Literature DB >> 15634751

Eliminating the daily life risks standard from the definition of minimal risk.

D B Resnik1.   

Abstract

The phrase "minimal risk," as defined in the United States' federal research regulations, is ambiguous and poorly defined. This article argues that most of the ambiguity that one finds in the phrase stems from the "daily life risks" standard in the definition of minimal risk. In this article, the author argues that the daily life risks standard should be dropped and that "minimal risk" should be defined as simply "the probability and magnitude of the harm or discomfort anticipated in research are not greater than those encountered during the performance of routine physical or psychological examinations or tests".

Keywords:  Biomedical and Behavioral Research; Legal Approach

Mesh:

Year:  2005        PMID: 15634751      PMCID: PMC1734001          DOI: 10.1136/jme.2004.010470

Source DB:  PubMed          Journal:  J Med Ethics        ISSN: 0306-6800            Impact factor:   2.903


  10 in total

1.  What makes clinical research ethical?

Authors:  E J Emanuel; D Wendler; C Grady
Journal:  JAMA       Date:  2000 May 24-31       Impact factor: 56.272

2.  Moral problems in assessing research risk.

Authors:  L M Kopelman
Journal:  IRB       Date:  2000 Sep-Oct

3.  Thinking clearly about research risk: implications of the work of Benjamin Freedman.

Authors:  C Weijer
Journal:  IRB       Date:  1999 Nov-Dec

Review 4.  The ethical analysis of risk.

Authors:  C Weijer
Journal:  J Law Med Ethics       Date:  2000       Impact factor: 1.718

5.  Estimating risk in human research.

Authors:  L Kopelman
Journal:  Clin Res       Date:  1981-02

6.  In loco parentis. Minimal risk as an ethical threshold for research upon children.

Authors:  B Freedman; A Fuks; C Weijer
Journal:  Hastings Cent Rep       Date:  1993 Mar-Apr       Impact factor: 2.683

7.  Children as research subjects: a dilemma.

Authors:  L M Kopelman
Journal:  J Med Philos       Date:  2000-12

8.  How do institutional review boards apply the federal risk and benefit standards for pediatric research?

Authors:  Seema Shah; Amy Whittle; Benjamin Wilfond; Gary Gensler; David Wendler
Journal:  JAMA       Date:  2004-01-28       Impact factor: 56.272

9.  Assessment of risk in research on children.

Authors:  J Janofsky; B Starfield
Journal:  J Pediatr       Date:  1981-05       Impact factor: 4.406

10.  Exploitation in biomedical research.

Authors:  David B Resnik
Journal:  Theor Med Bioeth       Date:  2003
  10 in total
  20 in total

1.  "Fair's fair argument" and voluntarism in clinical research: but, is it fair?

Authors:  M A Perna
Journal:  J Med Ethics       Date:  2006-08       Impact factor: 2.903

2.  A standard for assessing the risks of pediatric research: pro and con.

Authors:  David Wendler; Leonard Glantz
Journal:  J Pediatr       Date:  2007-06       Impact factor: 4.406

3.  Is it possible to protect pediatric research subjects without blocking appropriate research?

Authors:  David Wendler
Journal:  J Pediatr       Date:  2008-04       Impact factor: 4.406

4.  Reopening old divisions.

Authors:  David B Resnik
Journal:  Am J Bioeth       Date:  2011-06       Impact factor: 11.229

5.  Minimal Risk in Pediatric Research: A Philosophical Review and Reconsideration.

Authors:  John Rossi; Robert M Nelson
Journal:  Account Res       Date:  2017-08-04       Impact factor: 2.622

6.  Do U.S. regulations allow more than minor increase over minimal risk pediatric research? Should they?

Authors:  David Wendler
Journal:  IRB       Date:  2013 Nov-Dec

7.  Appraising Harm in Phase I Trials: Healthy Volunteers' Accounts of Adverse Events.

Authors:  Lisa McManus; Arlene Davis; Rebecca L Forcier; Jill A Fisher
Journal:  J Law Med Ethics       Date:  2019-06       Impact factor: 1.718

8.  Ethics of clinical research with mentally ill persons.

Authors:  Hanfried Helmchen
Journal:  Eur Arch Psychiatry Clin Neurosci       Date:  2012-01-03       Impact factor: 5.270

9.  Setting risk thresholds in biomedical research: lessons from the debate about minimal risk.

Authors:  Annette Rid
Journal:  Monash Bioeth Rev       Date:  2014 Mar-Jun

10.  Minimal or reasonable? Considering the ethical threshold for research risks to nonconsenting bystanders and implications for nonconsenting participants.

Authors:  Holly Fernandez Lynch
Journal:  Bioethics       Date:  2020-02-24       Impact factor: 1.898

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