Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa
Identifieur interne : 001E64 ( Istex/Corpus ); précédent : 001E63; suivant : 001E65Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa
Auteurs : Michael T. Krosin ; Robert Klitzman ; Bruce Levin ; Jianfeng Cheng ; Megan L. RanneySource :
- Clinical Trials [ 1740-7745 ] ; 2006.
English descriptors
- Teeft :
- Binomial test, Certain areas, Checkup, Chisquared test, Clinical trials, Consent, Consent comprehension, Consent comprehension assessment, Consent process, Correct answer, Correct answers, Correct choice, Correct responses, Cultural differences, Current health, Eligible parents, Foreign company, Future research, Healthcare access, Lower level, Malaria, Malaria vaccine trial, Miscomprehension, Multiple choice format, Null hypothesis, Other countries, Other studies, Participant, Poor nutrition, Pure guesswork, Relative degree, Scientific knowledge, Screening questions, Several factors, Side effect, Side effects, Social position, Specific areas, Study administration, Vaccine, Vaccine study, Village leaders, Voluntary participation, Voluntary withdrawal, Weekly checkups, West africa, Withdrawal criterion.
Abstract
Background Clinical trials undertaken by industrialized nations in undeveloped nations pose several critical ethical dilemmas. One key potential problem concerns misunderstandings of the consent process by participants. Though other reports have begun to explore this area, needs remain to identify specific areas of misunderstanding. Purpose To identify deficits in comprehension during consent processes in Mali, West Africa. Methods After obtaining informed consent for participation for a malaria vaccine trial being conducted in two West African villages, we administered to participants a nine-item questionnaire testing their understanding of information relevant for their consent. After testing their ability to understand a multiple choice format, 78 of 100 subjects were administered the questionnaire in one village and 85 of 100 in the other. Results Participants had difficulty comprehending several concepts relevant to informed consent: 90% of respondents did not understand withdrawal criterion, 93% did not understand the existence of study side effects, and 74% did not understand that they were enrolled in an investigation as opposed to receiving therapy. The response rate and percentage of correct answers was generally much higher in the village nearer an urban center than the more rural village. The percent of correct answers exceeded 50% for five questions in the urban village and for only two question in the more rural setting. Limitations Potential limitations of this study are relating to translation, cultural differences in the notion of informed consent, staff differences between each village, the proportion who could not understand the survey instrument and the fact that the study explored participants' understanding of the consent process but did not observe the process itself. Conclusions This study illustrates potential areas of miscomprehension in the consent process in a developing country. The degree of miscomprehension found in this study appeared to be more than that found in similar studies conducted in industrialized nations. Despite efforts to obtain truly informed consent, several factors make it more challenging in the developing world. This research highlights the need for more comprehensive studies of consent in developing countries. Such studies may eventually aid investigators in identifying, targeting and addressing specific areas of miscomprehension and thereby improve the informed consent process in the developing world.
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DOI: 10.1191/1740774506cn150oa
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ISTEX:1478F62FEC09481331DF7776586C7A042AA1534FLe document en format XML
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Krosin</name><affiliation><mods:affiliation>San Francisco Orthopedic Program at St. Mary's Medical Center, San Francisco, CA, USA; 1358 Powell Street, Emeryville, CA 94608, USA;</mods:affiliation></affiliation><affiliation><mods:affiliation>E-mail: mkrosin@hotmail.com</mods:affiliation></affiliation></author><author wicri:is="90%"><name sortKey="Klitzman, Robert" sort="Klitzman, Robert" uniqKey="Klitzman R" first="Robert" last="Klitzman">Robert Klitzman</name></author><author wicri:is="90%"><name sortKey="Levin, Bruce" sort="Levin, Bruce" uniqKey="Levin B" first="Bruce" last="Levin">Bruce Levin</name></author><author wicri:is="90%"><name sortKey="Cheng, Jianfeng" sort="Cheng, Jianfeng" uniqKey="Cheng J" first="Jianfeng" last="Cheng">Jianfeng Cheng</name></author><author wicri:is="90%"><name sortKey="Ranney, Megan L" sort="Ranney, Megan L" uniqKey="Ranney M" first="Megan L" last="Ranney">Megan L. Ranney</name><affiliation><mods:affiliation>Columbia University, College of Physicians and Surgeons, New York, USA</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:1478F62FEC09481331DF7776586C7A042AA1534F</idno><date when="2006" year="2006">2006</date><idno type="doi">10.1191/1740774506cn150oa</idno><idno type="url">https://api.istex.fr/ark:/67375/M70-0TKCGP4R-8/fulltext.pdf</idno><idno type="wicri:Area/Istex/Corpus">001E64</idno><idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Corpus" wicri:corpus="ISTEX">001E64</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa</title><author wicri:is="90%"><name sortKey="Krosin, Michael T" sort="Krosin, Michael T" uniqKey="Krosin M" first="Michael T" last="Krosin">Michael T. Krosin</name><affiliation><mods:affiliation>San Francisco Orthopedic Program at St. Mary's Medical Center, San Francisco, CA, USA; 1358 Powell Street, Emeryville, CA 94608, USA;</mods:affiliation></affiliation><affiliation><mods:affiliation>E-mail: mkrosin@hotmail.com</mods:affiliation></affiliation></author><author wicri:is="90%"><name sortKey="Klitzman, Robert" sort="Klitzman, Robert" uniqKey="Klitzman R" first="Robert" last="Klitzman">Robert Klitzman</name></author><author wicri:is="90%"><name sortKey="Levin, Bruce" sort="Levin, Bruce" uniqKey="Levin B" first="Bruce" last="Levin">Bruce Levin</name></author><author wicri:is="90%"><name sortKey="Cheng, Jianfeng" sort="Cheng, Jianfeng" uniqKey="Cheng J" first="Jianfeng" last="Cheng">Jianfeng Cheng</name></author><author wicri:is="90%"><name sortKey="Ranney, Megan L" sort="Ranney, Megan L" uniqKey="Ranney M" first="Megan L" last="Ranney">Megan L. Ranney</name><affiliation><mods:affiliation>Columbia University, College of Physicians and Surgeons, New York, USA</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Clinical Trials</title><idno type="ISSN">1740-7745</idno><idno type="eISSN">1740-7753</idno><imprint><publisher>SAGE Publications</publisher><date type="published" when="2006">2006</date><biblScope unit="volume">3</biblScope><biblScope unit="issue">3</biblScope><biblScope unit="page" from="306">306</biblScope><biblScope unit="page" to="313">313</biblScope></imprint><idno type="ISSN">1740-7745</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">1740-7745</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="Teeft" xml:lang="en"><term>Binomial test</term><term>Certain areas</term><term>Checkup</term><term>Chisquared test</term><term>Clinical trials</term><term>Consent</term><term>Consent comprehension</term><term>Consent comprehension assessment</term><term>Consent process</term><term>Correct answer</term><term>Correct answers</term><term>Correct choice</term><term>Correct responses</term><term>Cultural differences</term><term>Current health</term><term>Eligible parents</term><term>Foreign company</term><term>Future research</term><term>Healthcare access</term><term>Lower level</term><term>Malaria</term><term>Malaria vaccine trial</term><term>Miscomprehension</term><term>Multiple choice format</term><term>Null hypothesis</term><term>Other countries</term><term>Other studies</term><term>Participant</term><term>Poor nutrition</term><term>Pure guesswork</term><term>Relative degree</term><term>Scientific knowledge</term><term>Screening questions</term><term>Several factors</term><term>Side effect</term><term>Side effects</term><term>Social position</term><term>Specific areas</term><term>Study administration</term><term>Vaccine</term><term>Vaccine study</term><term>Village leaders</term><term>Voluntary participation</term><term>Voluntary withdrawal</term><term>Weekly checkups</term><term>West africa</term><term>Withdrawal criterion</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background Clinical trials undertaken by industrialized