1. 1. Catholic health care ethics 2. Research ethics Ms. Marleen Van Laethem Clinical Ethicist St Joseph’s Health Care London February 15, 2013

2. CARING FOR THE BODY, MIND & SPIRIT SINCE 1869 CATHOLIC HEALTH CARE ETHICS

3. CARING FOR THE BODY, MIND & SPIRIT SINCE 1869 Christian Health Care Our distinctive vocation in Christian health care is not so much to heal better or more efficiently than anyone else; it is to bring comfort to people by giving them an experience that will strengthen their confidence in life. The ultimate goal of our care is to give those who are ill, through our care, a reason to hope. Joseph Cardinal Bernadin

4. Catholic Health Alliance of Canada 2 nd edition 2000 3 rd edition 2012

5. CARING FOR THE BODY, MIND & SPIRIT SINCE 1869 Health Ethics Guide Not a major re-write, many articles are the same Some are improved, more clearly written A few NEW articles If you’ve recently read the 2000 version, don’t think you’ve wasted your time. This version has a lot of similarities. If it’s been a while since you read 2000 version, no need to re-read it. Just read 2012 version. Our existing ethics guidelines and corporate policies The Good News

6. CARING FOR THE BODY, MIND & SPIRIT SINCE 1869 During the Revision Concerns regarding episcopal governance within new and complex sponsorship arrangements Increased attention to “Catholic identity” Need for clarifying the goals and role of the HEG Different appreciations of the pluralistic context of health care for patients and providers Emerging Themes

7. CARING FOR THE BODY, MIND & SPIRIT SINCE 1869 HEG Chapters Introduction 1.The Social Nature of Care 2.Dignity of the Human Person 3.Care at the Beginning of Life 4.Care at the End of Life 5.Organ Donation 6.Research Involving Humans 7.Governance and Administration Appendix I – Making Moral Judgements Appendix II – Glossary of Terms

8. CARING FOR THE BODY, MIND & SPIRIT SINCE 1869 1. The Social Nature of Care Since life and health are gifts of God, “we must take reasonable care of them, taking in to account the needs of others and the common good.” Catechism of the Catholic Church 1 st Article of the Guide is Foundational

9. CARING FOR THE BODY, MIND & SPIRIT SINCE 1869 Ethical significance for both beginning-of-life and end-of-life decisions Ethical Guidelines: Medically assisted nutrition and hydration Treatment of Sexual Assault Victims Abortion and Counselling Treatment of Ectopic Pregnancies Tubal Ligation Vasectomy Research on Stem Cells: Overview and Guidelines

10. CARING FOR THE BODY, MIND & SPIRIT SINCE 1869 Corporate Policies (Intranet) Consent Policy Consent to Photography, Videography and/or Sound Recording of Patients Inhaled (Smoked) Medical Marijuana for Patient Use While in Hospital Policy for Disclosure to Patients/SDM

11. CARING FOR THE BODY, MIND & SPIRIT SINCE 1869 Corporate Policies cont. Refusal of Transfusion of Blood and/or Blood Products Resuscitation Decision-Making Policy Substitute Decision making for Care and Treatment Decisions Use of Personal Health Information for Research, Education and Quality Assurance

12. CARING FOR THE BODY, MIND & SPIRIT SINCE 1869 Ethics Pocket Tool Ethical Difficulties: Guide for our practice and dialogue

13. CARING FOR THE BODY, MIND & SPIRIT SINCE 1869 Available on the Clinical Ethics intranet website http://intra.sjhc.london.on.ca/ptcare/ethics/ Other resources: Health Ethics Guide (Catholic Health Alliance of Canada) Forming Health Care Leaders: A Guide (Catholic Health Alliance of Canada) Bioethics for Clinicians 27: Catholic Bioethics (CMAJ 2001, Markwell & Brown)

14. CARING FOR THE BODY, MIND & SPIRIT SINCE 1869 RESEARCH ETHICS

15. CARING FOR THE BODY, MIND & SPIRIT SINCE 1869 Manages the approval and monitoring process for the use of humans in research at the University and its affiliated hospitals and research institutes. All research involving humans conducted by faculty, staff or students at Western or its affiliated hospitals or research institutes must be approved by a University- sanctioned review board.

16. CARING FOR THE BODY, MIND & SPIRIT SINCE 1869 TCPS2 TCPS2 TRI-COUNCIL POLICY STATEMENT Ethical Conduct for Research Involving Humans 2010 Canadian Institutes of Health Research Natural Sciences and Engineering Research Council of Canada Social Sciences and Humanities Research Council of Canada

17. CARING FOR THE BODY, MIND & SPIRIT SINCE 1869 What is the same? underlying value of respect for human dignity as basis for the core principles proportionate approach to research ethics review respect for academic freedom and acknowledgement of associated responsibilities respect for the law and the need to balance it with ethics principles

18. CARING FOR THE BODY, MIND & SPIRIT SINCE 1869 More of the same… requirement for free, informed and ongoing consent responsibilities associated with participant privacy and information confidentiality fundamentals of research ethics board (REB) governance conflict of interest requirements

19. CARING FOR THE BODY, MIND & SPIRIT SINCE 1869 What has changed? core principles consolidated guidelines updated in the areas of: clinical trials human biological materials human genetics terminology e.g., “participant” instead of “subject,” or “delegated review” instead of “expedited and departmental reviews”

20. CARING FOR THE BODY, MIND & SPIRIT SINCE 1869 What is new? three chapters -Multi-Jurisdictional Research (Chapter 8) -Research Involving First Nations, Inuit and Métis Peoples of Canada (Chapter 9) -Qualitative Research (Chapter 10) clinical trial registration research ethics review during publicly declared emergencies

21. CARING FOR THE BODY, MIND & SPIRIT SINCE 1869 What else is new? institutional responsibilities associated with security of information reporting incidental findings research directives document structure index and glossary

22. CARING FOR THE BODY, MIND & SPIRIT SINCE 1869 Consent for research Higher standard than consent for clinical care Research is voluntary Document the consent

23. CARING FOR THE BODY, MIND & SPIRIT SINCE 1869 Confidentiality of PHI in research As a clinician, have appropriate access to personal health information for clinical purposes, to help the patient. Don’t assume this clinical access allows research on same PHI. Need to get REB approval. (PHIPA legislation) Default position is to get patient consent for research use of their data. (some exceptions)

24. CARING FOR THE BODY, MIND & SPIRIT SINCE 1869 Contact Information Marleen Van Laethem, Clinical Ethicist, St Joseph’s Health Care, London, pager 10522 Robert Sibbald, Clinical Ethicist, LHSC, pager 17511 UWO Research Ethics Board 519-661-3036, email: ethics@uwo.caethics@uwo.ca