CRO - Advarra - Page 14

Q&A Part 1 – Evaluating Payment to Participate in Research: Ethical and Regulatory Issues

In a recent webinar, Dr. Luke Gelinas, IRB Chair at Advarra, provided a framework for evaluating offers of payment to research participants. In addition to outlining the challenging ethical and regulatory issues and offering key regulatory guidance, he also provided hypothetical “case studies” to highlight challenging ethical and regulatory aspects of paying research participants. More than 1,000 clinical research professionals joined us for the webinar, which was followed by an engaging Q&A session. Below, Dr. Gelinas answers audience questions we weren’t able to address during the webinar. In the weeks ahead, we will publish part two of his responses, addressing additional questions from webinar attendees.

How Research Informs the COVID-19 Response

Research doesn’t just inform medical treatment; it informs public health and public policy, and it helps explain human behaviors.

IRB Review of Coronavirus and Other Emerging Infectious Disease Research: Issues to Consider

In this blog we discuss unique issues that research involving emerging infectious diseases like coronavirus can raise for IRB review and research informed consent.

Are “Virtual Trials” Mainstream Yet?

While some completely virtual trials are taking place, the real trend involves bringing virtual trial components to traditional study designs to improve study efficiency and reduce participant burden.

Key Biosafety Considerations for Coronavirus Research

The recent outbreak of the novel 2019 coronavirus in Wuhan, Hubei Province, China, has led to a surge of interest in coronavirus research and concern about the risks associated with coronaviruses. In this blog we introduce coronaviruses and cover strategies for developing medical countermeasures to combat the recent outbreak.

Revised Common Rule Compliance Now in Full Effect—and What That Means

After multiple delays, exceptions, and oh-so-many training sessions, on January 20, 2020, we reached the last remaining compliance milestone for the final revisions to the Federal Policy for the Protection of Human Subjects (“revised Common Rule”).

Beyond the Regulations: More Considerations for Emergency Research

In this blog post we go beyond the regulatory requirements and examine three other key actions that research organizations may want to consider before conducting planned emergency research at their facilities.

Most Popular Blogs of 2019

As we near the end of 2019, let’s take a look back at the blogs that generated the most interest this year from readers like you.

Reporting to the IRB: What NOT to Report

Despite clarification from FDA and OHRP, many of the “potential” unanticipated event reports IRBs receive are either submitted unnecessarily or don’t pertain to the aspects of research the IRB oversees.

Should Social Media Be Part of Your Research Toolbox?

Social media holds tremendous promise in the research sphere but requires sensitivity to pertinent regulatory and ethical considerations. Sponsors and investigators looking to incorporate social media into their research toolbox should devote themselves to understanding the details of particular social media platforms and work closely with their IRB to understand and apply the regulatory framework.

Compensating Clinical Trial Participants: The Basics

Participant compensation is often a complicated matter; this blog clarifies some issues by shedding light on what an IRB considers during its review.

What Is a Screening Consent?

Informed consent is an ongoing process to ensure the participant has an initial and ongoing understanding of the research and its risks. In this blog, we’ll take a look at a unique type of ICF known as the study-specific screening consent.