Informed consent for research in ICU obtained before ICU admission
To analyze the procedure of the informed consent for ICU research obtained before ICU admission. Prospective, open, observational study. 20-bed surgical ICU of a tertiary teaching university hospital and the ward before and after ICU. Patients, scheduled for elective cardiac surgery, who accepted to...
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| Veröffentlicht in: | Intensive care medicine 2006-03, Vol.32 (3), p.439-444 |
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| creator | CHENAUD, Catherine MERLANI, Paolo RICOU, Bara |
| description | To analyze the procedure of the informed consent for ICU research obtained before ICU admission.
Prospective, open, observational study.
20-bed surgical ICU of a tertiary teaching university hospital and the ward before and after ICU.
Patients, scheduled for elective cardiac surgery, who accepted to participate in a coagulation study.
Patients underwent the same informed consent procedure, including an oral presentation of the coagulation study and an informative leaflet the day before surgery on the ward.
Between January and August 2001, we included 38 patients; 36 survived ICU. Ten to 12 days after surgery, 8/36 (22%) patients did not know they had participated in a study, and 9/36 (25%) could not recall the study purpose and the related risk. Patients with incomplete recall stayed longer in ICU [median (range): 4 (3-6) vs 3 (1-5) days; p = 0.004]. None of these patients (0/9 vs 10/27; p < 0.04) had read the informative leaflet AND asked at least one question during the informed consent procedure.
Even when the informed consent is obtained in the most optimal conditions for ICU research, its ethical value remains questionable. Indeed, a substantial number of patients were unaware of their study participation, or of the related purpose and risks. When the ICU stay is prolonged, we should at least repeatedly and actively (re)-inform patients about their study participation. |
| doi_str_mv | 10.1007/s00134-005-0059-4 |
| format | Article |
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Prospective, open, observational study.
20-bed surgical ICU of a tertiary teaching university hospital and the ward before and after ICU.
Patients, scheduled for elective cardiac surgery, who accepted to participate in a coagulation study.
Patients underwent the same informed consent procedure, including an oral presentation of the coagulation study and an informative leaflet the day before surgery on the ward.
Between January and August 2001, we included 38 patients; 36 survived ICU. Ten to 12 days after surgery, 8/36 (22%) patients did not know they had participated in a study, and 9/36 (25%) could not recall the study purpose and the related risk. Patients with incomplete recall stayed longer in ICU [median (range): 4 (3-6) vs 3 (1-5) days; p = 0.004]. None of these patients (0/9 vs 10/27; p < 0.04) had read the informative leaflet AND asked at least one question during the informed consent procedure.
Even when the informed consent is obtained in the most optimal conditions for ICU research, its ethical value remains questionable. Indeed, a substantial number of patients were unaware of their study participation, or of the related purpose and risks. When the ICU stay is prolonged, we should at least repeatedly and actively (re)-inform patients about their study participation.</description><identifier>ISSN: 0342-4642</identifier><identifier>EISSN: 1432-1238</identifier><identifier>DOI: 10.1007/s00134-005-0059-4</identifier><identifier>PMID: 16477413</identifier><identifier>CODEN: ICMED9</identifier><language>eng</language><publisher>Heidelberg: Springer</publisher><subject>Admission and discharge ; Aged ; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy ; Biological and medical sciences ; Biomedical Research - organization & administration ; Clinical death. Palliative care. Organ gift and preservation ; Clinical trial. Drug monitoring ; Decision making ; Ethics ; Female ; General pharmacology ; Hospitals ; Hospitals, Teaching ; Humans ; Hypotheses ; Informed Consent ; Informed consent (Medical law) ; Intensive care medicine ; Intensive Care Units ; Laws, regulations and rules ; Male ; Medical sciences ; Middle Aged ; Participation ; Patient Admission ; Patients ; Pharmacology. Drug treatments ; Prospective Studies ; Surgery ; Switzerland</subject><ispartof>Intensive care medicine, 2006-03, Vol.32 (3), p.439-444</ispartof><rights>2006 INIST-CNRS</rights><rights>COPYRIGHT 2006 Springer</rights><rights>Springer-Verlag 2006</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c504t-dc6a4bf3f6d2234d7224782c944eca0014504222bf93ee81362cec4cab6e64363</citedby><cites>FETCH-LOGICAL-c504t-dc6a4bf3f6d2234d7224782c944eca0014504222bf93ee81362cec4cab6e64363</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27903,27904</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=17567756$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16477413$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>CHENAUD, Catherine</creatorcontrib><creatorcontrib>MERLANI, Paolo</creatorcontrib><creatorcontrib>RICOU, Bara</creatorcontrib><title>Informed consent for research in ICU obtained before ICU admission</title><title>Intensive care medicine</title><addtitle>Intensive Care Med</addtitle><description>To analyze the procedure of the informed consent for ICU research obtained before ICU admission.