nations in undeveloped nations pose several critical ethical dilemmas. One key potential problem concerns misunderstandings of the consent process by participants. Though other reports have begun to explore this area, needs remain to identify specific areas of misunderstanding. Purpose To identify deficits in comprehension during consent processes in Mali, West Africa. Methods After obtaining informed consent for participation for a malaria vaccine trial being conducted in two West African villages, we administered to participants a nine-item questionnaire testing their understanding of information relevant for their consent. After testing their ability to understand a multiple choice format, 78 of 100 subjects were administered the questionnaire in one village and 85 of 100 in the other. Results Participants had difficulty comprehending several concepts relevant to informed consent: 90% of respondents did not understand withdrawal criterion, 93% did not understand the existence of study side effects, and 74% did not understand that they were enrolled in an investigation as opposed to receiving therapy. The response rate and percentage of correct answers was generally much higher in the village nearer an urban center than the more rural village. The percent of correct answers exceeded 50% for five questions in the urban village and for only two question in the more rural setting. Limitations Potential limitations of this study are relating to translation, cultural differences in the notion of informed consent, staff differences between each village, the proportion who could not understand the survey instrument and the fact that the study explored participants' understanding of the consent process but did not observe the process itself. Conclusions This study illustrates potential areas of miscomprehension in the consent process in a developing country. The degree of miscomprehension found in this study appeared to be more than that found in similar studies conducted in industrialized nations. Despite efforts to obtain truly informed consent, several factors make it more challenging in the developing world. This research highlights the need for more comprehensive studies of consent in developing countries. Such studies may eventually aid investigators in identifying, targeting and addressing specific areas of miscomprehension and thereby improve the informed consent process in the developing world.</div></front></TEI><istex><corpusName>sage</corpusName><keywords><teeft><json:string>consent process</json:string><json:string>miscomprehension</json:string><json:string>clinical trials</json:string><json:string>side effects</json:string><json:string>correct answer</json:string><json:string>correct answers</json:string><json:string>voluntary participation</json:string><json:string>vaccine</json:string><json:string>west africa</json:string><json:string>participant</json:string><json:string>malaria</json:string><json:string>withdrawal criterion</json:string><json:string>null hypothesis</json:string><json:string>pure guesswork</json:string><json:string>consent comprehension assessment</json:string><json:string>binomial test</json:string><json:string>specific areas</json:string><json:string>screening questions</json:string><json:string>weekly checkups</json:string><json:string>checkup</json:string><json:string>eligible parents</json:string><json:string>vaccine study</json:string><json:string>voluntary withdrawal</json:string><json:string>several factors</json:string><json:string>healthcare access</json:string><json:string>study administration</json:string><json:string>foreign company</json:string><json:string>social position</json:string><json:string>current health</json:string><json:string>side effect</json:string><json:string>scientific knowledge</json:string><json:string>poor nutrition</json:string><json:string>lower level</json:string><json:string>consent comprehension</json:string><json:string>cultural differences</json:string><json:string>multiple choice format</json:string><json:string>malaria vaccine trial</json:string><json:string>correct choice</json:string><json:string>chisquared test</json:string><json:string>correct responses</json:string><json:string>relative degree</json:string><json:string>certain areas</json:string><json:string>other studies</json:string><json:string>other countries</json:string><json:string>future research</json:string><json:string>village leaders</json:string><json:string>consent</json:string></teeft></keywords><author><json:item><name>Michael T Krosin</name><affiliations><json:string>San Francisco Orthopedic Program at St. Mary's Medical Center, San Francisco, CA, USA; 1358 Powell Street, Emeryville, CA 94608, USA;</json:string><json:string>E-mail: mkrosin@hotmail.com</json:string></affiliations></json:item><json:item><name>Robert Klitzman</name></json:item><json:item><name>Bruce Levin</name></json:item><json:item><name>Jianfeng Cheng</name></json:item><json:item><name>Megan L Ranney</name><affiliations><json:string>Columbia University, College of Physicians and Surgeons, New York, USA</json:string></affiliations></json:item></author><articleId><json:string>10.1191_1740774506cn150oa</json:string></articleId><arkIstex>ark:/67375/M70-0TKCGP4R-8</arkIstex><language><json:string>eng</json:string></language><originalGenre><json:string>research-article</json:string></originalGenre><abstract>Background Clinical trials undertaken by industrialized nations in undeveloped nations pose several critical ethical dilemmas. One key potential problem concerns misunderstandings of the consent process by participants. Though other reports have begun to explore this area, needs remain to identify specific areas of misunderstanding. Purpose To identify deficits in comprehension during consent processes in Mali, West Africa. Methods After obtaining informed consent for participation for a malaria vaccine trial being conducted in two West African villages, we administered to participants a nine-item questionnaire testing their understanding of information relevant for their consent. After testing their ability to understand a multiple choice format, 78 of 100 subjects were administered the questionnaire in one village and 85 of 100 in the other. Results Participants had difficulty comprehending several concepts relevant to informed consent: 90% of respondents did not understand withdrawal criterion, 93% did not understand the existence of study side effects, and 74% did not understand that they were enrolled in an investigation as opposed to receiving therapy. The response rate and percentage of correct answers was generally much higher in the village nearer an urban center than the more rural village. The percent of correct answers exceeded 50% for five questions in the urban village and for only two question in the more rural setting. Limitations Potential limitations of this study are relating to translation, cultural differences in the notion of informed consent, staff differences between each village, the proportion who could not understand the survey instrument and the fact that the study explored participants' understanding of the consent process but did not observe the process itself. Conclusions This study illustrates potential areas of miscomprehension in the consent process in a developing country. The degree of miscomprehension found in this study appeared to be more than that found in similar studies conducted in industrialized nations. Despite efforts to obtain truly informed consent, several factors make it more challenging in the developing world. This research highlights the need for more comprehensive studies of consent in developing countries. Such studies may eventually aid investigators in identifying, targeting and addressing specific areas of miscomprehension and thereby improve the informed consent process in the developing world.