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Single-Patient Expanded Access: WIRB experience in 2018
In 2018 WIRB approved 100% of the single-patient EA requests that were submitted for review.
Virtual Clinical Trials Best Practices
IRBs can make the most of central IRB partnerships
The IRB at Inova Health System of Falls Church, VA, began working with a central IRB 15 years ago. Since then, the IRB developed a well-organized process for its partnerships with independent IRBs.
Limited IRB Review: Are You Prepared for January 21st?
On January 21, 2019, most federally funded research will need to follow the 2018 Requirements of the Common Rule. This post talks through the original and revised rules, and how they may apply to you.
Best Practices: Integration of IRB and IBC Review
Germline Modification for HIV Prevention is Unjustified
Daniel Kavanagh, PhD, responds to recent news of germline editing of human embryos in China.
Removing Barriers: Reimbursement and Compensation for Participation in Oncology Clinical Trials
The impact of participant payments on clinical trial recruitment.
WIRB Institutions Brochure
Returning Study Results to Research Participants
Studies show clinical trial participants want to know what was learned from their involvement. Many sponsors are implementing plans to deliver plain language summaries to trial participants.
Subject Recruitment Materials: Understanding the Requirements for IRB Review
Often, the only way for potential research subjects to learn about a clinical trial is through recruitment materials. But what materials must you submit to the IRB for review?
Written Procedures for IRBs: What Does the New Final Guidance from FDA and OHRP Mean to You?
WIRB 50: The Evolution of an IRB
Applied Clinical Trials:Single IRB Review for All Multicenter Clinical Trials
Pragmatic Clinical Trials: What You Need to Know
NIH Single IRB Review - Are You Ready
IRBs and IBCs: Critical Partners in Gene Research
Do the Right Thing: Unique Ethical Issues in Oncology Research
OhioHealth Case Study
Dissatisfied with its electronic IRB research management solution, OhioHealth Research & Innovation Institute searched for a solution to improve compliance, efficiency, customer service, and cost.
Interventional Clinical Trial or Registry Study? Writing Protocols that Demonstrate the Difference