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Evaluating eConsent: Some Considerations from an IRB Perspective

At Schulman IRB we’ve been seeing more and more eConsent studies recently, which is great—eConsent technology can often better inform participants than just the traditional paper consent, which is great from an IRB perspective. We also now have federal guidance on how to implement eConsent in clinical research, making it a bit easier to implement […]

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Compliance Corner – News Round Up

This month we continue to contemplate big data as we look at two New England Journal of Medicine Perspective pieces. In Bridging the Data-Sharing Divide – Seeing the Devil in the Details, Not the Other Camp, Dr. Lisa Rosenbaum reflects on the differing views of data-sharing evidenced at a recent NEJM-sponsored summit, during which clinical […]

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Does This Study Require IBC Review?

One of the fastest growing areas in clinical research is clinical trials involving recombinant DNA, or gene therapy research. It’s an exciting space that is full of promise, but because of the risks involved, it’s also a highly regulated space. As many clinical research professionals are new to gene therapy research, confusion is common regarding […]

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Upcoming Regulatory Deadlines: NIH Policy on sIRB Review, 21st Century Cures Act and Final Revisions to Common Rule

Update: On October 7, 2017, the US Department of Health and Human Services (HHS) submitted a proposal to the White House Office of Management and Budget (OMB) to delay implementation of the final revised Common Rule by 1 year (to January 2019).  As of October 13, 2017, this proposal is under review with OMB, and […]

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NIH Policy for sIRB Review of Multicenter Research: Research Community Perspectives

With the effective date for NIH’s single IRB (sIRB) policy coming in January, many institutions are still grappling with what this policy means for their research programs. To gain a better understanding of the research community’s response to this new policy, Schulman IRB conducted an online survey of 260 institutional research leaders and administrators in […]

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Compliance Corner – News Round Up

We generally treasure our convenience tools – laptops, smart phones, baby monitors, home security systems – yet we are aware these tools can be hacked with deleterious effects. Now add to that list of hackable devices life-sustaining, health tools and medical devices, from pacemakers to insulin pumps. In FDA, Industry Fear Wave of Medical-Device Hacks, […]

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Planning Gene Therapy Research? Plan for IBC Review

The completion of the human genome project and advances in genetic engineering have paved the way for clinical trials involving human gene transfer, colloquially known as gene therapy research, to enter the mainstream. Gene therapy research involves the deliberate transfer of engineered genetic material to humans, with the goal of compensating for genetic mutations, conferring […]

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eConsent in Clinical Research: Trends and Questions

As everyone familiar with eConsent is aware, FDA and OHRP released a Q&A-style guidance on electronic consent in clinical research last December. Using that guidance as a springboard, some Schulman colleagues and I met with several dozen research professionals to discuss the topic in Boston this past February. We discussed key challenges of implementing eConsent […]

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