Insights

Addressing the Challenges of Human Tissues and Cell Products Regulation

In 2017, the the New England Journal of Medicine  revealed troubling findings related to clinical studies using stem cells, as reported in the New York Times.      Regulatory oversight of research involving stem cells is tricky. They have a distinct regulatory classification from drugs, biologics, and devices. Read this white paper, authored by WCG experts in ethical […]

Subject Recruitment Materials: Understanding the Requirements for IRB Review

Oftentimes, the only way for potential research subjects to learn about a new clinical trial is through recruitment materials. These materials, such as flyers, advertisements, and letters, are an important part of a research study, and are considered to be the beginning of the informed consent process. While neither the Office of Human Research Protection (OHRP) […]

Interventional Clinical Trial or Registry Study? Writing Protocols that Demonstrate the Difference

Differentiating registry studies from interventional studies is essential in protecting research participants as well as ensuring proper regulatory compliance. While reviewing a protocol should answer the question of whether a study is interventional or a registry study, all too often, it does not. This whitepaper addresses how sponsors and investigators can design research protocols that […]

Infectious Disease Challenge Studies: Ethical Issues in Causing Disease for Medical Knowledge

Infectious Disease "challenge" studies are ones in which healthy participants are intentionally infected with pathogens in order to investigate the cause, prevention, and treatment of infectious diseases- but are they ethical? These studies, while useful, pose ethical concerns, and numerous criteria must be met for an infectious challenge to be ethically permissible. Read this whitepaper to […]

Towards Total Quality Management in Human Research Protection Programs: IRB Administrative and Reviewer Activities

Institutional Human Research Protection Programs (HRPPs) are under increasing pressure to evolve their processes and procedures in order to create a more efficient framework. IRB activities are receiving increased spotlight due to a decline in government funding, which cuts into many HRPP budgets, proposed changes to the Common Rule, and the recent NIH issued mandate […]

Managing Conflicts of Interest – Why an Independent IRB Should be Part of an Institution’s Policy

Research involving institutional and IRB member conflict of interest (COI) happens often, and can lead to concerns about the introduction of bias into research conduct. Read why institutions should consider independent IRBs as part of their institutional COI policy, and why sponsors and CROs should ensure that their sites have conflict of interest policies in […]

Under the Microscope – Biomarker and Diagnostic Tests as FDA-Regulated Devices

The technological boom in recent years has led to an explosion of biomarker and genetic mutation tests. This boom has raised issues regarding the conduct of FDA-regulated clinical investigations. In this paper,  our authors discuss the roles of the FDA, the sponsor, and the IRB in determining if a biomarker test is considered FDA-regulated medical […]

Clinical Trials and Social Media – Friends or Foes?

For many years, researchers, sponsors and clinical research organizations (CROs) have used social media to advertise clinical trials and recruit trial participants. Those interested in participating in a clinical trial can follow Twitter feeds, check Facebook pages, scan the “odd jobs” section of their local Craigslist site , and check webpages like Just Another Lab […]

Early Access to Investigational Drugs: Lessons Learned from Ebola

In an era of increasingly personalized cancer therapies, 24-hour news coverage and unprecedented social media reach, high-profile cases have brought the potential of providing early access to unproven, investigational drugs into the public forum. In the spring of 2014, a massive social media campaign aimed at the small biotech company, Chimerix, attempted to persuade the […]

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