How participatory is parental consent in low literacy rural settings in low income countries? Lessons learned from a community based study of infants in South India

Background A requisite for ethical human subjects research is that participation should be informed and voluntary. Participation during the informed consent process by way of asking questions is an indicator of the extent to which consent is informed. Aims The aims of this study were to assess the extent to which parents providing consent for children's participation in an observational tuberculosis (TB) research study in India actively participated during the informed consent discussion, and to identify correlates of that participation. Methods In an observational cohort study of tuberculosis in infants in South India, field supervisors who were responsible for obtaining informed consent noted down questions asked during the informed consent discussions for 4,382 infants who were enrolled in the study. These questions were post-coded by topic. Bivariate and multivariate analysis was conducted to examine factors associated with asking at least one question during the informed consent process. Results In total, 590 out of 4,382 (13.4%) parents/guardians asked any question during the informed consent process. We found that the likelihood of parents asking questions during the informed consent process was significantly associated with education level of either parent both parents being present, and location. Conclusions The findings have implications for planning the informed consent process in a largely rural setting with low levels of literacy. Greater effort needs to be directed towards developing simple participatory communication materials for the informed consent process. Furthermore, including both parents in a discussion about a child's participation in a research study may increase the extent to which consent is truly informed. Finally, continuing efforts need to be made to improve the communication skills of research workers with regard to explaining research processes and putting potential research participants at ease. Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Rajaraman, Divya [verfasserIn] Jesuraj, Nelson Geiter, Lawrence Bennett, Sean Grewal, Harleen MS Vaz, Mario

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2011

Schlagwörter:	Consent Process Informed Consent Process Field Supervisor Study Team Member Develop Country Setting

Anmerkung:	© Rajaraman et al; licensee BioMed Central Ltd. 2011

Übergeordnetes Werk:	Enthalten in: BMC medical ethics - London : BioMed Central, 2000, 12(2011), 1 vom: 15. Feb.
Übergeordnetes Werk:	volume:12 ; year:2011 ; number:1 ; day:15 ; month:02

