Newborn Screening Saves Lives Reauthorization Act (Public Law 113-240)

January 6, 2016

Newborn Screening Saves Lives Reauthorization Act (Public Law 113-240) – with an amendment added that requires prior informed consent to be obtained before any newborn blood spot may be used in federally-funded research.

A new provision of federal law requires prior informed consent for certain research conducted using any newborn blood spot collected after March 17, 2015:

Research Involving Newborn Blood Spots

Preliminary Guidance Related to Informed Consent for NIH-funded Research on Dried Blood Spots Obtained Through Newborn Screening

Newborn Screening Saves Lives Reauthorization Act (Public Law 113-240)

NIH New Workflow to Check if the Single IRB Requirements Apply

FDA Takes Steps to Further Harmonize Clinical Research Regulations with HHS Common Rule

NIH Implementation of the Revised Common Rule Provision Regarding Public Health Surveillance Activities Deemed Not to Be Research

New FDA Guidance on Certificates of Confidentiality

OHRP Decision Charts Updated