Search Results for Informed Consent

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Patients Not Always Informed of Study's Purpose in Noninferiority Trials By Michael Mezher - Published 23 August 2017

A study published in JAMA Internal Medicine this week finds that patients participating in noninferiority trials for antibiotics are not always accurately informed of the purpose of the study, based on an analysis of informed consent forms.

Categories: News, EMA, FDA, Clinical, Drugs, Ethics

Tags: Noninferiority, Superiority, Antibiotics, Clinical Trials, Informed Consent

FDA Issues Guidance on Informed Consent Waivers for Minimal Risk Studies By Michael Mezher - Published 24 July 2017

The US Food and Drug Administration (FDA) on Monday issued a final guidance detailing the circumstances in which the agency will not object to waiving or altering informed consent requirements for clinical studies that pose a minimal risk to participants.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Ethics, Medical Devices

Tags: Informed Consent, Minimal Risk, 21st Century Cures

Electronic Informed Consent: Final Q&A Spells Out New Recommendations By Zachary Brennan - Published 14 December 2016

The Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) and the US Food and Drug Administration (FDA) on Wednesday finalized a question and answer (Q&A) guidance on using electronic systems to obtain informed consent for both HHS-regulated human research and FDA-regulated clinical investigations of medical products.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: electronic informed consent, eIC, medical research and informed consent, informed consent and FDA guidance

FDA Seeks Info on New Tech Helping Conduct Clinical Research By Zachary Brennan - Published 28 October 2015

The US Food and Drug Administration (FDA) on Wednesday announced it's looking for more information on technologies and innovative ways to more efficiently conduct clinical research.

Categories: News, US, FDA, Clinical, Drugs, Research and development

Tags: clinical trials, informed consent, FDA, mobile technology

FDA Says it's OK With Modernizing the Clinical Trial Informed Consent Process By Alexander Gaffney, RAC - Published 09 March 2015

New guidance issued by the US Food and Drug Administration (FDA) could make it easier for companies to conduct clinical trials by explaining how federal regulators will permit companies to use electronic media like interactive websites to help facilitate the informed consent process.

Categories: News, US, FDA, Clinical, Drugs, Ethics

Tags: 21 CFR 50, Informed Consent, Electronic Informed Consent, Guidance, Draft Guidance

FDA Revises Policies on Obtaining Informed Consent in Clinical Trials By Alexander Gaffney, RAC - Published 15 July 2014

A new draft guidance document issued by the US Food and Drug Administration (FDA) is meant to eventually replace a 16-year-old guide outlining the regulator's views on informed consent.

Categories: News, US, FDA, Clinical, Ethics, Research and development

Tags: Informed Consent, Draft Guidance, IRB, Investigator, Sponsor, Obtaining Informed Consent

India’s CDSCO Issues Guidance on Recording Informed Consent By Louise Zornoza, RegLink - Published 10 January 2014

Categories: Audio, India, CDSCO

Tags: Informed Consent, clinical trials

India Requires Audio-Visual Record of Clinical Trial Subject Consent By Alexander Gaffney, RF News Editor - Published 21 November 2013

Categories: Audio, India, CDSCO

Tags: Informed Consent, clinical trials

Brazil Clarifies Informed Consent Requirements By Louise Zornoza, RegLink - Published 03 January 2013

Categories: Ethics

Tags: Informed Consent, Payment, Latest News, compensation, brazil, clinical trials, GCP

FDA Releases Small Entity Compliance Guide for Informed Consent Elements By Alexander Gaffney - Published 09 February 2012

Categories: FDA

Tags: Question and Answer, Guidance Document, Informed Consent, IRB, Latest News, clinical trials