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

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-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 languageEnglish (US)
Pages (from-to)1101-1120
Number of pages20
JournalThe Journal of allergy and clinical immunology
Volume91
Issue number6
DOIs
StatePublished - Jun 1993

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

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