Protecting Human Subjects from Risk in the Performance of Clinical Research and the Informed Consent Process

1999 ◽  
pp. 7-20
Author(s):  
A. U. Buzdar ◽  
C. A. Brunelli ◽  
L. A. Zwelling
Keyword(s):  
Informed Consent ◽  
Clinical Research ◽  
Human Subjects ◽  
Informed Consent Process ◽  
Consent Process

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.

Impact of Therapeutic Research on Informed Consent and the Ethics of Clinical Trials: A Medical Oncology Perspective

1999 ◽  
Vol 17 (5) ◽  
pp. 1601-1601 ◽  
Author(s):  
Christopher K. Daugherty
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Clinical Research ◽  
Controlled Trial ◽  
Informed Consent Process ◽  
Communication Process ◽  
Consent Process ◽  
Future Research ◽  
Trial Participation ◽  
Therapeutic Research

PURPOSE: To create a more meaningful understanding of the informed consent process as it has come to be practiced and regulated in clinical trials, this discussion uses the experience gained from the conduct of therapeutic research that involves cancer patients. DESIGN: After an introduction of the ethical tenets of the consent process in clinical research that involves potentially vulnerable patients as research subjects, background that details the use of written consent documents and of the term “informed consent” is provided. Studies from the cancer setting that examine the inadequacies of written consent documents, and the outcome of the consent process itself, are reviewed. Two ethically challenging areas of cancer clinical research, the phase I trial and the randomized controlled trial, are discussed briefly as a means of highlighting many dilemmas present in clinical trials. Before concluding, areas for future research are discussed. RESULTS: Through an exclusive cancer research perspective, many current deficiencies in the informed consent process for therapeutic clinical trials can be critically examined. Also, new directions for improvements and areas of further research can be outlined and discussed objectively. The goals of such improvements and research should be prevention of further misguided or ineffective efforts to regulate the informed consent process. CONCLUSION: To ignore this rich and interesting perspective potentially contributes to continued misunderstanding and apathy toward fulfilling the regulatory and ethically obligatory requirements involved in an essential communication process between a clinician-investigator and a potentially vulnerable patient who is considering clinical trial participation.

Family perceptions of clinical research and the informed consent process in the ICU

2020 ◽  
Author(s):  
Marie Labruyère ◽  
Nicolas Meunier-Beillard ◽  
Fiona Ecarnot ◽  
Audrey Large ◽  
François Aptel ◽  
...  
Keyword(s):  
Informed Consent ◽  
Clinical Research ◽  
Informed Consent Process ◽  
Consent Process ◽  
Family Perceptions

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.

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