The Final Rule published by the US Department of Health and Human Services on January 18, 2017, largely avoids major modifications to the Common Rule. However, it specifically addresses creation of biospecimen and data...more
2/7/2017
/ Clinical Trials ,
Department of Health and Human Services (HHS) ,
Human Rights ,
Informed Consent ,
IRB ,
Medical Devices ,
Medical Research ,
NPRM ,
Proposed Regulation ,
Scientific Research ,
The Common Rule
In a notice of proposed rulemaking (NPRM) released September 2, 2015, the U.S. Department of Health and Human Services (HHS), through the Office for Human Research Protections (OHRP) and 15 other federal departments and...more
9/9/2015
/ Clinical Trials ,
Comment Period ,
Data Security ,
Department of Health and Human Services (HHS) ,
Exemptions ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Human Genome Project ,
Informed Consent ,
IRB ,
Jurisdiction ,
Medical Research ,
NPRM ,
Proposed Regulation ,
Recordkeeping Requirements ,
Scientific Research ,
The Common Rule
Six months after the Precision Medicine Initiative’s (Initiative’s) debut, the White House has released a working draft of proposed privacy and trust principles (the Principles) to govern future design and development efforts...more
On March 9, 2015, the U.S. Food and Drug Administration (FDA) released a draft guidance, Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers, that provides recommendations for clinical...more