Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 200: Athlete Mental Health and Physical Conditioning With Dawn Staley
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Podcast - Discussing the Mission of Black Women's Health Imperative with CEO Linda Goler Blount
Verdict in T-Cell Immunotherapy IP Case Tests 'Reasonable Royalty' Concept for Large Damage Awards
BLACK HISTORY MONTH | KATHERINE JOHNSON AND CHARLES DREW
Technology in Healthcare
The HHS Office for Human Research Protections (OHRP) is currently operating with a 62% vacancy rate among staff, as it has not filled open positions, agency officials say. OHRP has a staff of 20, but there are an additional...more
Report on Research Compliance 18, no. 8 (August, 2021) - “As a steward of the nation’s biomedical research enterprise, NIH is dedicated to ensuring that when data and biospecimens are shared, that it is done ethically and...more
In this week’s episode, Richard Church interviews Rebecca Schaefer about the intersection and blurred line between clinical research and quality initiatives. The presenters discuss what factors to consider when defining...more
Gov. Gavin Newsom recently approved A.B. 713, a bill that creates further CCPA exceptions for healthcare and research information. The bill is especially potent in the COVID-19 era where the need for medical research is...more
On January 6, 2020, the California State Senate’s Health Committee unanimously approved California AB 713, a bill that would amend the California Consumer Privacy Act (CCPA) to except from CCPA requirements additional...more
The California Consumer Privacy Act of 2018 (“CCPA”) took effect on January 1, 2020. Days later on January 8, 2020, the California Senate Health Committee unanimously approved Senate bill A.B. 713 (the “Bill”) to establish...more
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
On October 12, FDA published guidance for sponsors, investigators, and IRBs titled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” ...more
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
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
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
The Federal Policy for the Protection of Human Subjects, or the “Common Rule,” was originally published in 1991 and has been adopted and codified in separate regulations by HHS and 15 other federal departments and agencies. ...more
The U.S. Department of Health and Human Services has delayed the effective and compliance date for the updates to the Common Rule for six months from January 19, 2018, until July 19, 2018. The updates make significant changes...more
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
On January 22, 2018, the White House again delayed the effective date of revisions to the Federal Policy for the Protection of Human Subjects, referred to as the Common Rule. Final revisions were published on January 19,...more
The updates to the Common Rule, effective January 19, 2018, make some significant changes of which those involved in government-funded clinical research involving human subjects should be aware. These changes include...more
Changes to the federal regulations governing the protection of human subjects participating in research (known as the Common Rule) were amended earlier this year. The changes to the Common Rule impact research conducted,...more
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
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
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
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
Late last month the Department of Health and Human Services (HHS) and other Federal Departments and Agencies announced an extension until January 6, 2016 to the comment period for the Federal Policy for the Protection of...more
Those wishing to comment on revisions to the Federal Policy for Protection of Human Subjects (known as the “Common Rule”) could add a 30-day comment period extension to the things they were grateful for at this year’s...more
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
The world has changed drastically since 1991 when Operation Desert Storm was underway; the USSR crumbled; Prince Charles and Princess Diana separated; the World Wide Web was born; gas cost $1.14; and the Dow peaked at 3168....more