Government Relations Update

NIH seeks comments on sharing of human brain imaging and related psychological data

The National Institutes of Health invites comments from the scientific and healthcare communities on “the administrative and technical issues involved in removing barriers to the sharing of human brain imaging data collected using NIH support.”  These issues include human subjects protections and management of related behavioral and psychosocial data.

The public is asked to respond to items such as:

“1.  Describe the current barriers to the standardization and sharing of neuroimaging data for secondary analysis.   Responses can include comments or suggestions about strategies to incentivize data sharing.

a. Mandatory (condition of award or mandated by journals)

b. Incentives to promote voluntary sharing and adoption of standard procedures

c. Technical or infrastructure/IT barriers

2.  Considerations of human-subjects protections

a. Issues and experiences related to informed consent of subjects for their data to be: 

  • stored indefinitely 
  • stored in a repository other than of the laboratory of data collection 
  • available to third parties for secondary analysis

b. Issues related to subject confidentiality, with respect to 

  • de-identification of brain image data 
  • potential for identification of subjects based on brain images (such as gyrus and sulcus morphology) 
  • extent of access for secondary analysis 
  • HIPAA compliance

3.  Suitability of different image data modalities for donation and federation across labs, and utility of different image modalities for secondary analysis

a. Resting-state or task-evoked functional MRI

b. Structural MRI (e.g. diffusion or volumetric)

c. Other image modalities like MRS or PET

d. Reconciling the need for standardization versus the value of methods innovation

4.  Conditions or qualifications under which data should be shared

a. Applicant eligibility or qualifications; composition of data access committee

b. Data quality or sample size

c. Embargo by collecting lab (duration) before furnishing data

d. Financial considerations (e.g. fee-for-access, current NIH funding status)

5.  Existing (including international) efforts, large scale databases, clearing houses, tools, and resources that facilitate sharing of imaging data

a. Lessons learned

b. Features and suitability for up-scaling to accommodate more data- especially of different modalities, or with different linked phenotypic data

c. Methods for harmonizing data from different extant or emerging extramural repositories

6.  Issues in standardization, sharing, and maintenance of image data and linked phenotypic or genetic data

a. Advantages, disadvantages, and costs of centralized repositories versus distributed hosting

b. Computational infrastructure, database management, and data processing software/algorithms

c. Data and meta-data formats, common data elements

d. Challenges, costs, sources, and other issues of long-term data storage (curation)

e. Linking image data with genetic or genomic data

f.  Interface with centralized referral  hubs, the HCP, or similar NIH-initiated infrastructures

7.  Issues of phenotypic harmonization or definitions with respect to:

a. Developmentally-sensitive measures (suitability at different life stages)

b. Objective behavioral metrics

c. Psychometric measures

d. Psychiatric disorders, other brain disorders, or histories of substance use

e. Family history, environmental or other psychosocial factors

f. Expansion of use (or a mandate) to adopt consensus phenotypic measures”

Further background and instructions for submitting comments can be found in the Request for Information (NOT-DA-11-021).  The deadline for submissions is October 14, 2011.