Informed Consent in Biomedical Research

Dankar, Fida K.; Gergely, Marton; Dankar, Samar K.

doi:10.1016/j.csbj.2019.03.010

Cited by 57 publications

(33 citation statements)

References 76 publications

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“…It followed the international and national ethic normativity for the research related to human beings. All participants over 18 years signed the consent, and those under 18 years signed the informed consent [18,19,20,21].…”

Section: Individuals and Proceduresmentioning

confidence: 99%

Prevalence of hyperlipidemia and its associated factors in university students in Colombia

Ramírez

Peláez

Bermúdez

et al. 2020

Heliyon

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in 2017. A descriptive cross-sectional study was performed in a sample of 361 students, with an average age of 21 (16-40) years. A sociodemographic survey was conducted, and blood samples and lipid profiles were obtained. The participants were predominantly female (77%), single (92.5%), and young adults (62.3%) and with an average socioeconomic level (55.1%). The overall prevalence of hyperlipidemia was 33.8%, with the following risk values: triglyceride (TG), 12.8%; hypercholesterolemia, 16.1%; high density lipoprotein cholesterol (cHDL), 15.0%; and low-density lipoprotein cholesterol (cLDL), 42.2%. Using the theory of the logistic regression models and chi-square likelihood ratio tests, the factors that were significantly associated with the risk of hyperlipidemia were male sex and consumption of alcoholic beverages (P-value < 0.05). In the two-way ANOVA, it was observed that the interaction of these two factors for TG was significant (P-value < 0.05), being higher in men who consume intoxicating beverages (Tukey's test, P value <0.05). Regarding cHDL and cLDL, only sex presented a significant effect on their values (P-value < 0.05), while for total cholesterol, none was significant (P-value > 0.05). The results obtained indicate the importance of early detection of blood lipid levels in young people to prevent the early development of noncommunicable diseases.

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Section: Individuals and Proceduresmentioning

confidence: 99%

Prevalence of hyperlipidemia and its associated factors in university students in Colombia

Ramírez

Peláez

Bermúdez

et al. 2020

Heliyon

View full text Add to dashboard Cite

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“…Therefore, information must be available in lay terminology and in a language understandable to the participants [ 3 ]. Long and cumbersome paper-based informed consent documents are the result of the increasing complexity of clinical research and the multitude of legal and regulatory requirements to satisfy informed consent needs [ 5 - 7 ]. Regulatory requirements refer to those related to the regulatory approval of medicines [ 8 ].…”

Section: Introductionmentioning

confidence: 99%

Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders’ Perspectives: Systematic Review

Sutter¹,

Zaçe²,

Boccia³

et al. 2020

J Med Internet Res

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Background Informed consent is one of the key elements in biomedical research. The introduction of electronic informed consent can be a way to overcome many challenges related to paper-based informed consent; however, its novel opportunities remain largely unfulfilled due to several barriers. Objective We aimed to provide an overview of the ethical, legal, regulatory, and user interface perspectives of multiple stakeholder groups in order to assist responsible implementation of electronic informed consent in biomedical research. Methods We conducted a systematic literature search using Web of Science (Core collection), PubMed, EMBASE, ACM Digital Library, and PsycARTICLES. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were used for reporting this work. We included empirical full-text studies focusing on the concept of electronic informed consent in biomedical research covering the ethical, legal, regulatory, and user interface domains. Studies written in English and published from January 2010 onward were selected. We explored perspectives of different stakeholder groups, in particular researchers, research participants, health authorities, and ethics committees. We critically appraised literature included in the systematic review using the Newcastle-Ottawa scale for cohort and cross-sectional studies, Critical Appraisal Skills Programme for qualitative studies, Mixed Methods Appraisal Tool for mixed methods studies, and Jadad tool for randomized controlled trials. Results A total of 40 studies met our inclusion criteria. Overall, the studies were heterogeneous in the type of study design, population, intervention, research context, and the tools used. Most of the studies’ populations were research participants (ie, patients and healthy volunteers). The majority of studies addressed barriers to achieving adequate understanding when using electronic informed consent. Concerns shared by multiple stakeholder groups were related to the security and legal validity of an electronic informed consent platform and usability for specific groups of research participants. Conclusions Electronic informed consent has the potential to improve the informed consent process in biomedical research compared to the current paper-based consent. The ethical, legal, regulatory, and user interface perspectives outlined in this review might serve to enhance the future implementation of electronic informed consent. Trial Registration PROSPERO International Prospective Register of Systematic Reviews CRD42020158979; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=158979

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“…Indeed, that is exactly why we have clear requirements and protocols for informed consent. Informed consent procedures must ensure that all relevant information is provided, that the participant understands this information and that participation in research is a voluntary act (Dankar et al, 2019). The question of to what extent do we need greater public awareness of research ethics and how much we can rely upon the informed consent process is one that requires further investigation.…”

Section: Discussionmentioning

confidence: 99%

Understanding and attitudes of the Jordanian public about clinical research ethics

Ababneh¹,

Al‐Azzam²,

Alzoubi³

et al. 2020

Research Ethics

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In Jordan, research ethics committees exist in most health settings. However, little is known about Jordanian public views regarding the ethics of clinical research. This study aimed to evaluate Jordanian public understanding and attitudes about ethics in clinical research. A questionnaire was used to collect information that included demographics, public knowledge, and attitudes towards ethics in clinical research. It was administered via face-to-face interviews in two major cities in Jordan from 1st June to 15th August 2017. Of the 2315 respondents, 2.33% were found to have poor knowledge, 22.16% had fair knowledge, and 75.51% had good knowledge of ethics in clinical research. Furthermore, 75.81% of respondents had positive attitudes towards ethics in research. However, only 45.23% reported that they trust clinical researchers in Jordan. Even though a large majority of respondents were aware of key features of research ethics, efforts are needed to address negative perceptions and knowledge deficits.

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Informed Consent in Biomedical Research

Cited by 57 publications

References 76 publications

Prevalence of hyperlipidemia and its associated factors in university students in Colombia

Prevalence of hyperlipidemia and its associated factors in university students in Colombia

Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders’ Perspectives: Systematic Review

Understanding and attitudes of the Jordanian public about clinical research ethics

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