Arts and Humanities Commons^™

Importance Of Informed Consent In Offering To Return Research Results To Research Participants, Conrad Fernandez, Eric Kodish, Charles Weijer

Charles Weijer

No abstract provided.

Offering To Return Results To Research Participants: Attitudes And Needs Of Principal Investigators In The Children's Oncology Group, Conrad Fernandez, Eric Kodish, Susan Shurin, Charles Weijer

Charles Weijer

PURPOSE: The offer to return a summary of results to participants after the conclusion of clinical research has many potential benefits. The authors determined current practice and attitudes and needs of researchers in establishing programs to return results to research participants.

METHODS: An Internet survey of all 236 principal investigators (PIs) of the Children's Oncology Group in May 2002 recorded PI and institutional demographics, current practice, and perceived barriers to and needs of PIs for the creation of research results programs.

RESULTS: One hundred fifty (63.8%) PIs responded. Few institutions (n = 5) had established, comprehensive programs to offer the …

Bioethics In Social Context, Edited By Barry Hoffmaster, Charles Weijer

Charles Weijer

No abstract provided.

The Ethics Of Placebo-Controlled Trials, Charles Weijer

Charles Weijer

No abstract provided.

Rehabilitating Equipoise, Paul Miller, Charles Weijer

Charles Weijer

When may a physician legitimately offer enrollment in a randomized clinical trial (RCT) to her patient? Two answers to this question have had a profound impact on the research ethics literature. Equipoise, as originated by Charles Fried, which we term Fried's equipoise (FE), stipulates that a physician may offer trial enrollment to her patient only when the physician is genuinely uncertain as to the preferred treatment. Clinical equipoise (CE), originated by Benjamin Freedman, requires that there exist a state of honest, professional disagreement in the community of expert practitioners as to the preferred treatment. FE and CE are widely understood …

Is The Use Of Placebo Controls Ethically Permissible In Clinical Trials Of Agents Intended To Reduce Fractures In Osteoporosis?, Baruch Brody, Nancy Dickey, Susan Ellenberg, Robert Heaney, Robert Levine, Richard O'Brien, Ruth Purtilo, Charles Weijer

Charles Weijer

Substantial progress has been made in developing treatments that reduce the risk of fractures in osteoporosis. However, available treatments are only partially effective, they are not widely used, and there is need to search for more effective means of fracture prevention. Currently known effective means of reducing fractures were found using randomized placebo-controlled trials. The use of placebo controls in clinical trials has been a subject of significant controversy in recent years. The Declaration of Helsinki revision of October 2000 caused great concern among clinical investigators about the future use of placebo controls if known effective therapeutic agents are available. …

Disclosure Of The Right Of Research Participants To Receive Research Results: An Analysis Of Consent Forms In The Children's Oncology Group, Conrad Fernandez, Eric Kodish, Shaureen Taweel, Susan Shurin, Charles Weijer

Charles Weijer

BACKGROUND: The offer of return of research results to study participants has many potential benefits. The current study examined the offer of return of research results by analyzing consent forms from 2 acute lymphoblastic leukemia studies of the 235 institutional members of the Children's Oncology Group.

METHODS: Institutional review board (IRB)-approved consent forms from 2 standard-risk acute lymphoblastic leukemia studies (Children's Cancer Group [CCG] 1991 and Pediatric Oncology Group [POG] 9407) were analyzed independently by 2 reviewers.

RESULTS: The authors received replies from 202 of the 235 institutions that were contacted (85%). One hundred eighty-one institutions had CCG 1991 (n …

Therapeutic Obligation In Clinical Research, Charles Weijer, Paul Miller

Charles Weijer

No abstract provided.

Informing Study Participants Of Research Results: An Ethical Imperative, Conrad Fernandez, Eric Kodish, Charles Weijer

Charles Weijer

No abstract provided.

Unethical Author Attribution, Charles Weijer, Akira Akabayashi

Charles Weijer

I am an M.D/Ph.D. student and work as a research assistant for the director of a division of the school of medicine who is an M.D. He assigned me to research a certain topic and gave me no guidelines or guidance as to how to do it. Nevertheless, I did the research and wrote it up. My supervisor liked the report and said that he thought it was so good that “I would like to offer you the opportunity to publish it and list you as the primary author.” Some bells went off when he so grandly offered to let …

Placebo Tribulations, Charles Weijer

Charles Weijer

No abstract provided.

Matters Of Life And Death: Making Moral Theory Work In Medical Ethics And The Law, James Anderson, Charles Weijer

Charles Weijer

No abstract provided.

