Skip to main content
Erschienen in: Intensive Care Medicine 7/2013

01.07.2013 | Original

ICU research: the impact of invasiveness on informed consent

verfasst von: Fabienne Gigon, Paolo Merlani, Catherine Chenaud, Bara Ricou

Erschienen in: Intensive Care Medicine | Ausgabe 7/2013

Einloggen, um Zugang zu erhalten

Abstract

Purpose

Studies into the preferences of patients and relatives regarding informed consent for intensive care unit (ICU) research are ongoing. We investigated the impact of a study’s invasiveness on the choice of who should give consent and on the modalities of informed consent.

Methods

At ICU discharge, randomized pairs of patients and relatives were asked to answer a questionnaire about informed consent for research. One group received a vignette of a noninvasive study; the other, of an invasive study. Each study comprised two scenarios, featuring either a conscious or unconscious patient. Multivariate models assessed independent factors related to their preferences.

Results

A total of 185 patients (40 %) and 125 relatives (68 %) responded. The invasiveness of a study had no impact on which people were chosen to give consent. This increased the desire to get more than one person to give consent and decreased the acceptance of deferred or two-step consent. Up to 31 % of both patients and relatives chose people other than the patient himself to give consent, even when the patient was conscious. A range of 3 to 17 % of the respondents reported that they would accept a waiving of consent. Younger respondents and individuals feeling coerced into study participation wanted to be the decision makers.

