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Research participants’ opinions of delayed consent for a randomised controlled trial of glucose control in intensive care

J. E. Potter, S. McKinley, A. Delaney
Original
Volume 39, Issue 3 / March , 2013

Pages 472 - 480

Abstract

Purpose

Critically ill patients are often unable to give informed consent to participate in clinical research. A process of delayed consent, enrolling patients into clinical trials and obtaining consent as soon as practical from either the participant or their substitute decision maker, has sometimes been used. The objective of this study was to determine the opinion of participants, previously enrolled in the NICE-SUGAR study, of the delayed consent process.

Methods

This observational study was conducted from 2009 to 2010 in the ICU of a tertiary referral hospital in Australia. Participants who were enrolled in the NICE-SUGAR study with delayed consent who survived, were cognitively intact, and proficient in English were posted a questionnaire regarding their opinion of the delayed consent process. The questionnaire was returned by post, fax, email, or completed during a telephone interview.

Results

Of 298 eligible participants, 210 responded, with an overall response rate of 79 %. Delayed consent to participate in the NICE-SUGAR study was obtained from participants (57/210; 27.1 %) or the substitute decision maker (152/210; 72.4 %). Most respondents (195/204; 95.6 %) would have consented to participate in the NICE-SUGAR study if asked before enrolment; most (163/198; 82.3 %) ranked first “the person who consented on their behalf for the NICE Study” as most preferred to make decisions, should they be unable; and most (177/202; 87.6 %) agreed with the decision made by their relative.

Conclusion

Delayed consent to participate in a clinical trial that includes critically ill patients is acceptable from research participant’s perspectives.

Keywords

References

  1. Annane D, Outin H, Fisch C, Bellissant E (2004) The effect of waiving consent on enrollment in a sepsis trial. Intensive Care Med 30:321–324
  2. Cooke CR, Erickson SE, Watkins TR, Matthay MA, Hudson LD, Rubenfeld GD (2010) Age, sex, and race-based differences among patients enrolled versus not enrolled in acute lung injury clinical trials. Crit Care Med 38:1450–1457
    • View reference on PubMed
    • View reference on publisher's website
  3. McAdam JL, Dracup KA, White DB, Fontaine DK, Puntillo KA (2010) Symptom experiences of family members of intensive care unit patients at high risk for dying. Crit Care Med 38:1078–1085
    • View reference on PubMed
    • View reference on publisher's website
  4. Pochard F, Azoulay E, Chevret S, Lemaire F, Hubert P, Canoui P, Grassin M, Zittoun R, le Gall JR, Dhainaut JF, Schlemmer B, French FG (2001) Symptoms of anxiety and depression in family members of intensive care unit patients: ethical hypothesis regarding decision-making capacity. Crit Care Med 29:1893–1897
    • View reference on PubMed
    • View reference on publisher's website
  5. Pochard F, Darmon M, Fassier T, Bollaert PE, Cheval C, Coloigner M, Merouani A, Moulront S, Pigne E, Pingat J, Zahar JR, Schlemmer B, Azoulay E (2005) Symptoms of anxiety and depression in family members of intensive care unit patients before discharge or death. A prospective multicenter study. J Crit Care 20:90–96
    • View reference on PubMed
    • View reference on publisher's website
  6. Mehta S, Pelletier FQ, Brown M, Ethier C, Wells D, Burry L, Macdonald R (2012) Why substitute decision makers provide or decline consent for ICU research studies: a questionnaire study. Intensive Care Med 38:47–54
  7. NICE-SUGAR Study Investigators, Finfer S, Chittock DR, Su SY-S, Blair D, Foster D, Dhingra V, Bellomo R, Cook D, Dodek P, Henderson WR, Hebert PC, Heritier S, Heyland DK, McArthur C, McDonald E, Mitchell I, Myburgh JA, Norton R, Potter J, Robinson BG, Ronco JJ (2009) Intensive versus conventional glucose control in critically ill patients. N Engl J Med 360:1283–1297
    • View reference on publisher's website
  8. RENAL Replacement Therapy Study Investigators, Bellomo R, Cass A, Cole L, Finfer S, Gallagher M, Lo S, McArthur C, McGuinness S, Myburgh J, Norton R, Scheinkestel C, Su S (2009) Intensity of continuous renal-replacement therapy in critically ill patients. N Engl J Med 361:1627–1638
    • View reference on publisher's website
  9. SAFE Study Investigators, Finfer S, Bellomo R, Boyce N, French J, Myburgh J, Norton R (2004) A comparison of albumin and saline for fluid resuscitation in the intensive care unit. N Engl J Med 350:2247–2256
    • View reference on publisher's website
  10. National Health and Medical Research Council, Australian Research Council, Australian Vice Chancellors’ Committee (2007) National statement on ethical conduct in human research. Australian Government. http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/e72.pdf. Accessed 28 August 2010
  11. Ciroldi M, Cariou A, Adrie C, Annane D, Castelain V, Cohen Y, Delahaye A, Joly LM, Galliot R, Garrouste-Orgeas M, Papazian L, Michel F, Barnes NK, Schlemmer B, Pochard F, Azoulay E, Famirea Study Group (2007) Ability of family members to predict patient’s consent to critical care research. Intensive Care Med 33:807–813
  12. Coppolino M, Ackerson L (2001) Do surrogate decision makers provide accurate consent for intensive care research? Chest 119:603–612
    • View reference on PubMed
    • View reference on publisher's website
  13. Scales DC, Smith OM, Pinto R, Barrett KA, Friedrich JO, Lazar NM, Cook DJ, Ferguson ND (2009) Patients’ preferences for enrolment into critical-care trials. Intensive Care Med 35:1703–1712
  14. Stephenson AC, Baker S, Zeps N (2007) Attitudes of relatives of patients in intensive care and emergency departments to surrogate consent to research on incapacitated participants. Crit Care Resusc 9:40–50
    • View reference on PubMed
  15. NICE-SUGAR Study Investigators (2005) The normoglycemia in intensive care evaluation (NICE) (ISRCTN04968275) and survival using glucose algorithm regulation (SUGAR) Study: development, design and conduct of an international multi-center, open label, randomized controlled trial of two target ranges for glycemic control in intensive care unit patients. Am J Resp Crit Care Med 172:1358–1359
  16. RAND Corporation RAND 36-Item Health Survey 1.0 Questionnaire Items. http://www.rand.org/content/dam/rand/www/external/health/surveys_tools/mos/mos_core_survey.pdf. Accessed October 28 2008
  17. Burns KE, Magyarody NM, Duffett M, Nisenbaum R, Cook DJ (2011) Attitudes of the general public toward alternative consent models. Am J Crit Care 20:75–83
    • View reference on PubMed
    • View reference on publisher's website
  18. Rose L, Burns KE, Smith OM, Marshall JC (2009) Quantifying threats to the feasibility of clinical trials in critically ill patients. Am J Resp Crit Care Med 179 (1 Meeting Abstracts): A1580
  19. Burns KE, Zubrinich C, Marshall J, Cook D (2009) The ‘Consent to Research’ paradigm in critical care: challenges and potential solutions. Intensive Care Med 35:1655–1658

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