News Flash Archive

• The NIH's Definition of Children to Change
  The NIH has issued Guide Notice NOT-OD-16-010 "Inclusion of Children in Clinical Research: Change in NIH Definition". Starting with applications/proposals submitted for due dates on or after January 25, 2016, for the purposes of inclusion policy, the age of a child will be defined as individuals under 18 years old instead of under 21 years old, the current NIH definition of a child for inclusion policy considerations.  Applicants/offerors for NIH funding will still be expected to justify the age range of the proposed participants in their clinical research, with particular attention paid to addressing the inclusion (or exclusion) of children (or subsets of children).  However, now that threshold applies to individuals under the age of 18 rather than under the age of 21. For more information on the child inclusion policy:  /grants/funding/children/children.htm.
   
• Human Chimera Research
  The NIH issued Guide Notice  NOT-OD-15-158 "NIH Research Involving Introduction of Human Pluripotent Cells into on-Human Vertebrate Animal Pre-Gastrulation Embryos".  The Notice informs the research community that the NIH will not fund research in which human pluripotent cells are introduced into non-human vertebrate animal pre-gastrulation stage embryos while the Agency considers a possible policy revision in this area.  Applications for such research will not proceed through the peer review process and no awards will be issued for research that fits the description.
   
• A Notice of Proposed Rulemaking (NPRM) for the Federal Policy for the Protection of Human Subjects (The Common Rule; 45 CFR 46) was released on September 8, 2015 by the Office of the Federal Register: https://www.federalregister.gov/articles/2015/09/08/2015-21756/federal-policy-for-the-protection-of-human-subjects. The document is now open for review and comments. 
  
  A brief summary of the proposed changes can be accessed at the following HHS website: http://www.hhs.gov/ohrp/humansubjects/regulations/nprm2015summary.html

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

NIH has published a Guide Notice (NOT-OD-15-127) describing the implementation of new research requirements contained in the Newborn Screening Saves Lives Reauthorization Act.  This legislation designates federally funded research using newborn dried blood spots collected on or after March 18, 2015  as non-exempt human subjects research for which parental permission must have been obtained.

Implementation questions should be directed to Dr. Tiina Urv at NICHD.

OHRP Notice Requesting Public Comment on Appropriateness of FDA's Draft Guidance Document on Electronic Informed Consent in Clinical Investigations for Research Regulated under 45 CFR part 46

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's FR Notice with instructions on how to submit comments to OHRP can be accessed at: http://www.gpo.gov/fdsys/pkg/FR-2015-03-09/pdf/2015-05301.pdf. Comments are due by May 7, 2015.

FDA's FR Notice with instructions on how to submit comments to FDA can be accessed at: http://www.gpo.gov/fdsys/pkg/FR-2015-03-09/pdf/2015-05377.pdf. Comments are due by May 8, 2015.

FDA's Draft Guidance document can be accessed at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM436811.pdf