Feature: Transplantation Ethics · 4 Announcements 6 MHSc Graduates Make a Contribu- tion to Research Ethics Literature 7 Article: Research Ethics Boards, Clinical Trials and the

September 2009 / Vol. 15 / No. 1

An Interview with Linda Wright & David Rodríguez-Arias Vailhen

Linda Wright is the Director of Bioethics for University Health Network (UHN), Toronto; Assistant Professor in the Department of Surgery, Faculty of Medicine; and a mem-ber of the Joint Centre for Bioethics at the University of Toronto. Linda provides clinical and organizational ethics consultation and teaching and has research expertise in organ transplantation ethics. She is a member of the UHN Research Ethics Board and ethics section editor of the jour-nal Progress in Transplantation.

David Rodriguez-Arias Vailhen, Assistant Professor, Faculty of Philosophy, University of Salamanca, Spain, is currently a visiting fellow at the Joint Centre for Bioethics and a visiting researcher at UHN collaborating with Linda Wright.

JCB: Tell us a bit about the UHN bioethics service:

Linda: The UHN Bioethics service provides case consultation, ethics education, policy review and contributes to research on bioethical issues. UHN Bioethics has an extensive Intranet site which provides a host of eth-ics related resources for staff, including educational modules. UHN’s three hospital sites are served by two bioethicists, each of whom sits on one of the hospital’s three Research Ethics Boards. Additionally, some UHN clini-cians have formal training and/or extensive experience in Bioethics. Some of them serve as point persons for ethical issues in their clinical areas, and make significant contributions to ethical practice at UHN via education, research and clinical practice.

JCB: How did you get involved in transplantation ethics?

Feature: Transplantation Ethics

cont’d on page 3...

In This Issue

1 Feature: Transplantation Ethics2 Director’s Corner4 Announcements6 MHSc Graduates Make a Contribu- tion to Research Ethics Literature 7 Article: Research Ethics Boards, Clinical Trials and the Ethics of Protection11 Advances in Technology12 2009-10 JCB Fellows13 2009-10 MHSc Students14 2009-10 CPB Students15 Book Excerpt17 Call for Applications18 Seminars, Events & Conferences19 JCB 10 Year Report24 Recent Publications26 Submission & Contact Information

September 2009 / Vol. 15 / No. 1 Page: 2

Director’s Corner

From Great Hall to Open Sky

The church at 88 College Street has been the home base and emblem of the University of Toronto Joint Centre for Bioethics for more than a decade. Those of us who work here, attend seminars and have meet-ings here on a regular basis are familiar with its quirks and eccentricities. Those who do not have a close affiliation with the church cannot appreciate the fond-ness that many of us in the JCB community have for it. Drafty and cold in the winter, hot in the summer, its ventilation is interesting to say the least. There are varied denizens in the rafters and curious artefacts in the basement. Yet, it has an undeniable charm and beauty.

Change is a non-ignorable and seemingly constant dimension of modern life. While the JCB is housed in a beautiful heritage building, it is a difficult one to main-tain. A decision has been made to move the Joint Centre for Bioethics out of the church on 88 College Street.

However, we are thrilled about our new location. We will go from the old to the new. Professor Jack Man-del, the Director of the Dalla Lana School of Public Health, has kindly offered the JCB lovely space on top of 155 College Street. This building, formerly owned by the Toronto District Board of Education, has been inhabited by the Faculty of Medicine for the past few years. Housed within this building are the Dalla Lana School of Public Health; the Bloomberg School of Nursing and the Department of Health Policy, Manage-ment, and Evaluation. Our new space is on the top floor which provides a beautiful view over the city, looking towards the lake and uptown. It is bright and airy. It also brings us in close proximity to several of

the most engaged academic partners with the Joint Centre for Bioethics and preserves our close proxim-ity to many of the academic health sciences centres. I think it may be even a few steps closer to the subway.

We have been approved to move to this location in December 2009. Thus we will start a new year, 2010, in our new home. We plan to celebrate our time at 88 College Street in the church in our traditional Pre-Winter Gathering. We are also planning a “Welcome to Our New Space” get together at 155 College Street once we are unpacked and settled.

Moving provokes anxiety and uncertainty but there is no reason why the Joint Centre for Bioethics cannot flourish and inhabit a new space with the same sense of community, vitality, and élan that we experienced in the church. We will be bringing with us many reminders of the church and our time there and we are hoping that all of the members of the Joint Centre for Bioethics community will assist us in making the move a successful one. I welcome members of the JCB community to send us their favourite recollections and stories about the church which we can collect as a remembrance.

Ross Upshur Director, Joint Centre for Bioethics; Director, Primary Care Research Unit; Canada Research Chair in Primary Care Research; Professor,

Department of Family and Community Medicine, and Dalla Lana School of Public Health, University of Toronto.


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Linda: I worked as a social worker in Nephrology and Transplantation for many years. As transplant and the use of living organ donors grew, new ethical issues challenged transplant teams. We consulted the JCB on a couple of difficult cases and found that very useful. I loved the academic stimulation of Bioethics and found that it was valued by my colleagues, so I decided to learn more about that field.

JCB: What is the biggest challenge you have faced?

Linda: Two factors have been challenging: 1). Coping with the large variety of ethical issues that arise. Organ transplant reflects social situations and factors so it is ever changing. 2.) The field is very special-ized. Only a few people were working in transplanta-tion ethics until recently. It is much more comfortable to have more colleagues working in this field as this enables collaboration.

JCB: What achievement are you most proud of?

Linda: There are individual achievements such our report on the ethical issues in Kidney Transplant Exchange programmes, which contributed to design-ing the first such Canadian programme here in Toronto. Also, the UHN “Ethical Guidelines for the Evaluation of Living Organ Donors” which is novel. The most satisfying achievement is the recognition of the value of bioethics in organ transplantation through its inclusion in education and clinical practice.

JCB: Tell us about your background?

David: After obtaining my Philosophy Degree in the University of Salamanca, Spain, I spent four years in France, at the University of Paris Descartes, dur-ing which time I did a Masters Degree in Biomedical

Ethics and began my PhD. My Masters thesis’ topic was on advance care planning. In France, I learned empirical methods of research and had the opportu-nity to discover the virtues of team work. In 2006, I became assistant professor at the University of Salamanca where I finished my PhD in 2008 on brain death and organ transplantation.

JCB: How did you get interested in transplantation ethics?

David: I got interested in transplantation ethics through the concept of brain death. As a philoso-pher interested in practical issues, I was amazed by how the definition of death could have such impact in medical practices. My PhD thesis included inter-national research in which 600 health professionals involved in the care of potential organ donors were asked about their knowledge, beliefs and attitudes towards brain death. While doing the interviews, I realized that although every policy on organ trans-plantation has to deal with the same ethical dilemma-to save a greater number of lives while violating the least amount of ethical requirements- each country has adopted specific strategies to face it. Spain is well known for having the highest rate of organ donation in the world. I was interested to know what factors related to the Spanish success, which was the “ethical cost” that Spain had paid to reach its rates in organ procurement and to what extent this model could be exported to other countries.

JCB: Why did you want to come and work at University of Toronto/University Health Network/Joint Centre for Bioethics?

