ADMINISTRATIVE SUPPLEMENTS FOR HUMAN POSTMORTEM BRAIN RESEARCH IN 
MENTAL ILLNESSES

Release Date:  October 30, 2001

NOTICE:  NOT-MH-01-010

National Institute of Mental Health
 (http://www.nimh.nih.gov/)

Receipt Date:  January 15, 2002

PURPOSE

The National Institute of Mental Health (NIMH) seeks to support supplements 
for the utilization of human postmortem brain tissue in neurobiological 
studies of mental illnesses such as schizophrenia and depression.  The goal 
of this initiative is increase the utilization of postmortem brain material 
and to help improve availability of these tissue resources.  This effort is 
targeted at defining disease-specific neural differences in brains of 
patients with mental illnesses.  It is expected that activities supported by 
these supplements will result in further research at multiple levels of 
analysis from genetics to systems level neurobiology, including rigorous 
neuroanatomy. 

RESEARCH OBJECTIVES

Background

It is clear that mental illnesses are the result of abnormal neural function.  
However, the exact neural mechanisms underlying these disorders are either 
unknown or poorly understood.  One research approach that has lead to 
promising findings is the detailed study of post-mortem human brains.  Modern 
neurobiological techniques and the availability of increasingly sophisticated 
biomarkers and tools for genetic analysis suggest that a renewed effort in 
psychiatric neuropathology may prove highly fruitful.  There are many 
difficulties which have impeded progress in this area.  Chief among these is 
accurate and reliable diagnosis of patients from whom tissue has been 
collected.  Similarly, there is no uniform standard for brain collection 
techniques, tissue preparation, and storage.  Although several outstanding 
brain collections exist, it has been difficult to share tissue or compare 
data across these collections.  Lack of replication of findings from post-
mortem studies currently in the literature has made it difficult to identify 
significant observations that are consistent and disease specific.  
Consequently, additional efforts to study greater numbers of psychopathology-
diagnosed and normal postmortem-human brains may be particularly beneficial 
to the field.  This Notice seeks to supplement currently funded NIMH grantees 
with demonstrated expertise and interest in new and ongoing neuropathological 
studies of mental disorders.  Supplements to existing grants are intended to: 
1) support collection efforts of psychopathology diagnosed and normal human 
brain specimens; 2) increase brain tissue resource dissemination and 
availability; and 3) expand the current use of postmortem brain material in 
planned and ongoing studies of the neural basis of mental illness.

Areas of Supplemental Support

Examples of activities suitable for supplemental support include, but are not 
limited to:

o  Efforts to identify, collect, and store additional postmortem brain tissue 
for the express purpose of expanding existing research protocols.

o  Efforts to compare postmortem data across different studies and protocols.

o  Support the formation of collaborations among investigators seeking to 
further postmortem brain analysis.

o  Creation of reliable and accurate resources for psychiatric diagnosis for 
post-mortem collections

FUNDS AVAILABLE 

The NIMH intends to commit approximately $2,000,000 in FY 2002 to fund new 
supplements to existing NIMH-supported grants in response to this Notice.  An 
applicant may only request supplemental funds for project periods 
corresponding to the number of active years remaining on a currently 
supported grant.  Direct costs will be awarded in modules of $25,000, less 
any overlap and other administrative adjustments.  Because the nature and 
scope of the research proposed may vary, it is anticipated that the size of 
each award will also vary.  Requests for total direct costs of up to $150,000 
per year will be considered.  Although the financial plans of the NIMH 
provide support for this program, supplements awarded as a result of this 
Notice are contingent upon the availability of funds and the receipt of a 
sufficient number of meritorious applications.

ELIGIBILITY

Principal Investigators holding the following grant mechanisms are eligible 
to apply: R01, P01, and P50.  Only parent grants with at least 15 months of 
support remaining from the date of issuance of this Notice are eligible for 
this program.  Applicants may request support under this notice only for each 
funded year remaining on the parent grant.  Applications will be reviewed 
administratively and it is expected that notice of award will be given within 
approximately three months of the receipt date.  Only one supplement request 
per parent grant may be submitted in response to this solicitation.

The NIMH will consider supplement requests from all eligible applicants.  
However, because funds are limited, highest priority will be given to 
supplemental requests that meet the following criteria:

o  The proposed postmortem brain research efforts are consistent with the 
scope of the parent grant and will significantly improve its progress.

o  Resources and expertise necessary to identify, collect, store, or 
disseminate/analyze postmortem brain tissue are available. 

o  The brain tissue and potential subsequent research material will be of 
value to the research community as a whole. 

o  Plans to release data and research resources in a timely manner are 
suitable (see REQUIREMENTS FOR SHARING RESEARCH RESOURCES below).

o  Clear documentation and justification is provided for the requested 
budget.


