Waivers of informed consent in research with competent participants and the Declaration of Helsinki

Dal‐Ré, Rafael

doi:10.1007/s00228-023-03472-w

Cited by 16 publications

(10 citation statements)

References 8 publications

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“…In response to the WMA's announcement that it will revise the DoH, Dal-Ré has already demanded clarification "under which it is ethically permissible to modify or waive written informed consent in research with competent participants." 51 The DoH does not address this issue.…”

Section: Waivers Of Informed Consent In Research With Competent Parti...mentioning

confidence: 99%

The Declaration of Helsinki in bioethics literature since the last revision in 2013

Ehni,

Wiesing

2024

Bioethics

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The World Medical Association has announced that a new revision process of the Declaration of Helsinki has been started. This article will identify the criticisms that have been made in the bioethics literature, particularly since the last revision. In addition, criticisms are discussed that were made in the literature even before the last revision and have not fallen silent. The plausibility of the recommendation for a change in the Declaration of Helsinki is examined.

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Section: Waivers Of Informed Consent In Research With Competent Parti...mentioning

confidence: 99%

The Declaration of Helsinki in bioethics literature since the last revision in 2013

Ehni,

Wiesing

2024

Bioethics

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“…Este estudio cuenta con la aprobación de los comités de ética pertinentes de la universidad y se desarrolló con estricta adherencia a los valores éticos, las normas básicas de ética y los principios éticos que rigen las investigaciones en seres humanos, tal como se establece en la Declaración de Helsinki de la Asociación Médica Mundial (14).…”

Section: Supuestos éTicosunclassified

Estudio de caso de una sobreviviente de acoso sexual en una universidad pública ecuatoriana

Vique López,

Saeteros Hernández,

Saeteros Hernández

et al. 2024

BIOSANA

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Este estudio se enfoca en el acoso sexual en una universidad ecuatoriana, destacando su prevalencia y las consecuencias para las víctimas y el ambiente académico. A través de un análisis detallado de un caso de una sobreviviente, se busca comprender las dinámicas subyacentes y la respuesta institucional. Este enfoque, al ofrecer una narrativa personal, promueve la empatía y comprensión más allá de las estadísticas. Además, se busca identificar patrones que informen estrategias de prevención y cambio cultural. El estudio destaca que el acoso sexual erosiona la integridad de las universidades y, por lo tanto, no solo expone problemas, sino que también ofrece perspectivas y recomendaciones para la prevención y la creación de entornos seguros. La importancia de este tipo de investigaciones radica en la transformación de las universidades en espacios de igualdad de género y libre de acoso sexual, resaltando la urgencia de abordar este problema en las Instituciones de Educación Superior.

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“…29 30 Waivers of consent may be provided for no more than minimal risk to the subjects when the waiver will not endanger the rights and welfare of the subjects like retrospective studies, secondary analysis of data wherein consent had been taken previously, use of open access databases with anonymized data, and emergency research as seen fit by the EC. 31 32 In emergencies like the coronavirus disease 2019 pandemic, waivers may be provided if the patient is incapacitated or in life-threatening situations where there is no time for informed consent. Pandemics like these may even call for common documents for risk disclosure and audio/video/electronic consent.…”

Section: Research Submission Process and Exemptionsmentioning

confidence: 99%

Ethics Committees: Structure, Roles, and Issues

Mehta,

Zimba,

Gasparyan

et al. 2023

J Korean Med Sci

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An Ethics Committee (EC) is an independent body composed of members with expertise in both scientific and nonscientific arenas which functions to ensure the protection of human rights and the well-being of research subjects based on six basic principles of autonomy, justice, beneficence, nonmaleficence, confidentiality, and honesty. MEDLINE, Scopus, and Directory of Open Access Journals were searched for studies relevant to this topic. This review is focused on the types of research articles that need EC approval, the submission process, and exemptions. It further highlights the constitution of ECs, their duties, the review process, and the assessment of the risk-benefit of the proposed research including privacy issues. It’s pertinent for academicians and researchers to abide by the rules and regulations put forth by ECs for upholding of human rights and protecting research subjects primarily, as well as avoiding other issues like retraction of publications. Despite various issues of cost, backlogs, lack of expertise, lesser representation of laypersons, need for multiple approvals for multisite projects, conflicts of interest, and monitoring of ongoing research for the continued safety of participants, the ECs form the central force in regulating research and participant safety. Data safety and monitoring boards complement the ECs for carrying out continuous monitoring for better protection of research subjects. The establishment of ECs has ensured safe study designs, the safety of human subjects along with the protection of researchers from before the initiation until the completion of a study.

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Waivers of informed consent in research with competent participants and the Declaration of Helsinki

Cited by 16 publications

References 8 publications

The Declaration of Helsinki in bioethics literature since the last revision in 2013

The Declaration of Helsinki in bioethics literature since the last revision in 2013

Estudio de caso de una sobreviviente de acoso sexual en una universidad pública ecuatoriana

Ethics Committees: Structure, Roles, and Issues

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