Conclusions

Study invasiveness had no impact on patients’ and relatives’ preferences about who should give consent. Many patients and relatives were reluctant to give consent alone. Deferred and two-step consent were less acceptable for the invasive study. Further work should investigate whether sharing the burden of informed consent with a second person facilitates participation in ICU research.
Anhänge
Nur mit Berechtigung zugänglich
Literatur
1.
Zurück zum Zitat Schwetz BA (2007) Protecting subjects without hampering research progress: guidance from the office for human research protections. Cleve Clin J Med 74(Suppl 2):S60–S62 discussion S68–9CrossRefPubMed Schwetz BA (2007) Protecting subjects without hampering research progress: guidance from the office for human research protections. Cleve Clin J Med 74(Suppl 2):S60–S62 discussion S68–9CrossRefPubMed
2.
Zurück zum Zitat Department of Health and Human Services (1991) Common Rule (45 CFR 46). Federal policy for the protection of human subjects; notices and rules Department of Health and Human Services (1991) Common Rule (45 CFR 46). Federal policy for the protection of human subjects; notices and rules
3.
Zurück zum Zitat Schmidt TA, Salo D, Hughes JA, Abbott JT, Geiderman JM, Johnson CX, McClure KB, McKay MP, Razzak JA, Schears RM, Solomon RC (2004) Confronting the ethical challenges to informed consent in emergency medicine research. Acad Emerg Med 11(10):1082–1089CrossRefPubMed Schmidt TA, Salo D, Hughes JA, Abbott JT, Geiderman JM, Johnson CX, McClure KB, McKay MP, Razzak JA, Schears RM, Solomon RC (2004) Confronting the ethical challenges to informed consent in emergency medicine research. Acad Emerg Med 11(10):1082–1089CrossRefPubMed
5.
Zurück zum Zitat Lemaire F, Bion J, Blanco J, Damas P, Druml C, Falke K, Kesecioglu J, Larsson A, Mancebo J, Matamis D, Pesenti A, Pimentel J, Ranieri M (2005) The European union directive on clinical research: present status of implementation in EU member states’ legislations with regard to the incompetent patient. Intensive Care Med 31(3):476–479CrossRefPubMed Lemaire F, Bion J, Blanco J, Damas P, Druml C, Falke K, Kesecioglu J, Larsson A, Mancebo J, Matamis D, Pesenti A, Pimentel J, Ranieri M (2005) The European union directive on clinical research: present status of implementation in EU member states’ legislations with regard to the incompetent patient. Intensive Care Med 31(3):476–479CrossRefPubMed
6.
Zurück zum Zitat Lemaire F (2006) The inability to consent in critical care research: emergency or impairment of cognitive function? Intensive Care Med 32(12):1930–1932CrossRefPubMed Lemaire F (2006) The inability to consent in critical care research: emergency or impairment of cognitive function? Intensive Care Med 32(12):1930–1932CrossRefPubMed
7.
Zurück zum Zitat Baren JM, Fish SS (2005) Resuscitation research involving vulnerable populations: are additional protections needed for emergency exception from informed consent? Acad Emerg Med 12(11):1071–1077CrossRefPubMed Baren JM, Fish SS (2005) Resuscitation research involving vulnerable populations: are additional protections needed for emergency exception from informed consent? Acad Emerg Med 12(11):1071–1077CrossRefPubMed
8.
Zurück zum Zitat Flanagan BM, Philpott S, Strosberg MA (2011) Protecting participants of clinical trials conducted in the intensive care unit. J Intensive Care Med 26(4):237–249CrossRefPubMed Flanagan BM, Philpott S, Strosberg MA (2011) Protecting participants of clinical trials conducted in the intensive care unit. J Intensive Care Med 26(4):237–249CrossRefPubMed
9.
Zurück zum Zitat Luce JM, White DB (2009) A history of ethics and law in the intensive care unit. Crit Care Clin 25(1):221–237CrossRefPubMed Luce JM, White DB (2009) A history of ethics and law in the intensive care unit. Crit Care Clin 25(1):221–237CrossRefPubMed
10.
Zurück zum Zitat Chenaud C, Merlani P, Ricou B (2006) Informed consent for research in ICU obtained before ICU admission. Intensive Care Med 32(3):439–444CrossRefPubMed Chenaud C, Merlani P, Ricou B (2006) Informed consent for research in ICU obtained before ICU admission. Intensive Care Med 32(3):439–444CrossRefPubMed
11.
Zurück zum Zitat Silverman H (2011) Protecting vulnerable research subjects in critical care trials: enhancing the informed consent process and recommendations for safeguards. Ann Intensive Care 1(1):8CrossRefPubMed Silverman H (2011) Protecting vulnerable research subjects in critical care trials: enhancing the informed consent process and recommendations for safeguards. Ann Intensive Care 1(1):8CrossRefPubMed
12.
Zurück zum Zitat Roberts I, Prieto-Merino D, Shakur H, Chalmers I, Nicholl J (2011) Effect of consent rituals on mortality in emergency care research. Lancet 377(9771):1071–1072CrossRefPubMed Roberts I, Prieto-Merino D, Shakur H, Chalmers I, Nicholl J (2011) Effect of consent rituals on mortality in emergency care research. Lancet 377(9771):1071–1072CrossRefPubMed
13.
Zurück zum Zitat Luce JM (2003) Is the concept of informed consent applicable to clinical research involving critically ill patients? Crit Care Med 31(3 Suppl):S153–S160CrossRefPubMed Luce JM (2003) Is the concept of informed consent applicable to clinical research involving critically ill patients? Crit Care Med 31(3 Suppl):S153–S160CrossRefPubMed
14.
Zurück zum Zitat Truog RD (2005) Will ethical requirements bring critical care research to a halt? Intensive Care Med 31(3):338–344CrossRefPubMed Truog RD (2005) Will ethical requirements bring critical care research to a halt? Intensive Care Med 31(3):338–344CrossRefPubMed
15.
16.
Zurück zum Zitat Siegel MD (2006) Alone at life’s end: trying to protect the autonomy of patients without surrogates or decision-making capacity. Crit Care Med 34(8):2238–2239CrossRefPubMed Siegel MD (2006) Alone at life’s end: trying to protect the autonomy of patients without surrogates or decision-making capacity. Crit Care Med 34(8):2238–2239CrossRefPubMed
17.
Zurück zum Zitat Barrett KA, Ferguson ND, Athaide V et al (2012) Surrogate decision makers’ attitudes towards research decision making for critically ill patients. Intensive Care Med 38(10):1616–1623CrossRefPubMed Barrett KA, Ferguson ND, Athaide V et al (2012) Surrogate decision makers’ attitudes towards research decision making for critically ill patients. Intensive Care Med 38(10):1616–1623CrossRefPubMed
18.
Zurück zum Zitat Barrett KA, Scales DC (2012) Considering the vulnerabilities of surrogate decision-makers when obtaining consent for critical care research. Intensive Care Med 38(1):4–6CrossRefPubMed Barrett KA, Scales DC (2012) Considering the vulnerabilities of surrogate decision-makers when obtaining consent for critical care research. Intensive Care Med 38(1):4–6CrossRefPubMed
19.
Zurück zum Zitat Iverson E, Celious A, Kennedy CR et al (2012) Real-time perspectives of surrogate decision makers regarding critical illness research—findings of focus group participants. Chest 142(6):1433–1439CrossRefPubMed Iverson E, Celious A, Kennedy CR et al (2012) Real-time perspectives of surrogate decision makers regarding critical illness research—findings of focus group participants. Chest 142(6):1433–1439CrossRefPubMed
