2019
December: Subject Injury Language
- German university finds ‘severe’ misconduct by researcher who promoted questionable cancer blood test
- Where were the women Gender parity in clinical trials
November: Informed Consent Template Revisions
October: IRBIS Tips and Tricks
September: Human Research Subjects’ Safety & The IRB’s Role: Part III—Operations Process
- See OHRE SOP 1402
August: Human Subject Rights & UPIRTSO/UPIRSO, Part II
- Analysis of FDA warning letters
- Controlling CRISPR-Cas9 Gene Editing
- Certify reproducibility with confidential data
- Estimating the success of re-identifications in incomplete datasets using generative models
July: Human Research Subjects Safety the IRB’s Role, Part I
- In wake of Trump’s fetal tissue clampdown, scientists strain to adjust
- Oldest evidence of marijuana use discovered in 2500
- Are Placebo-Controlled, Relapse Prevention Trials in Schizophrenia Research Still Necessary or Ethical
- How a New Jersey hospital used a misguided study of robotic surgery to wage an ill-fated war on breast cancer
June: UNC’s OHRE Future State – HRP Findings & Recommendations
- OHRE Executive June 2019
- Precision Medicine A Glossary of Terms
- Removing Barriers Reimbursement and Compensation for Participation in Oncology Clinical Trials
May: OHRE IRB Device Training
- OHRE IRB Device Training
- New GDPR Guidance from EU Commission on Interaction between Clinical Trials Regulation & GDPR
- Q&A on the Interplay between the Clinical Trials Regulation & The GDPR
- A Belmont Report for Health Data
- Powerful CRISPR cousin accidentally mutates RNA while editing DNA target
April: Carolina Data Warehouse
March: How to Review & Present Protocols as the Presenter
- 02-05-19-DrugTrialsSnapshotReport2018
- A recent meeting about the disconnect between scientific and public beliefs points to ways researchers can improve how they communicate with skeptics.
- CDER Drug Trials Report Shows Declining Enrollment
February: Expedited Review, Cat 9 and Continuing Review
January: Review Human Subjects Inclusion and Decision tree – Sex-gender & race-ethnicity