David: By coming to Canada, I wanted to understand the Canadian system of organ transplantation and to compare it to the Spanish one. I had the opportunity


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to apply to the Spanish Ministry of Education for a post-doc scholarship. I had to conceive a project of research and I had to choose a center where to accomplish it. I wanted a place where I could be in touch with health professionals and policy makers involved in organ transplantation, but also with bio-ethicists who could enrich my training in both clinical bioethics and normative ethics. The Joint Center for Bioethics, in conjunction with the University Health Network at the University of Toronto was just the place to carry out my research. With the help of Ross Upshur and Linda Wright, I submitted my application, and I got the scholarship.

JCB: Tell us how you plan to spend your year?

David: During this academic year, I hope to take advantage of the unique academic atmosphere offered by the Joint Center of Bioethics. Most of the time, I will do interviews with specialists in organ transplantation and share with the staff some experi-ences at the clinical setting. I also hope to have the chance to attend many lectures and conferences on bioethics.

Comments on this article? Email your response to [email protected]. We may publish your email in the next issue.

AnnouncementsDr. Rebecca Bruni has accepted the position of Clinical Ethicist at the Centre for Clinical Ethics, a Joint Venture of Providence Healthcare, St. Joseph’s Health Centre and St. Michael’s Hospital. Rebecca com-pleted her training as a nurse at

the University of Toronto, and received her PhD. in Bioethics from the Institute of Medical Science at the University of Toronto. She has recently completed a Fellowship in Clinical Ethics at the Joint Centre for Bioethics, part of which included a three month place-ment with the Centre for Clinical Ethics.

Evelyne Durocher (PhD student in the Graduate Department of Rehabilitation Sciences and the Collaborative Program in Bioethics) was awarded the K. M. Hunter Graduate Studentship valued at $20 000 for one year (renewable). Evelyne’s thesis research explores the ethics of discharge planning, and her thesis co-supervisors are Barbara Gibson and Susan Rappolt, with Barbara Secker as a Committee Member.

The CIHR awarded a catalyst grant to Principal Investigator: Jennifer Gibson and Co-Investigators: Karen Faith, Andrea Frolic, Barbara Secker, Ross Upshur, Shawn Winsor for their project “Evaluating the effectiveness of hospital-based ethics programs: a pilot study to identify key benchmarks, indicators, and success factors”. Term: 2009-11.

The following Collaborative Program in Bioethics (CPB) students were award winners for their work presented at the Department of Health Policy, Management and Evaluation, University of Toronto on May 6, 2009:

Eugene Vayda Best PhD Poster Award Health • Services Research; Winner - Renata Axler; Project - Marketing a ‘better world’: The many meanings of ‘benefit’ in the commercialization of medical innovations MSc 2nd Place Poster Award Health Services • Research; Winner - Kelley Ross; Project - Preliminary Results of Interviews with Transplant Professionals about Directed Organ Donations After Death


Announcements

Oral Presentation Award: Room 4; Winner - • Constance Williams; Project - With Care Project: Compassionate end-of-life care for new-borns after withdrawal of life sustaining treatment

The Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN) presented its 2009 Novice Researcher Award to Anne Simmonds, Ph.D.(c), MN, RN, BScN. The award was presented at AWHONN’s annual convention in San Diego, Calif. The AWHONN Novice Researcher Award is intended to help new researchers begin areas of study, investigate clinical issues or launch a pilot study. Anne is com-pleting a collaborative Ph.D. in Nursing and Bioethics at the University of Toronto.

University of Toronto Professor Emeritus Wayne Sumner of philosophy was awarded the 2009 Molson Prize in the social sciences in recognition of his out-standing lifetime work in ethical theory, bioethics and political philosophy. Professor Sumner, a fellow of the Royal Society of Canada and pre-eminent scholar, is a world renowned moral philosopher.

The Governing Council of CIHR has approved the appointment of Ross Upshur (Director of the JCB) as a new member to the Institute of Aging’s Advisory Board (IAB).

Nishardi Wijerante, JCB Academic Fellow in Clinical and Organizational Ethics, has had her poster “Priority setting in medical education-case study in bioethics curricular

development” accepted as a “WC One-Minute Wonder” poster presentation for the University of Toronto’s Wilson Centre Research Day. (The Wilson Centre Research Day is Friday October 9, 2009, and will be held at the Vaughn Estate of Sunnybrook.)

Connie Williams was selected as the 2009 winner of the JKR Wightman Award in Scholarship in Ethics for her cased-based ethics paper on end-of-life deci-sion making in the NICU. Her paper will be posted on the ethics page of the Royal College of Physicians and Surgeons of Canada website.

Sunnybrook Health Sciences Centre is thrilled to announce the recruit-ment of Shawn Winsor as the new Director of the Ethics Centre at Sunnybrook. Shawn comes to us from Trillium Health Centre where he provided ethics leadership to the Ethics Program as well as cre-ated and led the Regional Bioethics Service at the LHIN level. Shawn has broad-ranging experience in the area of organizational ethics through his work at Trillium, the Mississauga-Halton LHIN, and LifeQuest Centre for Reproductive Medicine. For the past two years, Shawn has been also been the Course Director of the Practicum in the MHSc in Bioethics program at the University of Toronto’s Joint Centre for Bioethics Shawn began his new position on July 6th.


MHSc Graduates Make a Contribution to Research Ethics Literature

The mission of the MHSc in Bioethics, International Stream is to strengthen individual and institutional leadership capacity in bioethics, with particular em-phasis on research ethics, in low- and middle-income countries. As of June 2008, under the auspices of the Fogarty International Centre funding, the University of Toronto MHSc in Bioethics, International Stream program at the JCB has successfully graduated 32 in-ternational trainees with professional Master’s degree training in bioethics, providing them with important legitimating credentials upon return to their home institutions. Indeed, graduates of our program are making—and will continue to make—important contri-butions to bioethics education, research, and service in their home countries.

A recent publication in Plos Medicine, a major peer re-viewed journal, demonstrates another type of contri-bution to scholarship: service to humanitarian orga-nizations. The July issue featured an editorial, Ethics Without Borders discussing a paper entitled Research Ethics Review in Humanitarian Contexts: The Experi-ence of the Independent Ethics Review Board of Mé-decins Sans Frontières. (http://www.plosmedicine.org/article/browseIssue.action). Three alumni of the MHSc Jerome Singh, Sunita Sheel Bandewar, Aasim Ahmad have served on the board and are co-authors on the paper. The article describes the functioning of the Médecins Sans Frontières independent ethics review board and the framework used for ethics review by the board. The paper outlines the challenging ethical issues encountered by the board since its inception. Many of these issues are specific to the types of chal-lenges involved in research in conflict situations and in very vulnerable populations.

Here are comments from Aasim, Jerome and Sunita regarding their experience serving on the MSR REB:

‘“Working on the MSF ERB has been a great learning experience; it is unique as ethical issues in research related to humanitarian assistance are extremely complex but the combined experience of the board helps in disentangling these for the protection of the research participants. This experience propelled me to help form a Working Group on Disaster Research and Ethics (WGDRE) with like minded individual of South Asia.”

Professor Aasim Ahmad, Chairperson, Bioethics Group & Director, & Hon. Senior Lecturer, Aga Khan University; Dean & Chief Nephrologist, The Kidney Centre, Karachi, Pakistan.