20.
Zurück zum Zitat 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 (2007) Ability of family members to predict patient’s consent to critical care research. Intensive Care Med 33(5):807–813CrossRefPubMed 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 (2007) Ability of family members to predict patient’s consent to critical care research. Intensive Care Med 33(5):807–813CrossRefPubMed
21.
Zurück zum Zitat Coppolino M, Ackerson L (2001) Do surrogate decision makers provide accurate consent for intensive care research? Chest 119(2):603–612CrossRefPubMed Coppolino M, Ackerson L (2001) Do surrogate decision makers provide accurate consent for intensive care research? Chest 119(2):603–612CrossRefPubMed
22.
Zurück zum Zitat Perner A, Ibsen M, Bonde J (2010) Attitudes to drug trials among relatives of unconscious intensive care patients. BMC Anesthesiol 10:6CrossRefPubMed Perner A, Ibsen M, Bonde J (2010) Attitudes to drug trials among relatives of unconscious intensive care patients. BMC Anesthesiol 10:6CrossRefPubMed
23.
Zurück zum Zitat 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(10):1703–1712CrossRefPubMed 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(10):1703–1712CrossRefPubMed
24.
Zurück zum Zitat Chenaud C, Merlani P, Verdon M, Ricou B (2009) Who should consent for research in adult intensive care? Preferences of patients and their relatives: a pilot study. J Med Ethics 35(11):709–712CrossRefPubMed Chenaud C, Merlani P, Verdon M, Ricou B (2009) Who should consent for research in adult intensive care? Preferences of patients and their relatives: a pilot study. J Med Ethics 35(11):709–712CrossRefPubMed
25.
Zurück zum Zitat Sim J, Wright CC (2005) The kappa statistic in reliability studies: use, interpretation, and sample size requirements. Phys Ther 85(3):257–268PubMed Sim J, Wright CC (2005) The kappa statistic in reliability studies: use, interpretation, and sample size requirements. Phys Ther 85(3):257–268PubMed
27.
Zurück zum Zitat 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(1):40–50PubMed 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(1):40–50PubMed
28.
Zurück zum Zitat Lautrette A, Peigne V, Watts J, Souweine B, Azoulay E (2008) Surrogate decision makers for incompetent ICU patients: a European perspective. Curr Opin Crit Care 14(6):714–719CrossRefPubMed Lautrette A, Peigne V, Watts J, Souweine B, Azoulay E (2008) Surrogate decision makers for incompetent ICU patients: a European perspective. Curr Opin Crit Care 14(6):714–719CrossRefPubMed
29.
Zurück zum Zitat Claudot F, Alla F, Fresson J, Calvez T, Coudane H, Bonaiti-Pellie C (2009) Ethics and observational studies in medical research: various rules in a common framework. Int J Epidemiol 38(4):1104–1108CrossRefPubMed Claudot F, Alla F, Fresson J, Calvez T, Coudane H, Bonaiti-Pellie C (2009) Ethics and observational studies in medical research: various rules in a common framework. Int J Epidemiol 38(4):1104–1108CrossRefPubMed
30.
Zurück zum Zitat Largent EA, Wendler D, Emanuel E, Miller FG (2010) Is emergency research without initial consent justified?: the consent substitute model. Arch Intern Med 170(8):668–674CrossRefPubMed Largent EA, Wendler D, Emanuel E, Miller FG (2010) Is emergency research without initial consent justified?: the consent substitute model. Arch Intern Med 170(8):668–674CrossRefPubMed
31.
Zurück zum Zitat Silbergleit R, Biros MH, Harney D, Dickert N, Baren J (2012) Implementation of the exception from informed consent regulations in a large multicenter emergency clinical trials network: the RAMPART experience. Acad Emerg Med 19(4):448–454CrossRefPubMed Silbergleit R, Biros MH, Harney D, Dickert N, Baren J (2012) Implementation of the exception from informed consent regulations in a large multicenter emergency clinical trials network: the RAMPART experience. Acad Emerg Med 19(4):448–454CrossRefPubMed
32.
Zurück zum Zitat Potter JE, McKinley S, Delaney A (2012) Research participants’ opinions of delayed consent for a randomised controlled trial of glucose control in intensive care. Intensive Care Med 39(3):472–480CrossRefPubMed Potter JE, McKinley S, Delaney A (2012) Research participants’ opinions of delayed consent for a randomised controlled trial of glucose control in intensive care. Intensive Care Med 39(3):472–480CrossRefPubMed
33.
Zurück zum Zitat Jansen TC, Kompanje EJ, Bakker J (2009) Deferred proxy consent in emergency critical care research: ethically valid and practically feasible. Crit Care Med 37(1 Suppl):S65–S68CrossRefPubMed Jansen TC, Kompanje EJ, Bakker J (2009) Deferred proxy consent in emergency critical care research: ethically valid and practically feasible. Crit Care Med 37(1 Suppl):S65–S68CrossRefPubMed
34.
Zurück zum Zitat Annane D, Outin H, Fisch C, Bellissant E (2004) The effect of waiving consent on enrollment in a sepsis trial. Intensive Care Med 30(2):321–324CrossRefPubMed Annane D, Outin H, Fisch C, Bellissant E (2004) The effect of waiving consent on enrollment in a sepsis trial. Intensive Care Med 30(2):321–324CrossRefPubMed
35.
Zurück zum Zitat Newman JT, Smart A, Reese TR, Williams A, Moss M (2012) Surrogate and patient discrepancy regarding consent for critical care research. Crit Care Med 40(9):2590–2594CrossRefPubMed Newman JT, Smart A, Reese TR, Williams A, Moss M (2012) Surrogate and patient discrepancy regarding consent for critical care research. Crit Care Med 40(9):2590–2594CrossRefPubMed
36.
Zurück zum Zitat Mason S, Barrow H, Phillips A, Eddison G, Nelson A, Cullum N, Nixon J (2006) Brief report on the experience of using proxy consent for incapacitated adults. J Med Ethics 32(1):61–62CrossRefPubMed Mason S, Barrow H, Phillips A, Eddison G, Nelson A, Cullum N, Nixon J (2006) Brief report on the experience of using proxy consent for incapacitated adults. J Med Ethics 32(1):61–62CrossRefPubMed
37.
Zurück zum Zitat Mehta S, Quittnat Pelletier F, 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(1):47–54CrossRefPubMed Mehta S, Quittnat Pelletier F, 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(1):47–54CrossRefPubMed
38.
Zurück zum Zitat Lim DA, Chan MF, Childs C (2013) Surrogate consent for critical care research: exploratory study on public perception and influences on recruitment. Crit Care 17(1):R5CrossRef Lim DA, Chan MF, Childs C (2013) Surrogate consent for critical care research: exploratory study on public perception and influences on recruitment. Crit Care 17(1):R5CrossRef
Metadaten
Titel
ICU research: the impact of invasiveness on informed consent
verfasst von
Fabienne Gigon
Paolo Merlani
Catherine Chenaud
Bara Ricou
Publikationsdatum
01.07.2013
Verlag
Springer-Verlag
Erschienen in
Intensive Care Medicine / Ausgabe 7/2013
Print ISSN: 0342-4642
Elektronische ISSN: 1432-1238
DOI
https://doi.org/10.1007/s00134-013-2908-x

