Notice Announcing Data Harmonization for NIMH Human Subjects Research via the PhenX Toolkit

Notice Number: NOT-MH-15-009

Key Dates
Release Date: January 16, 2015

Related Announcements

Issued by
National Institute of Mental Health (NIMH)


The purpose of this Notice is to announce a major data-harmonization effort at the National Institute of Mental Health (NIMH) and to describe the implications for investigators in the mental health research community.

One way to improve the yield and impact of research in any area of science is to provide investigators with a common set of tools and resources to facilitate sharing, comparing, and integration of data from multiple sources. NIMH has already made significant investments in data repositories such as the National Database for Autism Research, the National Database for Clinical Trials Related to Mental Illness, and the Research Domain Criteria Database. These repositories allow data from multiple sources to be aggregated and easily accessed by the research community.

With this Notice, NIMH announces the availability of a common set of data elements for use in collecting data from human subjects participating in mental health research. Three sets of common data elements are now available: measures for all mental health researchers (referred to as the Core Collection), specialty collections of measures related to suicide, and specialty collections related to post-traumatic stress psychopathology (including post-traumatic stress disorder [PTSD]). These measures are intended to promote the collection of comparable data across research studies. All of these measures have been defined with significant input from the research community.

NIMH very strongly encourages human-subject studies to incorporate the measures from the Core and Specialty collections, which are now available in the Mental Health Collection of the PhenX Toolkit (, into NIMH-funded projects and future projects.

For all mental health researchers, two tiers of core measures have been defined. Core Tier 1 requires very little time to collect and is deemed relevant and essential to all areas of mental health research. NIMH grantees/applicants conducting human-subject studies are very strongly encouraged to use the Core Tier 1 measures.

The measures in the Core Tier 2 collection are relevant to many areas of mental health research. This collection of measures is more specialized than the Core Tier 1 measures. NIMH grantees and applicants conducting human-subject studies are encouraged to incorporate the Core Tier 2 whenever possible and appropriate. NIMH grantees are discouraged from using alternative measures in lieu of the Core Tier 2 measures to collect similar data.

Collections for post-traumatic stress psychopathology (including PTSD) and suicide research have also been defined, and measures related to eating disorders are being established. The measures in those collections are deemed relevant within these more specialized research domains. NIMH grantees/applicants conducting human-subject studies in these specific areas are strongly encouraged to incorporate the specialty measures into research protocols and are discouraged from using alternative measures to collect similar data.

NIMH recognizes that researchers may have longstanding data collection protocols that do not incorporate the recommended measures. In such situations, it may be necessary to collect data using more than one measure to ensure compatibility with legacy data as well as to allow data from multiple laboratories to be easily aggregated as the field moves forward. Researchers may also want to include additional measures of a construct to best address their hypotheses. This Notice does not preclude the use of measures in addition to the common data elements (CDEs) that have been established.

In order to allow investigators to prepare to administer new instruments and to budget appropriately, NIMH expects that applications submitted for funding after May 1, 2015 will incorporate these measures in all research proposed that involves human participants. Current NIMH awardees are invited to talk to their program officer about the possibility of an administrative supplement to allow common data elements to be collected in ongoing studies.

Through the use of these measures, NIMH-funded researchers will be better able to share, compare, replicate findings, and integrate data across studies. By advocating the use of these common measures and aggregating the data in the repositories listed above, NIMH aims to optimize the value of this research and further accelerate and enhance our understanding of mental illness, while advancing a culture of scientific collaboration.


Please direct all inquiries to:

Gregory K. Farber, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-435-0778