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

Notice Number: NOT-OD-15-127

Key Dates
Release Date:  July 23, 2015

Related Announcements
None    

Issued by
National Institutes of Health (NIH)

Purpose

The purpose of this Notice is to provide preliminary guidance to investigators engaged in newborn screening-related research regarding  a new provision of the Newborn Screening Saves Lives Reauthorization Act of 2014 (P.L. 113-240), which was signed into law on December 18, 2014. 

Background

Section 12 of the “Newborn Screening Saves Lives Reauthorization Act of 2014" states:

“SEC. 12. INFORMED CONSENT FOR NEWBORN SCREENING RESEARCH.

(a) IN GENERAL. – Research on newborn dried blood spots shall be considered research carried out on human subjects meeting the definition of section 46.102(f)(2) of title 45, Code of Federal Regulations, for purposes of Federally funded research conducted pursuant to the Public Health Service Act until such time as updates to the Federal Policy for the Protection of Human Subjects (the Common Rule) are promulgated pursuant to subsection (c).  For purposes of this subsection, sections 46.116(c) and 46.116(d) of title 45, Code of Federal Regulations, shall not apply.

(b)  EFFECTIVE DATE. – Subsection (a) shall apply only to newborn dried blood spots used for purposes of Federally funded research that were collected not earlier than 90 days after the date of enactment of this Act.

NIH Policy Implementation
This legislation went into effect on March 18, 2015, and has several implications for NIH-funded research involving newborn dried blood:

  • NIH funded research using newborn dried blood spots collected on or after March 18, 2015, will be considered to be non-exempt human subjects research, and therefore, must follow the HHS protection of human subjects regulations at 45 CFR part 46.
  • Grant applications and R&D contract proposals submitted to NIH that will use such materials in research should be designated as non-exempt human subjects research and include a complete human subjects section per relevant NIH instructions including plans for inclusion on the basis of sex/gender, race, ethnicity, and age per the NIH Policies on the Inclusion of Women, Minorities, and Children. 
  • Such applications and proposals that are funded by NIH must comply with all the relevant federal regulatory and NIH policy requirements for human subjects research including the requirement that the awardee institution (and all engaged institutions) have a Federalwide Assurance (FWA) from OHRP and certification of IRB approval of the proposed research.
  • Parental permission must have been obtained in order to use newborn dried blood spots collected on or after March 18, 2015, in NIH-funded research.  Waiver of parental permission for such research is not permitted under this legislation.
  • Continuing NIH awards that are conducting research with newborn dried blood spots collected on or after March 18, 2015, will also have to comply with these new requirements.  Awardee institutions will need to meet all NIH requirements for human subjects research, including IRB approval, prior to starting such research.
  • NIH will add a specific term and condition to all new and continuing awards conducting applicable newborn dried blood spot research to ensure compliance with the new legislation.
  • Non-identifiable newborn dried blood spots collected prior to March 18, 2015, may continue to be used in NIH-funded research without parental permission, and this activity would continue to be considered research that does not involve human subjects under the current human subjects regulations. 
  • NIH recognizes that there is no universal agreement on the optimal timing for collection of parental permission for research purposes.  Obtaining permission at the time the dried blood spots are collected may be one option.  Ideally, an educational process could take place prior to the process of obtaining permission, and may be provided prenatally or after the birth of the child.
  • Section 12 of the Newborn Screening Saves Lives Reauthorization Act of 2014 applies to use of newborn dried blood spots in HHS funded research, as “research” is defined in 45 CFR 46.102 (d). Research funded solely by state or private entities does not constitute “Federally funded research” and is not subject to Section 12 of the new law.

NIH encourages investigators conducting NIH-funded research involving newborn dried blood spots to keep apprised of further developments on this issue.  The HHS Office for Human Research Protections will be issuing additional guidance on this law in the near future.

Inquiries

Inquiries about the implementation of Section 12 of the Newborn Screening Saves Lives Reauthorization Act of 2014 should be directed to:

Tiina Urv, Ph.D.
Email: urvtiin@mail.nih.gov