Weitere Artikel der Ausgabe 7/2013

Intensive Care Medicine 7/2013 Zur Ausgabe

Akuter Schwindel: Wann lohnt sich eine MRT?

28.04.2024 Schwindel Nachrichten

Akuter Schwindel stellt oft eine diagnostische Herausforderung dar. Wie nützlich dabei eine MRT ist, hat eine Studie aus Finnland untersucht. Immerhin einer von sechs Patienten wurde mit akutem ischämischem Schlaganfall diagnostiziert.

Bei schweren Reaktionen auf Insektenstiche empfiehlt sich eine spezifische Immuntherapie

Insektenstiche sind bei Erwachsenen die häufigsten Auslöser einer Anaphylaxie. Einen wirksamen Schutz vor schweren anaphylaktischen Reaktionen bietet die allergenspezifische Immuntherapie. Jedoch kommt sie noch viel zu selten zum Einsatz.

Hinter dieser Appendizitis steckte ein Erreger

23.04.2024 Appendizitis Nachrichten

Schmerzen im Unterbauch, aber sonst nicht viel, was auf eine Appendizitis hindeutete: Ein junger Mann hatte Glück, dass trotzdem eine Laparoskopie mit Appendektomie durchgeführt und der Wurmfortsatz histologisch untersucht wurde.

Ärztliche Empathie hilft gegen Rückenschmerzen

23.04.2024 Leitsymptom Rückenschmerzen Nachrichten

Personen mit chronischen Rückenschmerzen, die von einfühlsamen Ärzten und Ärztinnen betreut werden, berichten über weniger Beschwerden und eine bessere Lebensqualität.

Update AINS

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.