Developing a digital informed consent app: opportunities and challenges of a new format to inform and obtain consent in public health research.

Publication Year: 2023

DOI:
10.1186/s12910-023-00974-1

PMCID:
PMC10634039

PMID:
37941000

Journal Information

Full Title: BMC Med Ethics

Abbreviation: BMC Med Ethics

Country: Unknown

Publisher: Unknown

Language: N/A

Publication Details

Subject Category: Ethics

Available in Europe PMC: Yes

Available in PMC: Yes

PDF Available: No

Transparency Score
4/6
66.7% Transparent
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Evidence found in paper:

"Declarations Ethics approval and consent to participateThis study was carried out in preparation for the start of the Sarphati Cohort. All procedures were approved by the Registration Committee of the City of Amsterdam. Exemption from the Medical Research Involving Human Subjects Act (WMO) was granted by the Medical Ethical Committee of Amsterdam UMC, location AMC (W16_340 # 16.398). In addition, the Sarphati Cohort received legal approval from the Amsterdam Personal Data Commission (CPA). CPA is a committee that advises on the privacy policy of the Amsterdam municipality and its implementation. Only after a positive assessment of the Extensive Risk Analysis on Information Security and Privacy and the Privacy Impact Analysis of the data-infrastructure and the app, could the development on the app be started in the second quarter of 2017. All the methods were carried out in accordance with relevant national and international guidelines and regulations as laid down in the Declaration of Helsinki. Participation for the test was on voluntary basis. Prior to the test participants signed an informed consent for conducting and audiotaping the interviews. As an incentive participants received a gift voucher of 10 euros. Consent for publicationNot applicable. Competing interestsThe authors declare no competing interests. Competing interests The authors declare no competing interests."

Evidence found in paper:

"Funding This study was carried out in preparation for the start of the Sarphati Cohort and was funded by the City of Amsterdam."

Evidence found in paper:

"Declarations: Ethics approval and consent to participateThis study was carried out in preparation for the start of the Sarphati Cohort. All procedures were approved by the Registration Committee of the City of Amsterdam. Exemption from the Medical Research Involving Human Subjects Act (WMO) was granted by the Medical Ethical Committee of Amsterdam UMC, location AMC (W16_340 # 16.398). In addition, the Sarphati Cohort received legal approval from the Amsterdam Personal Data Commission (CPA). CPA is a committee that advises on the privacy policy of the Amsterdam municipality and its implementation. Only after a positive assessment of the Extensive Risk Analysis on Information Security and Privacy and the Privacy Impact Analysis of the data-infrastructure and the app, could the development on the app be started in the second quarter of 2017. All the methods were carried out in accordance with relevant national and international guidelines and regulations as laid down in the Declaration of Helsinki. Participation for the test was on voluntary basis. Prior to the test participants signed an informed consent for conducting and audiotaping the interviews. As an incentive participants received a gift voucher of 10 euros.: Consent for publicationNot applicable.: Competing interestsThe authors declare no competing interests. Ethics approval and consent to participate: This study was carried out in preparation for the start of the Sarphati Cohort. All procedures were approved by the Registration Committee of the City of Amsterdam. Exemption from the Medical Research Involving Human Subjects Act (WMO) was granted by the Medical Ethical Committee of Amsterdam UMC, location AMC (W16_340 # 16.398). In addition, the Sarphati Cohort received legal approval from the Amsterdam Personal Data Commission (CPA). CPA is a committee that advises on the privacy policy of the Amsterdam municipality and its implementation. Only after a positive assessment of the Extensive Risk Analysis on Information Security and Privacy and the Privacy Impact Analysis of the data-infrastructure and the app, could the development on the app be started in the second quarter of 2017. All the methods were carried out in accordance with relevant national and international guidelines and regulations as laid down in the Declaration of Helsinki. Participation for the test was on voluntary basis. Prior to the test participants signed an informed consent for conducting and audiotaping the interviews. As an incentive participants received a gift voucher of 10 euros."

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Paper is freely available to read
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Last Updated: Aug 05, 2025