NOT-MH-01-010: ADMINISTRATIVE SUPPLEMENTS FOR HUMAN POSTMORTEM BRAIN RESEARCH IN MENTAL ILLNESSES

Department of Health
and Human Services (HHS)

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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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