</abstract><qualityIndicators><score>9.707</score><pdfWordCount>4707</pdfWordCount><pdfCharCount>29786</pdfCharCount><pdfVersion>1.3</pdfVersion><pdfPageCount>8</pdfPageCount><pdfPageSize>611.52 x 850.56 pts</pdfPageSize><refBibsNative>true</refBibsNative><abstractWordCount>361</abstractWordCount><abstractCharCount>2496</abstractCharCount><keywordCount>0</keywordCount></qualityIndicators><title>Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa</title><pmid><json:string>16895047</json:string></pmid><genre><json:string>research-article</json:string></genre><host><title>Clinical Trials</title><language><json:string>unknown</json:string></language><issn><json:string>1740-7745</json:string></issn><eissn><json:string>1740-7753</json:string></eissn><publisherId><json:string>CTJ</json:string></publisherId><volume>3</volume><issue>3</issue><pages><first>306</first><last>313</last></pages><genre><json:string>journal</json:string></genre></host><namedEntities><unitex><date><json:string>2006</json:string></date><geogName></geogName><orgName><json:string>Society for Clinical Trials</json:string><json:string>Medical Center, San Francisco</json:string><json:string>United States and Europe</json:string><json:string>Mali, West Africa</json:string></orgName><orgName_funder></orgName_funder><orgName_provider></orgName_provider><persName><json:string>R. Ihe</json:string><json:string>Christopher Plowe</json:string><json:string>Mary DuVernay</json:string><json:string>Mike Krosin</json:string><json:string>Hochberg Y</json:string><json:string>Daniel WW</json:string><json:string>To</json:string><json:string>Tamhane AC</json:string></persName><placeName><json:string>Mali</json:string><json:string>Bamako</json:string></placeName><ref_url></ref_url><ref_bibl><json:string>[11]</json:string><json:string>Marcus et al.</json:string><json:string>[6,12]</json:string><json:string>Krosin et al.</json:string><json:string>July 2001</json:string><json:string>[1,2]</json:string><json:string>[4,5]</json:string></ref_bibl><bibl></bibl></unitex></namedEntities><ark><json:string>ark:/67375/M70-0TKCGP4R-8</json:string></ark><categories><wos><json:string>1 - science</json:string><json:string>2 - medicine, research & experimental</json:string></wos><scienceMetrix><json:string>1 - natural sciences</json:string><json:string>2 - mathematics & statistics</json:string><json:string>3 - statistics & probability</json:string></scienceMetrix><scopus><json:string>1 - Life Sciences</json:string><json:string>2 - Pharmacology, Toxicology and Pharmaceutics</json:string><json:string>3 - Pharmacology</json:string><json:string>1 - Health Sciences</json:string><json:string>2 - Medicine</json:string><json:string>3 - General Medicine</json:string></scopus><inist><json:string>1 - sciences humaines et sociales</json:string><json:string>2 - histoire des sciences et des techniques</json:string></inist></categories><publicationDate>2006</publicationDate><copyrightDate>2006</copyrightDate><doi><json:string>10.1191/1740774506cn150oa</json:string></doi><id>1478F62FEC09481331DF7776586C7A042AA1534F</id><score>1</score><fulltext><json:item><extension>pdf</extension><original>true</original><mimetype>application/pdf</mimetype><uri>https://api.istex.fr/ark:/67375/M70-0TKCGP4R-8/fulltext.pdf</uri></json:item><json:item><extension>zip</extension><original>false</original><mimetype>application/zip</mimetype><uri>https://api.istex.fr/ark:/67375/M70-0TKCGP4R-8/bundle.zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/ark:/67375/M70-0TKCGP4R-8/fulltext.tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher scheme="https://scientific-publisher.data.istex.fr">SAGE Publications</publisher><availability><licence><p>sage</p></licence></availability><p scheme="https://loaded-corpus.data.istex.fr/ark:/67375/XBH-0J1N7DQT-B"></p><date>2006</date></publicationStmt><notesStmt><note type="research-article" scheme="https://content-type.data.istex.fr/ark:/67375/XTP-1JC4F85T-7">research-article</note><note type="journal" scheme="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa</title><author xml:id="author-0000"><persName><forename type="first">Michael T</forename><surname>Krosin</surname></persName><email>mkrosin@hotmail.com</email><affiliation>San Francisco Orthopedic Program at St. Mary's Medical Center, San Francisco, CA, USA; 1358 Powell Street, Emeryville, CA 94608, USA;</affiliation></author><author xml:id="author-0001"><persName><forename type="first">Robert</forename><surname>Klitzman</surname></persName></author><author xml:id="author-0002"><persName><forename type="first">Bruce</forename><surname>Levin</surname></persName></author><author xml:id="author-0003"><persName><forename type="first">Jianfeng</forename><surname>Cheng</surname></persName></author><author xml:id="author-0004"><persName><forename type="first">Megan L</forename><surname>Ranney</surname></persName><affiliation>Columbia University, College of Physicians and Surgeons, New York, USA</affiliation></author><idno type="istex">1478F62FEC09481331DF7776586C7A042AA1534F</idno><idno type="ark">ark:/67375/M70-0TKCGP4R-8</idno><idno type="DOI">10.1191/1740774506cn150oa</idno><idno type="article-id">10.1191_1740774506cn150oa</idno></analytic><monogr><title level="j">Clinical Trials</title><idno type="pISSN">1740-7745</idno><idno type="eISSN">1740-7753</idno><idno type="publisher-id">CTJ</idno><idno type="PublisherID-hwp">spctj</idno><imprint><publisher>SAGE Publications</publisher><date type="published" when="2006"></date><biblScope unit="volume">3</biblScope><biblScope unit="issue">3</biblScope><biblScope unit="page" from="306">306</biblScope><biblScope unit="page" to="313">313</biblScope></imprint></monogr></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2006</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>Background Clinical trials undertaken by industrialized nations in undeveloped nations pose several critical ethical dilemmas. One key potential problem concerns misunderstandings of the consent process by participants. Though other reports have begun to explore this area, needs remain to identify specific areas of misunderstanding. Purpose To identify deficits in comprehension during consent processes in Mali, West Africa. Methods After obtaining informed consent for participation for a malaria vaccine trial being conducted in two West African villages, we administered to participants a nine-item questionnaire testing their understanding of information relevant for their consent. After testing their ability to understand a multiple choice format, 78 of 100 subjects were administered the questionnaire in one village and 85 of 100 in the other. Results Participants had difficulty comprehending several concepts relevant to informed consent: 90% of respondents did not understand withdrawal criterion, 93% did not understand the existence of study side effects, and 74% did not understand that they were enrolled in an investigation as opposed to receiving therapy. The response rate and percentage of correct answers was generally much higher in the village nearer an urban center than the more rural village. The percent of correct answers exceeded 50% for five questions in the urban village and for only two question in the more rural setting. Limitations Potential limitations of this study are relating to translation, cultural differences in the notion of informed consent, staff differences between each village, the proportion who could not understand the survey instrument and the fact that the study explored participants' understanding of the consent process but did not observe the process itself. Conclusions This study illustrates potential areas of miscomprehension in the consent process in a developing country. The degree of miscomprehension found in this study appeared to be more than that found in similar studies conducted in industrialized nations. Despite efforts to obtain truly informed consent, several factors make it more challenging in the developing world. This research highlights the need for more comprehensive studies of consent in developing countries. Such studies may eventually aid investigators in identifying, targeting and addressing specific areas of miscomprehension and thereby improve the informed consent process in the developing world.