The Research Subject As Wage Earner, James Anderson, Charles Weijer

Charles Weijer

The practice of paying research subjects for participating in clinical trials has yet to receive an adequate moral analysis. Dickert and Grady argue for a wage payment model in which research subjects are paid an hourly wage based on that of unskilled laborers. If we accept this approach, what follows? Norms for just working conditions emerge from workplace legislation and political theory. All workers, including paid research subjects under Dickert and Grady's analysis, have a right to at least minimum wage, a standard work week, extra pay for overtime hours, a safe workplace, no fault compensation for work-related injury, and …

Continuing Review Of Clinical Research Canadian-Style, Charles Weijer

Charles Weijer

No abstract provided.

Lessons From Everyday Lives: A Moral Justification For Acute Care Research, Andrew Mcrae, Charles Weijer

Charles Weijer

Progress in emergency and critical care requires that clinical research be performed on patients who are incapable of granting consent for research participation. Analyses of the ethics of such research have left some questions incompletely answered. Why should we be permitted to expose vulnerable patients to research risks without their consent? In particular, how do we justify research interventions that have no potential benefit for participants (nontherapeutic interventions)? This article presents a moral justification for nontherapeutic interventions in emergency research. By relying on a framework for assessing research risks, and by drawing on the example of pediatric research, this justification …

Placebo Trials And Tribulations, Charles Weijer

Charles Weijer

No abstract provided.

I Need A Placebo Like I Need A Hole In The Head, Charles Weijer

Charles Weijer

No abstract provided.

The Ethics Of Placebo-Controlled Trials, Charles Weijer, Kathleen Glass

Charles Weijer

No abstract provided.

When Argument Fails, Charles Weijer

Charles Weijer

No abstract provided.

A Critical Appraisal Of Protections For Aboriginal Communities In Biomedical Research, Charles Weijer, James Anderson

Charles Weijer

As scientists target communities for research into the etiology, especially the genetic determinants of common diseases, there have been calls for the protection of communities. This paper identifies the distinct characteristics of aboriginal communities and their implications for research in these communities. It also contends that the framework in the Belmont Report is inadequate in this context and suggests a fourth principle of respect for communities. To explore how such a principle might be specified and operationalized, it reviews existing guidelines for protecting aboriginal communities and points out problems with these guidelines and areas for further work.

Who Should Foot The Bill For Continuing Review Of Research?, Charles Weijer

Charles Weijer

No abstract provided.

Minimal Risk And Its Implications, Charles Weijer

Charles Weijer

No abstract provided.

Should Physicians Accept Gifts From Their Patients? No: Gifts Debase The True Value Of Care, Charles Weijer

Charles Weijer

No abstract provided.

Informing Patients Of Uncertainty In Clinical Trials, S. Halpern, J. Karlawish, Charles Weijer

Charles Weijer

No abstract provided.

Continuing Review Of Research Approved By Canadian Research Ethics Boards, Charles Weijer

Charles Weijer

No abstract provided.

The Ethics Wars: Disputes Over International Research, Charles Weijer, James Anderson

Charles Weijer

The effort to revise the Declaration of Helsinki and the CIOMS Guidelines has sparked a sometimes vitriolic debate centering on the use of placebo controls.

The Research Subject As Entrepreneur, James Anderson, Charles Weijer

Charles Weijer

No abstract provided.

Hospital Policy On Appropriate Use Of Life-Sustaining Treatment, Peter Singer, Geoff Barker, Kerry Bowman, Christine Harrison, Philip Kernerman, Judy Kopelow, Neil Lazar, Charles Weijer, Stephen Workman

Charles Weijer

OBJECTIVE: To describe the issues faced, and how they were addressed, by the University of Toronto Critical Care Medicine Program/Joint Centre for Bioethics Task Force on Appropriate Use of Life-Sustaining Treatment. The clinical problem addressed by the Task Force was dealing with requests by patients or substitute decision makers for life-sustaining treatment that their healthcare providers believe is inappropriate.

DESIGN: Case study.

SETTING: The University of Toronto Joint Centre for Bioethics/Critical Care Medicine Program Task Force on Appropriate Use of Life-Sustaining Treatment.

PARTICIPANTS: The 24-member Task Force included physician and nursing leaders from five critical care units, bioethicists, a legal …

Trial By Error, Charles Weijer

Charles Weijer

No abstract provided.

Family Duty Is More Important Than Rights, Charles Weijer

Charles Weijer

No abstract provided.