scholarly journals Awareness and Perception of Healthcare Providers about Proxy Consent in Critical Care Research

2021 ◽  
Vol 2021 ◽  
pp. 1-5
Author(s):  
Rania Mahafzah ◽  
Karem H. Alzoubi ◽  
Omar F. Khabour ◽  
Rana Abu-Farha
Keyword(s):  
Informed Consent ◽  
Healthcare Providers ◽  
Informed Consent Process ◽  
Consent Process ◽  
Proxy Consent ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Knowledge And Attitudes ◽  
Potential Benefits ◽  
Research Studies

Objective. Proxy consent respects patients’ autonomy when they are incapable of providing consent for research participation. Healthcare providers need to understand the ethical regulations and practices relevant to the proxy consent process. Thus, this study aimed to assess the knowledge and attitudes of healthcare providers about research proxy consent in the ICU setting. Methods. A cross-sectional survey-based design was used in the study. Study participants were resident and specialist physicians, registered nurses, and registered pharmacists from ICU units in Jordan. Participants were asked to fill out a questionnaire developed to assess their knowledge and attitudes towards informed proxy consent for research studies conducted at the ICU. Results. In this study, 145 healthcare providers completed the study questionnaire. The healthcare providers agreed that the purpose of the proxy consent is to inform the participants about the potential benefits (66.9%) and risks (66.9%) related to the research to study and respect patient's autonomy (44%), to discuss alternative options (62.1%), and to protect the researchers from any litigation (84.1%). Regarding the assessment of proxy consent, 65.5% of respondents believed that relatives are considered as an authorized legal representative for an informed consent decision on behalf of their ICU patients (65.5%) as they are knowledgeable about patients' values and preferences and have the desire to provide the necessary help. Respondents also agreed that the informed consent process should explain research protocols and procedures (76.6%), therapeutic alternatives (84.1%), potential benefits (41.4%), and potential risks (44.1%) and that participation in the research is voluntary (66.9%). No significant differences in the responses were found among different groups of healthcare providers. Conclusion. The majority of healthcare providers had inadequate awareness about the ethical aspects regarding the informed proxy consent process. Providing training regarding the informed consent process can improve the quality of the proxy consent process in clinical research studies in the ICU setting.

The practice of obtaining informed consent for elective surgery and anesthesia from patients’ perspective: An institutional based cross-sectional study

2021 ◽  
pp. 147775092199428
Author(s):  
Tadese Tamire ◽  
Aragaw Tesfaw
Keyword(s):  
Informed Consent ◽  
Elective Surgery ◽  
Healthcare Providers ◽  
Cross Sectional Study ◽  
Informed Consent Process ◽  
Consent Process ◽  
Sectional Study ◽  
Cross Sectional ◽  
Risks And Benefits ◽  
To Receive

Introduction Informed consent is a body of shared decision-making process and voluntary authorization of patients to receive medical or surgical intervention. There are limited studies conducted so far to examine the practice of informed consent in Ethiopia. This study aimed to assess the practice of informed consent process for surgery and Anesthesia. Method A cross-sectional study was conducted from March to May 2019. The data were collected using interviewer-administered structured questionnaire and analyzed in SPSS version 23. Results A total of 139 patients were interviewed in this study. Most 42(30.2%) of patients were in the age group of 29–38 years. Nearly half 68 (48.9%) of the patients were informed the benefits of the surgical procedure and 78(56.1%) of the patients were informed on the type of anesthesia to be administered while 65 (46.8%) were not informed on any complication related to the anesthesia. About 66 (47.5%) of patients were informed on alternatives to the surgery. Of these patients, 39(59%) were not informed of any benefits and possible risks associated with the alternative modes of treatment. About half (54%) of the patients were reported as they were understood the information provided during the pre-operative informed consent process. Conclusion This research revealed that patients were inadequately informed on the complications of proposed procedure, alternative forms of treatment, risks and benefits of the proposed procedure. Therefore, healthcare providers should provide adequate information regarding the proposed procedure and make sure whether patients understood the risks and benefits before the consent.