</p></abstract></profileDesc><revisionDesc><change when="2006">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><extension>txt</extension><original>false</original><mimetype>text/plain</mimetype><uri>https://api.istex.fr/ark:/67375/M70-0TKCGP4R-8/fulltext.txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="corpus sage not found" wicri:toSee="no header"><istex:xmlDeclaration>version="1.0" encoding="UTF-8"</istex:xmlDeclaration><istex:docType PUBLIC="-//NLM//DTD Journal Publishing DTD v2.3 20070202//EN" URI="journalpublishing.dtd" name="istex:docType"></istex:docType><istex:document><article article-type="research-article" dtd-version="2.3" xml:lang="EN"><front><journal-meta><journal-id journal-id-type="publisher-id">CTJ</journal-id><journal-id journal-id-type="hwp">spctj</journal-id><journal-title>Clinical Trials</journal-title><issn pub-type="ppub">1740-7745</issn><publisher><publisher-name>SAGE Publications</publisher-name><publisher-loc></publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.1191/1740774506cn150oa</article-id><article-id pub-id-type="publisher-id">10.1191_1740774506cn150oa</article-id><article-categories><subj-group subj-group-type="heading"><subject>Articles</subject></subj-group></article-categories><title-group><article-title>Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa</article-title></title-group><contrib-group><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Krosin</surname><given-names>Michael T</given-names></name><aff id="aff1">San Francisco Orthopedic Program at St. Mary's Medical Center, San Francisco, CA, USA; 1358 Powell Street, Emeryville, CA 94608, USA; <email xlink:type="simple">mkrosin@hotmail.com</email></aff></contrib></contrib-group><contrib-group><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Klitzman</surname><given-names>Robert</given-names></name></contrib></contrib-group><contrib-group><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Levin</surname><given-names>Bruce</given-names></name></contrib></contrib-group><contrib-group><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Cheng</surname><given-names>Jianfeng</given-names></name></contrib></contrib-group><contrib-group><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Ranney</surname><given-names>Megan L</given-names></name><aff id="aff2">Columbia University, College of Physicians and Surgeons, New York, USA</aff></contrib></contrib-group><pub-date pub-type="epub-ppub"><month>6</month><year>2006</year></pub-date><volume>3</volume><issue>3</issue><fpage>306</fpage><lpage>313</lpage><abstract><p><bold><bold><italic>Background</italic></bold></bold> Clinical trials undertaken by industrialized nations in undeveloped nations pose several critical ethical dilemmas. One key potential problem concerns misunderstandings of the consent process by participants. Though other reports have begun to explore this area, needs remain to identify specific areas of misunderstanding.</p><p><bold><bold><italic>Purpose</italic></bold></bold> To identify deficits in comprehension during consent processes in Mali, West Africa.</p><p><bold><bold><italic>Methods</italic></bold></bold> After obtaining informed consent for participation for a malaria vaccine trial being conducted in two West African villages, we administered to participants a nine-item questionnaire testing their understanding of information relevant for their consent. After testing their ability to understand a multiple choice format, 78 of 100 subjects were administered the questionnaire in one village and 85 of 100 in the other.</p><p><bold><bold><italic>Results</italic></bold></bold> Participants had difficulty comprehending several concepts relevant to informed consent: 90% of respondents did not understand withdrawal criterion, 93% did not understand the existence of study side effects, and 74% did not understand that they were enrolled in an investigation as opposed to receiving therapy. The response rate and percentage of correct answers was generally much higher in the village nearer an urban center than the more rural village. The percent of correct answers exceeded 50% for five questions in the urban village and for only two question in the more rural setting.</p><p><bold><bold><italic>Limitations</italic></bold></bold> Potential limitations of this study are relating to translation, cultural differences in the notion of informed consent, staff differences between each village, the proportion who could not understand the survey instrument and the fact that the study explored participants' understanding of the consent process but did not observe the process itself.</p><p><bold><bold><italic>Conclusions</italic></bold></bold> This study illustrates potential areas of miscomprehension in the consent process in a developing country. The degree of miscomprehension found in this study appeared to be more than that found in similar studies conducted in industrialized nations. Despite efforts to obtain truly informed consent, several factors make it more challenging in the developing world. This research highlights the need for more comprehensive studies of consent in developing countries. Such studies may eventually aid investigators in identifying, targeting and addressing specific areas of miscomprehension and thereby improve the informed consent process in the developing world.</p></abstract><custom-meta-wrap><custom-meta xlink:type="simple"><meta-name>sagemeta-type</meta-name><meta-value>Journal Article</meta-value></custom-meta><custom-meta xlink:type="simple"><meta-name>search-text</meta-name><meta-value> CLAN ICAI ETHICS Clinical Trials 2006; 3: 306-313 Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa Michael T Krosin G, Robert Klitzman b, Bruce Levinb, jianfeng Chengb and Megan L Ranneyb Background Clinical trials undertaken by industrialized nations in undeveloped nations pose several critical ethical dilemmas. One key potential problem con- cerns misunderstandings of the consent process by participants. Though other reports have begun to explore this area, needs remain to identify specific areas of misunderstanding. Purpose To identify deficits in comprehension during consent processes in Mali, West Africa. Methods After obtaining informed consent for participation for a malaria vaccine trial being conducted in two West African villages, we administered to participants a nine-item questionnaire testing their understanding of information relevant for their consent. After testing their ability to understand a multiple choice format, 78 of 100 subjects were administered the questionnaire in one village and 85 of 100 in the other. Results Participants had difficulty comprehending several concepts relevant to informed consent: 90% of respondents did not understand withdrawal criterion, 93% did not understand the existence of study side effects, and 74% did not understand that they were enrolled in an investigation as opposed to receiving therapy. The response rate and percentage of correct answers was generally much higher in the village nearer an urban center than the more rural village. The percent of correct answers exceeded 50% for five questions in the urban village and for only two question in the more rural setting. Limitations Potential limitations of this study are relating to translation, cultural differences in the notion of informed consent, staff differences between each village, the proportion who could not understand the survey instrument and the fact that the study explored participants' understanding of the consent process but did not observe the process itself. Conclusions This study illustrates potential areas of miscomprehension in the consent process in a developing country. The degree of miscomprehension found in this study appeared to be more than that found in similar studies conducted in industrialized nations. Despite efforts to obtain truly informed consent, several factors make it more challenging in the developing world. This research highlights the need for more comprehensive studies of consent in developing countries. Such studies may eventually aid investigators in identifying, targeting and addressing specific areas of miscomprehension and thereby improve the informed consent process in the developing world. Clinical Trials 2006; 3: 306-313. www.SCTjournal.com Background such trials is the comprehension of the informed consent process by participaints. While any clinical Clinical trials in the developing world sponsored by trial will involve some degree of miscomprehension industrialized countries raise numerous practical with participants, where exactly, and to what and ethical difficulties. One critical challenge in degree do these deficits exist [1,2]? C) Society for Clinical Trials 2006 aSan Francisco Orthopedic Program at St. Mary's Medical Center, San Francisco, CA, USA, bColumbia University, College of Physicians and Surgeons, New York, USA Author for correspondence: Mike Krosin, 1358 Powell Street, Emeryville, CA 94608, USA. E-mail: mkrosin@hotmail.com I 0. I 1 91 /I 740 7 745 06cn I 50oa Consent comprehension assessment 307 Prior studies Several stuLdies conducted in both Europe and the United States have assessed the degree of under- standing of the intofimied consenit process, and have illustrated flaws in comprehension [3]. Among con- senting parents with children entering clinical trials in nine European couintries, the notion of volun- tary withdrawal was particularly rmisunderstood, with 20.7%/o of the parents miscomprehending the concept 141. In a clirnical trial of a surgical proce- dure, 33% of participants did not know they could withdraw at aniv tijmie 151. In a study of