By Quorum Review’s Regulatory Attorney Team
In a rare foray into human subject protection, Congress has created a new provision under the Common Rule applicable to federally funded research using newborn dried spots (NDBS). Under this provision, known as “Amendment 12”:
- NDBS research is now declared to be “human subjects research” under 45 CFR Part 46; and
- IRBs are prohibited from waiving or altering consent requirements for federally funded research using newborn dried blood spots
Amendment 12 was enacted as a provision of the Newborn Screening Saves Live Reauthorization Act of 2014 (the Act). The Act, which is an extension of the Newborn Screening Saves Lives Act of 2008, reauthorizes nearly $20 million in funding and expands state-based infant screening programs.
Infant screening programs have been in place in the United States for more than 50 years. The programs, which are mandatory in 48 states, test newborns for more than 30 serious, but treatable, genetic disorders by taking a small sample of blood through a heel prick at birth. Collected samples are placed onto a small piece of filtered paper, known as a Guthrie card, and sent to a laboratory for testing. Results are then shared with the infant’s physician and parents. Today it is increasingly common for states to retain the cards and then use them – or make them available to researchers – for quality assurance purposes, program evaluation activities, and/or biomedical research.
Privacy advocates have objected to the release of dried blood spots to researchers without parental knowledge or consent. The ACLU, for example, says “parents have the right to know before the state stores their child’s blood and allows it to be used by researchers and others.” Several groups of parents pursued lawsuits in federal and state courts to prevent use of their babies’ DNA without parental consent. A suit filed in 2009 by five Texas families was settled in 2010, with the state agreeing to destroy all samples taken before May 27, 2009. That date was chosen because the Texas legislature passed a law, effective on that date, allowing the state to keep the DNA samples for research unless the parents specifically object.
With Amendment 12, Congress expressly categorizes research involving newborn dried blood spots as research involving human subjects under the Common Rule. Traditionally, under the Common Rule, research with biological specimens that are not linked to other identifying information is not considered “human subjects” research. Typically NDBS samples were provided to researchers without any identifiable information, and so research involving such NDBS typically has fallen outside of Common Rule jurisdiction. As a result of the Act’s re-categorization, federally funded research activities involving NDBS now will be considered human subjects research regardless of whether the NDBS are linked to identifiable information, and will be subject to the Common Rule, including IRB review and oversight.
In addition to changing the Common Rule’s applicability, the Act eliminates an IRB’s ability to alter or waive certain informed consent requirements. IRBs typically can grant waivers of informed consent requirements when the human subjects research involves no more than minimal risk to the subject and would not otherwise be able to occur without the waiver. This new provision prohibits an IRB from waiving or altering any required element of informed consent, no matter how impracticable the consent process or how minimal the risk posed by the research.
At its March 2015 meeting, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) made a number of recommendations regarding Amendment 12. SACHRP noted that IRBs should not over-interpret Amendment 12 to more generally expand the definition of human subjects research. SACHRP also recommended that OHRP provide in its guidance:
- Reinforcement that some activities involving residual newborn dried blood spot (such as public health practices) are not “research” under the Common Rule
- Emphasis that Amendment 12 applies only to federally funded studies, and that even institutions that have “checked the box” on their FWA applications do not have to apply Amendment 12 to research that is not federally funded
- A reminder that IRBs can use expedited review categories to review most newborn dried blood spot research
- A suggestion that IRBs consider waiving the documentation of informed consent under 45 CFR 46.117(c)(2) in order to achieve a “simplified consent process that can be more easily implemented” (such as allowing researchers to obtain parental signatures on the Guthrie card itself while providing the required written consent materials to parents separately)
- A suggestion that broad or “blanket” consent for future unspecified use for newborn dried blood spot is appropriate under the Common Rule
- Advice that even though NDBS research theoretically may be exempt from informed consent requirements under 45 C.F.R. 46.101(b)(4), which exempts research with de-identified data, IRBs should use caution in applying this exemption, “[g]iven the law’s deliberate elimination of waivers or alteration of informed consent”
Under the Act, OHRP is required to issue draft regulations this month and final regulations by December, 2016. Many are predicting that OHRP will fold the draft regulations into the highly anticipated Notice of Proposed Rulemaking to revise the Common Rule, which is anticipated as a follow-up to the 2011 FDA and OHRP Advanced Notice of Proposed Rulemaking (ANPRM). In the meantime, institutions should take steps to ensure that any researchers contemplating federally funded NDBS research understand that IRB review now is necessary. IRBs should take steps to ensure that IRB staff and ethics board members understand the need to require written consent of proposed federally funded NDBS research, regardless of how impracticable the consent process or how minimal the risk posed by the research.
 45 C.F.R. 46.102(d)
 45 C.F.R. 46.116(c) and 116(d)
 J. Geetter and C. Rutherford, “The Newborn Screening Saves Lives Reauthorization Act: Implications for Human Subjects Research,” The National Law Review McDermott Will & Emery newsletter,
 76 Fed. Reg. pp. 44512-44531 (July 26, 2011)