Electronic informed consent criteria for research ethics review: a scoping review

Yusof, Mohd Yusmiaidil Putera Mohd; Teo, Chin Hai; Ng, Chirk Jenn

doi:10.1186/s12910-022-00849-x

Cited by 16 publications

(8 citation statements)

References 58 publications

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“…Multimedia tools with interactive audio and video-based consent explanations have been developed. These tools enhance communication about risks and allow researchers to respond to questions and concerns [ 62 – 64 ]. Teleconsent combines e-consent with synchronous videoconferencing [ 54 , 65 ].…”

Section: Discussionmentioning

confidence: 99%

Narrative review of telemedicine applications in decentralized research

Cummins,

Soni,

Ivanova

et al. 2024

J. Clin. Trans. Sci.

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Telemedicine enables critical human communication and interaction between researchers and participants in decentralized research studies. There is a need to better understand the overall scope of telemedicine applications in clinical research as the basis for further research. This narrative, nonsystematic review of the literature sought to review and discuss applications of telemedicine, in the form of synchronous videoconferencing, in clinical research. We searched PubMed to identify relevant literature published between January 1, 2013, and June 30, 2023. Two independent screeners assessed titles and abstracts for inclusion, followed by singlereviewer full-text screening, and we organized the literature into core themes through consensus discussion. We screened 1044 publications for inclusion. Forty-eight publications met our inclusion and exclusion criteria. We identified six core themes to serve as the structure for the narrative review: infrastructure and training, recruitment, informed consent, assessment, monitoring, and engagement. Telemedicine applications span all stages of clinical research from initial planning and recruitment to informed consent and data collection. While the evidence base for using telemedicine in clinical research is not well-developed, existing evidence suggests that telemedicine is a potentially powerful tool in clinical research.

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Section: Discussionmentioning

confidence: 99%

Narrative review of telemedicine applications in decentralized research

Cummins,

Soni,

Ivanova

et al. 2024

J. Clin. Trans. Sci.

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“…The consent process is a fundamental step in clinical research that involves human subjects. [45][46][47] Almost half of the participants were willing to provide open access to their blood samples, while less than half agreed to provide open access to their health records. Fear of privacy being negatively affected was the most reported reason for rejecting to provide blanket consent, followed by a lack of trust in researchers.…”

Section: Discussionmentioning

confidence: 99%

Attitudes Toward Providing Open Access for Use of Biospecimens and Health Records: A Cross-Sectional Study from Jordan

Al-Shami¹,

Ahmed²,

Alzoubi³

2023

PPA

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Purpose Biospecimen repositories and big data generated from clinical research are critically important in advancing patient-centered healthcare. However, ethical considerations arising from reusing clinical samples and health records for subsequent research pose a hurdle for big-data health research. This study aims to assess the public’s opinions in Jordan toward providing blanket consent for using biospecimens and health records in research. Participants and Methods A cross-sectional study utilizing a self-reported questionnaire was carried out in different cities in Jordan, targeting adult participants. Outcome variables included awareness of clinical research, participation in clinical research, and opinions toward providing open access to clinical samples and records for research purposes. Descriptive analysis was utilized for reporting the outcome as frequency (percentages) out of the total responses. Univariate and multivariate logistic regression were used to investigate the association between independent variables and the outcome of interest. Results A total of 1033 eligible participants completed the questionnaire. Although the majority (90%) were aware of clinical research, only 24% have ever participated in this type of research. About half (51%) agreed on providing blanket consent for the use of clinical samples, while a lower percentage (43%) agreed on providing open access to their health records. Privacy concerns and lack of trust in the researcher were cited as major barriers to providing blanket consent. Participation in clinical research and having health insurance were predictors for providing open access to clinical samples and records. Conclusion The lack of public trust in Jordan toward data privacy is evident from this study. Therefore, a governance framework is needed to raise and maintain the public’s trust in big-data research that warrants the future reuse of clinical samples and records. As such, the current study provides valuable insights that will inform the design of effective consent protocols required in data-intensive health research.

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“…Literature suggests that the process of informed consent can be improved and standardized by teaching ethical and legal aspects using modern tools such as e-health and multimedia programs. A better method of obtaining consent can be accomplished on a study-by-study basis by establishing literature that assesses the quality of consent, understanding barriers to consent, community governance, structure, and whether the consent model is being appropriately used, which will help tailor an approach appropriate to culture [ 10 , 14 ]. A solution to this problem could be the standardization of pre-printed emergency consent forms, which may significantly improve documentation, enhance informed consent, and increase compliance with guidelines [ 8 , 15 ].…”

Section: Discussionmentioning

confidence: 99%

Practices of Informed Consent for Emergency Procedures at a Tertiary Care Hospital in Lahore, Pakistan

Munawar,

Ismail,

Mehmood Qadri

et al. 2023

Cureus

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Background The purpose of obtaining informed consent is to ensure that patients undergoing any medical or surgical intervention are neither deceived nor coerced. Accurately estimating surgical risks is critical for shared decision-making and informed consent. Probable complications and alternative procedures should be presented to the patient so that they can freely choose an operative option. However, this factor is difficult to carry on in emergencies where an urgent decision is required. Objective This study aimed to assess the ongoing clinical practices of informed consent in emergency surgeries at a tertiary care facility. Materials and methods A cross-sectional survey was carried out from March 2022 to June 2022 at the Department of General Surgery, Lahore General Hospital, Lahore, Pakistan, with patients who had undergone surgical procedures under local, spinal, or general anesthesia within 24 hours of presentation. A Google Form (Google Inc., Mountainview, CA) was designed, containing a predefined set of 32 standard questions, and patients were interviewed in their native language to assess their satisfaction regarding the pattern and components of emergency informed consent. Categorical data were assessed using measures of central tendency, frequencies, and percentages. Results A total of 169 patients were selected for the study. Only 1.6% of them signed the consent form themselves, while 93.5% of the forms were signed by their first-degree relatives. Verbal consent was taken in 4.8% of cases. In 88% of cases, informed consent was obtained by the house surgeons. The majority of patients, i.e., 78.2%, were not able to read the written consent form; however, 83.1% understood the verbal information. About 66.3% of patients agreed that they were informed about the nature of their disease, while 67.5%, 14.8%, and 13.7% affirmed that they were explained the nature of surgical intervention, associated risks, and type of anesthesia, respectively. Overall, 59.5% of patients felt satisfied with the process of informed consent. About 91.1% of the patients believed that their decisions were unaffected by the procurement of informed consent. Conclusion The existing practices of informed consent and comprehension by the population were found to be substandard. Physicians seem to ignore bioethics, and patients appear to be unaware of their basic rights. Although practiced at our center, not all components of informed consent were communicated to the patients. The risks of the procedures and the mode of anesthesia used were not well addressed by doctors. There is a grave need to educate the medical community about the legal and ethical aspects of informed consent, as well as the public masses regarding their rights.

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Electronic informed consent criteria for research ethics review: a scoping review

Cited by 16 publications

References 58 publications

Narrative review of telemedicine applications in decentralized research

Narrative review of telemedicine applications in decentralized research

Attitudes Toward Providing Open Access for Use of Biospecimens and Health Records: A Cross-Sectional Study from Jordan

Practices of Informed Consent for Emergency Procedures at a Tertiary Care Hospital in Lahore, Pakistan

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