experimen- tal chemotherapeutic agents for cancer, 480/o of enrolled participants did n(ot understand that the investigation was of a "'noIln-standard treatmient," [6] and 38% did not understand the potential for risks or side effects from the experimental chemother- apy. A qualitative study in East Africa confirmed many of these pitfalls in consent comprehension - specifically, understandling of risk, research versus treatment and autonron iy. Interviews with consent- ing individuals revealed corinni-ion themles such as, "It is inappropriate to questioni a doctor", and "there are no risks to this study ... people at the hospital have no bad intentions" 171. While mis- comprehensioni of consent is expected to some degree, these studies show particular areas predis- posed to misunderstanding. Yet questions remain concerning the presence and degree of miscompre- hension of studies in developing countries. With increasing research conducted in developiing nations, and vast cultural barriers between partici- pant and investigator, these questions are crucial. Though little data exist on this topic, research in the developing world, like that elsewhere, is predi- cated ethically on proper informed consent. We exanmined the consent process for a malaria vaccine trial pro-tocol in two villages in Mali, West Africa. This trial was a preliminary suLrvey studying the incideence of both malaria and anemia for cohorts randomized to eitller chloroquine or placebo groups, along with minimial-risk weekly medical screening of child subjects (aged six months to five years). Ihe trial's endpoints were malaria and anemTia incidence with versus without chloroquine regimrrens over the coutrse of one mnalaria seasonr, to be later compared with use of malaria vaccine. The consent process for the malaria trial, which our teanm observed, was an oral consent administered by a P1 to groups of two to four participants (ie, consenting parents) at a tiIme. It lasted for approximlately 40 Iminutes. Periodic breaks were taken to sumlimarize and allow for ques- tions as well as allotted time at the end for ques- tions. Conseint was given by thumlbprint. All aspects of the consent tested in ouir study were explained at least twice to participan-ts during this group consent process. Ihe process was interactive to the extent that participants did regularly ask questionis during the process. The exact nature and nu1mber of these questions was not quantified as the observer (MK) does not speak native Bambara. Methods Questionnaire development and administration This study was approved by the Malian IRB/Ethics Committee as well as discussed with the IRB from the sponsoring host country's institution in July 2001. The questionnaire (Appendix) contains nine questions that test details about the vaccine study's consent. Each question is intended to probe a spe- cific area in the consent process and has one correct answer, based on the vaccine study as explained during the consent process. These areas are summa- rized in Table 1. Ihe questionnaire was developed irn concert with the Malian IRB, who deemed the questions relevant and appropriate, over two ses- sions. VVe focused oCn assessing understandings of material presented in the consent process. It was hoped that relevant areas of comprehension could be examined. We based the questionnaire on obser- vations of a few sessions of the informed consent process, and intensive discussions with both promi- nent village leaders and investigators. The question- naire was translated from English to French by an experienced translator, and back-translated from French to English by a separate translator to ensure translational accuracy. 'lhe test administrator who orally delivered the test in each village was respon- sible for translation from French to Bamabara (the local language). T he purpose and significance of the project was discussed with the translators in order to einsure as much as possible that they conducted a cultuLrally accurate translation. The test adminis- trators were further trained on the importance of objective and consistent delivery of the question- naire, and observed by our team. TIhe test was multiple choice in nature. Due to illiteracy levels, picture symbols (box, moon, smile, star) repre- sented each choice. As this was in part a pilot study, we did not seek separately to test the validity of each question and the questionnaire as a whole. In two different villages, 200 individuals con- sented for participation in our study within 48 hours of the malaria trial's initial consent process. Groups of six to 14 participants were brought to each village's school, and seated at desks no less than 4 feet away from one another to prevent sharing of information. 'rhe test instructions were then read. Two screening questions (with obvious answers) were presented to ensure participants' ability to understand and use the multiple-choice Clinical Trials 2006; 3: 306-313 www.SCTjournal.com 308 MT Krosin et al. Table I Results of questionriaire % Responses Village R % Responses Village U Total combined Question Topic N = 78* N = 85 % correct 1) Voluntary participation N = 67 N = 85 57% a. Village elder 45% (30) 9% (8) b. Yourself 21% (14) 85% (72) c. Study teamf 21% (14) 5% (4) d. Spouse 13%(9) 1%(1) R=2 R 1 2) Compensation N 65 N= 85 44% a. Money and checkuIps 8% (5) 1 3% (11) b. Malaria mediciie and checkups 18% (12) 27% (23) c. Food and checkups 28% (18) 56% (48) d. Checkups only 46% (30) 4% (3) R-2 R-1 3) Withdrawal criterion N = 59 N - 85 10% a. At any time 12% (7) 9% (8) b. With scientist's permission 34% (20) 80% (68) c. Village leader's permission 20% (12) 6% (5) d. Spouse's permission 34% ( 20) 5% (4) R - 4 R - 2 (low) 4) Withdrawal consequerice N 37 N - 85 44%/o a. Checkups, but no food or money 27% (10) 45% (38) b. Nothing and no healthcare access 11% (4) 6% (5) c. Punished and fined 13% (5) 7% (6) d. Nothing but healthcare access 49% (18) 42% (36) R 1 R 2 5) Study versus treatment N 30 N 85 26% a. Determine CaUSe of malaria 53% ( 16) 26% (22) b. Provide village with medicine 13% (4) 22% (19) c. Study malaria/anemia incidence 20% (6) 28% (24) d. Cure malaria in village 13% (4) 24% (20) R-2 R 1 6) Study administration N - 65 N = 85 66% a. Malian and U.S. scientists 43% (28) 84% (71) b. Villagers 32% (21) 6% (5) c. French governmrent 12% (8) 8% (7) d. Foreign company 12% (8) 2% (2) e. Local political party 0% (0) 0% (0) R 1 R I 7) Randomization and placebo N 29 N 85 68% a. Past medical history 24% (7) 12% (10) b. Randomly 62% (18) 71% (60) c. Social position 0% (0) 2% (2) d. Current health 14% (4) 15% (13) R- 1 R 1 8) Side effects N 62 N 85 7% a. Risks and side effects 10% (6) 6% (5) b. Is a vaccine for life 27% (17) 25% (21) c. No side effect 1 8% (11) 28% (24) d. Will correct malnourishment 45% (28) 41% (35) R 4 R-4 9) Lay scientific knowledge N -78 N - 85 73% a. Vegetation 14% (11) 6% (5) b. Poor nutrition 9% (7) 5% (4) c. Sadness 10% (8) 6% (5) d. Night birds 4% (3) 1% (1) e. Mosquitos 63% (49) 82% (70) R 1 R=1 *Number eligible who answered screening questions adequately. See text. N = number of interpretable responses for each quLestion, R = Rank of correct answer (independent of percentage correct, when ordered from most often chosen answer [1 = 1 st] to least often [eg, 4 = 4th], when compared with other answer choices). Clinical Trials 2006; 3: 306-31 3 www.SCTjournal.com Consent comprehension assessment 309 format. Any participant who chose art incorrect answer for the first sam ple question had their imistake explainied to thenm, and was invited to try the second practice question. Regardless of performance on the first sample question, any par- ticipant who did niot answer the second sample question correctly had his or her responses excluded in entirety from the final results. Of the remaining individuals includCIied, any items not answered, incomprehensibly marked or double marked, were exclutiecd individually frorn final analysis. These exclusionrs explairn the differences in final sample size between-i the two villages, and in number of respondents on1 each question. In village R, on several questions, participants did nlot answer or mistakeinly double nmarked the questioninaire, reflecting in part the lower level of education and foreignness of testing in this village. The translator administering the questioninaire was the only indi- vidual who talked (luring the administration of the questionnaire. lc) minimize sharing of information, questions by participants were limited. Study sites To protect identity, the villages will be referred to as "Village R" (for ruLral) and "Village U" (for urban). Village R is a rural, agrarian village, 2.5 hours from the Malian capital of Bamako. Its population is approximatelv 8000; its economy is agrariani suLbsis- tence farming, and it has no electricity. Greater than 90% of conseinting parents who took part in the study had not attended school, and were illiterate. Participarnts fromn Village R involved in the questionnaire were 92% mnale, andi had, on average, 2.5 children enriolled in the larger study. These demographics for Village R suggest that the miale population works in close proximity to the village (in farnming) and is thuts able to be present as head of household, and that there are relatively larger numbers of children per faimily as coimpared with Village U. Village U is a suburb of the capital city of Bamako (25 minutes from the city center, directly off Mali's main highway). Its population is approx- imately 13 000 aniid its econorny is comrmierce- oriented. It h-as electricity and telephones in over 60% of households. Siince the mrajority of the men work in the city, 83"X% of the consenit for children to participate in the vaccine study was given by the female head of hiousehold. Of the consenting indi- viduals (83% female, 13%/o mlale), 67%-Yo had primary education aind 70%YO were literate to some degree. In general, the degree of education and political awareness was greater in Village U than Village R. Many of the villagers in Village U spoke French, but Bambara was thel prinmary langutage. Village U's consenting parents had, on average, 1.5 children enrolled in the study, indicating smaller family size. T he expendable income per family, as demnon- strated by the presence of clothiing and accessories, was substantially higher than in Village R, and access to "modern" goods and current news was facilitated by the village's urban proximity. In each village, 100 consenting individuals initially participated in our study and were ques- tioned. In Village R, 100 out of 103 eligible parents were questioned, with 78 participants eligible following screening questions. In Village U, 100 out of 167 eligible parents were questioned, with 85 participanits eligible. Statistical methods We present results in this study both as absolute percentages of participants who answered correctly, as well as rank numbers comparing how the correct answer choice faired against the other, incorrect "decoy" answer choices. Statistical analyses were performed using both a chi-squared and a binomial test. Tl he chi-squared statistic tested the null hypothesis that respondents selected any answer choice with equal probability without regard to the correct answer (pure guess work), whereas the bino- mial z-statistic tested the broader null hypothesis that respondents selected the correct answer with probability 0.20 (when there were five choices) or 0.25 (when there were four choices) irrespective of their distribution across other incorrect choices. For example, Question 1 in Village R gives a chi-squared P-value of 0.005 and a binomial P'-value of 0.22. The chi-squared P-value of <0.005 allows one to reject the null hypothesis that participants were guessing at all answers, whereas the binomial P-value of 0.22 suggests that the proportion of people answering correctly (21 t1A) is inot significanitly different from what we would expect by chance (25%). Because the null hypotheses are nested (ie, pure guesswork in all choices implies guesswork on the correct choice), we used a "closed" test procedure, whereby one tests the hypothesis of guesswork on the correct choice if and only if one first rejects the hypothesis of pure guesswork in all choices (by the chi-squared test at the 0.05 level). It is easy to dernonstrate that this closed test procedure controls the probability of committing one or two type 1 errors at the 0.05 level per item (see more generally Marcus et al. 18] and Hochberg and Tamhane 19]). If the chi-squared test was not significant at the 0.05 level, the procedure stopped - ie, we did not con- sider the binomial test for this item. If the chi- squared test was significant, we proceeded with the binomial test at the 0.05 level, to address whether or not the departure from pure guesswork favored Clinical Trials 2006; 3: 306-313 www.SCTjournal.com 310 MTKrosinetal. the correct answer. Ini additiorn, we also calculated the 950/% confidenice interval for the percentage of correct answers based on the method illustrated by Daniel -1.01. Results The survey results are r eported in Tables 1 and 2. As previously notedI, 22 of 100 participants in Village U and 15 of 100 in Village R cotuld not understand the multiple choice format anld were deemed ineli- gible for this survey. Almrost all eligible participants answered every question in Village U, whereas Village R had highly variable usable response rates, between 37%/o (Q7) and 100%o (Q9). This wide range may have occurred due to lower level of education, and consequent foreigniness of testiing. The chi- squared test rejected the null hypothesis (P < 0.005) for all items in both villages separately, indicating an overall pattern not consistent with guessing, except for Questions 3 (P < 0.05 in Village R and 5 (P = 0.87) in Village U. All of the binomial results were signtificarit, indicating a percerntage for the correct answer that statistically differed frorn chance, except for questions about voluntary par- ticipation (Q ]), a-nd( com pensatiorn (Q2) in Village R, and treatment versus research (QS) in both vil- lages, in which the percentage of correct responses were 20-28%Y (close to chance). The percentage of correct answers exceedecd 50%/6 for five questionis in Village U, and two qUestions in Village R. Ihe correct answer was t-he most frequent one chosen for six questions inl Village U aind four questions in Village R. T he percerntage of correct answers was sta- tistically significanitly highier in Village U than Village R for four of the questions; voluntary partic- ipation (85% versus 21 %), compeensation (56% versus 28%), study administration (84% versus 43%) and knowledge about the cause of malaria (82%-Yo versus 63%/6). Discussion While deficits with consent comprehension exist universally, the results here illustrate the relative degree of miscomprehension between demographi- callv different towns in West Africa and, more impor- tantly, rniscomprehension in the developing world, relative to industrialized nations. By focusing on those areas with low percentages of correct responses, problematic areas are best identified. As poor as these results are, it is likely that the percentages of correct answers observed here are high relative to the popu- lation sampled, since 15%-Yo of questioned adults in Village U and 22% in Village R could not reliably use a multiple choice format, and were ineligible for this survey. However, all of these individuals had provided consent for the parent study. The differences between Village R and Village U can be attributed to several factors. In general, par- ticipants from Village R answered incorrectly more often than those from Village U. The most likely r eason for Village U's better performance, as described above, is Village U's much higher percent- age of literate adults and school attendance. While demographics of age and sex invariably influences response, the sample size impeded our ability to conitrol for these factors formally. Ihe most troublesome aspect of these results is not just the extent of miscomprehension in certain areas, but the relative degree of miscomprehension whein coinpared to studies conducted in industrial- ized nations, particularly concerning withdrawal criteria and side effects. As described above, studies conducted in the United States and Europe have illustrated that between 20% and 330% of partici- pants miscomprehend withdrawal criterion [4,5], while our study illustrates that 90% of participants miscomprehended withdrawal criterion. Moreover, the other three answer options for the question on voluntary withdrawal - that the study team, the village chief, or one's spouse must give permission Table 2 Statistical analysis of percentage of correct answers on questionnaire. The binomal P-value tests whether the reported percentage deviates from the percentage expected by chance (ie, 25% for four-response questions and 20% for five-responses) Village R Village U Question P-value Percent correct (95% Cl) P-value Percent correct (95% Cl) 1) Voluntary participation 0.22 0.21 (0.11, 0.31) <0.005 0.85 (0.77, 0.93) 2) Compensation 0.31 0.28 (0.17, 0.39) <'0.005 