March 17, 2015
On December 18, 2014 the Newborn Screening Saves Lives Reauthorization Act of 2014 (Public Law No: 113-240), an extension of the Newborn Screening Saves Lives Act of 2008 was signed into law. The bill includes an amendment addressing research uses of newborn dried blood spots, requiring immediate new interpretations of the HHS regulations for the protections of human subjects effective 90 days from the enactment of the law (see below). The amendment also requires HHS to promulgate proposed revisions to Federal Policy for the Protection of Human Subjects within six months and final regulations within two years.
The law includes two significant changes to the human subjects regulations as they apply to research with newborn dried blood spots. First, the law requires that all research funded pursuant to the Public Health Service Act using newborn dried spots be considered human subjects research regardless of whether the specimens are identifiable. Second, the law eliminates the ability of the IRB to waive informed consent under 45 CFR 46.116(c) and 116(d) for research involving newborn dried blood spots.
Note that this law applies only to HHS-funded research, and not to research funded by other entities that is conducted at institutions that have extended their FWA to cover all research, regardless of funding (institutions that have “checked the box.”)
This law went into effect Monday, March 16, 2015. Note that this law applies only to HHS funded research that specifically involves the use of newborn dried blood spots. OHRP advises that stakeholders initially consult the relevant funding agencies for advice regarding implementation of this law. OHRP may be contacted with further questions.
TEXT OF 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 new- born 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.
(c) REGULATIONS. - Not later than 6 months after the date of enactment of this Act, the Secretary of Health and Human Services shall promulgate proposed regulations related to the updating of the Federal Policy for the Protection of Human Subjects (the Common Rule), particularly with respect to informed consent. Not later than 2 years after such date of enactment, the Secretary shall promulgate final regulations based on such proposed regulations.
March 12, 2015
On March 9, 2015, the Food and Drug Administration (FDA) announced in the Federal Register (FR) the availability of a draft guidance for industry, clinical investigators, and institutional review boards entitled “Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers.” The guidance provides recommendations for clinical investigators, sponsors, and institutional review boards on the use of electronic media and processes to obtain informed consent for FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices and combinations thereof. The Office for Human Research Protections (OHRP) in the same issue of the FR published a notice requesting public comment on whether FDA’s draft guidance document would be appropriate for all research regulated under 45 CFR part 46.
The OHRP and FDA have been actively working to harmonize the agencies’ regulatory requirements and guidance for human subject research, and the FDA draft guidance document was developed as a part of these efforts. Although this document is issued by FDA and is drafted as guidance that would apply to FDA-regulated clinical investigations, OHRP is considering whether to adopt the positions and recommendations proposed in this guidance for research regulated under the HHS protection of human subjects regulations, 45 CFR part 46, and to issue a joint OHRP and FDA guidance document on this topic when the final guidance document is developed. OHRP will consider comments received from the public before deciding whether to issue a joint final guidance document with the FDA.
March 4, 2015
February 6, 2015
Today the FDA posted a final guidance document on medical device data systems (MDDS)
. This guidance confirms our intention to not enforce regulations for technologies that receive, transmit, store, or display data from medical devices. We hope that finalization of this policy will create an impetus for the development of new technologies to better use and display this data. We also updated the Mobile Medical Apps
guidance to be consistent with the MDDS final guidance.
We will discuss these guidance documents, along with two draft guidances released last month on low risk products intended for general wellness
and medical device accessories
, at a webinar scheduled for February 24, 2015. The webinar is intended to help manufacturers and other interested stakeholders understand the policies described in these guidance documents.