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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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“Single IRB” vs “Central IRB” – What’s the Difference?

In 2016, the NIH policy on IRB review for multisite research brought a new-ish term into the clinical research lexicon: “single IRB review,” or “sIRB review.” This term seems to be on its way to replacing “central IRB” or “cIRB” in discussions about one IRB review conducted on behalf of all (or most) participating sites […]

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120,000 Nurses Who Shook Public Health

In this season of reflection and gratitude, I thought it most fitting to feature Alfredo Morabia’s “resounding, and unrestrained round of applause” for the 120,000 nurses who participated in the first Nurses’ Health Study (NHS). Dr. Morabia, Editor-in-chief of the America Journal of Public Health, writes “[t]his cohort of 121,700 nurses assembled in 1976 has […]

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Digital and Social Media Recruitment: Do’s and Don’ts

The internet offers scores of communication channels, many of which may provide effective ways to recruit participants for clinical trials. It’s important to remember, however, that internet-based recruitment methods are beholden to the same regulatory requirements as other forms of recruitment. The federal regulations consider direct advertising for study participants to be the start of […]

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