Learn eCORE is happy to post this guest blog, from Solutions IRB that is the second in a two-part series on virtual focus groups.  This blog provides a handy check-list of key considerations for virtual focus groups that were discussed in detail in the prior blog on this topic.   Thanks to the Solutions IRB team for letting us share this practical information with our readers.   Considerations for Design of Virtual Focus Group Consider: Do the risks outweigh the benefits? Can taking notes suffice instead of recording? And then discard the notes immediately after an ..read more

  Learn eCORE frequently blogs on topics related to protecting the rights and welfare of human research participants.  This guest blog, from Solutions IRB, addresses consent and privacy considerations for virtual focus groups, which have become more common since the COVID pandemic.   Thanks to the Solutions IRB team for letting us share this with our readers.    Considerations for Design of Virtual Focus Groups  A focus group is a qualitative research method that uses a moderated format to gather descriptive data from a small group of participants specificall ..read more

  Population-based surveys, which are typically conducted at the household level, are the primary source of public health data in low and middle-income countries (LMICs). These surveys collect data on demographics, health, nutrition, HIV and other infectious diseases and are a key source of data on the health status of women and children globally. Additionally, household surveys are the major source of indicators of the sustainable development goals (SDGs). But conducting population-based surveys can be challenging. Fortunately, not all challenges are inevitable or equal: some can be reso ..read more

  Protecting the privacy of research participants and maintaining the confidentiality of their data is an important aspect of ensuring adequate protections in human subjects research. For most investigators, this means having strong physical and electronic methods to protect research information. However, for research that collects sensitive information where release to those outside of the research might cause harm to participants, investigators also need to consider additional protections against legal and other demands for research information. For example:   An investigator is co ..read more

  All federally funded human subjects research, and at many institutions, all human subjects research, must be approved by an Institutional Review Board (IRB). The IRB is an independently functioning committee charged with reviewing human subjects research to ensure that participants are protected according to accepted ethical standards and regulatory requirements. IRBs can be based within an institution (such as a university or hospital) or can be an independent IRB that reviews studies for a variety of institutions and research groups. All IRB operate according to federal regulations ..read more

  Title: “Research Compliance Unveiled:  The How and Why”. Presenters: Sherry Mills, MD, MPH and Ann Hardy, DrPH, CIP, Learn eCORE Founders Date & Time:  Thursday October 19, 2023 from 2-3 EST This event will review the research compliance landscape of particular relevance to new biotech and life sciences companies. Interested? Click HERE to register. The post Learn eCORE Presents a Free Research Compliance Webinar Hosted by VA BIO first appeared on Learn eCORE ..read more

  Clinical trials are the cornerstone of medical advancement, offering hope for improved treatments and cures. However, their success is not solely defined by the groundbreaking therapies they investigate. Instead, it relies on the effectiveness of clinical operations and the collaborative engagement of clinical research sites. Achieving clinical trial success means recognizing the interplay between stakeholders including sponsors, contract research organizations (CROs), sites, and patients. In this blog, we will explore some approaches that can help achieve optimal clinical operations.&n ..read more

  The 2018 revised Common Rule included a new requirement that consent forms begin with a presentation of the key information most likely to help potential participants understand why they might or might not want to participate in the research. This section must be short and be presented to facilitate comprehension.  Unfortunately, many investigators are either not aware of this new requirement or are unclear about what it should include.  This confusion often increases the time needed for IRB approval, leading to delays in starting the research.  What is the purpose of the ..read more

  Learn eCORE is pleased to feature this blog on clinical research project management authored by Desiree Underwood-Williams, a well-regarded clinical research professional and a dedicated mentor to others working in this field.  Learn eCORE’s library of soft skills training that are included with all subscriptions has project management courses directly related to the tips for success Desiree describes in this blog.   Clinical research is a complex and challenging field. It necessitates the coordination of various people and resources and must be conducted in compliance with ri ..read more

  Dr. Stephen Rosenfeld is an experienced researcher and IRB executive, having served in leadership positions at Western IRB and Quorum Review.  Together with colleagues, he recently founded the non-profit North Star Review Board.  We recently had the opportunity to talk to Stephen about the role of IRBs, including independent IRBs, and the recent GAO report on IRB oversight and effectiveness. We hope you find this as thought-provoking as we did!     Stephen, tell us about yourself, including your background, the kinds of research you have conducted, and how you g ..read more