Psychometric evaluation of the Informed Consent Process Scale in Chinese

2019 ◽  
Vol 26 (7-8) ◽  
pp. 2456-2466
Author(s):  
Shu Yu Chen ◽  
Shu-Chen Susan Chang ◽  
Chiu-Chu Lin ◽  
Qingqing Lou ◽  
Robert M Anderson
Keyword(s):  
Informed Consent ◽  
Clinical Research ◽  
Informed Consent Process ◽  
Chinese Version ◽  
Consent Process ◽  
Institutional Review Boards ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Informed Consent Form ◽  
Process Scale

Background: Informed consent is essential for the ethical conduct of clinical research and is a culturally sensitive issue. But, a measurable Chinese version of the scale to evaluate the informed consent process has not yet been explored in the existing literature. Research objectives: This study aimed to develop and psychometrically test the Chinese version of the Informed Consent Process Scale. Research design: Back-translation was conducted to develop the Chinese version of the questionnaire. A cross-sectional survey was administered, after which an exploratory factor analysis was conducted. Participants: We recruited a total of 375 participants who had experience in signing an informed consent form within the previous 3 years in Taiwan. Ethical considerations: This study was approved by two Institutional Review Boards and the autonomy of the participants was respected. Findings: The Chinese version of the Informed Consent Process Scale is composed of three factors with 23 items showing evidence of acceptable reliability and validity. Three major factors were extracted and labeled: Factor 1 – ‘Understanding of the research’, Factor 2 – ‘Trust and confidence’ and Factor 3 – ‘Doubt and uncertainty’. The three factors accounted for is 52.954 of the total variance with Cronbach’s α of .917. Discussion and conclusion: The finding corroborates previous studies showing that participants had too little understanding on the informed consent forms they signed and implied the need to clarify the critical points in clinical research. The psychometric results indicated good internal consistency and validity for this newly constructed instrument, and it was found worthy of conducting further testing and application.

scholarly journals Evaluation of Parents' Knowledge and Attitudes Regarding Self-Medication in the Dental Problems of Their Child During the COVID-19 Pandemic

2020 ◽  
Author(s):  
Emine Sen Tunc ◽  
Emre Aksoy ◽  
Hatice Arslan ◽  
Zeynep Kaya
Keyword(s):  
Healthcare Providers ◽  
Cross Sectional Survey ◽  
Self Medication ◽  
Cross Sectional ◽  
Knowledge And Attitudes ◽  
Previous Medication ◽  
Important Health ◽  
Important Health Issue ◽  
Medicating Children ◽  
Structured Questionnaire

Abstract Background: Self-medication means taking medicine without consultation with any doctor or dentist and an important health issue, especially during the COVID-19 pandemic. The present study aims to evaluate the knowledge and attitudes of parents regarding self-medication in dental problems of their children during to COVID-19 pandemic in Northern Turkey. Methods: A cross-sectional survey was carried out in the pediatric dental clinic immediately after the COVID-19 lockdown ended. A total of 389 parents who agreed to participate in the study completed the questionnaire for three months. A structured questionnaire with 18 items was designed to collect information on the parents’ knowledge and attitudes regarding when, why, and how to use drugs and on their practices medicating children. Results: The majority of parents (n = 273; 70.2%) were practiced self-medication to their children's dental problems. Self-medication with a previous medication was usually preferred to their children by parents (n = 179; 62.2%). It was observed the analgesics practiced by parents (98%) were the most commonly used self-medication for their children's dental problems.Conclusion: New healthcare systems like tele-dentistry may be useful to overcome self-medication problems directed to children in unusual times that limit to reach healthcare providers such as pandemics.

scholarly journals Undergraduate medical students. Simulation-based activity to conduct the informed consent process for health research studies