REQUIREMENTS FOR SHARING RESEARCH RESOURCES

The sharing of brain tissue, biomaterials, and data, in a timely manner, is 
an important element in progress toward understanding the neurobiological 
basis of severe mental disorders.  NIH policy requires that investigators 
make unique research resources readily available for research purposes to 
qualified individuals within the scientific community when they have been 
published [NIH Grants Policy Statement:
http://grants.nih.gov/grants/policy/nihgps; Sharing Biomedical Research 
Resources; Principles and Guidelines for Recipients of NIH Research Grants 
and Contracts; Final Notice, December 1999 
(http://www.nih.gov/od/ott/RTguide_final.htm)].  

It is expected that biomaterials and other research resources (e.g., tissue 
samples, brain sections, or extracted genetic material) produced in projects 
funded by these administrative supplements will be made available and 
distributed to the broader scientific community.  The costs associated with 
these activities are allowable and may be requested in the budget of 
proposals.

HUMAN SUBJECTS

Although this Notice applies to postmortem human tissue, and does not entail 
the recruitment of living individuals into research protocols, all applicable 
regulations that govern human subjects protection from research risk must be 
addressed.  For example, protection of tissue identity and anonymity are 
important considerations in the collection of postmortem material.

Under this policy, the definition of human subjects in Title 45 CFR Part 46, 
the Department of Health and Human Services regulations for the protection of 
human subjects applies, i.e., "Human subject means a living individual about 
whom an investigator (whether professional or student)conducting research 
obtains (1) data through intervention or interaction with the individual ,or 
(2) identifiable private information."  These regulations specifically 
address the protection of human subjects from research risks.  It should be 
noted that there are research areas(Exemptions 1-6) that are exempt from 
these regulations.  However, under these guidelines, NIH-supported biomedical 
and behavioral research projects involving human subjects, whether of not 
exempt from the human subjects regulations must still address the inclusion 
of women and minorities in their study design 
(http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm, and 
children http://grants.nih.gov/grants/guide/notice-files/not98-024.html).

Thus, all biomedical and behavioral research projects involving human 
subjects will be evaluated for compliance with this policy.  Research 
involving the collection or study of existing data, documents, records, 
pathological specimens, diagnostic specimens, or tissues that are 
individually identifiable also is included within the term "research 
involving human subjects."

APPLICATION PROCEDURES

The request for the supplemental award MUST include the following: 

1.  A completed face page, including appropriate signatures, from Grant 
Application Form PHS 398.  Include the title and grant number of the parent 
grant on line 1 and enter “Administrative Supplement for Human Postmortem 
Brain Collection in Severe Mental Disorders” on line 2.

2.  An itemized proposed budget entered on the budget pages from Grant 
Application Form PHS 398.  Supplements should be requested in modules of 
$25,000 in DIRECT COSTS, up to a maximum of $150,000.  The supplement budget 
must be concurrent with the parent grant funding cycle.  Therefore, if the 
initial 12-month period of the supplement does not coincide with the parent 
grant funding cycle, it may be necessary to prorate the supplement budget to 
coincide with the parent grant’s yearly budget period.

3.  The abstract and current aims of the parent grant (maximum 2 pages).

4.  A detailed description (maximum 5 pages) of the plans for collection and 
utilization of postmortem tissue including: a) how the tissue will be used to 
enhance the pursuit of the specific aims of the parent grant; b) technical 
resources available to diagnose, collect, store, and use postmortem brain 
tissue from control and affected individuals; c) the significance of the work 
proposed in the supplement; d) a description of the utility of the postmortem 
tissue to the wider research community; and e) plans for providing tissue 
resources to the broader scientific community.

5.  Letters indicating approval and commitment of resources from 
collaborating institutions/companies.

6.  The original and two copies of the entire application package must be 
sent directly to Dr. Douglas L. Meinecke at the address listed under 
INQUIRIES.

7.  Applications must be received by January 15, 2002.

INQUIRIES

Inquiries concerning this notice are encouraged.  The opportunity to clarify 
any issues or answer questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Douglas L. Meinecke, Ph.D.
Clinical Neuroscience Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 7179, MSC 9639
Bethesda, MD  20892-9633
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-1692
FAX:  (301) 402-4740
Email:  dmein@helix.nih.gov

Direct inquiries regarding fiscal matters to:

Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD  20892-9605
Telephone:  (301) 443-2805
FAX:  (301) 443-6885
Email:  Diana_Trunnell@nih.gov

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