On March 1, 2024, the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the US Food & Drug Administration (FDA) released a draft guidance document entitled Key Information and...more
The European Data Protection Supervisor, the independent European Union authority responsible for data protection regulatory oversight, issued a preliminary opinion on data protection and scientific research. The Opinion...more
1/24/2020
/ Advisory Opinions ,
Compliance ,
Consent ,
Data Protection ,
Data Protection Authority ,
Data Subjects Rights ,
EU ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Member State ,
Personal Data ,
Scientific Research ,
The Common Rule ,
Transparency
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