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Biomedical subjects

Charles Weijer

Publications and source records attributed to Charles Weijer.

At least 19 recordsLinked to original sources
PubMed2003

Disclosure of the right of research participants to receive research results: an analysis of consent forms in the Children's Oncology Group.

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 = 96) or POG 9905 (n = 85) protocols that were approved by an IRB. Most institutions provided contact information for the principal investigator (n = 175; 97%) and a member of the institution's research services office (n = 154; 85%). Only 5 (2.8%) institutions provided an indication of a participant's right to receive a summary of research results; most of these institutions provided details on how (n = 5) or when (n = 5) this was to occur. All of these institutions (n = 162; 89.5%) provided a specific statement offering new information that might affect a participant's decision to continue to participate in a study. Only 2 institutional consent forms offered participants the option to receive research results, and only 10 (5.5%) consent forms contained an unambiguous, specific statement offering to provide new information after the study was closed. CONCLUSIONS: Few institutional review board-approved consent forms explicitly indicate the right of research recipients to receive a summary of the results of the research in which they have participated.

Child↗
PubMed2003

Offering to return results to research participants: attitudes and needs of principal investigators in the Children's Oncology Group.

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 return of results. PIs indicated that major impediments to the implementation of such programs are the preparation of lay summaries, time constraints, the task of contacting participants, and potential distress for the participants. PIs identified the following facilitators to the establishment of a program in their own institution: lay summaries, web site, preparation of an oncologist's summary, and financial credits. There was no clear consensus as to when the results should be shared: 30% indicated after the study was closed and 24% indicated at the time of publication of results. A substantial proportion of respondents opposed or strongly opposed the implementation of a universal offering of results to research participants. CONCLUSIONS: Few Children's Oncology Group institutions have programs that offer the return of results to research participants. Significant barriers and facilitators to this process have been identified.

Academies and Institutes↗
PubMed2003

Is the use of placebo controls ethically permissible in clinical trials of agents intended to reduce fractures in osteoporosis?

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. A working group of ethicists, clinical trial design experts, and clinical investigators examined the current state of knowledge of osteoporosis treatment and trials. They concluded that if placebo controls put subjects at substantial risk of serious outcomes, they are not ethically permissible. Placebo controls in osteoporosis trials with fracture as the measured outcome are permissible only under narrowly defined conditions. Placebo controls may be used if competent, well-informed patients refuse approved therapies for sound reasons, there is a reasonable basis for substantial disagreement or lack of consensus among professionals about whether approved treatments are better than placebos, or subjects are refractory to known effective agents. Active control trials are permissible and desirable if they can be designed and conducted in ways that overcome the interpretive difficulties often associated with such trials.

Clinical Trials as Topic↗
PubMed2002

The research subject as wage earner.

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 union organization. If we accept that paid research subjects are wage earners like any other, then the implications for changes to current practice are substantial.

Canada↗
PubMed2002

Lessons from everyday lives: a moral justification for acute care research.

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 is founded in how institutional review boards, and society in general, analyze risk. Our justification for emergency research also suggests additional protections for emergency research participants, including a stringent threshold for research risk, that still permit important research to proceed.

Child↗