How to obtain informed consent for research

Manti, Sara; Licari, Amelia

doi:10.1183/20734735.001918

Cited by 126 publications

(89 citation statements)

References 28 publications

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“…Participants were directed to complete the demographic details then a set of several questions followed which the participants were to answer. No personal or private data was collected and similarly, the data collection procedure followed the provisions of the Declaration of Helsinki on human subjects [3] .…”

Section: Experimental Design Materials and Methodsmentioning

confidence: 99%

Evaluation of knowledge, impacts and government intervention strategies during the COVID – 19 pandemic in Nigeria

et al. 2020

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The SARS-CoV-2 is a novel strain of coronavirus which is ravaging many countries, and this has become a global public health concern. With the increasing number of COVID-19 confirmed cases and deaths in Nigeria, the pandemic has led to massive public reactions. This data attempted to evaluate the knowledge, impacts, and government intervention during the pandemic. An online survey was conducted using a questionnaire shared via social media using a Snowball sampling technique. The data were analyzed using descriptive statistics and analysis of variance (ANOVA). A total of 387 responses was received. Results show that a significant number of respondents had adequate knowledge about COVID-19 modes of transmission, symptoms, and preventive measures. Respondents maintain personal hygiene as 67% wash their hands with soap. The pandemic has caused worry (65%), anxiety (42%), panic (35%), and depression (16%) among respondents, even as government intervention is seen as inadequate by 70%. There is a need for mental health support and increased information campaigns about COVID-19.

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Section: Experimental Design Materials and Methodsmentioning

confidence: 99%

Evaluation of knowledge, impacts and government intervention strategies during the COVID – 19 pandemic in Nigeria

et al. 2020

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“…1 The procedure of obtaining informed consent from human subjects in medical research is firmly regulated. 2 The informed consent form (ICF), which indicates the agreement of the human subject -or their guardian-to participate in the research project is part of the procedure. 3,4 The International Conference on Harmonization-Good Clinical Practice (ICHGCP) outlined minimum requirements for the ICF, where it should include essential information to enable participants to make an informed decision.…”

Section: Introductionmentioning

confidence: 99%

<p>Informed Consent Form Challenges for Genetic Research in Jordan</p>

Alkaraki¹,

Khabour²,

Alzoubi³

et al. 2020

JMDH

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Background: Informed consent is an obligatory requirement for research engaging human subjects. Informed consent form (ICF) should be provided for human subjects to confirm their willingness for voluntary participation in a study. Ethical and legal obligations necessitate the presence of informed consent essential items to be built into the ICF. Objective: To evaluate the content of ICFs obtained from different genetic studies accomplished in Jordan and their adherence to ethical guidelines proposed by the International Conference on Harmonization-Good Clinical Practice (ICHGCP). Methods and Measures: A total of 44 ICFs obtained from master theses and grant proposals at two major universities in Jordan were analyzed according to the good clinical practice criteria proposed by ICHGCP. ICFs were scored for the presence or absence of ICF main items/categories. Results: Results show inadequate information present in the examined ICFs. The highest information score was 17 out of 20, while the lowest score was one out of 20. The average score for all studied ICFs was 6.18±3.65. Among essential items/categories that were absent from the majority of studied ICFs were a statement about voluntary participation, confidentiality of data, compensation to study participants, risk/benefits of the study, and researchers' contact information. Conclusion: The ICFs were missing a number of required items. This could reflect inadequate knowledge about minimal informed consent requirements among Jordanian investigators highlighting the need for research ethical training in the country.

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“…Editors of dental journals could contribute to more adequate translational research in our field by requiring comprehensive information on the potential harm of the new techniques/ procedures reported in the submitted manuscripts that involve treatment in humans. When such evidence does not exist or is weak, the authors should present a strong rationale to justify the submission of the manuscripts Editors should also require, from researchers submitting case reports and case series based on weak evidence, a detailed informed consent signed by the patients (70). This consent should provide detailed information that: (i) the patient was aware that the evidence supporting the respective therapy was weak or even non-existent, and (ii) the patient accepted the proposed therapy and the potential risks of receiving the therapy.…”

Section: Discussionmentioning

confidence: 99%

The (in)adequacy of translational research in dentistry

Faggion

2020

European J Oral Sciences

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Translational research, as the name suggests, “translates” research findings into clinical practice to improve the health of human beings. The translational process builds on information from experiments conducted at a basic level (i.e., in vitro and/or animal studies) and progresses over experimental human studies for efficacy, efficiency, and safety to implementation. Therefore, all steps in the process should be based on studies conducted with the highest methodological quality possible in order to provide accurate and useful information. Furthermore, the systematic dissemination of new procedures/techniques should be done only when they have been proven to be effective and safe. This focus article describes examples of new techniques/procedures in dentistry that have not resulted from an adequate translational research process since the initial evidence was published. These procedures are generally characterised by lack of good evidence, particularly on their potential harms, and lack of adequate chronological order, regarding the translational research process (i.e., human research being conducted before animal research). Even so, they seem to be widely disseminated, and their promotion involves a wide range of sources, including social media. Some guidance is proposed to improve the quality of the translational research process in dentistry, as well as the level of awareness of all parties involved with the use of this research: clinicians, researchers, and patients. By improving the translational research process, optimization of the application and use of these resources, with less risk to the patients, is expected.

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How to obtain informed consent for research

Cited by 126 publications

References 28 publications

Evaluation of knowledge, impacts and government intervention strategies during the COVID – 19 pandemic in Nigeria

Evaluation of knowledge, impacts and government intervention strategies during the COVID – 19 pandemic in Nigeria

<p>Informed Consent Form Challenges for Genetic Research in Jordan</p>

The (in)adequacy of translational research in dentistry

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