2020 ◽  
Vol 21 (2) ◽  
pp. 106-111 ◽  
Author(s):  
Gregorio Cetina-Sauri ◽  
Oswaldo Huchim-Lara ◽  
Alberto Alvarez-Baeza ◽  
Martín Inurreta-Díaz ◽  
Herbert Puga-Matu ◽  
...  
Keyword(s):  
Informed Consent ◽  
Medical Students ◽  
Health Research ◽  
Informed Consent Process ◽  
Consent Process ◽  
Undergraduate Medical Students ◽  
Simulation Based ◽  
Research Studies

Study of Awareness and Practice of Informed Consent Process Among Clinical Trial Participants and Their Motives Behind Participation

2019 ◽  
Vol 31 (8) ◽  
pp. 710-718
Author(s):  
Rajesh Ranjan ◽  
Nidhi B. Agarwal ◽  
Prem Kapur ◽  
Amit Marwah ◽  
Rizwana Parveen
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Human Subjects ◽  
Cross Sectional Study ◽  
Informed Consent Process ◽  
Consent Process ◽  
Cross Sectional ◽  
Contract Research ◽  
Research Organizations ◽  
Informed Consent Document

Process to obtain informed consent is an essential component in research involving human subjects. However, much is not known about the level of awareness participants have about optimal consenting process and the motives that drive their participation in the trials. A cross-sectional study was conducted among volunteers who had been participating in clinical trials in contract research organizations of Delhi. Validated questionnaires were used to assess their knowledge, attitude, and practice of informed consent process. Most of the volunteers, 226 (56.5%), had participated in 1 to 3 clinical trials. Majority (54%) were unaware about any informed consent document. None of them were aware of their right of profession competence, privacy and integrity, transparency, nonexploitation, and nonusage of their biological samples. Effective implementation of principles of informed consenting is largely lacking among contract research organizations in Delhi, India. This could potentially cause risk to the participants.

scholarly journals Cardiologists’ and patients’ views about the informed consent process and their understanding of the anticipated treatment benefits of coronary angioplasty: A survey study

2019 ◽  
Vol 19 (3) ◽  
pp. 260-268 ◽  
Author(s):  
Felicity Astin ◽  
John Stephenson ◽  
Joy Probyn ◽  
Janet Holt ◽  
Keith Marshall ◽  
...  
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Informed Consent ◽  
Coronary Intervention ◽  
Informed Consent Process ◽  
Consent Process ◽  
Survey Study ◽  
Cross Sectional ◽  
Patient Comprehension ◽  
Treatment Benefits ◽  
Percutaneous Coronary

Background: Percutaneous coronary intervention is a common revascularisation technique. Serious complications are uncommon, but death is one of them. Seeking informed consent in advance of percutaneous coronary intervention is mandatory. Research shows that percutaneous coronary intervention patients have inaccurate perceptions of risks, benefits and alternative treatments. Aim: To assess cardiologists’ and patients’ views about the informed consent process and anticipated treatment benefits. Methods: Two cross-sectional, anonymous surveys were distributed in England: an electronic version to a sample of cardiologists and a paper-based version to patients recruited from 10 centres. Results: A sample of 118 cardiologists and 326 patients completed the surveys. Cardiologists and patients shared similar views on the purpose of informed consent; however, over 40% of patients and over a third of cardiologists agreed with statements that patients do not understand, or remember, the information given to them. Patients placed less value than cardiologists on the consent process and over 60% agreed that patients depended on their doctor to make the decision for them. Patients’ and cardiologists’ views on the benefits of percutaneous coronary intervention were significantly different; notably, 60% of patients mistakenly believed that percutaneous coronary intervention was curative. Conclusions: The percutaneous coronary intervention informed consent process requires improvement to ensure that patients are more involved and accurately understand treatment benefits to make an informed decision. Redesign of the patient pathway is recommended to allow protected time for health professionals to engage in discussions using evidence-based approaches such as ‘teach back’ and decision support which improve patient comprehension.