Links:	Volltext

DOI / URN:	10.1186/1472-6939-12-3

Katalog-ID:	SPR028193687

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520			\|a Background A requisite for ethical human subjects research is that participation should be informed and voluntary. Participation during the informed consent process by way of asking questions is an indicator of the extent to which consent is informed. Aims The aims of this study were to assess the extent to which parents providing consent for children's participation in an observational tuberculosis (TB) research study in India actively participated during the informed consent discussion, and to identify correlates of that participation. Methods In an observational cohort study of tuberculosis in infants in South India, field supervisors who were responsible for obtaining informed consent noted down questions asked during the informed consent discussions for 4,382 infants who were enrolled in the study. These questions were post-coded by topic. Bivariate and multivariate analysis was conducted to examine factors associated with asking at least one question during the informed consent process. Results In total, 590 out of 4,382 (13.4%) parents/guardians asked any question during the informed consent process. We found that the likelihood of parents asking questions during the informed consent process was significantly associated with education level of either parent both parents being present, and location. Conclusions The findings have implications for planning the informed consent process in a largely rural setting with low levels of literacy. Greater effort needs to be directed towards developing simple participatory communication materials for the informed consent process. Furthermore, including both parents in a discussion about a child's participation in a research study may increase the extent to which consent is truly informed. Finally, continuing efforts need to be made to improve the communication skills of research workers with regard to explaining research processes and putting potential research participants at ease.
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allfields	10.1186/1472-6939-12-3 doi (DE-627)SPR028193687 (SPR)1472-6939-12-3-e DE-627 ger DE-627 rakwb eng Rajaraman, Divya verfasserin aut How participatory is parental consent in low literacy rural settings in low income countries? Lessons learned from a community based study of infants in South India 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Rajaraman et al; licensee BioMed Central Ltd. 2011 Background A requisite for ethical human subjects research is that participation should be informed and voluntary. Participation during the informed consent process by way of asking questions is an indicator of the extent to which consent is informed. Aims The aims of this study were to assess the extent to which parents providing consent for children's participation in an observational tuberculosis (TB) research study in India actively participated during the informed consent discussion, and to identify correlates of that participation. Methods In an observational cohort study of tuberculosis in infants in South India, field supervisors who were responsible for obtaining informed consent noted down questions asked during the informed consent discussions for 4,382 infants who were enrolled in the study. These questions were post-coded by topic. Bivariate and multivariate analysis was conducted to examine factors associated with asking at least one question during the informed consent process. Results In total, 590 out of 4,382 (13.4%) parents/guardians asked any question during the informed consent process. We found that the likelihood of parents asking questions during the informed consent process was significantly associated with education level of either parent both parents being present, and location. Conclusions The findings have implications for planning the informed consent process in a largely rural setting with low levels of literacy. Greater effort needs to be directed towards developing simple participatory communication materials for the informed consent process. Furthermore, including both parents in a discussion about a child's participation in a research study may increase the extent to which consent is truly informed. Finally, continuing efforts need to be made to improve the communication skills of research workers with regard to explaining research processes and putting potential research participants at ease. Consent Process (dpeaa)DE-He213 Informed Consent Process (dpeaa)DE-He213 Field Supervisor (dpeaa)DE-He213 Study Team Member (dpeaa)DE-He213 Develop Country Setting (dpeaa)DE-He213 Jesuraj, Nelson aut Geiter, Lawrence aut Bennett, Sean aut Grewal, Harleen MS aut Vaz, Mario aut Enthalten in BMC medical ethics London : BioMed Central, 2000 12(2011), 1 vom: 15. Feb. (DE-627)326645403 (DE-600)2041552-7 1472-6939 nnns volume:12 year:2011 number:1 day:15 month:02 https://dx.doi.org/10.1186/1472-6939-12-3 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 12 2011 1 15 02
spelling	10.1186/1472-6939-12-3 doi (DE-627)SPR028193687 (SPR)1472-6939-12-3-e DE-627 ger DE-627 rakwb eng Rajaraman, Divya verfasserin aut How participatory is parental consent in low literacy rural settings in low income countries? Lessons learned from a community based study of infants in South India 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Rajaraman et al; licensee BioMed Central Ltd. 2011 Background A requisite for ethical human subjects research is that participation should be informed and voluntary. Participation during the informed consent process by way of asking questions is an indicator of the extent to which consent is informed. Aims The aims of this study were to assess the extent to which parents providing consent for children's participation in an observational tuberculosis (TB) research study in India actively participated during the informed consent discussion, and to identify correlates of that participation. Methods In an observational cohort study of tuberculosis in infants in South India, field supervisors who were responsible for obtaining informed consent noted down questions asked during the informed consent discussions for 4,382 infants who were enrolled in the study. These questions were post-coded by topic. Bivariate and multivariate analysis was conducted to examine factors associated with asking at least one question during the informed consent process. Results In total, 590 out of 4,382 (13.4%) parents/guardians asked any question during the informed consent process. We found that the likelihood of parents asking questions during the informed consent process was significantly associated with education level of either parent both parents being