Quorum Review

Is eConsent adoption poised to grow?

Friday, September 1, 2017

Activity in the eConsent sector has risen considerably during the past six months, with Medidata’s acquisition of electronic informed consent pioneer Mytrus and the entry of new market players, even though widespread industry adoption of the technology has appeared to have stalled.

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OHRP/FDA offer final guidance on electronic informed consent

Saturday, April 1, 2017

On December 15, 2016, the Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services (HHS) and the FDA published final guidance aimed at providing answers to commonly asked questions about using electronic informed consent (eConsent)in clinical investigations. The guidance applies to “electronic systems and processes that may employ multiple electronic media to obtain informed consent for both HHS-regulated human subject research and FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof.”1 This guidance finalizes the draft guidance Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers that was issued in March 2015. The final guidance was developed in collaboration with FDA and OHRP and is issued as a joint final guidance.

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HHS appoints Quorum’s Dr. Stephen Rosenfeld SACHRP Chair

Wednesday, December 21, 2016

Dr. Stephen J. Rosenfeld, executive IRB chair for Quorum Review IRB, has accepted an invitation from Sylvia Burwell, the Secretary of the Department of Health and Human Services (DHHS), to chair the Secretary’s Advisory Committee for Human Research Protections (SACHRP). SACHRP comprises experts in the fields of research and ethics, and provides advice and recommendations to the Secretary of DHHS on issues pertaining to the protection of human subjects in research.

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IRBs react to new model for registering proposed gene trials

Monday, May 2, 2016

On April 27, the National institutes of Health (NIH) enacted a new administrative model for the review of proposed human gene trials; the new guidelines upend a process that has been in place for more than 40 years. Predictably, reaction throughout the industry is mixed. Larger firms are adjusting quickly to the change and retooling their processes to comply with the new model. At the other end of the spectrum, some IRBs, including IntegReview, declined to comment on the changes, stating that the matter is still under internal review.

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