IRB Advisor – October 1, 2017
October 1, 2017
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FDA’s Informed Consent Change Is Step Toward Harmonizing
The FDA’s recent move to allow a waiver of informed consent for studies involving minimal risk could be a first step toward harmonization with the existing Common Rule.
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IRBs Share Strategies to Prepare for New Common Rule
Some IRBs have been preparing for months for the Jan. 19, 2018, implementation of the new Common Rule. Others have taken a more casual, wait-and-see-if-it’s-delayed approach. IRBs that are preparing for a January rollout have found that preparation is time-consuming and resource-intensive.
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NIH Considers Action on Pay-to-Participate Trials
Recent action by federal authorities against stem cell clinics charged with questionable practices appear to validate concerns raised by bioethicists like Leigh Turner, PhD, who recently warned that some stem cell clinics are charging research subjects exorbitant fees for participation in experimental treatments marketed as clinical trials on ClinicalTrials.gov.
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FDA Lowers the Boom on Stem Cell Clinics
The FDA recently cracked down on two stem cell clinics for questionable research practices, including one clinic that was using smallpox vaccine as part of a treatment protocol.
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Broad Consent Issues raised by SACHRP and Others
With broad consent, patients would have an easy and speedy opportunity to opt out of future research uses of their biospecimens. But if they didn’t opt out — and most people probably would agree to the research use of their specimens — then scientific progress could proceed without the consent roadblock.
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AllTrials Seeks Transparency in Big Pharma Studies
The AllTrials campaign, striving to achieve full disclosure of all results in clinical trials, recently conducted an audit of the transparency policies of pharmaceutical companies, finding them open enough on the surface — but beset with devils in the details.
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Study: Trial Results for New Neurological Drugs Often Go Unpublished
Results of clinical trials for “stalled” neurological drugs — those which had at least one completed Phase III trial but failed to receive FDA approval — are heavily underreported, found a new study.