present, and location. Conclusions The findings have implications for planning the informed consent process in a largely rural setting with low levels of literacy. Greater effort needs to be directed towards developing simple participatory communication materials for the informed consent process. Furthermore, including both parents in a discussion about a child's participation in a research study may increase the extent to which consent is truly informed. Finally, continuing efforts need to be made to improve the communication skills of research workers with regard to explaining research processes and putting potential research participants at ease. Consent Process (dpeaa)DE-He213 Informed Consent Process (dpeaa)DE-He213 Field Supervisor (dpeaa)DE-He213 Study Team Member (dpeaa)DE-He213 Develop Country Setting (dpeaa)DE-He213 Jesuraj, Nelson aut Geiter, Lawrence aut Bennett, Sean aut Grewal, Harleen MS aut Vaz, Mario aut Enthalten in BMC medical ethics London : BioMed Central, 2000 12(2011), 1 vom: 15. Feb. (DE-627)326645403 (DE-600)2041552-7 1472-6939 nnns volume:12 year:2011 number:1 day:15 month:02 https://dx.doi.org/10.1186/1472-6939-12-3 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 12 2011 1 15 02
allfields_unstemmed	10.1186/1472-6939-12-3 doi (DE-627)SPR028193687 (SPR)1472-6939-12-3-e DE-627 ger DE-627 rakwb eng Rajaraman, Divya verfasserin aut How participatory is parental consent in low literacy rural settings in low income countries? Lessons learned from a community based study of infants in South India 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Rajaraman et al; licensee BioMed Central Ltd. 2011 Background A requisite for ethical human subjects research is that participation should be informed and voluntary. Participation during the informed consent process by way of asking questions is an indicator of the extent to which consent is informed. Aims The aims of this study were to assess the extent to which parents providing consent for children's participation in an observational tuberculosis (TB) research study in India actively participated during the informed consent discussion, and to identify correlates of that participation. Methods In an observational cohort study of tuberculosis in infants in South India, field supervisors who were responsible for obtaining informed consent noted down questions asked during the informed consent discussions for 4,382 infants who were enrolled in the study. These questions were post-coded by topic. Bivariate and multivariate analysis was conducted to examine factors associated with asking at least one question during the informed consent process. Results In total, 590 out of 4,382 (13.4%) parents/guardians asked any question during the informed consent process. We found that the likelihood of parents asking questions during the informed consent process was significantly associated with education level of either parent both parents being present, and location. Conclusions The findings have implications for planning the informed consent process in a largely rural setting with low levels of literacy. Greater effort needs to be directed towards developing simple participatory communication materials for the informed consent process. Furthermore, including both parents in a discussion about a child's participation in a research study may increase the extent to which consent is truly informed. Finally, continuing efforts need to be made to improve the communication skills of research workers with regard to explaining research processes and putting potential research participants at ease. Consent Process (dpeaa)DE-He213 Informed Consent Process (dpeaa)DE-He213 Field Supervisor (dpeaa)DE-He213 Study Team Member (dpeaa)DE-He213 Develop Country Setting (dpeaa)DE-He213 Jesuraj, Nelson aut Geiter, Lawrence aut Bennett, Sean aut Grewal, Harleen MS aut Vaz, Mario aut Enthalten in BMC medical ethics London : BioMed Central, 2000 12(2011), 1 vom: 15. Feb. (DE-627)326645403 (DE-600)2041552-7 1472-6939 nnns volume:12 year:2011 number:1 day:15 month:02 https://dx.doi.org/10.1186/1472-6939-12-3 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 12 2011 1 15 02
allfieldsGer	10.1186/1472-6939-12-3 doi (DE-627)SPR028193687 (SPR)1472-6939-12-3-e DE-627 ger DE-627 rakwb eng Rajaraman, Divya verfasserin aut How participatory is parental consent in low literacy rural settings in low income countries? Lessons learned from a community based study of infants in South India 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Rajaraman et al; licensee BioMed Central Ltd. 2011 Background A requisite for ethical human subjects research is that participation should be informed and voluntary. Participation during the informed consent process by way of asking questions is an indicator of the extent to which consent is informed. Aims The aims of this study were to assess the extent to which parents providing consent for children's participation in an observational tuberculosis (TB) research study in India actively participated during the informed consent discussion, and to identify correlates of that participation. Methods In an observational cohort study of tuberculosis in infants in South India, field supervisors who were responsible for obtaining informed consent noted down questions asked during the informed consent discussions for 4,382 infants who were enrolled in the study. These questions were post-coded by topic. Bivariate and multivariate analysis was conducted to examine factors associated with asking at least one question during the informed consent process. Results In total, 590 out of 4,382 (13.4%) parents/guardians asked any question during the informed consent process. We found that the likelihood of parents asking questions during the informed consent process was significantly associated with education level of either parent both parents being present, and location. Conclusions The findings have implications for planning the informed consent process in a largely rural setting with low levels of literacy. Greater effort needs to be directed towards developing simple participatory communication materials for the informed consent process. Furthermore, including both parents in a discussion about a child's participation in a research study may increase the extent to which consent is truly informed. Finally, continuing efforts need to be made to improve the communication skills of research workers with regard to explaining research processes and putting potential research participants at ease. Consent Process (dpeaa)DE-He213 Informed Consent Process (dpeaa)DE-He213 Field Supervisor (dpeaa)DE-He213 Study Team Member (dpeaa)DE-He213 Develop Country Setting (dpeaa)DE-He213 Jesuraj, Nelson aut Geiter, Lawrence aut Bennett, Sean aut Grewal, Harleen MS aut Vaz, Mario aut Enthalten in BMC medical ethics London : BioMed Central, 2000 12(2011), 1 vom: 15. Feb. (DE-627)326645403 (DE-600)2041552-7 1472-6939 nnns volume:12 year:2011 number:1 day:15 month:02 https://dx.doi.org/10.1186/1472-6939-12-3 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 12 2011 1 15 02
