael Wasdell Legal Representation: Ms. Camille Ciarniello [LLB] Ms. Mara Stickland [LLB] Lay member: Mrs. Nancy Magnees

5. OBLIGATIONS OF THE REB “ The consent form is not meant to reassure the subject, quite the contrary, it is meant to raise every possible concern that might be relevant to the subject’s participation.” Time 2002 April 22

6. APPLICATION FORM BOX 28 28a. Will the data be completely anonymized (i.e. the data becomes anonymous because it is completely stripped of all identifiers such that there is no possibility of relinking data to the subject’s identity)? Yes No 28b. If NO, will the data be “de-identified” by using a unique code ONLY before leaving the FH site? Yes No 28c. If YES, describe how the data will be “de-identified”. 28d. If NO, describe what identifier(s) will be used. e.g. DOB 28e. Clarify where the data will reside. Will it be kept at FH or sent elsewhere. Specify location if sent offsite.

7. THE CONSENT FORM: A LEGAL DOCUMENT Three basic elements: 1.Complete and Accurate Information 2.Readable -well organized -lay terms -grade 7 level 3.Voluntary -avoid coercion and undue influence FH REB Consent Form Template @ http://www.fraserhealth.ca/Initiatives/Research/Forms+and+ Templates.htm http://www.fraserhealth.ca/Initiatives/Research/Forms+and+ Templates.htm

8. Common Consent Form Errors First Page Introduction Your Participation Is Voluntary Who Is Conducting The Study? Background What is the Study Purpose? Who Can Participate In the Study? Who Should Not Participate In The Study? What Does The Study Involve? What Are My Responsibilities? What Are The Possible Harms And Side Effects Of Participating? What Are The Benefits Of Participating? What Are The Alternatives To The Study Treatment

9. Common Consent Form Errors What If New Information Becomes Available? What Happens If I Decide To Withdraw My Consent? What Happens If Something Goes Wrong? Can I Be Asked To Leave The Study? After the Study Is Finished What Will This Study Cost Me? Will My Taking Part In This Study Be Kept Confidential? Contact For Questions About Study Participation Contact For Questions About Subject's Rights Subject Consent Signatures Other Consent Issues Format Guidelines

10. Titles: for optional studies, always include “Optional” in the title Co-investigators: Emergency Contact #: if applicable

11. Introduction: “you are being invited to participate” because you have/are….. Your Participation is Voluntary: –free to participate –free not to participate –free to participate and to withdraw at any time –no explanation required –discuss with others Who is Conducting Study? –Differences between a ‘sponsor’ and a ‘grant’

12. Background: Describes: –extent of the problem, i.e. incidence, prevalence –significance of problem –previous research [animal and human] –Links to Purpose Purpose = Objective

13. Who Can Participate: Inclusion criteria Who Cannot Participate: Exclusion criteria that lay person knows of –pregnancy –disease –use of drugs/alcohol –Age/gender

14. WHAT DOES THE STUDY INVOLVE? When – duration and # visits, Where – as inpatient/outpatient/home How – type of design: –RCT, placebo-controlled, standard care –Experimental intervention - tests –Data collection only – questionnaire/interview

15. Specific Treatment Procedures Under MRI scan: State that the subject will be in a confined space and there could be a risk of claustrophobia Describe ECG, blood tests Consistency, e.g. –This paragraph states that “blood will be collected from you at one additional time” while page 3, states that “before each treatment …some blood…will be taken…”. Reconcile these 2 statements to clarify how often blood is collected and for what purposes.

16. Consistency: Under Lab Tests: Provide an equivalent measure for the total amount of blood. Describe how the blood will be taken and from what location in the body. Delete “part of the blood sample will be processed….” as the protocol states that this site is not participating in these optional exploratory studies.

17. Data Collection: Specify where data comes from – i.e. medical chart Subject Responsibilities Specific instructions Reporting side effects Reporting pregnancy

18. Harms Quantify, quantify, quantify the risk of the harm! Table format Provide a lay equivalent for the exposure to X-rays Benefits Usually benefits other than to knowledge and society should never be promised – avoid coercion

19. Alternatives to Study Treatment? –Applicable only to therapeutic trials New Information What Happens if I Withdraw My Consent? - “By law, this data cannot be destroyed”

20. What Happens if Something Goes Wrong –Delete “No further compensation…available”. Can I Be Asked to Leave the Study? –Complete withdrawal without explanation/safety issues After the Study is Finished –Expensive drugs What will the Study Cost Me? –Explain how subjects can be reimbursed for expenses