“Serving on the MSF international research ethics board these last seven years has been a wonderful and enriching experience for me. MSF is one of the few organisations that actively works in humani-tarian contexts on a global scale. Likewise, MSF’s research ethics board is distinctive in that it reviews research in humanitarian settings on a global scale. As such, the board has a unique oppor-tunity to contribute to the protection of vulnerable people in those regions, even when their governments and international agencies are unable, or unwilling to. Playing such an important behind-the-scenes role is one of the major reasons why serving on the board has meant so much to me on a personal level.”

Dr. Jerome Singh, Head, Ethics and Health Law, Center for the AIDS Programme of Research in South Africa (CAPRISA), Nelson R. Mandela School of Medicine & Honorary Research Fellow and Course Director for Bioethics and the Law at Howard College School of Law, University of KwaZulu-Natal (UKZN), Durban, South Africa; Adjunct Professor, Dalla Lana School of Public Health Sciences and Joint Center for Bio-ethics, University of Toronto.

“My experience serving on the MSF REB since August 2006 to date, indeed, testifies to the challenges most of us as professionals face when presented with real-life situations. It has been challenging to translate research ethics principles because of the unique situa-tions in which MSF research endeavours take place. Whether these challenges confirm the relativism in research ethics or offers a huge opportunity to unravel the wider spectrum of interpretations of research ethics principles within the universalism is something I would hope to learn and appreciate in the coming time. For sure, it feels like my research ethics training has been continuously put to test for good by being on the MSF REB. It has been an extremely enriching experience.“

Dr. Sunita Sheel Bandewar, Post Doctoral Fellow, Ethical, Social, and Cultural (ESC) Program for Grand Challenges in Global Health & Research Coordinator, Community Engagement Global Case Study Research, McLaughlin-Rotman Centre.

http://www.plosmedicine.org/article/browseIssue.action

http://www.plosmedicine.org/article/browseIssue.action


Article: Research Ethics Boards, Clinical Trials and the Ethics of Protection

If we knew what we were doing it wouldn’t be research.

- Albert Einstein 1

Intuitively - Einstein’s observation coupled with the daunting obligations placed on researchers and re-search ethics boards (REB) to “ensure the safety of [research participants]”2 makes for nervous delibera-tions at many of our monthly REB meetings. Any obli-gation, stated in such strong language as: “to ensure”, causes legal members on REB’s much consternation. Fundamentally, how can any person ensure the safety of another? Particularly in the high stakes game of clinical research- where profit and medicine are inter-twined and the end users are vulnerable patients. Understanding Risk and BurdensAny action approximating that of a reasonable at-tempt at “ensuring the safety of research participants” will require that researchers and the REB have some common understanding of the risk and burdens being transferred to research subjects in the course of their participation in a study.

Clinical research is ethical only when the risks and burdens to participants are reasonable and justified by the potential benefits3. This entails having a shared appreciation of the social value of the knowledge ob-tained and that true equipoise exist to warrant placing human subjects in the study: No equipoise and/or no value = No study. Once the moral ends of the science has been accepted, the next task is to determine if the means proposed to achieve those ends are in fact moral. This task, shared by all in the development of research protocols from the design stage to the ex-ecution stage, is fragmented and lacks broad consen-sus in its implementation.

Risk is inherent in clinical research - and the tenet of informed consent requires that potential participants have been given accurate and timely information of the risk and burdens the study may entail. But do REB’s or researchers share the same understanding and definition of risk as the potential subjects to be enrolled in a study? Research suggests that REB’s have a much lower appetite for risks than many par-ticipants- which might suggest that REB’s have a lean-ing towards paternalistic assessments of trial risks.

REB’s will attempt to use the principle of proportional-ity in the type of review and scrutiny a given protocol will receive prior to its approval for implementation – and to equally apply this principle in its recommen-dation that appropriate safeguards be put into place such that an a priori limit on risk is sustained.

The use of risk matrix is gaining some currency in REB reviews- the principle being that researcher and REB’s seek a common understanding of the risks involved in the study. The overarching premise of this approach is that once risk is sufficiently categorized – an appropri-ate plan to mitigate and monitor the study can be put into place. Risk matrix construction is typically based on an assessment/analysis of each component of a study (i.e. looking at each of the activities involved and assigning an appropriate risk category):


ArticleIn terms of a baseline comparator- risk of any identi-fied component is then compared to what would be construed as the standard definition of minimal risk: A risk that does not exceed the risk one would expect to encounter in daily life (i.e. “daily life” as understood in the context of clinical trials, means the life a patient would experience when undergoing the standard of care for their given medical condition. Implicit in this definition is the understanding that being a patient in health care also means living with some risk- however, in health care the negotiations of whether or not to accept additional risk lies initially with the physician who determine if offering a treatment will occur – pre-mised that the offering is in the context of a patient’s best interest- and secondarily by the patient through the informed consent process).

Newer permutations of the risk matrix add consider-ation of subject vulnerability as a further determinant of a component analysis- with the assumption that highly vulnerable research subjects- by the nature of their vulnerability defines the basis of risk assessment, i.e. incapable patients require more protection than capable patients for the same degree of component intervention. Concepts of who or what defines vulner-ability remains contentious. The quality of vulnerability can be known and identified, in part, by the research participants, specific disease group representation, treating clinicians, etc. – others such as susceptibility to therapeutic misconception, selection bias, or con-flict of interest- need a more objective (i.e. paternalis-tic) consideration.

Basic trial design can, in and of itself, imply a unique set of risk considerations that need to be addressed: Phase I and II trials are typically exploratory in na-ture, whereas Phase III and IV studies are designed as confirmatory.4 Each type of trial design may call into use slightly different ethics lens to bring different

concerns into focus. Exploratory studies having more unknown and immediate risks therefore may require the primacy of an individual ethics approach (i.e. put-ting the interest of individual participants within the trial before those of future patients), whereas confir-matory studies should incorporate a more collective ethics approach (putting the interest of future patients who may be at benefit or risk, ahead of or minimally on par with those of the individual participants).5 This has led several funders and regulators to favor inde-pendent data and safety monitoring reviews- which looks at both the research subjects at hand, and beyond to the displacement of risk to future patients. In addition, more academic research into the ethics of protection is needed, for setting criteria to aid in determining which trials should proceed beyond the exploratory phase. However, this needs to be under-taken at a level beyond the institutional REB. Addi-tionally, a system to outline proportionality between benefit and risk needs further dialogue and consensus to ensure better REB consistency of reviews.

Measures of Protection: Independent OversightLarge clinical trials- bring together many different players to the table: Sponsors (usually industry, gov-ernment funding agencies, cooperatives, etc), Regula-tors (Health Canada, FDA, EU equivalent, etc.) and the local institutional REB and Researchers. They all share complementary and conflicting mandates- and yet each are charged with part of the ethical oversight (referred to as an ethics of protection) of a clinical study - be it in a design, approval, operational, moni-toring, analysis and ultimately reporting functions which contribute to maximizing the protection of-fered to participants. Smaller independent researcher initiated studies bring a different set of challenges to account for REB’s- but trust and duty form the basis of the essential responsibility for all involved. Good clini-cal trial designs can create the requisite set of checks


Articleand balances to mitigate risk, error, bias, and actual and/or perceived conflicts of interest- but how far will these help in dealing with the ever murky debts of known/known, known/unknown, and the unknown/unknown risks of human research?

