Medicine and Health Sciences Commons^™

Will The Real Charles Fried Please Stand Up?, Paul Miller, Charles Weijer

Charles Weijer

In response to the preceding commentary by Jerry Menikoff in this issue of the Journal, the authors argue that Fried's central concern is not that randomized clinical trials (RCTs) are conducted without consent, but rather that various aspects of the design and conduct of RCTs are in tension with physicians' duties of personal care to their patients. Although Fried does argue that the existence of equipoise cannot justify failure to obtain consent from research subjects, informed consent by itself does not supplant ill subjects' rights to personalized judgment and care embodied in Fried's equipoise.

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.

Community Consent For Genetic Research, 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 …

Ethical Issues In Palliative Care Research, Neil Macdonald, Charles Weijer

Charles Weijer

No abstract provided.