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Articles Tagged With: studies

  • IRB Reduces Student Study Review Time from 65 Days to 8 Days

    It is possible to shorten IRB review time dramatically, but it requires some resources and time. The IRB of Northcentral University serves a nontraditional population of students, some of whom want to complete a research study as part of their academic plan. The IRB’s streamlining process reduced the submission-to-approval time to eight days, down from an average of 65 days before the new process, according to new, unpublished data.

  • Researchers and IRBs Reconsider Minimal Risk After Trial Results

    A clinical trial that involved studying electronic health record alerts for acute kidney injury seemed to be minimal risk to both the researchers and the IRBs that approved it. However, when two hospitals involved in the study reported an increased mortality rate, the researchers and the IRBs reconsidered what is truly minimal risk in these types of studies.

  • Investigators Benefit from Using Online Self-Auditing Tools

    One method to improve regulatory compliance while maintaining IRB efficiency lies in teaching investigators how to conduct self-audits of their protocols and studies.

  • Tips for Reopening or Closing Research Studies

    The 2020 landscape for clinical trials looks different than it did five or 10 years ago. Even before the worldwide disruption in research from the COVID-19 pandemic, there were systemic shifts that have squeezed trials in ways that add pressure to investigators and IRBs.

  • IRBs Look at How to Get Through Pandemic — and Beyond

    As human research protection programs and IRBs enter the next leg of the COVID-19 pandemic, they can draw on experience to find the best balance between safety and efficiency. Each institution and IRB will face its own challenges. But one of the more common challenges as the United States copes with more than eight months of the crisis is pandemic fatigue and burnout.

  • IRBs, Research Organizations Adjust to New Norms in COVID-19 Era

    The research world’s axis shifted in 2020 with the COVID-19 pandemic. Research organizations and IRBs should expect that shift to be the new normal. There will be no return to the way it was before.

  • Biometrics Expert Discusses Data Integrity for COVID-19 Clinical Trials

    The first remdesivir double-blind, placebo-controlled clinical trial for treating COVID-19 was published recently in Lancet. A member of the trial’s data safety monitoring board is Weichung Shih, PhD. Shih discussed the role of biostatisticians in protecting data integrity for clinical trials and the challenges during the COVID-19 pandemic.

  • Small IRB Copes with COVID-19 Pandemic Under Limited Budget

    Many IRBs have seen clinical trial submissions decline since the COVID-19 pandemic began. Clinical trials also were put on hold. But work at Great Bay Community College — a one-person IRB office — has increased.

  • Q&A Part 1: IRBs Face Their Toughest Challenges with COVID-19

    IRB leaders describe the challenges staff faced during the transition to remote working.

  • IRBs Can Prepare for Cannabis Research

    The cannabis industry is a booming economic force across the nation as states increasingly legalize the sale of medical and/or recreational marijuana. It remains on the national Schedule I list of drugs that are not acceptable for legal sale. But what do healthcare providers really understand about the drug’s safety, risks, and benefits? Not enough, human research protection professionals say.