Much has been written (descriptively) on the topic of data and safety monitoring in clinical trials and yet no overarching consensus seems to exist- from the stand-point of REB require-ments- on a prescrip-tive approach to the design and imple-mentation of data and safety monitoring plans (DSMP).6 A brief literature search on the subject of clinical trial safety- identi-fied (Table 2) a wide range of formal or informal, localized or independent over-sight mechanism and bodies- which could possibly be employed towards the goal of protecting current and future patients.

Despite this rather encouraging list of oversight mechanism to choose from- few definitive/normative standards seems to exist to direct an REB to their appropriate use and/or application in various clinical trial settings.

In North America, the data safety monitoring board (DSMB) is probably the best known of the list- with the data monitoring committee (DMC) - its virtual equivalent, coming a close second in regards to us-age. However, as might be the case for any oversight mechanism, DSMB’s (DMC’s) have utility and an im-portant role in some, though not all, research settings.

Our institutional REB wanted clearer guide-lines and direction on what constituted a means to maximize research participant safety in clinical trials and to build consen-sus with other REB’s and ultimately lo-cal researchers and study sponsors on an appropriate plan to be incorporated into study designs. To this end, our initial foray was to present a set of criteria (based on best practice and regulator guidelines) for the appropriate use of DSMB’s into clinical studies, and this criteria is be-ing reviewed by the board, with intent to build consensus on

its use in various studies. (Table 3 and 4 on the fol-lowing page)


ArticleThe appropriate use of a DSMB requires that they operate under a suitable charter and that the board’s independence and compositional ex-pertise are duly considered. To this end our REB references the guide-lines and charter templates issued by the DAMOCLES study group,7 or the European Medicines Agency guidelines for DMC’s8 when studies are originated in the EU.

ConclusionAs previously noted, much of the literature on participant safety and protection is written for researchers by researchers, academics, funders and sponsors. It is believed that REB’s- poised as the last check point in a long process of checks and balances, and charged with the shared responsibility to ensure patient safety- has a duty to contribute to this field in novel and exciting ways. Working towards establishing industry standards for the requirements of data and safety monitoring plans is one important contribution REB’s can make.

References:Albert Einstein (1879-1955) German-Swiss-U.S. scientist 1. <http://en.proverbia.net/citastema.asp?tematica=1017>.“When appropriate, the research plan makes adequate 2. provisions for monitoring the data collected to ensure the safety of the subject” 45 CFR 46.111[a][6].D Wendler and F G Miller, Assessing research risk system-3. atically: the net risks test. Journal of Medical Ethics 2006; 33: 481-486.This terminology was used for the purposes of a meta-4. understanding of trial intent, however, as Dr. Philip Hebert states: strictly speaking, trials cannot “confirm” the truth of any statement but can falsify the null hypothesis / the acceptability of the thesis – ie, disproving is not the same as confirming (Popper).

The balance of individual versus collective ethics is not as 5. clearly delineated by the phase of a study only; however, in Phase I studies, true consent can be said to be less achievable given the unknown- unknowns, and as such individual protection is a imminent moral imperative.ICH GCP <6. http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6-eng.php> Specifi-cally sections 5 Sponsor Responsibility (5.5.2) and Sec-tion 6 Clinical Trial Protocol and Protocol Amendments (6.8.1/.2/.3/.4).Grant, AM, et al and the DAMOCLES study group, Issues 7. in data monitoring and interim analysis of trials, Health Technology Assessment 2005; Vol. 9: No. 7.European Medicines Agency regulations (Doc. Ref. EMEA/8. CHMP/EWP/5872/03) <http://www.emea.europa.eu/pdfs/human/ewp/587203en.pdf>.

Contributed by:Blair Henry, Clinical and Research Ethicist, Sunnybrook Health Sciences Centre

http://en.proverbia.net/citastema.asp?tematica=1017

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6-eng.php

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6-eng.php

http://www.emea.europa.eu/pdfs/human/ewp/587203en.pdf

http://www.emea.europa.eu/pdfs/human/ewp/587203en.pdf


Advances in Technology

Technology’s Role in Response to H1N1

With national and international authorities warning of a possible spike in H1N1 influenza activity in the upcoming months, it was felt that this month’s article ought to examine previously discussed technologies

and how they may be of benefit in the case that social distancing measures are ad-opted. In the case of an increase of H1N1 activity, experts have discussed the pos-sibility enacting social distancing measures, such as school clo-

sures, the cancelling of large social gatherings, and so on. With a robust online environment, such social distancing measures need not negate social interac-tion or productivity.

Blogging: Simply put, a blog is a website that is used by an individual (the blogger) in order to com-municate regular commentaries of personal thoughts, ideas, events, or graphics – much like sharing an on-line diary, with the ability for others to comment. Due to the broad reach of blogs, people have been able to share, discuss, and update research related to H1N1 influenza that they have been involved with. These blogs can come from experts in epidemiology and infectious disease, or even from lay citizens who wish to voice their opinion on the pandemic (an example of a blog concerned solely with H1N1 can be found at http://h1n1blog.org/).

Social Networking (i.e. Twitter): Twitter is a me-dium in which text-based updates of any nature can be broadcast to a large audience. While previously embraced primarily by celebrities and bands, Twitter has become an outlet for lay citizens and experts alike in order to disseminate thoughts, opin-ions, and news updates, as well as to engage the public on the H1N1 pandemic. For instance, Helen Branswell, a Medical Reporter with the Canadian Press, updates her status regularly with insightful commentary concerning the pandemic (see these updates at http://twitter.com/cp_branswell).

Videoconferencing: Finally, videoconferencing is a form of technology that enables even those ill with H1N1 to have face-to-face meetings (if one is so inclined). Videoconferencing is now being utilized by institutions and individuals in order to simultaneously interact from two or more locations, eliminating issues of space, distance, and most important during the pandemic, proximity to those who may be shedding the virus. If social distancing measures are war-ranted during the pandemic, meetings, classes, and other gatherings may be held virtually with little to no decrease in interaction or productivity.

Contributed by:Maxwell J. Smith, CanPREP Project Coordinator

http://h1n1blog.org/

http://twitter.com/cp_branswell

http://twitter.com/cp_branswell


2009-10 Academic Fellows in Clinical & Organizational Ethics

The JCB would like to welcome the following Academic Fellows in Clinical & Organizational Ethics for 2009-10:

Michael Campbell holds a Bachelor of Arts degree in Philosophy from York University and a Master of Health Science degree in Bioethics from the University of Toronto. He has helped develop ethics education modules at the former Scar-

borough CCAC and the Toronto CCAC. He has also worked in the areas of transplantation ethics at the University Health Network, organizational ethics at St. Joseph’s Hospital, and the ethics of genomic research at Mount Sinai Hospital.

Jennifer Flynn holds a Ph.D. in philosophy from the University of Virginia, where she wrote her dissertation in moral philosophy. While at Virginia, she held a research and teaching assistantship

within the Program in Bioethics. Her BAH (Politi-cal Science) and MA (Philosophy) are from Queen’s University. Jennifer comes to the University of Toronto from Memorial University in St. John’s, where she held positions as Assistant Professor (term appointment) in the Department of Philosophy, and as Clinical Ethicist in the Faculty of Medicine/for Eastern Health. Among other committees, she served on Memorial’s Inter-disciplinary Committee on Ethics in Human Research. Jennifer has designed and taught survey courses in bioethics and introductory philosophy, and more spe-cialized courses on topics such as the ethics of genetic

research, bioethics and philosophical feminism, and philosophy and literature.

