De Minimis Risk: A Proposal for a New Category of Research Risk
@article{Rhodes2011DeMR,
title={De Minimis Risk: A Proposal for a New Category of Research Risk},
author={R. Battin Rhodes and Jody Azzouni and Stefan Bernard Baumrin and Keith J. Benkov and Martin J. Blaser and Barbara L Brenner and Joseph Warren Dauben and William James Earle and Lily Frank and Nada Gligorov and Joseph Goldfarb and Kurt Hirschhorn and Rochelle Hirschhorn and Ian R. Holzman and Debbie Indyk and Ethylin Wang Jabs and Douglas P. Lackey and Daniel A. Moros and Sean Philpott and Matthew E. Rhodes and Lynne D. Richardson and Henry S Sacks and Abraham P. Schwab and Rhoda S. Sperling and Brett E. Trusko and Arnulf Zweig},
journal={The American Journal of Bioethics},
year={2011},
volume={11},
pages={1 - 7},
url={https://api.semanticscholar.org/CorpusID:205859554}
}De Minimis Risk: A Proposal for a New Category of Research Risk Rosamond Rhodes a , Jody Azzouni b , Stefan Bernard Baumrin c , Keith Benkov a , Martin J. Blaser d , Barbara Brenner a , Joseph W. Dauben c , William J. Earle c , Lily Frank c , Nada Gligorov a , Joseph Goldfarb a , Kurt Hirschhorn a , Rochelle Hirschhorn d , Ian Holzman a , Debbie Indyk a , Ethylin Wang Jabs a , Douglas P. Lackey c , Daniel A. Moros a , Sean Philpott e , Matthew E. Rhodes f , Lynne D. Richardson a , Henry S…
31 Citations
Microbiome Forensic Biobanking: A Step toward Microbial Profiling for Forensic Human Identification
- 2021
Biology, Medicine
The creation of large population microbiome biobanks, specifically dedicated to forensic human identification, could be worthwhile and useful to increase the practical applications of forensic microbiology for identification purposes, given that this type of evidence is currently absent from most real casework investigations and judicial proceedings in courts.
Early COVID-19 Therapy with Azithromycin Plus Nitazoxanide, Ivermectin or Hydroxychloroquine in Outpatient Settings Significantly Reduced Symptoms Compared to Known Outcomes in Untreated Patients.
- 2020
Medicine
Apparent benefits of the combination between early detection and early pharmacological approaches for COVID-19 demonstrated to be consistent when when compared to different control groups of untreated patients.
De Minimis Normativism: a New Theory of Full Aptness
- 2020
Philosophy
Full aptness is the most important concept in performance-based virtue epistemology. The structure of full aptness, in epistemology and elsewhere, is bilevelled. At the first level, we evaluate…
Enhancing ethics review of social and behavioral research: developing a review template in Ethiopia
- 2019
Medicine, Sociology
A review assessment tool that could potentially be useful to raise awareness, focus attention, and strengthen the review of social and behavioral studies by ethics review committees, particularly in settings without a long-standing tradition of reviewing such research.
Promoting Research with Organ Transplant Patients.
- 2018
Medicine
It is argued that all transplant candidates should be invited and encouraged to participate in research and that early discussion with patients about participating in research may help to overcome reluctance about and the ethical challenges of transplantation research with human subjects.
Help, hope and hype: ethical considerations of human microbiome research and applications
- 2018
Medicine, Philosophy
This paper presents a meta-analysis of 148 cases of neglected bowel disease in China over a 25-year period from 1993 to 2002 and shows clear patterns of decline in the number of cases of meningitis and its complications.
When Is Participation in Research a Moral Duty?
- 2017
Philosophy, Medicine
This paper argues against the widely accepted views of Han Jonas and all of those who have accepted his declarations without challenge and shows why it is both just and fair to invite and encourage people to participate in studies.
37 References
Reforming the regulations governing research with human subjects.
- 2011
Law, Medicine
A working group convened by the Office of Management and Budget (OMB) has drafted a proposal to revise the Common Rule and seeks public comment.
Identifiability in biobanks: models, measures, and mitigation strategies
- 2011
Medicine, Biology
The extent to which biospecimens and affiliated data can be designated as identifiable and the policy implications, particularly as they pertain to biobank security and access policies are discussed.
Protecting Participants of Clinical Trials Conducted in the Intensive Care Unit
- 2011
Law, Medicine
The key literature addressing the various scientific and ethical issues raised by critical care research, including questions of equipoise and the selection of control groups, informed consent, therapeutic misconception, conflict of interest, and quality improvement projects are reviewed.
Caught you: threats to confidentiality due to the public release of large-scale genetic data sets
- 2010
Biology
Depending on the degree of supplemental information, there is a good chance that at least a few individuals can be identified from an anonymized data set, however, any re-identification may potentially harm study participants because it will release individual genetic disease risks to the public.
Surrogate consent for research involving adults with impaired decision making: Survey of Institutional Review Board practices
- 2010
Law, Medicine
Much variability exists in Institutional Review Board surrogate consent practices and limits on risks in studies involving incapacitated adults, and this variability may have adverse consequences for needed research involving incapacitate adults.
Is Deidentification Sufficient to Protect Health Privacy in Research?
- 2010
Medicine, Law
The revolution in health information technology has enabled the compilation and use of large data sets of health records for genomic and other research, but the manipulation of large quantities of health information creates substantial challenges for protecting the privacy of patients and research subjects.
Urge Overkill: Protecting Deidentified Human Subjects at What Price?
- 2010
Law, Medicine
The Recipe for Overreaching Regulation
- 2010
Law
Three features of the federal regulations and their application that produce institutional review boards’ tendency toward over-reaching regulation are identified: too broad, ambiguous and vague language, and a protectionist attitude.