scholarly journals 6ER-023 The role of institutional review boards, and hospital pharmacists as members, in the informed consent process in clinical research: a retrospective observational study

2020 ◽  
Author(s):  
E Villamañán ◽  
C Sobrino ◽  
M Freire ◽  
JN Inmaculada ◽  
SR Luis ◽  
...  
Keyword(s):  
Informed Consent ◽  
Observational Study ◽  
Clinical Research ◽  
Informed Consent Process ◽  
Consent Process ◽  
Retrospective Observational Study ◽  
Institutional Review Boards ◽  
Hospital Pharmacists ◽  
Institutional Review

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.

Ethical Conduct of Clinical Trials, Institutional Review Boards, Informed Consent, and Financial Conflicts of Interest

2017 ◽  
Author(s):  
Christian B. Ramers
Keyword(s):  
Informed Consent ◽  
Conflicts Of Interest ◽  
Institutional Review Boards ◽  
Ethical Considerations ◽  
Governmental Organizations ◽  
Institutional Review ◽  
The Us ◽  
Guidelines And Recommendations ◽  
Study Designs

Ethics and conflicts of interest are important considerations when planning and carrying out research. It is the role of the institutional review board to weigh these against protection of the research subject when evaluating research proposals. The ethical considerations when performing research include basic ethical principles (e.g., autonomy, confidentiality, non-maleficence, informed consent, beneficence, justice, and utility), as well as nuances such as appropriate study designs, investigator conflict of interests, and bias in all its forms. To help guide clinicians, a number of professional and governmental organizations have published guidelines and recommendations on various aspects of clinical research (e.g., the American Medical Association, the National Institutes of Health, and the US Food and Drug Administration).

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.

Predictive Genetic Testing,Uncertainty, and Informed Consent

2009 ◽  
pp. 474-495
Author(s):  
Eduardo A. Rueda
Keyword(s):  
Genetic Testing ◽  
Informed Consent ◽  
Informed Consent Process ◽  
Predictive Genetic Testing ◽  
Three Dimensions ◽  
Consent Process ◽  
The Public ◽  
The Individual

This chapter focuses on showing legitimate ways for coping with uncertainties within the informed consent process of predictive genetic testing. It begins by indicating how uncertainty should be theoretically understood. Then, it describes three dimensions of uncertainty with regard to both the role of genes in pathogenesis and the benefit to patients of undergoing predictive genetic testing. Subsequently, the ways by which institutions tame these uncertainties are explained. Since viewing genes as exceptional informational entities plays an important role in taming uncertainties, it explains why this conception should be abandoned. Then, it discusses how institutional taming of uncertainty becomes a source of paternalism. What is stressed is that in order to avoid paternalism and ensure transparency within the informed consent process, open-to-uncertainty mechanisms should be implemented before the public and the individual. How patients should deal with potential implications of testing for their relatives is also considered.

Ethical Conduct of Clinical Trials, Institutional Review Boards, Informed Consent, and Financial Conflicts of Interest

2019 ◽  
pp. 545-548
Author(s):  
Christian B. Ramers
Keyword(s):  
Informed Consent ◽  
Ethical Issues ◽  
Conflicts Of Interest ◽  
Ethical Conduct ◽  
Institutional Review Board ◽  
Institutional Review Boards ◽  
Institutional Review ◽  
Essential Components ◽  
Financial Conflicts Of Interest

Describe the essential components of the ethical conduct of research, the role of the institutional review board, the process of informed consent, the potential areas of conflict of interest for clinicians participating in research, and other ethical issues related to research in HIV medicine.

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