0.56 (0.46, 0.66) 3) Withdrawal criterion 0.01 0.12 (0.04, 0.20) <-z0.005 0.09 (0.03, 0.15) 4) Withdrawal consequence -<0.005 0.49 (0.33, 0.65) <0.005 0.42 (0.32, 0.52) 5) Study versus treatment 0.26 0.20 (0.06, 0.34) 0.25 0.28 (0.18, 0.38) 6) Study administrationi <0.005 0.43 (0.31, 0.55) <0.005 0.84 (0.76, 0.92) 7) Randomization and placebo < 0.005 0.62 (0.44, 0.80) <0.005 0.71 (0.61, 0.81) 8) Side effects <0.005 0.1 (0.02, 0.18) <0.005 0.06 (0.01, 0.11) 9) Lay scientific knowledge <0.005 0.63 (0.53, 0.73) <0.005 0.82 (0.74, 0.90) Clinical Trials 2006; 3: 306-31 3 www.SCTjournal.com Consent comprehension assessment 311 for a child to withdraw - imply a perceived loss of self-determinationr to withdraw from the study. A consenting pareint's belief that third party permis- sion is required to withdraw their child from the stLdy inherently implies the child imay be kept in the study despite the wishes of the parents or child. The miscomprehension of drug side effects is also troubling. While studies conducted in industri- alized nations demonstrated 38% of participants miscomprehending the existence of side effects 16], in Village U anTd Village IR, 93t% of residenits failed to identify, the existenice of side effects with study drugs. Misunrderstood study risks have critical ethical consequen-ce. Other investigator-s have noted that participarnts consistenitly identify the existeince of risks as the major impediment to par- ticipating in r esearch trials [11]. Without fully understanding a studly's side effects, a participant cannot make an informed decision as to the degree of risk he/she is willin-g to accept by participating. This trend of miscomprehension of side effects in developing nations has been nioted by others [6,12], but the presenit dlata heip provide a quantitative assessment of tlhis imiiportant phernornenon. A final area of coTrnnon m-Tniscoimprehension involved differentiation between study and treat- ment. Question 5, evokes the so-called "ttherapeutic misconception" 1 13,141! in which participants mistake experimental research for effective treat- ment. In Village R, 80%YO failed to understand that researchers were providing an investigational agent, as opposed to therapy. 'I hough this miscomprehen- sion may also exist in Village U, the statistical distri- bution of responses was consistent with participants guessing randomnly, wthich is not reassuring, either. As described above, a lowei level of education ancd literacy may correspond with a greater difficulty understanding key aspects of research. A second possibility may also be involved in Village R's low understanding of VolUntary participation (Question 1). In a commaunal society, many believe that the village chief or government directs actions. Participants might presunme a leader's benevolence - that the village chief or government wouldl only have citizens participate it the trial was therapeuitic. Other studies on trials in the) developing world have suggested, too, that the idiea of inforrried consent may be iniapp)opriate in conu-irnunal societies such as those in Mali becautse con-sernt can -iever be truly "voluntary" in a society that values community above individuality 11 51. Whatever the reason is for this misconception! an-d the degree to which it exists in Village t as well, the ethical dilemma of patients mistakenly expecting benefit from a ino- benefit study is apparenlt aind slhould be taken seri- ously in both ruiral and urban. settings. This study has several potential limitations. We observed the consent process in both villages, however did not formally assess its inherent quality directly, but rather indirectly through participants' understanding of it. Although the process was con- sistently delivered by the same researchers in both villages, both cLltural and lainguage barriers make an accuirate full assessment of the process itself dif- ficult. In addition, different translators were used in each of the two villages, making a complete statisti- cal comparison between the two villages difficult. However, the two translators received the same instructions and training concerning this study and the procedures involved. Moreover, despite differ- ences in translation, the uniformity of ranking of responses for each question between villages sug- gests certain trends in miscomprehension and a generally consistent trainslation effort. The potentially threatening nature of "exams" in schools, particularly for those who are illiterate and had very little experience of schools may also have affected results. The data here cannot be assumed to be wholly generalizable to other developing nations outside West Africa. I-However, this study suggested a high degree of miscomprehension relative to industrialized nations that highlights the need to investigate further these areas in other countries and contexts as well. As other cultures have differ- ing understandings of autonomy and individuality, Western standards in the consent process may be somewhat inapplicable to other countries, because of cultural reasons. The present data do not address whether and to what degree Western concepts of informed consent are valid in the developing world. On the one hand, critics argue that, "informed consent is neither nec- essary nor sufficient for ethical clinical research" [1161, and that one need only the "capacity to under- stand," not a true understanding, for informed consent to be valid L17]. Still others write that, "the premise of informed consent as a rational decision making process ... may be perceived as an ideal in the nature of a myth" [18]. Nonetheless, current Western bioethical standards maintain at least the ideal of informed consent as a critical aspect of ethical clinical research. Thus, a strong argument can be made that investigators working in develop- inlg nations have an ethical responsibility to insure that their research subjects are as well-informed as possible. Tlhese results also underscore the need to consider innovative and creative approaches to achieve that. Despite cultural differences regarding informed consent, it appears to be appropriate to err on the side of over-informing study participants, so as to minimize the likelihood of participation deci- sions being made based oin faulty information. Adverse events stemming from miscomprehension occurring in a trial jeopardize not only that trial, but also the larger relationship between foreign research teams, foreign science, and developing nations. Clinical Trials 2006; 3: 306-313 www.SCTjournal.corTi 312 MTKrosinetal. Tohis study suggests several arIeas for future research. First, qualitative inethods can help clarify several of the isSsues raised here as to how participants unlderstand the informed consent process. For example, participants may feel that they cannot withdraw at any time because either they did not understand that this option was pre- sented to them by the investigator, or they did not believe (due to cLltural attitudes and norms) that such autonomy is in fact possible within the context of thI'n culture. lingluistically, fututre research can- assess why therapeutic rmiscornceptiorn remains such. a diffictult problerri, and whether ways may exist to address this mnisconceptioni, within these villages own language, that may better clarify the differeinces between treatinent and research. This study illustrates degrees of miscomnprehen- sion in developing- niationis (that can be viewed in comparison with other studies conducted in the industrializedl v odrld), specific areas of miscompre- hension in these countries, and needs for future research. 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Social Science and fMedlicine 2004; 59: 2547-S9. 8. Marcus R, Peritz E, Gabriel KR. On closed testing procedures with special reference to ordered analysis of variance. Biometrika 1976; 63: 655-60. 9. Hochberg VY Tamhane AC. Miultiple conparison procedures. Wiley. 1987. 10. Daniel WW. Biosta:tistics: a foiundation tbr analysis iv the hlealth science, 7th edition. John Wiley & Sons, 1998. l 1. Bergler JH, Pennington AC, Metcalfe M, Freis ED. Informed consent: how much does the patient understand? Clin Pharmtacol ThIer 1980; 27: 435-40. 12. Lynoe N, Hyder Z, Chowdhury M, Ekstrom L. Obtaining iniformed consent in Bangladesh. NE/M 2001; 344: 460-61. 13. Appelbaum PS, Roth LH, Lidz C. The therapeutic misconception: informed consent in psychiatric research. Jut I Law Psychiatry 1982; 5: 319-29. 14. Appelbaum PS, Roth I,H, Lidz CW, Benson P, Winslade W. False hopes and best data: Consent to research and the therapeutic misconiception. Hastings Cent Rep 1987; 17: 20-24. 