21. Confidentiality : Personal = Identifiable Health Information cannot be retained –Sponsor ?, Health Canada ?, FDA ? FHREB always –Data Protection sections should be replaced with standard FHREB wording Your confidentiality will be respected. You will be assigned a unique study number as a subject in this study. Only this number will be used on any research-related information, including medical records, personal data and research data, collected about you during the course of this study, so that your identity [i.e. your name or any other information that could identify you] as a subject in this study will be kept confidential. [Explain where the research- related information will be sent]. Information that directly discloses your identity will remain only with the Principal Investigator and/or designate. The list that matches your name to the unique identifier that is used on your research-related information will not be released without your knowledge and consent unless required by law or regulation.

22. Identifiable Data “It is unusual to include [name the non- standard identifiers, e.g. date of birth] on research records and material forwarded to others. Most studies submit information identified by code numbers or letters only.”

23. No information that discloses your identity will be released or published without your specific consent to the disclosure. However, research records and medical records identifying you may be inspected in the presence of the Investigator or his or her designate by representatives of Amgen Inc., Health Canada, the U.S. Food and Drug Administration, and the FH Research Ethics Board for the purpose of monitoring the research. These personnel are required to keep your identity and personal information confidential. However, no records which identify you by name will be allowed to leave the Investigators' offices.

24. Out of Canada -disclosure required by FOIPPA “I understand that as part of the [Name of Study] research study to which I have consented, identifiable information about me will be sent to [specify the name and location of the foreign institution or organization]. I have been informed that the BC Freedom of Information and Protection of Privacy Act (FOIPPA) prohibits the disclosure of personal information outside of Canada without my consent. All the questions I have asked have been answered in a satisfactory manner and I consent to the disclosure of the information as described during the study for the [number of months] period beginning [date of disclosure].”

25. Questions re Subject Participation Questions re Subject Rights “If you have any concerns about your rights as a research subject and/or your experiences while participating in this study, contact Dr. Marc Foulkes and/or Dr. Allan Belzberg, Research Ethics Board [REB] co-Chairs by calling 604-587-4681. You may discuss these rights with the co-chairmen of the Fraser Health REB.”

26. Subject Consent Page -title -“I” -Signatures Required for Health Records

27. Process Tips Full Board Review – meetings held 2 nd Tuesday of each month; hard copy submissions required 2 weeks in advance Expedited Review – conducted weekly by co-Chairs; submissions by email

28. FH RESEARCH REVIEW PROCESS Application completed & submitted to admin. supervisor for signature PI/designate submits appl’n to FH Research for Expedited Review PI/designate submits Appl’n to FH Research for Full Board Review EmailMail Appl’n screened for completeness Yes No FHREB co-Chair conducts review Appl’n & consent form pre-reviewed 5 business days Full Board Review 10 business days 1 business day Study approved? Yes FH Research issues Certificate of Ethical Approval to PI No FHREB ‘approves’ Expedited Review Request for Modifications sent to PI Deferral Notice sent to PI 5 business days PI responds within 6 months FHREB co-Chair conducts review of response Study Approved? Yes No 5 business days If applicable, PI submits to FH Research: Signed DAR Form Contract for clinical trial research Health Canada No Objection Letter Has all of the required documentation been submitted? Yes FH Research issues “Letter of Authorization to Conduct Research”

29. EXPEDITED REVIEW PROCESS Minimal Risk Applications, Amendments, & Renewals Application completed & submitted to admin. supervisor for signature PI/designate submits appl’n to FH Research for Expedited Review Email Appl’n screened for completeness Yes No FHREB co-Chair conducts review 5 business days 1 business day Application approved? Yes FH Research issues Certificate Approval to PI No FHREB ‘approves’ Expedited Review Request for Modifications sent to PI 5 business days PI responds within 6 months FHREB co-Chair conducts review of response Application Approved? Yes No 5 business days If applicable, PI submits to FH Research: Signed DAR Form For New Applications ONLY: Has all of the required documentation been submitted? Yes FH Research issues “Letter of Authorization to Conduct Research” Expedited Renewal Applications: - Notice of Renewal sent to PI 4 weeks prior to due date - PI to send Renewal Appl’n 2 weeks prior to due date **NO NEW SUBJECTS CAN BE ENROLLED UNTIL RENEWAL CERTIFICATE IS ISSUED**