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Small IRB Shows How to Handle Challenges

One small IRB has evolved in less than a decade from a board that had no full-time or part-time IRB professionals to having its own IRB administrator with part-time assistance. Limited staffing is one of the top challenges of small research programs.

IRB Methods for Reviewing Gun Violence Study Protocols

Gun violence researchers must be sensitive to the emotional risks of participants.

IRBs Can Expect Increase in Gun Violence Studies

In 2018, a spending bill allowed for research by the CDC into the causes of gun violence, paving the way for new studies to explore the issue. IRBs will need to anticipate these protocols and better understand risks and ethical issues involved in gun research.

Reducing Long-Term Patient Costs Requires Going Above and Beyond

Case managers in hospitals and community settings often have to go beyond point of care activities to help patients make significant improvements in their health and healthcare costs. This is particularly true with patient populations experiencing major barriers to maintaining disease control and health improvement, including housing, food access, transportation.

FDA Streamlines Expanded Access to Oncology Drugs

Project Facilitate calls for a new call center, which will be a single point of contact for physicians seeking expanded access to investigational oncology drugs. FDA oncology staff will help physicians through the process of submitting the request for expanded access and follow-up as needed.

Unique Informed Consent Challenges of Sequentially Randomized Trials

Some people initially appear to be good candidates for transplant. But complications of treatment may develop — changing the risk-benefit analysis. A repeat consent conference is necessary before each sequential randomization.

Study Finds That All Financial Conflicts of Interest Influence Findings

All financial conflicts of interest influence whether study authors report findings favorable to industry sponsors, according to a recent investigation.

IRBs and Institutions Could Improve Monitoring Sites for Protocol Fidelity

When IRBs review multisite studies, particularly when the sites are at different research institutions, there is a question about how faithfully each site sticks to the protocol and avoids deviations. With large, multisite, non-biomedical studies, fidelity — or maintaining protocol compliance — requires considerable resources.