Christine Jamieson is an Associate Professor in the Department of Theological Studies at Concordia Uni-versity where she teaches courses in Clinical Ethics, Applied Ethics and Theology and Bioethics. She is able to participate in the Shared Academic Fellowship with the Joint Centre for Bioethics and the Centre for Clinical Ethics thanks to a one-year sabbatical. She received her doctorate from Saint Paul University/University of Ottawa. Her dissertation was titled: The Significance of the Body in Ethical Discourse: Julia Kristeva’s Con-tribution to Moral Theology. Since 1999, she has been writing background papers and doing research for Health Canada on ethical issues related to a variety of bioethical topics (for example, genetic testing for late onset diseases, stem-cell research, and research eth-ics). She is a member of the International Association of Catholic Bioethicists (IACB).

Nishardi Wijerante holds a Bachelor of Medicine and Sur-gery degree from the University of Colombo, Sri Lanka and a Masters of Health Science in Bioethics from the Joint Cen-tre for Bioethics, University of Toronto. She has worked as a lecturer in Medical Ethics in Colombo. She is also a research fellow at the Wilson Centre and Centre for Faculty Development at the University of Toronto.


2009 Incoming Students: MHSc in Bioethics

MHSc Domestic - Class of 2011

Anjali Aggarwal is a Clinical Fellow in Pediatric and Adolescent Gynaecology at the Hospital for Sick Chil-dren, with a background in Obstetrics and Gynaecol-ogy. She holds a Doctor of Medicine degree from Queen’s University and Bachelor of Science (Hons) in Molecular Genetics from the University of Alberta.

Kirsty Bourret is a Registered Midwife and has prac-ticed in both Northern Ontario and Nunavut. She is currently a full-time faculty member for the Laurentian University Midwifery Education Program. Kirsty holds a Bachelor of Science degree from the University of Wisconsin, Madison, and a Bachelor of Health Scienc-es degree in Midwifery from Laurentian University.

Judith (Judy) Cooper is a Manager, Patient Safety and Ethics at York Central Hospital in Richmond Hill, Ontario, with a background in Critical Care Medicine. She holds a BSc in Nursing from Ryerson University and a CNA Certification in Critical Care.

Lorrie Hamilton is the Manager of Patient Safety and SHN! at Toronto East General Hospital. Lorrie has a background in nursing and holds a BScN from the University of Toronto.

Mary Huska is an Ethics Advisor at the St. Joseph’s Health Centre and the Sudbury Regional Hospital in Sudbury, with a background in critical care nursing. She holds a BScN degree from Laurentian University.

Sylvie Labelle-Stimac is a clinical pharmacist spe-cializing in intensive care. Sylvie presently works at the Hamilton Health Science Corporation, a McMaster University hospital. She holds a BSc(Hons) degree and a BSc degree in pharmacy from University of Toronto.

Jacky Parker is an emergency room physician at the Ottawa Hospital, and an assistant professor in the Department of Emergency Medicine, University of Ot-tawa. Jacky has an interest in quality of care, geri-atric care in the ER, and the sexual assault/domestic violence treatment centre. She holds a MBBS from the University of Newcastle upon Tyne, England, and a CCFP EM.

Hamid-Reza Raziee is an assistant professor at Mashhad University of Medical Sciences in Iran, with a background in Radiation Oncology. He holds an MD degree from Mashhad University of Medical Sciences and a Radiation Oncology Specialist degree from the same university in Iran.

Graham Turrall is a clinical psychologist in private practice. His background is in forensic psychology and neuropsychology. He holds degrees from Sir George Williams University (Concordia University), University of Toronto (OISE) and Boston University.

MHSc International - Class of 2010

Celestine Afi Sappor is an Administrative Assistant on the Rotateq Vaccine Trial in Noguchi Memorial Institute for Medical Research, with a background in Political Science. She Holds a Bachelor of Arts degree from the University of Ghana.

Salima Bano Virani is a Senior Instructor at the Aga Khan University School of Nursing. Her background is in the field of bioethics and critical care/emergency nursing. Salima holds a nursing diploma and a Post RN Degree from Aga Khan University School of Nurs-ing. She worked as a critical care nurse for a number of years and has been teaching nursing since.


2009 Incoming Students: MHSc in BioethicsSalah-Ud-Din is a professor at Hamdard College of Medicine and Dentistry, Hamdard University, Karachi in the Department of Biochemistry, with a background in clinical biochemistry and biomedical ethics. He holds a PhD degree from Hamdard University, and M Phil and MBBS degrees, along with a Post Graduate Diploma in Bio Medical Ethics, from University of Karachi.

Juan Gutierrez Mejia is a clinical fellow at Toronto General Hospital in the Medical Surgical ICU with a background in Internal Medicine. He holds a medical

degree from the University of Ciudad Juarez Chihua-hua, Mexico and an Internal Medicine degree from the Autonomous University of Nuevo Leon in Mexico.

Bini Toms is an Assistant Professor in the Depart-ment of Biotechnology and Vice Principal, at T. John College in Bangalore, India, with a background in Genetics and Plant Breeding. Bini holds a Masters degree from the University of Jawaharlal Nehru Krishi Vishwavidyalaya and a Doctorate from the Allahabad Agricultural Institute, Deemed University.

2009 Incoming Students: Collaborative Program in Bioethics

Heather Burnett is enrolled in Ulysses, an interna-tional MSc program in Health Technology Assessment & Management offered through the Department of Health Policy, Management and Evaluation. Heather holds a BSc and a MSc in Molecular Biology and Genetics from the University of Guelph. Her thesis research will focus on parental willingness to pay for high cost biologic medications in the treatment of juvenile idiopathic arthritis. Her thesis supervisor is Wendy Ungar with Fiona Miller as a committee member.

Mark Camp is a third year surgical resident in the division of Orthopaedic Surgery at the University of Toronto and is also enrolled in the MSc program in the Institute of Medical Sciences. Mark holds a Bachelor of Science in Physiology from the University of West-ern Ontario and a degree in Medicine from Queen’s University. Mark thesis topic is conflict of interest between orthopaedic surgeons and industry, and his thesis supervisor is Martin McKneally.

Jana Crawford is enrolled in the PhD program in the Department of Philosophy at the University of Toronto.

Jana holds a Bachelor of Arts in Philosophy and Gen-der and Women’s Studies from Dalhousie University, and a Master of Arts in Philosophy from the University of Toronto. Jana’s thesis will explore the rational sta-tus of eating disorder behavior. Her thesis supervisor is Kathryn Morgan with Barbara Russell as a commit-tee member.

Kimberley Ibarra is enrolled in the MSc in Health Services Research Program in the Department of Health Policy, Management and Evaluation (HPME). Kimberley holds an Honors BA in Philosophy and Bioethics from the University of Toronto. Kimberley’s thesis research will focus on performance measure-ment and evaluation of ethics programs. Her thesis supervisor is Jennifer Gibson.

