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Medical Research Informed Consent

Benesch

HHS and FDA Release Updated Guidance on Informed Consent

Benesch on

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

Sheppard Mullin Richter & Hampton LLP

Time to Refresh? FDA Issues Draft Guidance on Key Information and Informed Consent

Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued a draft guidance, “Key Information and Facilitating Understanding in Informed Consent”, with notable implications for clinical trial sponsors,...more

McDermott Will & Emery

HHS and FDA Seek Comments on Informed Consent Draft Guidance

McDermott Will & Emery on

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Services (HHS) Office for Human Research Protections (OHRP) and the US Food & Drug Administration (FDA) released a draft guidance document entitled Key Information and...more

Health Care Compliance Association (HCCA)

Understanding the requirements for waiving or altering HIPAA authorization for research

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

Goodwin

Master(ing) Protocols for Randomized Umbrella and Platform Trials

Goodwin on

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance, “Master Protocols for Drug and Biological Product Development”, that echoes and builds on principles that the Agency previously set forth in...more

Morgan Lewis - As Prescribed

Better Late Than Never: FDA Issues Long-Awaited Final Informed Consent Guidance

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

McDermott Will & Emery

FDA Issues Final Guidance on Informed Consent in Clinical Investigations

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

Epstein Becker & Green

FDA Issues Final Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors

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

BakerHostetler

FDA Issues Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors

BakerHostetler on

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

Nelson Mullins Riley & Scarborough LLP

FDA Publishes Informed Consent Final Guidance for Drug and Medical Device Clinical Investigations

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

Spilman Thomas & Battle, PLLC

The Story of Henrietta Lacks and the Biotechnology Company Accused of Selling Her Cells for Profit

Two articles (Newsweek and Fierce Biotech) describe the new lawsuit by the Henrietta Lacks Estate surrounding the HeLa cell line. The claim is "unjust enrichment," a difficult claim to win, but one that seems to fit this...more

Latham & Watkins LLP

EDPB Clarifies Use of Consent and Other Legal Grounds for Clinical Trials, but Challenges Remain

Latham & Watkins LLP on

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

Verrill

Tag, You’re It: FDA Issues Guidance Ahead of Revisions to its Human Subjects Protection Regulations

Verrill on

Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued new guidance (“Guidance”) for sponsors, investigators, and institutional review boards (“IRBs”) regarding how recent changes to the Federal Policy for...more

Bricker Graydon LLP

Clinical research compliance alert: Common Rule update - Additional proposed delay

Bricker Graydon LLP on

The Department of Health and Human Services (HHS) and 16 other federal departments and agencies released a Notice of Proposed Rulemaking (NPRM) proposing to delay the compliance date for updates to the Common Rule for an...more

K&L Gates LLP

Federal Agencies Propose to Further Delay Implementation of Sweeping Revisions to the “Common Rule”—but Offer Incentives for...

K&L Gates LLP on

On April 20, 2018, as anticipated, 17 federal departments and agencies (the “Agencies”) issued a notice of proposed rulemaking (“2018 NPRM”) in which the Agencies propose a six-month delay to the general compliance date for...more

Hogan Lovells

Clinical trials: Digital technology for recruitment, consent, and data capture

Hogan Lovells on

The conduct of clinical trials still relies heavily on the use of paper documents. Of course, electronic case report forms (eCRF) have been commonly used for many years – the medical information on a patient that is...more

Nelson Mullins Riley & Scarborough LLP

A Framework for Readying Your Institution for Complying With the Revised Common Rule

Earlier this year, the long-awaited revision to the Federal Policy for the Protection of Human Subjects, known as the ‘‘Common Rule,’’ was published in the Federal Register (the ‘‘Final Rule’’). 82 Fed. Reg. 7149 (Jan. 19,...more

K&L Gates LLP

Federal Agencies Delay Implementation of Common Rule Revisions

K&L Gates LLP on

On January 17, 2018, sixteen federal departments and agencies (the “Agencies”) delayed implementation of sweeping changes to the Federal Policy for the Protection of Human Subjects (the “Common Rule”) adopted a year ago that...more

Hogan Lovells

Italy approves new provisions on informed consent and advance decision of medical treatments – Why it matters for clinical trials...

Hogan Lovells on

On December 14th, 2017, the Italian Senate passed a long-awaited bill (DDL no 2801) governing the informed consent to medical treatments, which also allows individuals to express their wishes on medical treatments in the...more

Morgan Lewis

FDA Clarifies Consent Requirements for Certain Minimal Risk Clinical Investigations

Morgan Lewis on

FDA’s guidance, which permits institutional review boards to waive informed consent for certain clinical investigations, may facilitate valuable personalized medicine research....more

Kilpatrick

FDA Issues New Guidance on IRB Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations

Kilpatrick on

As July comes to an end, the Food and Drug Administration (FDA or agency) has issued a new guidance document for “immediate implementation” entitled “IRB Waiver or Alteration of Informed Consent for Clinical Investigations...more

Alston & Bird

HHS Subjects Human Research to an Updated Common Rule

Alston & Bird on

The Department of Health and Human Services has taken a step toward harmonizing the complex regulatory requirements for federal human subjects research. Our Health Care Group breaks down the changes to the Common Rule due to...more

Brownstein Hyatt Farber Schreck

Updates to the Common Rule for the Protection of Human Subjects Research

On Sept. 8, 2015, the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rule Making (NPRM) to seek input on changes to the Federal Policy for the Protection of Human Subjects, otherwise known as...more

Epstein Becker & Green

Six Key Changes to the Common Rule

Epstein Becker & Green on

On January 19, 2017, sixteen federal agencies, including the Departments of Health and Human Services and Labor, published the first revision to the federal regulations governing the protection of human subjects participating...more

McDermott Will & Emery

HHS Finalizes Toned-Down Version of Common Rule Overhaul

The Final Rule published by the US Department of Health and Human Services on January 18, 2017, largely avoids major modifications to the Common Rule. However, it specifically addresses creation of biospecimen and data...more

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