Tag: NPRM

Blog Posts (9)

December 5, 2016

Looking Back at the Bioethics Commission’s Blog

Throughout its tenure, the Bioethics Commission has maintained an active digital presence to connect with a global audience. A major component of this has been through its blog. This final blog post reflects on the role the blog has played in disseminating the Bioethics Commission’s work.
April 7, 2016

Fisher describes innovative approach to research involving vulnerable adolescents at OHRP conference

Fordham University Center for Ethics Education Director and Marie Ward Doty University Chair in Ethics Dr. Celia B. Fisher gave the keynote address this morning at an Office for Human Research Protections (OHRP) conference, entitled “Vulnerable, Marginalized and At-Risk Participants in … Continue reading
October 12, 2015

Human Subjects Research “Vulnerability”

by J.S. Blumenthal-Barby, Ph.D., MA

Revisions are being suggested to the Federal Policy for the Protection of Human Subjects through the Notice of Proposed Rulemaking (NPRM).…

October 9, 2015

Modernizing Human Subjects Research Protections: Legally Authorized Representatives and Consent Capacity

This is the last installment in a series of blog posts about recent proposed changes to the Common Rule, and how they relate to the work of the Bioethics Commission. The Common Rule currently requires permission from a legally authorized representative (LAR) to enroll participants who lack consent capacity in research. LARs consider and evaluate […]
October 5, 2015

Modernizing Human Subjects Research Protections: A Plan for Return of Results

The notice of proposed rulemaking (NPRM), issued in the Federal Register on September 8, 2015, proposes revisions to the Common Rule—federal regulations that govern the protection of human subjects in research—including changes to the criteria for institutional review board (IRB) approval of research. This is the next installment in a blog series about those changes […]
October 1, 2015

Modernizing Human Subjects Research Protections: Changing the Landscape of Biospecimen Research

In this fourth post in a new blog series, we zoom in on changes to the Common Rule—proposed in the notice of proposed rulemaking (NPRM) released earlier this month—that would alter oversight processes for biospecimen research. In its current form, the Common Rule contains a regulatory gap, recognized throughout the Bioethics Commission’s work. Today, when […]
September 24, 2015

Modernizing Human Subjects Research Protections: Informed Consent for Genetic Research

This is the third installment of a new blog series—Modernizing Human Subject Research Protections—taking a closer look at the recent notice of proposed rulemaking (NPRM) that suggests revisions to the Common Rule governing federally funded human subjects research. The NPRM draws on the work of the Bioethics Commission, and its ethical underpinnings mirror the analysis […]
September 23, 2015

Modernizing Human Subjects Research Protection: Applying the Principle of Regulatory Parsimony

This is the second blog post in our series Modernizing Human Subjects Research Protections, which analyzes the relationship between the recently released notice of proposed rulemaking (NPRM), proposing changes to the Common Rule governing federally supported human subjects research, and the Bioethics Commission’s work. This post reviews the relationship between the NPRM and portions of […]
September 23, 2015

Modernizing Human Subjects Research Protection: Applying the Principle of Regulatory Parsimony

This is the second blog post in our series Modernizing Human Subjects Research Protections, which analyzes the relationship between the recently released notice of proposed rulemaking (NPRM), proposing changes to the Common Rule governing federally supported human subjects research, and the Bioethics Commission’s work. This post reviews the relationship between the NPRM and portions of […]