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The effect of waiving consent on enrollment in a sepsis trial

Abstract

Objective

Illustration of the difficulties in approaching critically ill patients for informed consent for inclusion into a randomized controlled trial and the impact of a waiver of consent from the patient’s next of kin in the conduction of such studies.

Design

Descriptive survey of the inclusion rates into the Ger-Inf-05 study before and after a waiver of consent from the patient’s next of kin.

Setting

Nineteen intensive care units in France.

Patients

Septic shock patients (n=300) included in a placebo-controlled randomized double-blind study on the efficacy and safety of a 7-day treatment with 50 mg hydrocortisone every 6 h intravenously and 50 µg fludrocortisone every 24 h orally.

Intervention

Introduction, 10 months after the beginning of the study, of a waiver of consent from the patient’s next of kin if it was not present at the time of the patient’s inclusion.

Measurements and results

The mean inclusion rate was four patients per month before the introduction of the waiver of consent and increased to 10 patients per month after the study amendment including the waiver of consent. Informed consent was obtained from the patient himself or herself in 10 patients (3%) and from next of kin in 70 patients (23%). For the 220 other patients (74%), the investigators could not contact the responsible relative within the inclusion period.

Conclusions

Recruitment rate in the Ger-Inf-05 study was clearly improved after the waiver of consent from the patient’s next of kin. This probably contributed to the successful completion of the study.

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Fig. 1

References

  1. 1.

    Matot I, Pizov R, Sprung CL (1998) Evaluation of institutional review board review and informed consent in publications of human research in critical care medicine. Crit Care Med 26:1596–1602

  2. 2.

    World Medical Association Declaration of Helsinki (1989) Revised edn. 41st World Medical Assembly, Hong Kong

  3. 3.

    American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference (1992) Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. Crit Care Med 20:684–874

  4. 4.

    Truog RD, Robinson W, Randolph A, Morris A (1999) Is informed consent always necessary for randomised controlled trials ? N Engl J Med 340:804–807

  5. 5.

    Loi n°88-1138 du 20 décembre 1988 relative à la protection des personnes qui se prêtent à des recherches biomédicales, modifiée par les lois n°90-86 du 23 janvier 1990, n°91-73 du 18 janvier 1991 et n°94-630 du 25 juillet 1994. Code de la Santé Publique—Livre II bis

  6. 6.

    Annane D, Sebille V, Charpentier C, Bollaert PE, Francois B, Korach JM, Capellier G, Cohen Y, Azoulay E, Troche G, Chaumet-Riffaut P, Bellissant E (2002) Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA 288:862–871

  7. 7.

    Délégation Régionale à la Recherche Clinique d’Ile de France.http://www.drrc.aphp.fr/ (acceded August 20, 2003)

  8. 8.

    Waiver of informed consent requirements in certain emergency research (1996) Federal Register 61 :51531–51533

  9. 9.

    Corwin HL, Gettinger A, Pearl RG, Fink MP, Levy MM, Shapiro MJ, Corwin MJ, Colton T, EPO Critical Care Trials Group (2002) Efficacy of recombinant human erythropoietin in critically ill patients. A randomised controlled trial. JAMA 288:2827–2835

  10. 10.

    Directive 2001/20/EC of the European Parliament and of the Council of the European Union of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official Journal of the European Communities L121, 1.5.2001, 34–44

  11. 11.

    Abraham E, Evans T (2002) Corticosteroids and septic shock. JAMA 288:886–887

  12. 12.

    Freeman BD, Danner RL, Banks SM, Natanson C (2001) Safeguarding patients in clinical trials with high mortality rates. Am J Respir Crit Care Med 164:190–192

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Author information

Correspondence to Djillali Annane.

Additional information

Two editorials regarding this article can be found in the same issue (http://dx.doi.org/10.1007/s00134-003-2063-x) and (http://dx.doi.org/10.1007/s00134-003-2064-9)

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Annane, D., Outin, H., Fisch, C. et al. The effect of waiving consent on enrollment in a sepsis trial. Intensive Care Med 30, 321–324 (2004). https://doi.org/10.1007/s00134-003-2065-8

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Keywords

  • Randomized controlled trial
  • Recruitment
  • Informed consent
  • Waiver of consent