Question: Can participants be reconsented over the phone when an ICF is updated?
Question: What are ethical considerations for a trial with a pre-study washout period?
We are working with a sponsor on the design and conduct of a double-blind placebo-controlled study of an investigational new drug for Alzheimer’s disease. The study design includes a one-month...
Question: Is IRB review required for survey results that may be published?
I am working with a for-profit company to develop survey questions for patients who have a specific illness. Without IRB approval I may not be able to publish any results; but, getting IRB approval or
An Introduction to Ask the IRB Experts Forum
Clinical research is complicated. At WCG, we get questions about clinical research all the time— from researchers, from clinical team members at biopharma companies, from members of institutional...
Question: Do sponsors have to change their informed consent documents?
I work for a small biotech company. We’ve been hearing some of our investigators talk about a new regulatory requirement for informed consent documents that includes a summary section in the front...
Single-Patient Expanded Access: WIRB experience in 2018
In 2018 WIRB approved 100% of the single-patient EA requests that were submitted for review.
Recommendations for Study Sponsors on Informed Consent Documents
Is the Government Shutdown Already Impacting Drug Development?
For biopharma sponsors, investigators, patients and families, these limitations are already translating into real impacts on development programs.
Looking Ahead in 2019 Whitepaper
In this paper, 17 WCG thought-leaders provide insights on what they anticipate in 2019 in clinical trial technology, regulatory changes, and scientific developments.
Removing Barriers: Reimbursement and Compensation for Participation in Oncology Clinical Trials
The impact of participant payments on clinical trial recruitment.
The Eligibility Conundrum in Clinical Trial Protocols: FDA Issues Workshop Report
Importance of Training Today’s Oncology Research Reviewers on Tomorrow’s Science
Citizen Ethicists: Does moving protocol review into the hands of potential participants provide adequate protections?
Not Like Everyone Else: Unique Challenges for Small & Emerging Biopharma Companies
Small and emerging biopharmas are conducting almost 50% of clinical trials in the U.S., often with lean teams, resources and infrastructure. Learn how to reduce the pressure on teams and timelines.
Do the Right Thing: Unique Ethical Issues in Oncology Research
Fifty Years of Change: Henry K. Beecher and Protecting Human Subjects
In June of 1966, physician-researcher Henry K. Beecher published a paper entitled “Ethics and Clinical Research.” Explore the history and motivation that led to Dr. Beecher’s ground-breaking paper.
Early Access to Investigational Drugs: Lessons Learned from Ebola
Learn about the regulatory framework that governs the use of investigational drugs outside clinical trials (formerly called “compassionate use”), and the ethical challenges surrounding it.
Clinical Data Disclosure: The Complicated Efforts to Make Research Transparent
Learn status of the requirements and recommendations for data-sharing from EMEA, FDA and PhRMA, and how to determine the steps to navigate the complicated field of data transparency compliance.
Looking Ahead in 2018: Insights into Clinical Research Trends from Our Experts
In this paper, WCG thought-leaders provide insights on what they anticipate in 2018 in clinical trial technology, regulatory changes, and scientific developments.
Clinical Trial Recruitment Practices: The Evolution of Ethical Considerations
Rectangle 2 60px/account-group-circle 60px/ambulance 48px/ambulance Group 2 arrow arrow-right-2-blue arrow right arrow 48px/bio-safety 48px/checklist a Path 3 close-2 Combined Shape 48px/cloud-app 48px/cloud-person 48px/computer-verify 48px/doctor 48px/document-exchange 48px/e-consent 48px/endpoint-adjudication Group 85 Group 85 external-link-icon facebook Group 48px/facilities 48px/file-bar-graph-search 60px/file-check 60px/graph-line 48px/group Combined Shape Copy 15 hex crop hex-end hex-overlay Combined Shape Copy 15 Combined Shape Copy 15 if_instagram_circle_color_107172 institutions 48px/learning-management left-crop linkedin Shape 48px/local-ibcs 48px/medical-certificate 60px/medical-pills-bottle 60px/medicine-capsule Group 60px/newspaper 48px/newspaper 48px/patient-files 48px/patient-identification 48px/patient-recruitment 48px/patient 48px/people-talking Combined Shape play plus-2 Group Combined Shape Copy 15 Polygon 2 48px/product-contact quote icon 48px/ribbon-check 48px/safety-docs-icon Group 29 search 48px/site-contracting 48px/site-payments 48px/siteid 48px/study-marketing Group wcg-logo youtube