allfieldsSound	10.1186/1472-6939-12-3 doi (DE-627)SPR028193687 (SPR)1472-6939-12-3-e DE-627 ger DE-627 rakwb eng Rajaraman, Divya verfasserin aut How participatory is parental consent in low literacy rural settings in low income countries? Lessons learned from a community based study of infants in South India 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Rajaraman et al; licensee BioMed Central Ltd. 2011 Background A requisite for ethical human subjects research is that participation should be informed and voluntary. Participation during the informed consent process by way of asking questions is an indicator of the extent to which consent is informed. Aims The aims of this study were to assess the extent to which parents providing consent for children's participation in an observational tuberculosis (TB) research study in India actively participated during the informed consent discussion, and to identify correlates of that participation. Methods In an observational cohort study of tuberculosis in infants in South India, field supervisors who were responsible for obtaining informed consent noted down questions asked during the informed consent discussions for 4,382 infants who were enrolled in the study. These questions were post-coded by topic. Bivariate and multivariate analysis was conducted to examine factors associated with asking at least one question during the informed consent process. Results In total, 590 out of 4,382 (13.4%) parents/guardians asked any question during the informed consent process. We found that the likelihood of parents asking questions during the informed consent process was significantly associated with education level of either parent both parents being present, and location. Conclusions The findings have implications for planning the informed consent process in a largely rural setting with low levels of literacy. Greater effort needs to be directed towards developing simple participatory communication materials for the informed consent process. Furthermore, including both parents in a discussion about a child's participation in a research study may increase the extent to which consent is truly informed. Finally, continuing efforts need to be made to improve the communication skills of research workers with regard to explaining research processes and putting potential research participants at ease. Consent Process (dpeaa)DE-He213 Informed Consent Process (dpeaa)DE-He213 Field Supervisor (dpeaa)DE-He213 Study Team Member (dpeaa)DE-He213 Develop Country Setting (dpeaa)DE-He213 Jesuraj, Nelson aut Geiter, Lawrence aut Bennett, Sean aut Grewal, Harleen MS aut Vaz, Mario aut Enthalten in BMC medical ethics London : BioMed Central, 2000 12(2011), 1 vom: 15. Feb. (DE-627)326645403 (DE-600)2041552-7 1472-6939 nnns volume:12 year:2011 number:1 day:15 month:02 https://dx.doi.org/10.1186/1472-6939-12-3 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 12 2011 1 15 02
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Lessons learned from a community based study of infants in South India</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2011</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">© Rajaraman et al; licensee BioMed Central Ltd. 2011</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Background A requisite for ethical human subjects research is that participation should be informed and voluntary. Participation during the informed consent process by way of asking questions is an indicator of the extent to which consent is informed. Aims The aims of this study were to assess the extent to which parents providing consent for children's participation in an observational tuberculosis (TB) research study in India actively participated during the informed consent discussion, and to identify correlates of that participation. Methods In an observational cohort study of tuberculosis in infants in South India, field supervisors who were responsible for obtaining informed consent noted down questions asked during the informed consent discussions for 4,382 infants who were enrolled in the study. These questions were post-coded by topic. Bivariate and multivariate analysis was conducted to examine factors associated with asking at least one question during the informed consent process. Results In total, 590 out of 4,382 (13.4%) parents/guardians asked any question during the informed consent process. We found that the likelihood of parents asking questions during the informed consent process was significantly associated with education level of either parent both parents being present, and location. Conclusions The findings have implications for planning the informed consent process in a largely rural setting with low levels of literacy. Greater effort needs to be directed towards developing simple participatory communication materials for the informed consent process. Furthermore, including both parents in a discussion about a child's participation in a research study may increase the extent to which consent is truly informed. 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author	Rajaraman, Divya
spellingShingle	Rajaraman, Divya misc Consent Process misc Informed Consent Process misc Field Supervisor misc Study Team Member misc Develop Country Setting How participatory is parental consent in low literacy rural settings in low income countries? Lessons learned from a community based study of infants in South India
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topic_title	How participatory is parental consent in low literacy rural settings in low income countries? Lessons learned from a community based study of infants in South India Consent Process (dpeaa)DE-He213 Informed Consent Process (dpeaa)DE-He213 Field Supervisor (dpeaa)DE-He213 Study Team Member (dpeaa)DE-He213 Develop Country Setting (dpeaa)DE-He213
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title	How participatory is parental consent in low literacy rural settings in low income countries? Lessons learned from a community based study of infants in South India
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title_full	How participatory is parental consent in low literacy rural settings in low income countries? Lessons learned from a community based study of infants in South India
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title_sort	how participatory is parental consent in low literacy rural settings in low income countries? lessons learned from a community based study of infants in south india
