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.

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

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.

scholarly journals Regulatory developments in the conduct of clinical trials in India

2016 ◽  
Vol 1 ◽  
Author(s):  
R. Roy Chaudhury ◽  
D. Mehta
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Clinical Research ◽  
Supreme Court ◽  
Large Scale ◽  
Ethics Committees ◽  
Informed Consent Process ◽  
Consent Process ◽  
Regulatory Institutions ◽  
Indian Supreme Court

There has been a drop in clinical research in India following stringent conditions put in place by the Indian Supreme Court in 2013. The Court's orders came in the wake of irregularities highlighted in the conduct of clinical trials in the country. This paper highlights the steps taken by the Indian regulator, the Central Drugs Standard Control Organisation to comply with these directions. These are of three kinds: strengthening regulatory institutions, protecting participant safety and creating regulatory certainty for sponsors and investigators. Examples include the large-scale training of Ethics Committees, framing detailed guidelines on compensation and audiovisual recording of the informed consent process, as well as reducing the time taken to process applications. It is expected that these measures will inspire confidence for the much-needed resumption of clinical research.

scholarly journals Facilitating The Informed Consent Process Using Teleconsent: A Study Protocol (Preprint)

2018 ◽  
Author(s):  
Saif Khairat ◽  
Paige Ottmar ◽  
Christina Smith ◽  
Betsy Sleath ◽  
Brandon Welch ◽  
...  
Keyword(s):  
Clinical Trials ◽  
South Carolina ◽  
Informed Consent ◽  
Rural Communities ◽  
Clinical Research ◽  
Phase 1 ◽  
Informed Consent Process ◽  
Consent Process ◽  
University Of South Carolina ◽  
Novel Approach

BACKGROUND Informed consent is among the biggest challenges in recruiting participants for clinical research studies. Researchers face many challenges in conducting clinical trials, some of which include budgetary restrictions, lack of trained personnel, and difficulty recruiting study participants--particularly minorities and participants from rural communities. OBJECTIVE The objective of this study is to utilize telemedicine to improve the informed consent process for the clinical trials and studies. METHODS This study will be conducted separately yet concurrently at two institutions, the Medical University of South Carolina (MUSC) and the University of North Carolina at Chapel Hill (UNC), in order to compare results both within and across institutions. RESULTS Enrollment for Phase 1 began in March of 2018 and concluded in May 2018. Data transcription and analysis will be conducted through June and September of 2018. CONCLUSIONS In this paper, we present a novel approach to conducting the informed consent using a new telemedicine modality namely, teleconsent. Teleconsent presents the ability to conduct a live interaction among clinical research coordinators and potential participants while synchronously presenting the consent form on the screen and obtaining participant’s signature through doxy.me, the teleconsent system. The aim of this research is to assess the feasibility and efficacy of the teleconsent intervention among residents in urban and rural settings. Teleconsent provides potential to improve obtaining informed consent from potential clinical trial participants.

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.

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