Suggested approaches for research protocols involving the potential for life-threatening reactions

Daniel L. Hamilos; John J. Oppenheimer; Harold S. Nelson; Sally Wenzel; Sue Driscoll; Richard F. Lockey; David B.K. Golden; Leland Fan; Ralph J. Sanks; S. Allen Bock; John W. Yunginger; Donald Stevenson; Timothy Sullivan; Thomas Corbridge

doi:10.1016/0091-6749(93)90312-4

Suggested approaches for research protocols involving the potential for life-threatening reactions

Daniel L. Hamilos, John J. Oppenheimer, Harold S. Nelson, Sally Wenzel, Sue Driscoll, Richard F. Lockey, David B.K. Golden, Leland Fan, Ralph J. Sanks, S. Allen Bock, John W. Yunginger, Donald Stevenson, Timothy Sullivan, Thomas Corbridge

Research output: Contribution to journal › Article › peer-review

13 Scopus citations

Abstract

These guidelines are intended to reduce the potential for serious or life-threatening reactions when clinical research is conducted. The following issues were addressed: identifying the risks involved in the research, providing adequate safeguards in the protocol design and during withholding of medication, anticipating risks, minimizing the chances for human error, providing resuscitative equipment sufficient to deal with the most serious anticipated life-threatening reactions, planning for medical support in case of a life-threatening emergency, and optimizing the use of medical personnel and expertise to handle emergency situations. The guidelines also discuss important general issues about protocol design and implementation and the human subject consent form, which should facilitate the approval of protocols by the governing institutional review board. The guidelines are not meant to be inflexible or applicable to all research situations. However, it is our hope that they will allow for clinical research to be conducted in a manner that affords the research subjects a high degree of protection from unnecessary and possibly fatal injuries.

Original language	English (US)
Pages (from-to)	1101-1120
Number of pages	20
Journal	The Journal of allergy and clinical immunology
Volume	91
Issue number	6
DOIs	https://doi.org/10.1016/0091-6749(93)90312-4
State	Published - Jun 1993
Externally published	Yes

ASJC Scopus subject areas

Immunology and Allergy
Immunology

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Hamilos, D. L., Oppenheimer, J. J., Nelson, H. S., Wenzel, S., Driscoll, S., Lockey, R. F., Golden, D. B. K., Fan, L., Sanks, R. J., Bock, S. A., Yunginger, J. W., Stevenson, D., Sullivan, T., & Corbridge, T. (1993). Suggested approaches for research protocols involving the potential for life-threatening reactions. The Journal of allergy and clinical immunology, 91(6), 1101-1120. https://doi.org/10.1016/0091-6749(93)90312-4

Hamilos, DL, Oppenheimer, JJ, Nelson, HS, Wenzel, S, Driscoll, S, Lockey, RF, Golden, DBK, Fan, L, Sanks, RJ, Bock, SA, Yunginger, JW, Stevenson, D, Sullivan, T & Corbridge, T 1993, 'Suggested approaches for research protocols involving the potential for life-threatening reactions', The Journal of allergy and clinical immunology, vol. 91, no. 6, pp. 1101-1120. https://doi.org/10.1016/0091-6749(93)90312-4

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abstract = "These guidelines are intended to reduce the potential for serious or life-threatening reactions when clinical research is conducted. The following issues were addressed: identifying the risks involved in the research, providing adequate safeguards in the protocol design and during withholding of medication, anticipating risks, minimizing the chances for human error, providing resuscitative equipment sufficient to deal with the most serious anticipated life-threatening reactions, planning for medical support in case of a life-threatening emergency, and optimizing the use of medical personnel and expertise to handle emergency situations. The guidelines also discuss important general issues about protocol design and implementation and the human subject consent form, which should facilitate the approval of protocols by the governing institutional review board. The guidelines are not meant to be inflexible or applicable to all research situations. However, it is our hope that they will allow for clinical research to be conducted in a manner that affords the research subjects a high degree of protection from unnecessary and possibly fatal injuries.",

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AU - Sanks, Ralph J.

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AU - Sullivan, Timothy

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Suggested approaches for research protocols involving the potential for life-threatening reactions

Abstract

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