Debbie Rolfe is enrolled in the PhD program in the Lawrence S. Bloomberg Faculty of Nursing at the Uni-versity of Toronto. Debbie holds a Masters in Social Work and Masters of Health Science in Bioethics from the University of Toronto, and a Bachelor of Social Work from Ryerson University. Debbie’s thesis project


2009 Incoming Students: Collaborative Program in Bioethicswill explore the impact of crisis on informed decision-making and notions of autonomy in pregnant women confronting prenatal genetic diagnosis or late stage fetal anomaly. Her thesis supervisor is Elizabeth Peter.

Shawn Tracy is enrolled in the PhD Program in the Institute of Medical Science. Shawn holds a Bachelor

of Psychology (Honors) from Trent University and has previously studied in the Graduate Department of Community Health at the University of Toronto. Shawn’s thesis will address the ethics of pandemic preparedness and response, and his thesis supervisor is Ross Upshur.

Book Excerpt “Brooklyn Beginnings: A Geriatrician’s Odyssey”

Dr. Michael Gordon has been a member of the Joint Centre for many years, having completed his Masters Degree in Ethics at the University of Toronto in 2001. In addition to being an academic geriatrician at Baycrest Geriatric Health Care System and a Profes-sor in the University of Toronto’s Department of Medicine, he is an author.

Below is an excerpt from his recent book, “Brooklyn Beginnings: A Geriatrician’s Odyssey” with his website link to provide more information about his writings and how one can order a book from Amazon.ca and Chapters: http://www.drmichaelgordon.com/

“I need help with the son, who is a doctor and has just flown in from out of town. He is upsetting the whole family with what he thinks the living will means.”

The attending physician had been struggling with the family of an elderly male patient whose blood disease had taken a very malignant turn. The struggle was over whether or not he should be given any further blood transfusions. They had agreed to give a few more units.

Each transfusion had a beneficial effect for only a few days until the hemoglobin fell and he became symptom-atic again. The attending physician felt that, according to the written living will on record, no heroic measures should be taken, and only comfort care should be pro-vided in the end-of-life situation. Previously, the family had agreed that, after the most recent transfusion, his discomfort and shortness of breath would be treated symptomatically and all efforts should focus on ensuring him some comfortable last days and as quiet a death as possible.

“This is not acceptable,” the physician son insisted, even though his mother was the designated substitute deci-sion maker, and, because the patient was quite somno-lent most of the time, could not make his own decisions. The mother was now clearly deferring to her physician son whereas, prior to his arrival, she had been willing to listen to, and discuss the course with, her daughter and youngest son, both of whom lived in the same city as the parents. Her daughter, in fact, had been closest to the patient and had often been involved in his care over the past few years. “Giving blood is not heroic,” said the son. “It is symptomatic treatment. It would be inhuman and immoral to deprive him of such treatment.”

The attending physician, very conscious of the patient’s course as he had looked after him for over a year, felt

http://www.drmichaelgordon.com/









































Book Excerptthat the patient would not have wanted to have his life dragged out like this. When he brought this into the dis-cussion, the son replied, “You could not know our father as we do, and, even though I have been away for the past year-other than one short visit a few months ago-I know my father; and I know medicine, so the decision is quite clear-give him as much blood as often as needed to keep him comfortable and alive.”

The attending physician was very upset with the son’s approach. He felt that he, as the patient’s physician, un-derstood the patient well for they had spoken often over the past year. Should the patient have been able to indi-cate his wishes, he likely would have asked to have the blood transfusions discontinued. The physician also felt that to use such a scarce resource as blood for someone who was clearly in the process of dying was not just pa-tently unfair to all who donated blood in good faith, but also to those in need of the blood (even though there was no indication that there was a shortage of blood in the system at the time these events were taking place).

A meeting was held between the staff, the family, and me, in my role as ethicist. I began, “Why do you think your father wrote what he did in his living will about be-ing allowed to die comfortably and not being subjected to heroics? Also, why do you think your father spoke to the doctor about his wishes all these months if he could not count on him to act in his best interests and as he would have wanted?”

I continued, “Is there anywhere that he indicated that he would want his life prolonged in this manner when he is not going to gain consciousness and literally lives from one transfusion to the next, with the day in between being more and more uncomfortable? The doctor would like to treat him in a palliative fashion, with medication to deal with his shortness of breath so that his last days can be comfortable.

This transfusing over and over again is really interfering with that approach.”

There was a pause as the physician son looked at his mother, the attending physician, the nurses, and, lastly, at me.

“Could we agree to give him blood transfusions for an-other week, and not give him any potent analgesics that will make him sleepy, to see if he might rally and wake up so that we can all have a few last words with him?” the son pleaded. He had tears in his eyes. It was becom-ing clear why he was pursuing this particular course. He had not seen his father for a number of months, and the way things would likely go without the attempt he was suggesting meant there would be no chance for him to say good-bye to his father.

The attending physician looked at him and said, “Sure, we could do that; let us say up to six units of blood? That may give us up to three weeks, depending on how quickly his hemoglobin falls. As long as he is not ex-pressing severe pain or shortness of breath, I can hold off on the opiates and other such drugs.”

The mother took her son’s hand and said, “We can hope he will wake up enough to see you one last time. If not, I know how much he loved you and always knew how much you cared about him.” Three weeks and six units of blood passed by, and the patient did not wake up. We stopped the transfusions, and, as he became short of breath, treated him for his symptom, with the son and his mother almost always by his side. They had come to accept the reality of the situation and the limits of care, as well as the importance of trying to heed the wishes of those we love.

















































































Call for Applications

Visiting Faculty Fellowships 2010-11

The University of Toronto’s Centre for Ethics invites applications for its Visiting Faculty Fellowships. For the academic year 2010-11, two fellowships will be awarded to outstanding scholars and teachers inter-ested in writing and conducting research about ethics during a year in residence at the University of Toronto.

Fellows will participate in a bi-weekly seminar at the Centre, together with local faculty as well as the Cen-tre’s graduate and post-doctoral fellows. Fellows are also expected to participate regularly in the Centre’s other activities, including seminars, colloquia, and public lectures; and to be in residence in Toronto for the term of their appointments, which will run from September 1, 2010 to May 15, 2011. Although regular teaching obligations are not attached to the Fellow-ships, one of the goals of the Centre for Ethics is to enhance the undergraduate student experience at the University of Toronto. We strongly encourage Fellows to participate in informal events in the Ethics, Society and Law program and in Trinity College, and to con-sider teaching a one-term course at the upper level.

Faculty fellows will receive stipends intended to help maintain their salary during the fellowship year at its usual level. Stipends will normally amount to up to one half of the fellow’s academic year salary, up to a maximum of C$ 50, 000. In addition, fellows will receive a research allowance; an office in the Cen-tre, equipped with a computer; and access to library and other University facilities. Their home institution is expected to provide at least half of their salaries,

in addition to all benefits. Fellows between regular academic appointments are eligible for funding to be determined on an individual basis.

Fellows are selected by an interdisciplinary faculty committee in the Centre for Ethics. Applicants are judged on the quality of their achievements in their field of specialization and their ability to benefit from work in the Centre; the contributions they are likely to make in the future in higher education through teach-ing and writing about ethics; and the probable signifi-cance of their proposed research and its relevance to the purposes of the Centre. Applicants must hold a university faculty appointment at the time of applica-tion. There is no restriction on discipline or citizenship.