Prospective, open, observational study.
20-bed surgical ICU of a tertiary teaching university hospital and the ward before and after ICU.
Patients, scheduled for elective cardiac surgery, who accepted to participate in a coagulation study.
Patients underwent the same informed consent procedure, including an oral presentation of the coagulation study and an informative leaflet the day before surgery on the ward.
Between January and August 2001, we included 38 patients; 36 survived ICU. Ten to 12 days after surgery, 8/36 (22%) patients did not know they had participated in a study, and 9/36 (25%) could not recall the study purpose and the related risk. Patients with incomplete recall stayed longer in ICU [median (range): 4 (3-6) vs 3 (1-5) days; p = 0.004]. None of these patients (0/9 vs 10/27; p < 0.04) had read the informative leaflet AND asked at least one question during the informed consent procedure.
Even when the informed consent is obtained in the most optimal conditions for ICU research, its ethical value remains questionable. Indeed, a substantial number of patients were unaware of their study participation, or of the related purpose and risks. When the ICU stay is prolonged, we should at least repeatedly and actively (re)-inform patients about their study participation.</description><subject>Admission and discharge</subject><subject>Aged</subject><subject>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy</subject><subject>Biological and medical sciences</subject><subject>Biomedical Research - organization & administration</subject><subject>Clinical death. Palliative care. Organ gift and preservation</subject><subject>Clinical trial. Drug monitoring</subject><subject>Decision making</subject><subject>Ethics</subject><subject>Female</subject><subject>General pharmacology</subject><subject>Hospitals</subject><subject>Hospitals, Teaching</subject><subject>Humans</subject><subject>Hypotheses</subject><subject>Informed Consent</subject><subject>Informed consent (Medical law)</subject><subject>Intensive care medicine</subject><subject>Intensive Care Units</subject><subject>Laws, regulations and rules</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Participation</subject><subject>Patient Admission</subject><subject>Patients</subject><subject>Pharmacology. Drug treatments</subject><subject>Prospective Studies</subject><subject>Surgery</subject><subject>Switzerland</subject><issn>0342-4642</issn><issn>1432-1238</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2006</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNptkU1PGzEQhq2qVQm0P4BLtWoFtwV_zNrZI434iITUC5wtr3cWjDY22JsD_54JiYSKImtkzfh5x2O_jB0LfiY4N-eFc6Gg5rzZRFvDFzYToGQtpJp_ZTOuQNagQR6ww1KeiDa6Ed_ZgdBgDAg1Y3-XcUh5hX3lUywYp4rSKmNBl_1jFWK1XNxXqZtciAR1SMf4XnP9KpQSUvzBvg1uLPhztx-x-6vLu8VNffvverm4uK19w2Gqe68ddIMadC-lgt5ICWYufQuA3tFsQJiUshtahTgXSkuPHrzrNGpQWh2x023f55xe1lgmSwN4HEcXMa2L1Ua3ErQh8Pcn8Cmtc6TZrBRatA1XLUF_ttCDG9EG-oUpO7_paC9EoyRvxfud9R7qASNmN6aIQ6Dyf_zZHp5Wj6vg9wrEVuBzKiXjYJ9zWLn8agW3G5Pt1mRLBm-itUCaX7v3rTty7kOxc5WAkx3ginfjkF30oXxwptGGQr0Bp7eqOw</recordid><startdate>20060301</startdate><enddate>20060301</enddate><creator>CHENAUD, Catherine</creator><creator>MERLANI, Paolo</creator><creator>RICOU, Bara</creator><general>Springer</general><general>Springer Nature B.V</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M7Z</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20060301</creationdate><title>Informed consent for research in ICU obtained before ICU admission</title><author>CHENAUD, Catherine ; MERLANI, Paolo ; RICOU, Bara</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c504t-dc6a4bf3f6d2234d7224782c944eca0014504222bf93ee81362cec4cab6e64363</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2006</creationdate><topic>Admission and discharge</topic><topic>Aged</topic><topic>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy</topic><topic>Biological and medical sciences</topic><topic>Biomedical Research - organization & administration</topic><topic>Clinical death. Palliative care. Organ gift and preservation</topic><topic>Clinical trial. Drug monitoring</topic><topic>Decision making</topic><topic>Ethics</topic><topic>Female</topic><topic>General pharmacology</topic><topic>Hospitals</topic><topic>Hospitals, Teaching</topic><topic>Humans</topic><topic>Hypotheses</topic><topic>Informed Consent</topic><topic>Informed consent (Medical law)</topic><topic>Intensive care medicine</topic><topic>Intensive Care Units</topic><topic>Laws, regulations and rules</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Participation</topic><topic>Patient Admission</topic><topic>Patients</topic><topic>Pharmacology. Drug treatments</topic><topic>Prospective Studies</topic><topic>Surgery</topic><topic>Switzerland</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>CHENAUD, Catherine</creatorcontrib><creatorcontrib>MERLANI, Paolo</creatorcontrib><creatorcontrib>RICOU, Bara</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Biochemistry Abstracts 1</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>Intensive care medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>CHENAUD, Catherine</au><au>MERLANI, Paolo</au><au>RICOU, Bara</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Informed consent for research in ICU obtained before ICU admission</atitle><jtitle>Intensive care medicine</jtitle><addtitle>Intensive Care Med</addtitle><date>2006-03-01</date><risdate>2006</risdate><volume>32</volume><issue>3</issue><spage>439</spage><epage>444</epage><pages>439-444</pages><issn>0342-4642</issn><eissn>1432-1238</eissn><coden>ICMED9</coden><abstract>To analyze the procedure of the informed consent for ICU research obtained before ICU admission.
Prospective, open, observational study.
20-bed surgical ICU of a tertiary teaching university hospital and the ward before and after ICU.
Patients, scheduled for elective cardiac surgery, who accepted to participate in a coagulation study.
Patients underwent the same informed consent procedure, including an oral presentation of the coagulation study and an informative leaflet the day before surgery on the ward.
Between January and August 2001, we included 38 patients; 36 survived ICU. Ten to 12 days after surgery, 8/36 (22%) patients did not know they had participated in a study, and 9/36 (25%) could not recall the study purpose and the related risk. Patients with incomplete recall stayed longer in ICU [median (range): 4 (3-6) vs 3 (1-5) days; p = 0.004]. None of these patients (0/9 vs 10/27; p < 0.04) had read the informative leaflet AND asked at least one question during the informed consent procedure.
Even when the informed consent is obtained in the most optimal conditions for ICU research, its ethical value remains questionable. Indeed, a substantial number of patients were unaware of their study participation, or of the related purpose and risks. When the ICU stay is prolonged, we should at least repeatedly and actively (re)-inform patients about their study participation.</abstract><cop>Heidelberg</cop><cop>Berlin</cop><pub>Springer</pub><pmid>16477413</pmid><doi>10.1007/s00134-005-0059-4</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 0342-4642 |
| ispartof | Intensive care medicine, 2006-03, Vol.32 (3), p.439-444 |
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| subjects | Admission and discharge Aged Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy Biological and medical sciences Biomedical Research - organization & administration Clinical death. Palliative care. Organ gift and preservation Clinical trial. Drug monitoring Decision making Ethics Female General pharmacology Hospitals Hospitals, Teaching Humans Hypotheses Informed Consent Informed consent (Medical law) Intensive care medicine Intensive Care Units Laws, regulations and rules Male Medical sciences Middle Aged Participation Patient Admission Patients Pharmacology. Drug treatments Prospective Studies Surgery Switzerland |
| title | Informed consent for research in ICU obtained before ICU admission |
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