scholarly journals Recruiting for Epigenetic Research: Facilitating the Informed Consent Process

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Nancy Jallo ◽  
Debra E. Lyon ◽  
Patricia Anne Kinser ◽  
Debra Lynch Kelly ◽  
Victoria Menzies ◽  
...  
Keyword(s):  
Informed Consent ◽  
Informed Consent Process ◽  
Recruitment Strategy ◽  
Consent Process ◽  
Environment Interaction ◽  
Health Issues ◽  
Health States ◽  
Gene Environment ◽  
Epigenetic Research ◽  
Research Studies

Because the effects of epigenetic (gene-environment interaction) changes have been associated with numerous adverse health states, the study of epigenetic measures provides exciting research opportunities for biobehavioral scientists. However, recruitment for studies focusing on any aspect of genetics poses challenges. Multiple factors, including lack of knowledge regarding a research study, have been identified as barriers to recruitment. Strengthening the informed consent process through extended discussion has been found to be effective in recruiting for research studies in general, yet there is a paucity of information that focused on such a recruitment strategy for epigenetic studies. In this paper, we share our experiences with strategies to strengthen the informed consent process as well as provide samples of materials developed to heighten potential participants’ understanding of epigenetics, in 4 epigenetic research studies with women from diverse backgrounds experiencing a range of health issues. The combined enrollment success rate for epigenetic studies using the process was 89% with participants representing a diverse population. We posit that carefully developed recruitment scripts provided a foundation for improving potential participants’ understanding of the research project. Easy to understand illustrations of the epigenetic process provided a basis for active engagement and encouraged individual questions.

Application of Ethical Principles During the Informed Consent Process for Clinical Trials

2006 ◽  
Author(s):  
Joanne Russell ◽  
David Barnard ◽  
Maurice Clifton
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Informed Consent Process ◽  
Ethical Principles ◽  
Consent Process

Informed Consent Process Scale--Chinese Version

2019 ◽  
Author(s):  
Shu Yu Chen ◽  
Shu-Chen Susan Chang ◽  
Chiu-Chu Lin ◽  
Qingqing Lou ◽  
Robert M. Anderson
Keyword(s):  
Informed Consent ◽  
Informed Consent Process ◽  
Chinese Version ◽  
Consent Process ◽  
Process Scale

Knowledge and Communication of the National Core Standards Tool

2018 ◽  
Vol 20 (2) ◽  
Author(s):  
Winnie Thembisile Maphumulo ◽  
Busisiwe Bhengu
Keyword(s):  
Pearson Correlation ◽  
Healthcare Delivery ◽  
Healthcare Providers ◽  
Sampling Technique ◽  
Quality Of Healthcare ◽  
Survey Study ◽  
Public Healthcare ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Professional Nurses

The National Department of Health in South Africa has introduced the National Core Standards (NCS) tool to improve the quality of healthcare delivery in all public healthcare institutions. Knowledge of the NCS tool is essential among healthcare providers. This study investigated the level of knowledge on NCS and how the NCS tool was communicated among professional nurses. This was a cross-sectional survey study. Purposive sampling technique was used to select hospitals that only offered tertiary services in KwaZulu-Natal. Six strata of departments were selected using simple stratified sampling. The population of professional nurses in the selected hospitals was 3 050. Systematic random sampling was used to recruit 543 participants. The collected data were analysed using SPSS version 25. The study showed that only 16 (3.7%) respondents had knowledge about NCS, using McDonald’s standard of learning outcome measured criteria regarding the NCS tool. The Pearson correlation coefficient between the communication and knowledge was r = 0.055. The results revealed that although the communication scores for the respondents were high their knowledge scores remained low. This study concluded that there is a lack of knowledge regarding the NCS tool and therefore healthcare institutions need to commit themselves to the training of professional nurses regarding the NCS tool. The findings suggest that healthcare institutions implement the allocation of incentives for nurses that attend the workshops for NCS.

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