For fellowships beginning in September 2010, appli-cants must submit hard copies of:

A curriculum vitae;1. A scholarly paper in English written or published in 2. the past three years (no more than 10,000 words, on longer papers, applicants must indicate their own excerpt);A statement (no more than 1,500 words) describ-3. ing the proposed research project;Three letters of reference (at least one from some-4. one who was not a dissertation supervisor) sent directly to the Director, Centre for Ethics at the address below.

All materials, including letters of reference, must be received by November 16, 2009. Suc-cessful applicants will be asked to provide salary infor-mation on a confidential basis to the Centre’s Director.

Please send applications to: Professor Melissa Williams (Director), Centre for Ethics, University of Toronto, 6 Hoskin Avenue, Toronto, Ontario Canada M5S 1H8.


Seminars, Events & Conferences

JCB Bioethics Seminars This Month:(Seminars are held at 3:10-4:30 pm, Great Hall, 88 College St. and are webcast through ePresence)

September 16, 2009Tom Tomlinson, PhD, Professor, Department of Philosophy and Director, Cen-ter for Ethics and Humanities in the Life Sciences, Michigan State University. “Protection of Non-Welfare Interests in the Research Uses of Archived Biologi-cal Samples”.

September 23, 2009 NO SEMINAR September 30, 2009TBA

September 9, 2009Global Health Discussion Forum with Dr. Barry Pakes discussing “Global Health: Education, Ethics and Evaluation”. 12:00–1:00pm, Office of SickKids Inter-national, 7th Floor Conference Room, 525 University Avenue (SE Corner, Elm Street) RSVP to [email protected]

September 17, 2009Bioethics Grand Rounds Treatment Decisions, Best Interests and Mature Minors - Latest from the Supreme Court of Canada. Professor Joan M. Gilmour, BA, LLB (Toronto), JSM, JSD (Stanford), of the Bars of Ontario and British Columbia. 12:00-1:00 pm at The Hospital for Sick Children, 1250 Elm Wing. For more information please contact [email protected]

September 17, 2009Issues in Clinical Research - Mark H. Yudin, MD, MSc, FRCSC Obstetrics, Gynecology, & Reproductive Infectious Diseases, St. Michael’s Hospital. ”Is-sues in Research in the Area of Pregnancy Planning Among HIV+ Individuals and Couples”. 12:00– 1:00pm at St. Michael’s Hospital, 30 Bond Street in the 2-010 Bond Assembly Hall. Bring your lunch. For more information, please call Dharmista Patel (416) 864–6060 ext 2557.

ePresence Registration Instructions:

Most of our bioethics seminars are now being webcast live. All archived seminars are avail-able under Published Events. ePresence supports both PC and MAC videostreaming. You can register to view and participate in live events by following the steps below:

Go to the 1. Centre for Global eHealth Innova-tion’s ePresence Click on the Join button 2. (at the top blue bar) Enter your information in 3. the join screen, including userid and password You will need remember 4. your userid and password so that you can join future seminar web casts Please report by email to 5. [email protected] if you have any difficul-ties registering You will only need to reg-6. ister once For subsequent seminars, 7. login with your userid and password – you do not have to re-registerPlease note this registra-8. tion process should be done well before the event itself. If you have dif-ficulty viewing your first seminar, you should check with your IT professional.

mailto:[email protected]


http://epresence.ehealthinnovation.org/epresence/1.aspx







September 21, 2009Centre for Ethics Seminar Series - Vagueness, Plans and the Puzzle of the Self-Torturer. Sergio Tenenbaum, Department of Philosophy, University of Toronto. 2:00-4:00pm at Room 200, Centre for Eth-ics, Larken Building, Trinity College, 15 Devonshire Place. For more information please contact: [email protected]

September 21, 2009The Jackman Humanities Institute will be hosting a roundtable called “Humanities for Inhumane Times” featuring a discussion of IHAB members Avi Lewis and John Ralston Saul, along with Jill Matus (Vice-Provost, Students, University of Toronto) and Chad Gaffield (President, SSHRC). 7:00-9:00pm, George Ignatieff Theatre. Free and open to all. Seat-ing is available on a first-come, first-served basis. For more information please see: http://www.humanities.utoronto.ca/event_details/id=138

September 24, 2009The Tommy Douglas Distinguished Speakers Series - Publicly Funded Health Care & Its Preservation in Canada. An evening with Ralph Nader & Shirley Douglas to commemorate the introduction of Univer-sal Health Care in Saskatchewan in 1962. 7:00pm, The Great Hall, Hart House, University of Toronto A fundraising event to support the Health Studies Program at the University of Toronto. For more infor-mation and to buy tickets please go to: www.bring-backtommy.ca

September 30, 2009The Centre for Addiction and Mental Health Brown Bag Research Ethics Discussion Groups 2009 - “Clini-cal Trial Applications (CTAs) When, Why and the Process at CAMH”, Sandhya Patel, ManagerResearch Quality & Regulatory Affairs, CAMH. 12:00-1:00pm, Room 2022 ELCLC (Eli Lilly Computer Learn-ing Centre) 33 Russell Street. For more information please contact: [email protected]

October 23, 2009The McGill School of Nursing will again host the Joan Gilchrist Nursing Explorations Series in Montreal, Que-bec, Centre Mont-Royal, rue 2200 Mansfield. The topic of this one-day Conference is “Innovative Nursing Practice: Transforming Care at the Bedside and Beyond.” Simultaneous translation will be provided for all sessions. For more information and to register now, please visit the Conference website:www.medicine.mcgill.ca/nursing-explorations2009

May 11-14, 2010Call for abstracts and invitation to attend the 6th In-ternational Conference on Clinical Ethics Consultation be held in Portland, Oregon, USA. Abstract deadline extended to October 15, 2009. We are especially still interested in abstracts for case study panels and point-counter-point panels. For more information visit website at http://www.ethics2010.org.

The JCB is pleased to present the report “Working for an Ethical Future: The First Decade of the University of Toronto Joint Centre for Bioethics”. If you would like copies of the report mailed to you, please send an email request (including your mailing address) to [email protected]. Al-ternatively, copies can be picked up at the JCB, 88 College Street, Toronto.



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Rights and Wrongs: Life, Death and the Pursuit of Happiness

A Conference in Honour of L. Wayne Sumner

Saturday, October 24, 2009at the Jackman Humanities Building, Room 100A,

University of Toronto

Conference is open to all. Admission is free and no ticket required. To register for conference, please email: [email protected]

9:00am-3:45pm Papers by: Lisa Fuller (PhD, ’06), SUNY Albany•Anthony Skelton (PhD, ’04), University of Western Ontario•Michael Stingl (PhD, ’86), University of Lethbridge•Gustav Arrhenius (PhD, ’00), University of Stockholm•

11:45am-1:00pm Catered Lunch

4:00-4:30pm Closing statement by L. Wayne Sumner

4:30-5:00pm Prize Presentation: The Canada Council for the Arts awards L. Wayne Sumner the Molson Prize in the Humanities

5:00-6:30pm Reception



Recent Publications

Benatar SR. Global health: where to now? Journal of Global Health Governance. Fall 2008/Spring 2009; 11(2).

Buetow S, McAllum C, Upshur R. Using Philosophy to help manage the fear of death. Journal of Palliative Care 2009; 25(2): 111-6.

