Search

Your search keyword '"Fernandez Lynch, Holly"' showing total 173 results
Start Over Author "Fernandez Lynch, Holly"
173 results on '"Fernandez Lynch, Holly"'

1. List of Contributors

Author

Cohen, I. Glenn, Fernandez Lynch, Holly, Robertson, Christopher T., and Sunstein, Cass R.

Published
2016

3. Index

Author

Cohen, I. Glenn, Fernandez Lynch, Holly, Robertson, Christopher T., and Sunstein, Cass R.

Published
2016

7. Cover

Author

Cohen, I. Glenn, Fernandez Lynch, Holly, Robertson, Christopher T., and Sunstein, Cass R.

Published
2016

21. Part IV: Crowding Out

Author

Cohen, I. Glenn, Fernandez Lynch, Holly, Robertson, Christopher T., and Sunstein, Cass R.

Published
2016

33. Acknowledgments

Author

Cohen, I. Glenn, Fernandez Lynch, Holly, Robertson, Christopher T., and Sunstein, Cass R.

Published
2016

37. Setting the Stage

Author

Cohen, I. Glenn, Fernandez Lynch, Holly, Robertson, Christopher T., and Sunstein, Cass R.

Published
2016

38. Foreword

Author

Cohen, I. Glenn, Fernandez Lynch, Holly, Robertson, Christopher T., and Sunstein, Cass R.

Published
2016

39. Table of Contents

Author

Cohen, I. Glenn, Fernandez Lynch, Holly, Robertson, Christopher T., and Sunstein, Cass R.

Published
2016

40. Engaging Key Stakeholders to Overcome Barriers to Studying the Quality of Research Ethics Oversight

Author

Anderson, Emily E., Hurley, Elisa A., Serpico, Kimberley, Johnson, Ann, Rowe, Jessica, Singleton, Megan, Bierer, Barbara E., Cholka, Brooke, Chaudhari, Swapnali, and Fernandez Lynch, Holly

Abstract

The primary purpose of Institutional Review Boards (IRBs) is to protect the rights and welfare of human research participants. Evaluation and measurement of how IRBs satisfy this purpose and other important goals are open questions that demand empirical research. Research on IRBs, and the Human Research Protection Programs (HRPPs) of which they are often a part, is necessary to inform evidence-based practices, policies, and approaches to quality improvement in human research protections. However, to date, HRPP and IRB engagement in empirical research about their own activities and performance has been limited. To promote engagement of HRPPs and IRBs in self-reflective research on HRPP and IRB quality and effectiveness, barriers to their participation need to be addressed. These include: extensive workloads, limited information technology systems, and few universally accepted or consistently measured metrics for HRPP/IRB quality and effectiveness. Additionally, institutional leaders may have concerns about confidentiality. Professional norms around the value of participating in this type of research are lacking. Lastly, obtaining external funding for research on IRBs and HRPPs is challenging. As a group of HRPP professionals and researchers actively involved in a research consortium focused on IRB quality and effectiveness, we identify potential levers for supporting and encouraging HRPP and IRB engagement in research on quality and effectiveness. We maintain that this research should be informed by the core principles of patient- and community-engaged research, in which members and key stakeholders of the community to be studied are included as key informants and members of the research team. This ensures that relevant questions are asked and that data are interpreted to produce meaningful recommendations. As such, we offer several ways to increase the participation of HRPP professionals in research as participants, as data sharers, and as investigators.

Published
2023
Full Text
View/download PDF

41. Facilitating Efficient and Ethical Trials at the Intersection of Research and Clinical Care.

Author

Fernandez Lynch, Holly and Kramer, Daniel B.

Subjects
*PREMATURE infants, *NORMATIVITY (Ethics), *INSTITUTIONAL review boards, *PATIENT preferences, *ATRIAL fibrillation
Abstract

The editorial discusses the challenges faced by investigators conducting research within clinical care settings, particularly in navigating institutional review board (IRB) approval processes. The authors propose a normative framework to align ethical oversight with the level of risk and burden posed by research activities, advocating for a more proportionate approach to consent requirements. They argue that current regulatory interpretations have led to confusion and propose adjustments to facilitate efficient and ethical trials at the intersection of research and clinical care. The authors emphasize the need for regulatory clarity to support ethical goals and encourage IRBs to focus on the unique risks of research activities rather than conflating them with standard care risks. [Extracted from the article]

Published
2025
Full Text
View/download PDF

45. Developing Recommendations for Oversight of Patient-Centered Outcomes Research—The PCOROS Study

Author

Weissman, Joel, primary, Cohen, I. Glenn, additional, Campbell, Eric, additional, Fernandez Lynch, Holly, additional, Largent, Emily, additional, Gupta, Avni, additional, Rozenblum, Ronen, additional, Abraham, Melissa, additional, Spikes, Karen, additional, Fagan, Maureen, additional, Gelinas, Luke, additional, Lipsitz, Stuart, additional, and Carnie, Martie, additional

Published
2020
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results