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Week-in-Review

Week-in-Review | Independent Review Board | Scoop.it
A collection of stories and blogs that Jim Gearhart has collected that seemed interesting from the past week.
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Biobanks in the United States: Surveying a changing landscape

Biobanks in the United States: Surveying a changing landscape | Independent Review Board | Scoop.it
A survey of biobanks sheds light on the number of U.S. biobanks, where they obtain funding, how many specimens they store, and more.
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Ampersand: Confronting the Potential and Pitfalls of Mobile Technology and Privacy

Ampersand: Confronting the Potential and Pitfalls of Mobile Technology and Privacy | Independent Review Board | Scoop.it
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In The Paper Kingdom: Fight Dragons, Conquer Fear

In The Paper Kingdom: Fight Dragons, Conquer Fear | Independent Review Board | Scoop.it
The NIH worked with the NERI and others to put together a game that confronts the fears and concerns youth have about clinical trials.
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Quorum Review IRB | Institution Bulletin | OHRP & IRB Review of Registries

Quorum Review IRB | Institution Bulletin | OHRP & IRB Review of Registries | Independent Review Board | Scoop.it
This Institution Bulletin article discusses OHRP's recent responses regarding IRB review of Registries.
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Halloween Food Safety Tips for Parents

Halloween Food Safety Tips for Parents | Independent Review Board | Scoop.it
Halloween Feature item provides Food Safety tips parents can use to prepare for trick-or-treating and parties at home
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Consent for Future Research

Consent for Future Research | Independent Review Board | Scoop.it
Increasingly, participants in clinical trials are asked to allow their samples to be stored for future research. Read more...
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Research Using Human Specimens and Data

Research Using Human Specimens and Data | Independent Review Board | Scoop.it
This article helps clinical researchers understand U.S. regulatory flexibility for research involving specimens and data from human subjects
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David R. Van Houten's curator insight, October 3, 2014 10:16 AM

2 points on flexibility in HSRP regulations.  IRB issues involving biospecimens & data.  

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Access to Investigational Devices Outside of a Clinical Trial

Access to Investigational Devices Outside of a Clinical Trial | Independent Review Board | Scoop.it
Learn how investigative medical devices are allowed outside of clinical trials with emergency use, compassionate use, or treatment use mechanisms.
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Ethical Questions from Clinical Studies in India

Ethical Questions from Clinical Studies in India | Independent Review Board | Scoop.it
Quorum Review's Jim Gearhart on recent ethical issues with clinical trials that were conducted in India.
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Recording Available—eConsent for Research: Considerations in Implementation and IRB Review

Recording Available—eConsent for Research: Considerations in Implementation and IRB Review | Independent Review Board | Scoop.it
eConsent technology is changing the clinical trials industry. This webinar helps you make sense of the eConsent revolution.
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Digital Health: Will Pharma Follow or Lead? | C...

Digital Health: Will Pharma Follow or Lead? | C... | Independent Review Board | Scoop.it
The digital health movement is growing rapidly. Almost everyday we hear of new technology, apps and ideas that bring the promise of improved medical care, health and wellness.
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Ampersand: Looking Ahead and Looking Back: Lessons from the 2014 AER Conference

Ampersand: Looking Ahead and Looking Back: Lessons from the 2014 AER Conference | Independent Review Board | Scoop.it
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Post-Six Tips for Submitting a Clinical Study for Expedited Review

Post-Six Tips for Submitting a Clinical Study for Expedited Review | Independent Review Board | Scoop.it
Six Tips for Submitting a Research Study for Expedited Review Expedited review is a type of IRB review of research carried out by the IRB
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FDA Draft Guidance and the SUPPORT Trial

FDA Draft Guidance and the SUPPORT Trial | Independent Review Board | Scoop.it
A discussion of OHRP's recently issued draft guidance on disclosing reasonably foreseeable risks in research evaluating standards of care.
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Quorum Review IRB | Institution Bulletin | IRB Transfer Guidance

Quorum Review IRB | Institution Bulletin | IRB Transfer Guidance | Independent Review Board | Scoop.it
This article discusses recent FDA guidance on transferring clinical studies to a different IRB.
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Quorum Review IRB | Blog | Gamification Designs Some Serious Fun

Quorum Review IRB | Blog | Gamification Designs Some Serious Fun | Independent Review Board | Scoop.it
Quorum Review IRB's Jim Gearhart discusses the fun new trend of gamification in the clinical trials industry.
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Drawn to Science: Using Animation and Wit to Inform

Drawn to Science: Using Animation and Wit to Inform | Independent Review Board | Scoop.it
A look at Roche pRED's innovative use of video to communicate clinical trial information.
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Big Data Biorepositories and the IRB Conference

Big Data Biorepositories and the IRB Conference | Independent Review Board | Scoop.it
Join leading biorepository experts exploring best practices to collecting, storing and using large data and biospecimen collections with approval of the IRB
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What Can Human Subject Research Learn from the FDA's Draft Guidance on Internet/Social Media?

What Can Human Subject Research Learn from the FDA's Draft Guidance on Internet/Social Media? | Independent Review Board | Scoop.it
Human subject researchers can learn from the FDA’s draft guidance on platforms with character space limitations.
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Experiments in the Emergency Room

Experiments in the Emergency Room | Independent Review Board | Scoop.it
Quorum Review's Jim Gearhart discusses the critical differences between two recent, controversial studies.
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Understanding Reporting Obligations to the IRB Webinar

Understanding Reporting Obligations to the IRB Webinar | Independent Review Board | Scoop.it
IRB safety reporting is a maze of regulatory requirements. This webinar helps you understand IRB reporting obligations.
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DIA 2014 - Quorum Review

Mitchell Parrish, JD,RAC, Regulatory Attorney, Quorum Review, Inc., United States, provides a brief introduction to his presentation, Research Consent in Acu...
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FDI policy in pharmaceuticals sector set for major overhaul - Economic Times

FDI policy in pharmaceuticals sector set for major overhaul - Economic Times | Independent Review Board | Scoop.it
Economic Times FDI policy in pharmaceuticals sector set for major overhaul Economic Times NEW DELHI: The government is set to make major changes in the current FDI policy in the pharmaceuticals sector to protect domestic generic industry in the...
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