Investigators' successful strategies for working with Institutional Review Boards.

This study was designed to identify successful strategies used by investigators for working with their Institutional Review Boards (IRBs) in conducting human subjects research. Telephone interviews were conducted with 46 investigators representing nursing, medicine, and social work. Interview transcripts were analyzed using qualitative descriptive methods. Investigators emphasized the importance of intentionally cultivating positive relationships with IRB staff and members, and managing bureaucracy. A few used evasive measures to avoid conflict with IRBs. Few successful strategies were identified for working with multiple IRBs. Although most investigators developed successful methods for working with IRBs, further research is needed on how differences in IRB culture affect human subjects protection, and on best approaches for obtaining IRB approval of multi-site studies.

Compassion and vigilance: investigators' strategies to manage ethical concerns in palliative and end-of-life research.

BACKGROUND: Ethical concerns were identified as a potential barrier to advancing palliative and end-of-life science at the 2004 National Institutes of Health State of the Science Meeting. However, data are lacking about the nature of ethical concerns and strategies for balancing the need to advance science with human subjects protections. METHODS: A qualitative case-study design was used to follow 43 end-of-life studies from proposal development through the review process and implementation. Investigators participated in semi-structured telephone interviews and provided document data regarding their experiences with grant and IRB reviews. Using constant comparative analysis within and across cases, the investigators identified commonly encountered and unique concerns and strategies for managing these concerns. FINDINGS: Investigator strategies fell into two broad categories: 1) Recruitment and consent strategies related to subject identification and enrollment; and 2) Protocol-related strategies related to the process of data collection. These strategies shared the overarching meta-themes of compassion, as evidenced by a heightened sensitivity to the needs of the population, coupled with vigilance, as evidenced by close attention to the possible effects of study participation on the participants' well-being, clinical care, and the needs of research staff. CONCLUSIONS: Ethical concerns have led to the development of compassionate and vigilant strategies designed to balance the potential for risk of harm with the need to advance the science of palliative and end-of-life care. These strategies can be used by investigators to address ethical concerns and minimize barriers to the development of palliative and end-of-life care science.

Student perspectives on transitioning to new technologies for distance learning.

This article reports on students' perceptions of their learning experiences when an existing distance-learning master's program transitions to new technologies and new instructional strategies. Unique elements addressed in this article include (1) findings when a program with extensive experience delivering distance education changes to new technologies and (2) findings when a multidimensional format is used to evaluate program delivery. The technology changes involved migrating from a satellite-based technician-supported videoconferencing system to a land-based faculty-operated videoconferencing system and the addition of class Web materials and asynchronous computer conferencing to course delivery. The multidimensional evaluation format examined student experiences within the context of specific interactions among instructional activities, technology applications, and desired learning outcomes. The evaluation process involved (1) open-ended and structured items in course surveys and (2) an end-of-year student focus group discussion. A formative evaluation approach was used; this article reports on efforts to address the problems identified. Findings include (1) program planners should not assume that prior institutional experiences with distance education facilitate a smooth transition to use of different technologies and (2) a formative multidimensional approach to program evaluation is critical for understanding student experiences with technology-mediated distance education.