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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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Compliance Corner – News Round Up

  Novel system to get dying patients an experimental cancer drug raises hopes – and thorny questions Compassionate use and “right to try” initiatives have been regular staples in the US news lately. Patient advocacy groups continue to push for greater access to experimental treatments, working with state and federal legislators to expand the ways […]

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When Is It Appropriate to Waive Informed Consent?

Informed consent is a critical part of the research process, but there are certain instances when the IRB may waive the requirement. In these situations, one of the important criteria to consider is whether the research could be practicably be carried out without the waiver of informed consent. FDA and OHRP regulations clearly state that […]

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