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Biomedical subjects

Leslie E Wolf

Publications and source records attributed to Leslie E Wolf.

10 recordsLinked to original sources
PubMed2005

Ethics and sample size.

The belief is widespread that studies are unethical if their sample size is not large enough to ensure adequate power. The authors examine how sample size influences the balance that determines the ethical acceptability of a study: the balance between the burdens that participants accept and the clinical or scientific value that a study can be expected to produce. The average projected burden per participant remains constant as the sample size increases, but the projected study value does not increase as rapidly as the sample size if it is assumed to be proportional to power or inversely proportional to confidence interval width. This implies that the value per participant declines as the sample size increases and that smaller studies therefore have more favorable ratios of projected value to participant burden. The ethical treatment of study participants therefore does not require consideration of whether study power is less than the conventional goal of 80% or 90%. Lower power does not make a study unethical. The analysis addresses only ethical acceptability, not optimality; large studies may be desirable for other than ethical reasons.

Bias↗
PubMed2005

Institutional review board guidance on pediatric research: missed opportunities.

OBJECTIVE: To examine whether and how institutional review boards (IRBs) are using their web-sites to provide guidance to investigators conducting pediatric research. STUDY DESIGN: We studied guidance on pediatric research from IRB web-sites at the 25 US medical schools, plus affiliated hospitals, research centers, and public health schools, and the top National Institutes of Health-funded (>5 million dollars) children's hospitals with separate IRBs. We also included 1 IRB that was not otherwise eligible because other IRBs use its web-based research ethics training program. Our final study population was 39 IRB web-sites. RESULTS: IRB web-sites generally provide basic information about pediatric research. However, few IRBs discuss important ethical issues on which the regulations are silent. Moreover, some IRBs provide incorrect advice about the regulations. More detailed IRB guidance may help pediatric investigators think through ethical issues and protect children in clinical research. Helpful approaches we identified include checklists and "points to consider," concrete examples to illustrate regulatory requirements, and discussion of areas of controversy. CONCLUSION: Few IRBs present the kind of detailed guidance that investigators might need to ensure ethically designed protocols. IRBs should revise their web-sites to ensure that they provide accurate, comprehensive, and sufficiently detailed guidance.

Child↗
PubMed2002

The challenges of IRB review and human subjects protections in practice-based research.

Practice-based research raises unique challenges with respect to human subjects protections and institutional review board (IRB) review. In this paper, three challenges posed by practice-based research are analyzed: (1) IRB review for clinician investigators who are not affiliated with an institution that has an IRB; (2) multiple IRB review; and (3) required human subjects protection training of key personnel. Investigators should be proactive in addressing required IRB review in practice-based research. In particular, they need to ensure that appropriate IRB review is obtained for all performance sites and plan for review for unaffiliated investigators. Practice-based research investigators and professional societies should educate IRB members and policy makers and publish articles regarding how IRBs might best address human subjects concerns in practice-based research. Furthermore, practice-based research investigators and professional societies should work with IRBs and the Office for Human Research Protections to facilitate centralized or cooperative review of practice-based research. Finally, practice-based research investigators need to ensure that their clinician investigators receive appropriate training in human subjects protection. Practice-based research investigators and professional societies can facilitate this process by helping to define and implement the appropriate training for busy practice-based research clinicians and office staff.

Ethics↗
PubMedDate not supplied

Human subjects issues and IRB review in practice-based research.

PURPOSE: This article explores the challenges that practice-based research networks (PBRNs) face with respect to the regulatory requirements for institutional review board (IRB) review and the protection of human subjects in research. METHODS: We used a regulatory and literature review, our previous research involving PBRN researchers, and our experience to identify issues in regulatory compliance and human subjects protections that present challenges to PBRNs and to suggest possible responses. RESULTS: We identified 3 challenges that PBRNs face with respect to regulatory compliance and human subjects protections. First, ensuring compliance with federal regulations governing human subjects research across all participating practices may be difficult. Clinicians may be unfamiliar with the regulatory requirements and may not have access to an IRB that can provide the required protocol review; moreover, different IRBs may impose inconsistent requirements. Second, conducting research in the practice setting presents unique issues regarding identification of human subjects, consent, and confidentiality. Finally, the use of electronic databases across practices for research raises concerns about how to respect the wishes of participants when combining data and how to maintain confidentiality of data. CONCLUSIONS: PBRN research makes unique contributions to the clinical evidence base by collecting data in community settings where most clinical care is provided. Such research, however, also presents unique challenges to human subject protections and regulatory compliance. Addressing these challenges is necessary to maintain public trust in and support for PBRN research. With careful planning, these ethical and regulatory challenges can be overcome.

Biomedical Research↗
PubMedDate not supplied

A new era in the ethics of human embryonic stem cell research.

Scientific progress in human embryonic stem cell (hESC) research and increased funding make it imperative to look ahead to the ethical issues generated by the expected use of hESCs for transplantation. Several issues should be addressed now, even though phase I clinical trials of hESC transplantation are still in the future. To minimize the risk of hESC transplantation, donors of materials used to derive hESC lines will need to be recontacted to update their medical history and screening. Because of privacy concerns, such recontact needs to be discussed and agreed to at the time of donation, before new hESC lines are derived. Informed consent for phase I clinical trials of hESC transplantation also raises ethical concerns. In previous phase I trials of highly innovative interventions, allegations that trial participants had not really understood the risk and benefits caused delays in subsequent trials. Thus, researchers should consider what information needs to be discussed during the consent process for hESC clinical trials and how to verify that participants have a realistic understanding of the study. Lack of attention to the special ethical concerns raised by clinical trials of hESC transplantation and their implications for the derivation of new hESC lines may undermine or delay progress toward stem cell therapies.

Cell Line↗