Protecting boundaries of consent in clinical research

2013 ◽  
Vol 21 (1) ◽  
pp. 16-27 ◽  
Author(s):  
Shirley T Bristol ◽  
Rodney W Hicks
Keyword(s):  
Quality Improvement ◽  
Informed Consent ◽  
Clinical Research ◽  
Patient Care ◽  
Current Practice ◽  
Informed Consent Process ◽  
Legal Requirements ◽  
Research Outcomes ◽  
Rigorous Research ◽  
Improving Patient Care

Successful clinical research outcomes are essential for improving patient care. Achieving this goal, however, implies an effective informed consent process for potential research participants. This article traces the development of ethical and legal requirements of informed consent and examines the effectiveness of past and current practice. The authors propose the use of innovative monitoring methodologies to improve outcomes while safeguarding consent relationships and activities. Additional rigorous research will help direct policy efforts at standardizing quality improvement processes.

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.

scholarly journals The regulation of informed consent to participation in clinical research by mentally ill persons: An overview

2010 ◽  
Vol 16 (4) ◽  
pp. 6
Author(s):  
A Nienaber
Keyword(s):  
Informed Consent ◽  
Clinical Research ◽  
South African ◽  
Mentally Ill ◽  
Common Law ◽  
Case Law ◽  
Legal Requirements ◽  
Mentally Ill Persons ◽  
South African Constitution ◽  
National Health Act

The article examines the legal requirements relating to the informed consent of mentally ill persons to participation in clinical research in South Africa. First, the juridical basis of informed consent in South African law is outlined; and second, the requirements for lawful consent developed in South African common law and case law are presented. Finally, the article deliberates upon the requirements for the participation of mentally ill persons in research as laid down by the Mental Health Care Act and its regulations, the National Health Act and its (draft) regulations, and the South African Constitution.

scholarly journals Improving patient care through CPD: revised guidance from the Royal College of Psychiatrists

2016 ◽  
Vol 22 (4) ◽  
pp. 269-276
Author(s):  
Guy Brookes
Keyword(s):  
Professional Development ◽  
Patient Care ◽  
Royal College ◽  
Current Practice ◽  
Continuing Professional Development ◽  
Effective Practice ◽  
Knowledge And Skills ◽  
New Knowledge ◽  
Continued Learning ◽  
Improving Patient Care

SummaryContinued learning is essential to doctors' safe and effective practice throughout their careers. To improve the care they provide, they need not only to acquire new knowledge and skills but also to consider how their current practice compares and what they need to change. Such reflection is not usually automatic; time, and often help from peers, is needed to make it effective; formalised, this is continuing professional development (CPD). Revised guidance from the Royal College of Psychiatrists emphasises the importance of linking learning to improved practice through reflection and promotes the CPD peer group's role in supporting psychiatrists to do this.

scholarly journals A survey of the current practice of the informed consent process in general surgery in the Netherlands

2013 ◽  
Vol 7 (1) ◽  
pp. 4 ◽  
Author(s):  
Wouter KG Leclercq ◽  
Bram J Keulers ◽  
Saskia Houterman ◽  
Margot Veerman ◽  
Johan Legemaate ◽  
...  
Keyword(s):  
Informed Consent ◽  
The Netherlands ◽  
General Surgery ◽  
Current Practice ◽  
Informed Consent Process ◽  
Consent Process

Improving Patient Care Through Student Leadership in Team Quality Improvement Projects

2015 ◽  
Vol 30 (2) ◽  
pp. 181-186 ◽  
Author(s):  
Dana Tschannen ◽  
Michelle Aebersold ◽  
Mary Jo Kocan ◽  
Francene Lundy ◽  
Kathleen Potempa
Keyword(s):  
Quality Improvement ◽  
Patient Care ◽  
Student Leadership ◽  
Improving Patient Care
Sign in / Sign up

Export Citation Format

Share Document