15. Moodly K. HIV vaccine trial participation in South Africa - an ethical assessmnent. J Med Philos 2002; 27: 197-215. 16. Emmanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000; 283: 2701-1.1. 17. Mayberry MK, Mayberry JF. Consent with uLnlderstanding: A moveement toward infornmed decisions. Clin Med 2002; 2: 523-26. 18. Verheggen FW, Van Wijmen FC. Myth and reality of informed consenit in clinical trials. Mcel Law 1997; 16: 53-69. Appendix 1: Questionnaire 1) The participation of your child in the study- a) - Was decided upon by the village leaders as necessary. b) - Was decided upon by you and your husband and is completely optional. If you do not want your child enrolled, your child need not participate. c) - Was decided upon by the scientists and doctors. d) - Was decided upon by yoLr husband. 2) As compensation for participating in the study, your family and your child will receive- a) - A sinall amiount of nmoney in addition to weekly physical checkups for your child. b) - Malaria medicine everyday, money, anid weekly checkups for your child. c) - A small amount of food (rice, millet or sugar) in addition to weekly checkups for your child. d) - Weekly checkups, btut nothing more. Clinical Trials 2006; 3: 306-313 www.SCTiournal.com Consent comprehension assessment 313 3) Once the stuidy has begun- a) - You may remiove your child from the study at aniy time. b) - You nmay remove your child from the study only if the study organizers say it is OK. c) - Yol may renmoveV your child from the study with the permission of village leaders. d) - You may remove your child from the stucyV wsNith permlissionl fromni your husbanrid. 4) If you decide for youir child to drop out of the study- a) - Your chlild will still be given weekly checkups, hutt no food or money. b) - You will be giveni nothing - including nio access to) healthcare services for your clhildreni. c) - You will be fined and punished. d) - You will be givein nothing, but will always have access to healthcare in case of a mnedical problem or emergency. 5) The purpose of this project is- a) - To determine the cause of malaria. b) - Ti provide your village with malaria nmedicatiorns and healthi care. c) - 'lo study the amount of malaria and anemia in your village and possibly develop a cure for malaria. d) - To p)rovide your village with a cure for malaria. 6) This project is run by- a) - Scientists and doctors working for the governments of Mali and the United States of America. b) - Your village health and medical officials. c) - The French government. d) - A foreign company. e) - Adama (local political party). 7) Children are selected to take this medicine- a) - Based on a past medical history. b) - By random assignment - like drawing lots. c) - Based on social position of family. d) - Based on current health of child. 8) The medicine that some children receive- a) - Will prevent malaria right now, but carries a small risk of some side effects such as rash, nausea, or other problems. b) - Is a vaccine which will prevent malaria for the rest of your child's life. c) - Carries no known side effect. d) - Will correct nutritional deficiencies and other health problems your child might now have. 9) Malaria is caused by- a) - Vegetation. b) - Poor nutrition. c) - Lack of sleep, excessive crying, and exces- sive sadness. d) - A bird flying over you during the night. e) - The bite from an infected mosquito. 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1358 Powell Street, Emeryville, CA 94608, USA;</affiliation><affiliation>E-mail: mkrosin@hotmail.com</affiliation></name><name type="personal"><namePart type="given">Robert</namePart><namePart type="family">Klitzman</namePart></name><name type="personal"><namePart type="given">Bruce</namePart><namePart type="family">Levin</namePart></name><name type="personal"><namePart type="given">Jianfeng</namePart><namePart type="family">Cheng</namePart></name><name type="personal"><namePart type="given">Megan L</namePart><namePart type="family">Ranney</namePart><affiliation>Columbia University, College of Physicians and Surgeons, New York, USA</affiliation></name><typeOfResource>text</typeOfResource><genre type="research-article" displayLabel="research-article" authority="ISTEX" authorityURI="https://content-type.data.istex.fr" valueURI="https://content-type.data.istex.fr/ark:/67375/XTP-1JC4F85T-7">research-article</genre><originInfo><publisher>SAGE Publications</publisher><dateIssued encoding="w3cdtf">2006</dateIssued><copyrightDate encoding="w3cdtf">2006</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><abstract lang="en">Background Clinical trials undertaken by industrialized nations in undeveloped nations pose several critical ethical dilemmas. One key potential problem concerns misunderstandings of the consent process by participants. Though other reports have begun to explore this area, needs remain to identify specific areas of misunderstanding. Purpose To identify deficits in comprehension during consent processes in Mali, West Africa. Methods After obtaining informed consent for participation for a malaria vaccine trial being conducted in two West African villages, we administered to participants a nine-item questionnaire testing their understanding of information relevant for their consent. After testing their ability to understand a multiple choice format, 78 of 100 subjects were administered the questionnaire in one village and 85 of 100 in the other. Results Participants had difficulty comprehending several concepts relevant to informed consent: 90% of respondents did not understand withdrawal criterion, 93% did not understand the existence of study side effects, and 74% did not understand that they were enrolled in an investigation as opposed to receiving therapy. The response rate and percentage of correct answers was generally much higher in the village nearer an urban center than the more rural village. The percent of correct answers exceeded 50% for five questions in the urban village and for only two question in the more rural setting. Limitations Potential limitations of this study are relating to translation, cultural differences in the notion of informed consent, staff differences between each village, the proportion who could not understand the survey instrument and the fact that the study explored participants' understanding of the consent process but did not observe the process itself. Conclusions This study illustrates potential areas of miscomprehension in the consent process in a developing country. The degree of miscomprehension found in this study appeared to be more than that found in similar studies conducted in industrialized nations. Despite efforts to obtain truly informed consent, several factors make it more challenging in the developing world. This research highlights the need for more comprehensive studies of consent in developing countries. Such studies may eventually aid investigators in identifying, targeting and addressing specific areas of miscomprehension and thereby improve the informed consent process in the developing world.</abstract><relatedItem type="host"><titleInfo><title>Clinical Trials</title></titleInfo><genre type="journal" authority="ISTEX" authorityURI="https://publication-type.data.istex.fr" valueURI="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</genre><identifier type="ISSN">1740-7745</identifier><identifier type="eISSN">1740-7753</identifier><identifier type="PublisherID">CTJ</identifier><identifier type="PublisherID-hwp">spctj</identifier><part><date>2006</date><detail type="volume"><caption>vol.</caption><number>3</number></detail><detail type="issue"><caption>no.</caption><number>3</number></detail><extent unit="pages"><start>306</start><end>313</end></extent></part></relatedItem><identifier type="istex">1478F62FEC09481331DF7776586C7A042AA1534F</identifier><identifier type="ark">ark:/67375/M70-0TKCGP4R-8</identifier><identifier type="DOI">10.1191/1740774506cn150oa</identifier><identifier type="ArticleID">10.1191_1740774506cn150oa</identifier><recordInfo><recordContentSource authority="ISTEX" authorityURI="https://loaded-corpus.data.istex.fr" valueURI="https://loaded-corpus.data.istex.fr/ark:/67375/XBH-0J1N7DQT-B">sage</recordContentSource></recordInfo></mods><json:item><extension>json</extension><original>false</original><mimetype>application/json</mimetype><uri>https://api.istex.fr/ark:/67375/M70-0TKCGP4R-8/record.json</uri></json:item></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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