Cohen ERM, O’Neill JM, Joffres M, Upshur REG, Mills E. Reporting of informed consent, standard of care and post-trial obligations in global randomized intervention trials: a systematic survey of registered trials. Developing World Bioethics 2009; 9(2): 74-80.

Cox S, Townsend A, Preto N, Woodgate RL, Kol-opack P. Ethical challenges and evolving practices in research on ethics in health research. Health Law Review 2009; 17(2-3):33-9.

Ford N, Mills EJ, Zachariah R, Upshur R. Ethics of conducting research in conflict settings. BioMedCentral Conflict and Health 2009; 3:7.

Goodyear MDE, Lemmens T, Sprumont D, Tang-wa G. Does the FDA possess the authority to trump the Declaration of Helsinki? British Medical Journal 2009; 338: 1157-8. Available online at: http://www.bmj.com/cgi/content/full/338/apr21_1/b1559

Hurdowar A, Urmson L, Bohn D, Geary D, Laxer R, Stevens P. Compliance with a pediatric clinical practice guideline for intravenous fluid and electrolyte administration. Healthcare Quarterly 2009; 12(Special Issue): 129-34. Jackson C, MacDonald M, Anderson M, Stevens P, Gordon P, Laxer R. Improving communication

of critical test results in a pediatric academic setting: key lessons in achieving and sustaining positive outcomes. Healthcare Quarterly 2009; 12(Special Issue): 116-22.

Krleza-Jeric K, Lem-mens T. The 7th revision of the Declaration of Helsinki: good news for the transpar-ency of clinical trials. Croatian Medical Journal 2009; 50(2): 105-10. Available online at: http://www.cmj.hr/2009/50/2/19399942.htm

Lemmens T. Institutional conflicts of interest. In: Weijer C, McKnight D. editors. Bioethics education program, Royal Society of Physicians and Surgeons. Available online at: http://rcpsc.medical.org/bioethics/cases/case_3_4_1_e.php

Lemmens T. Pharmaceutical research practices under siege: what are the regulatory responses? 2009 July; (online discussion forum on Canadian health care issues) available online at: http://thefirstcanadian-healthcareconference.ca/index.php?/Pharmaceutical-Research-Practices-Under-Siege

Lemmens T. Biobanken en nieuw genetisch onder-zoek: een uitdaging voor de bescherming van de privacy van medische gegevens. [Biobanks and New Genetic Research: A Challenge for the Protection of Privacy of Medical Data] In: Wouters J, Ryngaert C, editors. Mensenrechten: Actuele Brandputen [Human Rights: Contemporary Issues] Leuven: Acco: 2008. p. 135-156.

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Recent Publications

Miler FA. The complex promise of newborn screening. Indian Journal of Medical Ethics 2009; VI(3): 142-8.

Owen M, Emerson C, Kolopack P, Preto N, Sampson H, Townsend A, Willison D, Woodgate RL. Informing governance through evidence-based research on REBs: challenges and opportunities. Health Law Review 2009; 17(2-3): 40-6.

Pomfret S, Abdool Karim Q, Benatar SR. Inclu-sion of adolescent women in microbicide trials: a public health imperative! Public Health Ethics. (Ad-vance Access published June 12, 2009 doc.10.1093/phe/php013)

The PLoS Medicine Editors. Ethics Without Bor-ders. PLoS Med 2009; 6(7): e1000119.

Rapoport A. Addressing ethical concerns regarding pediatric palliative care research. Archives of Pediat-rics & Adolescent Medicine 2009 Aug; 163(8): 688-91.

Russell B. Book review, “The book of ethics: expert guidance for professionals who treat addiction”. Psy-chiatric Times 2009; 26(6).

Russell B. Some distinctions, ‘hair splitting’, and added worries. American Journal of Bioethics 2009; 9 (10): 35-7.

Sampson H, Cox S, Saginur R, Owen M. Ex-amining and understanding the need for Canadian Research Ethics Board (REB) member standardized education: governance views from the field. Health Law Review 2009; 17(2-3): 739.

Sampson H, Weijer C, Pullman D. Research gov-ernance lessons from the National Placebo Initiative.

Health Law Review 2009; 17(2-3): 26-32.

Saginur R, Deschamps P, Owen M, Sampson H. Ethics review of multi-centre trials: where do we stand? Health Law Review 2009; 17(2-3): 59-65.

Schopper D, Upshur R, Matthys F, Singh JA, Bandewar SS, Ahmad A, van Dongen E. Research ethics review in humanitarian contexts: the experi-ence of the independent ethics review board of Mé-decins Sans Frontières. PLoS Medicine 2009; 6(7): e1000115.

Schwartz B. An innovative approach to teaching ethics and professionalism. Journal of the Canadian Dental Association 2009 June; 75(5): 338-40.

Upshur R, Singh J, Ford N. Apocalypse or redemp-tion: responding to extensively drug-resistant tubercu-losis. Bulletin of the World Health Organization 2009; 87: 481-3.

Sprumont D, Lemmens T. Les conflits d’intérêts dans la recherche biomédicale. In: Guillod O, editor. Conflits d’intérêts dans le système de la santé. 15e journée de droit de la santé. Neuchâtel: Institut de droit de la santé de l’Université de Neuchâtel: 2009. p. 223-248.

Viens AM, Bensimon CM, Upshur REG. Your liberty or your life: reciprocity in the use of restrictive measures in contexts of contagion. Bioethical Inquiry 2009; 6: 207-17.

Zlotnik Shaul, R, McDonald MZ, Langer JC. Facili-tating innovation in the clinical setting: a pathway for operationalizing accountability. Healthcare Quarterly 2009; 12(3): 60-5.

The purpose of this newsletter is to facilitate communication among people interested in bioethics throughout the Joint Centre for Bioethics, participat-ing institutions and elsewhere. The newsletter is published and distributed by email at the beginning of each month. If you would like to receive the newslet-ter, please contact:

Editor: Adrienne GrapkoEmail: [email protected]: (416) 978-1911

Submission & Contact Information

The Joint Centre for Bioethics (JCB) is a partnership among the University of Toronto; Baycrest Centre for Geriatric Care; Bloorview Kids Rehab; Centre for Addiction and Mental Health; Centre for Clinical Ethics, a joint venture of Providence Centre, St. Joseph’s Health Centre, and St. Michael’s Hospital; The Hospital for Sick Children; Humber River Regional Hospital; Mount Sinai Hospital; North York General Hospital; Ontario Genomics Institute; Sunnybrook Health Sciences Centre; Toronto Community Care Access Centre; Toronto East General Hospital; Toronto Rehabilitation Institute; Trillium Health Centre; and University Health Network.

The University of Toronto Joint Centre for Bioethics

Submissions to the newsletter must be made by the 25th of the preceding month.Previous issues of the newsletter are posted on our website at:

http://www.jointcentreforbioethics.ca/enewsletter/enewsletter.shtml

Joint Centre for BioethicsUniversity of Toronto88 College StreetToronto, Ontario M5G 1L4Canada

Phone: (416) 978-2709Fax: (416) 978-1911Email: [email protected]: http://www.jointcentreforbioethics.ca/


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Documents

Feature: Transplantation Ethics · 4 Announcements 6 MHSc Graduates Make a Contribu- tion to Research Ethics Literature 7 Article: Research Ethics Boards, Clinical Trials and the