Exploring Digitization of Health and Medical Data and Records Part Two
Life Sciences Quarterly (Q4 2017): The Use of Social Media and Mobile Applications
The Evolution of Informed Consent in U.S. Courts
What patients misunderstand about their right of informed consent
On March 1, 2024, the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the US Food & Drug Administration (FDA) unveiled a preliminary guidance document named Enhancing...more
Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued a draft guidance, “Key Information and Facilitating Understanding in Informed Consent”, with notable implications for clinical trial sponsors,...more
On March 1, 2024, the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the US Food & Drug Administration (FDA) released a draft guidance document entitled Key Information and...more
The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical...more
The HIPAA Privacy Rule sets forth provisions related to the waiver or alteration of authorization in relation to clinical research studies for circumstances in which it would be impractical or impossible to obtain...more
The Food and Drug Administration ("FDA") expands informed consent exceptions with a final rule permitting institutional review board ("IRB") waiver or alteration of elements for certain FDA-regulated minimal-risk clinical...more
The U.S. Food and Drug Administration (FDA) recently issued a draft guidance, “Master Protocols for Drug and Biological Product Development”, that echoes and builds on principles that the Agency previously set forth in...more
In this episode, Alexa Sengupta and Cindy Ortega Ramos analyze the FDA’s latest guidance on informed consent regulations for clinical investigations. They discuss the basic elements of the consent form, documentation...more
After almost a decade, the Food and Drug Administration (FDA or Agency) finalized the Informed Consent guidance document (Final Guidance). The Final Guidance finalizes the 2014 draft Informed Consent Information Sheet...more
On August 15, 2023, the Food and Drug Administration (FDA) issued its updated guidance on informed consent for clinical investigations. The FDA’s updated guidance is titled Informed Consent Guidance for IRBs, Clinical...more
On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new examples and limited...more
On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July...more
Nearly nine years to the day the Food and Drug Administration (FDA) issued a draft “information sheet” on informed consent, the agency published a 66-page final guidance document on the topic—marking the first time since 1998...more
On Aug. 15, the Food and Drug Administration (FDA) issued new guidance aimed at assisting institutional review boards (IRBs), clinical investigators and sponsors in complying with the FDA’s informed consent requirements for...more
The U.S. Food and Drug Administration (FDA or the Agency) has issued the final guidance document, “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” (Final Guidance). The...more
On August 15, the U.S. Food and Drug Administration (FDA or the Agency) published the final guidance document, “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” (Final...more
Report on Research Compliance 19, no. 2 (January 27, 2022) - The trial was to be like any other that the clinical research organization (CRO) would oversee. The six-month study, known as VESTRI, would involve pediatric...more
The U.S. Food and Drug Administration’s (FDA’s) Office of Bioresearch Monitoring Operations (OBIMO) oversees domestic and foreign agency field inspections for clinical and non-clinical research. In particular, OBIMO manages...more
Consent Forms (ICF) to include an explicit reference as to the possibility that EU inspectors would have access to medical records and personal data of clinical trial participants....more
Conducting medical product clinical trials during the COVID-19 public health emergency presents unprecedented challenges. In light of the challenges presented by COVID-19, the Food and Drug Administration (FDA) issued...more
On June 3, 2020, the U.S. Food & Drug Administration (“FDA”) again updated its guidance on the “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” with new information on the use of...more
Many sectors of the economy have ground to a halt in the effort to curtail the COVID-19 pandemic (the “Pandemic”), and the clinical research industry is not immune to the effects of these business shutdowns. While the...more
Big Pharma is testing crucial boundaries in the way that the nation determines the safety and effectiveness of prescription medications. And regulators, for patients’ sake, need to shove back — hard....more
Clinical trials in the EU include the collection of sensitive health data from patients. Trial sponsors are obliged to reconcile their respect of regulations governing data protection with regulations governing the conduct of...more
European regulators are expected to align their processes and guidance to accommodate the EDPB’s recommended approach to processing special categories of personal data. In January, the European Data Protection Board (EDPB)...more