Literature DB >> 972643

Injuries to research subjects A survey of investigators.

P V Cardon, F W Dommel, R R Trumble.   

Abstract

A task force of the Department of Health, Education, and Welfare conducted a survey aimed at estimating the incidence of research-related injuries, with a view to determining the feasibility of compensating subjects injured during research. The data were obtained by telephone from 331 investigators conducting research on nearly 133,000 human subjects over the past three years. Eighty-five investigators reported at least one injury. Of the 4957 reported injuries, 3926 were classified as trivial, and 974 as temporarily disabling; of 57 injuries resulting in death or permanent disability, one disabling stroke, not clearly related to the research, occurred three days after a non-therapeutic procedure; the rest resulted from treatments expected to benefit the patients directly, usually cancer chemotherapy. The data suggest that the risks of participation in nontherapeutic research may be of no greater than those of everyday life, and in therapeutic research, no greater than those of treatment in other settings.

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Year:  1976        PMID: 972643     DOI: 10.1056/NEJM197609162951205

Source DB:  PubMed          Journal:  N Engl J Med        ISSN: 0028-4793            Impact factor:   91.245


  11 in total

1.  Adverse events in phase one studies: a study in 430 healthy volunteers.

Authors:  M Sibille; N Deigat; V Olagnier; D V Durand; R Levrat
Journal:  Eur J Clin Pharmacol       Date:  1992       Impact factor: 2.953

2.  Payments to healthy volunteers--ethical problems.

Authors:  D W Vere
Journal:  Br J Clin Pharmacol       Date:  1991-08       Impact factor: 4.335

3.  Weight of financial reward in the decision by medical students and experienced healthy volunteers to participate in clinical trials.

Authors:  J Bigorra; J E Baños
Journal:  Eur J Clin Pharmacol       Date:  1990       Impact factor: 2.953

4.  When a serious adverse event in research occurs, how do other volunteers react?

Authors:  Caitlin E Kennedy; Nancy Kass; Rachel K Myers; Edward J Fuchs; Charles Flexner
Journal:  J Empir Res Hum Res Ethics       Date:  2011-06       Impact factor: 1.742

5.  The myth of informed consent: in daily practice and in clinical trials.

Authors:  W A Silverman
Journal:  J Med Ethics       Date:  1989-03       Impact factor: 2.903

6.  Some ethical problems of hazardous substances in the working environment.

Authors:  W R Lee
Journal:  Br J Ind Med       Date:  1977-11

7.  A classification of clinical paediatric research with analysis of related ethical themes.

Authors:  J Pearn
Journal:  J Med Ethics       Date:  1987-03       Impact factor: 2.903

8.  [Therapeutic trials with cytostatics (author's transl)].

Authors:  H O Klein
Journal:  Blut       Date:  1977-08-29

9.  Patient attitudes following participation in a health outcome survey.

Authors:  D P Funch; J R Marshall
Journal:  Am J Public Health       Date:  1981-12       Impact factor: 9.308

10.  High rate of awarding compensation for claims of injuries related to clinical trials by pharmaceutical companies in Japan: a questionnaire survey.

Authors:  Chieko Kurihara; Hideo Kusuoka; Shunsuke Ono; Naoko Kakee; Kazuyuki Saito; Kenji Takehara; Kiyokazu Tsujide; Yuzo Nabeoka; Takuya Sakuhiro; Hiroshi Aoki; Noriko Morishita; Chieko Suzuki; Shigeo Kachi; Emiko Kondo; Yukiko Komori; Tetsu Isobe; Shigeru Kageyama; Hiroshi Watanabe
Journal:  PLoS One       Date:  2014-01-08       Impact factor: 3.240

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