title_auth	How participatory is parental consent in low literacy rural settings in low income countries? Lessons learned from a community based study of infants in South India
abstract	Background A requisite for ethical human subjects research is that participation should be informed and voluntary. Participation during the informed consent process by way of asking questions is an indicator of the extent to which consent is informed. Aims The aims of this study were to assess the extent to which parents providing consent for children's participation in an observational tuberculosis (TB) research study in India actively participated during the informed consent discussion, and to identify correlates of that participation. Methods In an observational cohort study of tuberculosis in infants in South India, field supervisors who were responsible for obtaining informed consent noted down questions asked during the informed consent discussions for 4,382 infants who were enrolled in the study. These questions were post-coded by topic. Bivariate and multivariate analysis was conducted to examine factors associated with asking at least one question during the informed consent process. Results In total, 590 out of 4,382 (13.4%) parents/guardians asked any question during the informed consent process. We found that the likelihood of parents asking questions during the informed consent process was significantly associated with education level of either parent both parents being present, and location. Conclusions The findings have implications for planning the informed consent process in a largely rural setting with low levels of literacy. Greater effort needs to be directed towards developing simple participatory communication materials for the informed consent process. Furthermore, including both parents in a discussion about a child's participation in a research study may increase the extent to which consent is truly informed. Finally, continuing efforts need to be made to improve the communication skills of research workers with regard to explaining research processes and putting potential research participants at ease. © Rajaraman et al; licensee BioMed Central Ltd. 2011
abstractGer	Background A requisite for ethical human subjects research is that participation should be informed and voluntary. Participation during the informed consent process by way of asking questions is an indicator of the extent to which consent is informed. Aims The aims of this study were to assess the extent to which parents providing consent for children's participation in an observational tuberculosis (TB) research study in India actively participated during the informed consent discussion, and to identify correlates of that participation. Methods In an observational cohort study of tuberculosis in infants in South India, field supervisors who were responsible for obtaining informed consent noted down questions asked during the informed consent discussions for 4,382 infants who were enrolled in the study. These questions were post-coded by topic. Bivariate and multivariate analysis was conducted to examine factors associated with asking at least one question during the informed consent process. Results In total, 590 out of 4,382 (13.4%) parents/guardians asked any question during the informed consent process. We found that the likelihood of parents asking questions during the informed consent process was significantly associated with education level of either parent both parents being present, and location. Conclusions The findings have implications for planning the informed consent process in a largely rural setting with low levels of literacy. Greater effort needs to be directed towards developing simple participatory communication materials for the informed consent process. Furthermore, including both parents in a discussion about a child's participation in a research study may increase the extent to which consent is truly informed. Finally, continuing efforts need to be made to improve the communication skills of research workers with regard to explaining research processes and putting potential research participants at ease. © Rajaraman et al; licensee BioMed Central Ltd. 2011
abstract_unstemmed	Background A requisite for ethical human subjects research is that participation should be informed and voluntary. Participation during the informed consent process by way of asking questions is an indicator of the extent to which consent is informed. Aims The aims of this study were to assess the extent to which parents providing consent for children's participation in an observational tuberculosis (TB) research study in India actively participated during the informed consent discussion, and to identify correlates of that participation. Methods In an observational cohort study of tuberculosis in infants in South India, field supervisors who were responsible for obtaining informed consent noted down questions asked during the informed consent discussions for 4,382 infants who were enrolled in the study. These questions were post-coded by topic. Bivariate and multivariate analysis was conducted to examine factors associated with asking at least one question during the informed consent process. Results In total, 590 out of 4,382 (13.4%) parents/guardians asked any question during the informed consent process. We found that the likelihood of parents asking questions during the informed consent process was significantly associated with education level of either parent both parents being present, and location. Conclusions The findings have implications for planning the informed consent process in a largely rural setting with low levels of literacy. Greater effort needs to be directed towards developing simple participatory communication materials for the informed consent process. Furthermore, including both parents in a discussion about a child's participation in a research study may increase the extent to which consent is truly informed. Finally, continuing efforts need to be made to improve the communication skills of research workers with regard to explaining research processes and putting potential research participants at ease. © Rajaraman et al; licensee BioMed Central Ltd. 2011
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title_short	How participatory is parental consent in low literacy rural settings in low income countries? Lessons learned from a community based study of infants in South India
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How participatory is parental consent in low literacy rural settings in low income countries? Lessons learned from a community based study of infants in South India

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