An Ethical Debate Live facilitated discussion and debate of Virtual Research Ethics Board (VREB) Case # 5 “Graft versus host disease (GVHD) Research” Provide a session overview Background on VREB initiative and how to participate, location of past cases and past debriefs

INTRODUCTIONS Michel Bergeron Delilah Ofosu-Barko Associate Professor, Department of Social and Preventive Medicine, Public Heath School, Université de Montréal and Consultant Director Education CAREB-ACCER Corporate Manager Research Operations & Project Management Trillium Health Partners, Institute for Better Vice President Business & Education CAREB-ACCER CAREB-ACCER VREB Case#5

SESSION OVERVIEW Case details VREB Advisory Case Debrief Key issues and considerations Action plan Session and initiative feedback CAREB-ACCER VREB Case#5

VREB Case #5 Details CAREB-ACCER VREB Case#5

VREB Case #5 Details BACKGROUND Bone marrow transplants are commonly used to treat leukemia to rebuild the blood supply and create a new immune system capable of attacking the cancer. ~900 bone marrow transplant patients a year in Canada and nearly half of them develop Graft-versus-host disease (GVHD) GVHD occurs when new immune system turns against host's body with sometimes fatal results. Rash in a transplant patient may indicate the onset of acute GVHD or it could be a side effect of the antibiotics commonly used in after transplant care. Skin biopsy has been the only reliable way of differentiating the two causes. RESEARCH QUESTION/OBJECTIVES Physicians would like a simple blood test that will reliably indicate whether the patient has GVHD more quickly than a biopsy Identify blood based biomarkers that will allow doctors to diagnose acute GVHD more quickly than they can now

VREB Case #5 - VREB ADVISORY CASE DEBRIEF; Issues/considerations & Action Plan CAREB-ACCER VREB Case#5

1. Determination of review level according to the level of risks Phase 1 : Minimal risk - secondary use of human biological material - delegated review.   Phase 2: Level of review depends on the REB’s context. Option 1: A second application with full review; Option 2: One application for both phases. Delegated review. Use of continuing review and conditions required in the Informed Consent process.  2. Ethical Issues about the proposed research (methods, procedures, purpose, rationale, researchers’ expertise and qualifications). Researchers’ expertise and qualifications OK based on grant from CIHR. Project with standard procedures. No issue. CAREB-ACCER VREB Case#5

3. Ethical issues identified relating to Participants: Were patients diagnosed with GVHD previously informed?   Possible emotional impacts upon recontact if presence of biomarkers without actual symptoms. A plan for communication to be developed and approved by the REB. 4. Ethical issues relating to Population, inclusion or exclusion criteria: Are the 100 participants the entire population of the Center? Possible impact on the confidentiality of participation. This is a first step aiming at a multicentered study if proves successful. CAREB-ACCER VREB Case#5

5. Ethical issues related to recruitment, compensation, incentives: Phase 1: Incentives not required for use of existing samples – no issue. Phase 2: Is PI’s decision In both phases, information to be included in the Informed Consent Form. 6. Ethical Issues related to risks vs benefits analysis: The onus of information is on the researcher. Consent must indicate that the only benefits are for the community. Risks are very minor. Not a vulnerable population. Participants to be informed that blood sampling is not due to concerns about their condition. Possible incidental findings if a biomarker identifies a patients with no exhibited GVHD. CAREB-ACCER VREB Case#5

7. Ethical issues identified relating to the Consent Process: Phase 1 : Secondary use of anonymized human biological material. Blood samples considered non-identifiable to the research team. Identification must be possible at some point for conducting phase 2. Plan for recontact to be developed and approved by the REB prior to any contact made for phase 2. Details to be included about reidentification process. Is Dr. Smith or any member of the research team part of the circle of care? Research staff should not be contacting the participants. Informed Consent Form to be provided to a family physician, not part of the circle of care. Therapeutic misconception must be addressed at this point. CAREB-ACCER VREB Case#5

8. Ethical issues related to Confidentiality and Anonymity: Phase 1 : No problem, process is clear. Phase 2 very difficult to evaluate due to the lack of information. Considerations about biobanking. Details to be provided during the Free, Informed and Continuous Consent Process (FIC). 9. Ethical issues identified relating to Data Security and Secondary Use: No information provided. It needs to be included in the FIC. No information provided about samples collected during Phase 2. Any other ethical issues to be considered? CAREB-ACCER VREB Case#5

REFERENCES & ACKNOWLEDGEMENTS Case developed by and used with permission from the Secretariat on the Responsible Conduct of Research/Secrétariat sur la conduite responsable de la recherche Acknowledgements VREB Advisory Members: Pierre Boulos, chair Kuo-Hsing Kuo Julie Joza Michel Bergeron, secretary CAREB-ACCER VREB Case#5

Careb-acCer vreb - SESSION & initiative feedback CAREB-ACCER VREB Case#5

THANK YOU! CAREB-ACCER VREB Case#5