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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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Compliance Corner – News Round Up

Considering Technology, Privacy and Its Impact on Health Technological advancements have made it possible for us to communicate and collaborate in incredible new ways. This same technology has also brought us new ethical challenges in what and how we share with each other. This month, we look at three recent developments in the realm of […]

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Compliance Corner – News Round Up

Clinical Promise and Safety in First-in-Human Studies In our January wrap up of 2016 events, we speculated the ripple effects of the French Phase I trial gone wrong would endure as we continue to learn and seek ever better means to protect the rights, safety and welfare of research participants. In this month’s Nature, bioethicists […]

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Component Analysis: Analyzing Benefits and Risks of Individual Interventions to Ensure Appropriate Research Participant Protections

A major element of any IRB review is the examination of potential benefits and risks to study participants. In studies involving multiple interventions and/or placebo, applying component analysis can help IRB members understand the different levels of risk associated with each intervention. Component analysis differs from an overall risk assessment, in which a study’s combined […]

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IRB Review of Adaptive Design Studies

The popularity of adaptive design in clinical research continues to grow. Adaptive design can be more efficient than traditional study design, and it can help speed decision making. Considering these benefits, plus the ever-increasing cost of conducting clinical research, it’s no wonder adaptive design is so appealing to researchers. Adaptive design may involve changes to […]

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Significant Events from 2016 and How They May Shape the Year Ahead

As 2016 fades in the rear-view mirror, we will remember it as an eventful year for health and human subject research. At Schulman IRB, we read, we learned, we taught, we published. To all our contributors and consumers – thank you for your time, your efforts and your feedback. In this month’s edition, we look […]

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Key Takeaways from the FDA-HHS eConsent Guidance

In December 2016, FDA released its guidance on the use of eConsent in clinical research. Jointly prepared by HHS and FDA, the document provides IRBs, investigators and sponsors with recommendations on using electronic systems and processes to obtain consent in HHS-regulated and FDA-regulated clinical trials.

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