IRB

News & Analysis as of

European Banking Authority Publishes Final Guidelines on Application of Definition of Default 

The European Banking Authority published the final Guidelines specifying the application of the definition of default in relation to the Internal Ratings Based Approach and the Standardized Approach under the Capital...more

NIH Signals “Paradigm Shift” with Policy on Multi-Site Studies

Federally-funded clinical trials conducted at multiple sites will move to a single Institutional Review Board (IRB) review scheme under a new National Institutes of Health (NIH) Policy. The NIH has finalized its policy to...more

FDA Streamlines the Expanded Access Approval Process for Individual Patients

The U.S. Food and Drug Administration (FDA) just made it easier for physicians to get critically needed, but not yet approved in the U.S., treatments to some of the nation’s most critically ill patients. FDA Commissioner...more

FDA Issues Guidance on Expanded Access Use of Investigational Drugs

The U.S. Food and Drug Administration (FDA) issued three final guidance documents on June 2, 2016, that address FDA's rules and regulations governing "expanded access" to investigational drugs. The expanded access process –...more

The Proposed Common Rule: The Tribe Has Spoken, and They Have Concerns (Part 2)

On September 28, 2015, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a notice of proposed rulemaking (NPRM) updating federal policy for the Protection of Human Subjects, more...more

UK Financial Regulatory Developments - May 2016 #6

Industry associations agree cyber principles - ISDA, the European Banking Federation and the Global Financial Markets Association have published a set of common principles they hope will encourage effective global policy...more

Basel Committee on Banking Standards Proposes Amendments to the Internal Rating Based Approach

The Basel Committee on Banking Standards launched a consultation on changes to the advanced internal ratings based approach and the foundation IRB approach so as to reduce variation in capital requirements for credit risk...more

UK Financial Regulatory Developments - February 2016 #10

EBA publishes MCD passporting compliance table - EBA has published a table noting the compliance status of Member States in relation to EBA’s guidelines on passport notifications for credit intermediaries under the...more

The Food and Drug Administration Announces a Stay Related to IND Guidance

On October 30, 2015, the Food and Drug Administration (FDA) announced in the Federal Register a stay of certain portions of a September 2013 final guidance for clinical investigators, sponsors and institutional review boards...more

PRA updates statement on IRB approaches

PRA has updated its supervisory statement on internal ratings based (IRB) approaches to credit risk. It has removed expectations now superseded because of actions by the Commission. The updates made include: - deleting...more

What To Do About Junk Science That’s Published?

We’ve been corresponding recently with long-time friend-of-the blog, Dr. Frank Woodside over the unfortunate fact that junk science these days doesn’t only mean stuff (in the Jeb! sense) that isn’t published in what passes...more

EBA consults on harmonised definition of default

EBA is consulting on draft guidelines under the Capital Requirements Regulation (CRR) to harmonise the definition of default across the EU prudential framework, which is intended to bring consistency in the way EU banks apply...more

Prudential requirements supplements in OJEU

Delegated Regulations relating to Regulatory Technical Standards (RTS) under the CRR have been published in the OJEU. These concern: - forms for disclosure of information in relation to the compliance of institutions...more

HHS Issues Proposed Rule That Would Revise the Federal Policy for the Protection of Human Subjects

Proposals are Intended to Enhance Protections for Higher Risk Clinical Research and Privacy Safeguards, including Uses of Biospecimens and Identifiable Private Information - On September 8, 2015, the Department of Health...more

HHS Releases Notice of Proposed Rulemaking Updating Rules for Human Subjects Research

On September 2, 2015, HHS issued the long-awaited Notice of Proposed Rulemaking (NPRM) on revisions to the rules governing federally-funded research involving individuals, commonly referred to as the Common Rule (Subpart A of...more

HHS Releases Highly Anticipated Proposal to Modernize U.S. Human Subjects Research Protections

In a notice of proposed rulemaking (NPRM) released September 2, 2015, the U.S. Department of Health and Human Services (HHS), through the Office for Human Research Protections (OHRP) and 15 other federal departments and...more

Drastic Changes Proposed for Clinical Research Rules

The U.S. Department of Health and Human Services (“HHS”) and fifteen other Federal Departments and Agencies have announced a proposal to update the Federal Policy for the Protection of Human Subjects known as the “Common...more

Agencies Release Proposed Overhaul of the Common Rule

On September 2, 2015, sixteen federal departments and agencies, including the US Department of Health and Human Services (HHS) released a proposed rule to modernize regulations governing human research subjects under the...more

OIG finds CFPB headquarters renovation costs to be reasonable

The Office of Inspector General for the Fed and CFPB (OIG) has issued a report on the results of its audit of the construction costs for the CFPB’s Washington, D.C. headquarters renovation. The renovation costs have been the...more

EBA Publishes RWA Assessment as the Next Step in Improving Consistency of Internal Model Outcomes

The European Banking Authority (EBA) has published two reports on the consistency of Risk-Weighted Assets (RWAs) across large EU institutions for large corporate, sovereign and institutions’ Internal Ratings-Based (IRB)...more

Blog: JAMA: Study Shows “Significant Positive Progress” in Managing Conflicts of Interest Among IRB Members, But More Work Needed

JAMA Internal Medicine published a report this week titled, Industry Relationships Among Academic Institutional Review Board Members: Changes From 2005 Through 2014, which is an update to a similar study conducted in 2005....more

OIG finds flaws in approval process used for CFPB headquarters renovation

The ballooning cost estimates for renovating the CFPB’s Washington, D.C. headquarters was the subject of verbal sparring between Director Cordray and Republican Congressmen during Director Cordray’s most recent appearance...more

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