Informed Consent

News & Analysis as of

Federal Court Dismisses Accused Student’s Title IX Lawsuit Against Vassar College

Last week, a federal judge in New York (Abrams, J.) dismissed an accused student’s lawsuit against Vassar College alleging that the institution discriminated against him by failing to conduct an equitable investigation into a...more

Washington Healthcare Update

This Week: CMS Releases Three Documents on Biosimilar Reimbursement... SCOTUS: Agencies, Not State Courts, in Charge of Medicaid Rate Setting... HHS OIG and Treasury IG Release Report on ACA’s Advanced Premium Tax Credits....more

FDA Issues Draft Guidance on Use of Electronic Informed Consent in Clinical Trials

On March 9, 2015, the U.S. Food and Drug Administration (FDA) released a draft guidance, Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers, that provides recommendations for clinical...more

Health Update - March 2015

Supporting Informed Decision Making in the Health Insurance Marketplace: A Progress Report - Editor’s note: As Affordable Care Act (ACA) implementation moves forward and the marketplace continues to evolve, there is a...more

Alert: Website Terms and Conditions: A Call for Clarity

The UK House of Commons has highlighted the need for clarity of website terms and conditions in order to allow users to provide their "informed consent" to the terms....more

New FDA Guidance Opens the Door for Electronic Consent Forms That Come with Significant Advantages and Raise Privacy and Secure...

On March 9, 2015, the U.S. Food and Drug Administration (FDA) published a draft guidance that allows for the use of electronic informed consent (eIC) in human clinical trials. eICs have the potential to...more

Going Paperless: FDA Releases Draft Guidelines to Digitize Clinical Trials

The FDA released draft guidelines (“Guidelines”) on Monday, March 9, 2015 establishing recommendations on the use of e-media and processes to obtain informed consent for clinical investigations (trials) of medical products...more

A Review of New York’s Proposed Sexual Violence Legislation – Part I: Consent

As we noted in our last post, we will be taking a closer look at the specific provisions of New York’s proposed sexual violence legislation over the next week or so. With the Governor’s Office urging New York colleges and...more

HK's Christine Helwick Tells the Daily Journal That "Only Yes Means Yes In California Schools"

California has become the first state in the nation to enact a "yes means yes" standard in university disciplinary hearings involving claims of sexual assault, domestic violence, dating violence and stalking. All colleges and...more

Another Blow to Call Recording Class Actions

Back in February, the California Court of Appeal in Hataishi v. First American Home Buyers Protection Corp., 223 Cal. App. 4th 1454 (Feb. 21, 2014), dealt a significant blow to call recording class actions across California. ...more

FDA Updates Manual on Review of INDs Seeking Exception from Informed Consent for Emergency Research under 21 C.F.R. § 50.24

On November 17, 2014, the U.S. Food and Drug Administration (FDA) published a revised version of its internal review procedures and policies for Investigational New Drug applications (INDs) that implicate the exception to the...more

A Quick Summary of New Changes to California Law

Our friends at Legsilative Intent Service (a great resource for digging deep into the history of California legislation) have recently published their list of changes to California law coming in 2015. These legislative...more

Office for Human Research Protections Releases Draft Guidance

On October 24, 2014, the Office for Human Research Protections (OHRP) announced in the Federal Register that it has released, and is seeking comment on, its Draft Guidance on Disclosing Reasonably Foreseeable Risks in...more

Are Browsewrap Agreements Enforceable?

Almost all social media sites contain “Terms of Service” (“TOS”). Are they enforceable against users? It depends on the presentation and the issue....more

FDA Releases Draft Guidance Updating Agency Policies on the Informed Consent Process for Clinical Trials

On July 15, 2014, the U.S. Food and Drug Administration (“FDA”) released draft guidance that provides extensive commentary on FDA’s current thinking regarding the clinical trial informed consent process. Once finalized, this...more

The Evolution of Informed Consent in U.S. Courts [Video]

Learn about the history of how informed consent has been handled by our court system - 202-742-1500. We also invite you to read more about the landmark case, Canterbury v. Spence:...more

Palliative care – navigating the difficult path of informed consent

Medical practitioners are placed in a difficult position when close family members disagree about the treatment that should be provided to a loved one who is no longer capable of making his or her own decisions. ...more

The FDA’s Informed Consent Draft Guidance: Insights and Challenges for IRBs, Clinical Investigators and Sponsors

On July 15, 2014, the FDA released a draft guidance document (“Guidance”), proposing recommendations to Institutional Review Boards (IRBs), clinical investigators and research sponsors relating to the informed consent process...more

What patients misunderstand about their right of informed consent [Video]

Many patients misunderstand what "informed consent" is all about. They often believe it's about signing a form ahead of surgery that acts as a waiver against any rights they may have for legal recourse if the surgery goes...more

Federal Court Holds Manufacturer of Investigational Drug and Medical Device Responsible for Clinical Trial Investigator’s...

In a recent decision subject to multiple flaws, the United States District Court for the District of Massachusetts refused to dismiss a suit against the manufacturer of an investigational drug and medical device used in a...more

Foley Hoag Authors Good Practice Note on Indigenous Peoples’ Rights and Free, Prior, and Informed Consent

The U.N. Global Compact recently released a Good Practice Note on Indigenous Peoples’ Rights and the Role of Free, Prior, and Informed Consent (“FPIC”) authored by Amy Lehr, an associate in Foley Hoag’s Corporate Social...more

European Union Negotiations Reach Agreement on New Clinical Trials Regulation

The European Union (“EU”) has cleared the way for adoption of a new clinical trials regulation within the EU. On December 20, 2013, the Committee of Permanent Representatives of the European Union endorsed proposed revisions...more

FTC Reaches $32.5 Million Settlement Agreement with Apple, Inc. Over Deceptive Billing Practices in Mobile Apps for Children

The Federal Trade Commission announced its sizeable settlement agreement with Apple, Inc. on Wednesday, over allegations that the company had violated Section 5 of the Federal Trade Commission Act by billing consumers...more

Agricultural Sector Companies Face Increased Scrutiny on Human Rights-Related Risks

Agricultural sector companies, and companies with large agricultural supply chains, face new scrutiny from investors and other stakeholders concerning human rights-related risks in their corporate supply chains. Key issues...more

Controversial U.S. Medical Study Raises Informed Consent Questions

The recent controversy surrounding a study of newborn babies in universities across the United States demonstrates the importance of compliance with human subject protection regulations in medical research....more

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