NINDS ADMINISTRATIVE SUPPLEMENT TO CLINICAL STUDIES FOR COLLECTION OF BLOOD SAMPLES AND DATA FOR REPOSITORY BANKING IN EPILEPSY, PARKINSON'S DISEASE AND STROKE RELEASE DATE: May 21, 2003 NOTICE: NOT-NS-03-016 National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov) The National Institute of Neurological Disorders and Stroke (NINDS) announces an administrative supplement program for currently funded NINDS clinical research projects in order to encourage the collection and timely sharing of whole blood samples via the NINDS Human Genetics Repository ("the repository") (http://locus.umdnj.edu/ninds). The NINDS repository allows receipt, storage, maintenance, standardization, quality control, and equitable, ethical distribution of DNA and other resources important in the genetic study of Neurological diseases. The sharing of data, biomaterials and other unique research resources is an essential element towards understanding the genetic basis of neurological disorders. This supplement initiative is responsive to the NIH Grants Policy Statement requiring investigators to provide prompt and effective access to unique research resources generated by NIH funds (http://grants.nih.gov/grants/policy/nihgps_2001/part_iia_6.htm #_Toc504811860). These supplements are intended to assist researchers who have an ongoing NINDS clinical project to perform additional blood sample collection. The supplement will do this by defraying some of the added costs of collecting and characterizing samples for submission to the Repository. Costs associated with the actual clinical research project are not part of this supplement program. Those eligible to apply are NINDS Principal Investigators (PIs) with Clinical Trials, epidemiological projects, and other clinical studies under any of the following mechanisms: Research Project (R01), Phase II SBIR (R44), Program Project (P01), Specialized Center (P50 or U54), or Cooperative Agreement (U01) grants. To be eligible, projects must be ongoing during the time of the supplement period (studies that have been awarded a no cost extension may also be eligible). There will be a maximum award per year (direct costs) of $100,000 for any of the above mechanisms. Supplemental funds can be used for personnel to facilitate sample collection as well as for sample collection itself. Goals may include, but are not limited to, the following: o Resources (such as personnel time) required by project personnel for working with their local institution, including the local Institutional Review Board, in development of the consent form and project logistics. Note that a sample consent form is available at http://locus.umdnj.edu/ninds/comm/submit/icmodel.pdf. to facilitate these efforts. o Resources needed to ensure that clinical data collection and samples meet repository requirements for submission. See http://locus.umdnj.edu/ninds for sample submission standards and clinical data guidelines. o Recruitment and ascertainment of subjects. NOTE THAT SUBJECTS SCREENED FOR BUT EXCLUDED FROM THE PARENT CLINICAL TRIAL MIGHT STILL BE APPROPRIATE FOR SAMPLE COLLECTION UNDER THIS SUPPLEMENT, AND THAT SOME SUBJECTS APPROPRIATE FOR CLINICAL TRIAL INCLUSION MIGHT NOT BE APPROPRIATE FOR SUBMISSION. o Sample collection including phlebotomy costs. The amount of award will be based on number of blood samples and sample type submitted and accepted into the repository. Award will occur after at least one minimal sample set is submitted successfully as specified below. There are two types of possible sample submissions: o Affected siblings (a.k.a. a "sib pair"). Two affected siblings from the same family with the same diagnosis constitute a sib pair in this context. This type of sample will be reimbursed at $400 per collected affected (concordant) sib pair. A minimum of 10 sib pairs is required for a complete sib pair sample set. o Cases and control series sets (minimum of 25 samples from cases and 25 samples from controls). Each sample of this type will be reimbursed at a rate of $150 each sample following submission to the repository of a complete case control series sample set. The following types of sample submissions will NOT be accepted: o Existing sample collections (e.g., blood, DNA or cell lines previously collected and stored) o Samples other than whole blood (such as brain tissue, cerebrospinal fluid) o Samples without accompanying clinical data according to repository guidelines All samples submitted must be accompanied by required clinical data (Clinical data elements or CDEs) strictly according to the repository guidelines (see http://locus.umdnj.edu/ninds). A minimum of 10 sib pairs per grantee (a complete sib pair set), or a complete case control series (25 in each group) must be collected in order to be reimbursed under this award. Samples submitted in addition to the required minimum number are encouraged. Collections from a single investigator may include one or more sets of each type. We realize that it is not feasible for all samples from a set to be submitted to the repository at a single time; therefore single sample submissions will be accepted to the repository and tracked until the minimum number is met prior to reimbursement. Note that all samples collected under this supplement will be made available immediately to the research community as a sample resource. As a benefit of contributing, investigators submitting samples to the repository will be able to withdraw cell lines or DNA samples created from the blood samples they have submitted as well as access an equal number of the other samples available via the repository, for a nominal fee. All samples must be collected according to NIH policy and under an IRB approved protocol. IRB approval must be documented and a copy of the (unsigned) IRB approved consent form that will be used must be submitted prior to sample acceptance. The guidelines of ethical standards protecting subject confidentiality and rights as described at http://grants.nih.gov/grants/funding/SBIRConf2000/Scharke/ apply and must be followed in regard to these and all other NINDS repository activities. Applicants should consider applying for a certificate of confidentiality for subject characterization and sample collection done under this supplement (see http://www.ninds.nih.gov/funding/certificates_of_confidentiality.htm). The NINDS Repository is HIPAA compliant (http://www.hhs.gov/ocr/hipaa/). HOW TO APPLY Applicants should submit an original and five copies of a complete written application, signed by an authorized business official at their institution, to Dr. Katrina Gwinn-Hardy at the address listed at the end of this notice. The following sections should be included: 1) A cover page citing this NOTICE and requesting an administrative supplement, including the PI name, grant number and title, name and title of the institutional business official, and phone, email, and address information for the PI and institutional official. For P01s and P50s and U54s, the named PI must submit the request for a supplement. 2) A letter (5-page limit) describing the project, including: o An abstract o The timeframe and numbers of samples anticipated o Anticipated budget 3) Documentation of IRB approval or agreement to obtain IRB approval within timeline projected prior to sample submission. 4) Agreement to submit required clinical data elements to the repository with each sample. 5) Agreement to allow immediate release of all submitted samples and non-personally identifiable data to the research community via the repository. BUDGET INFORMATION These supplements will be awarded as DIRECT COSTS. Requests will be limited to a maximum of $100,000 for R01, R44, P01, P50, U01, or U54 grants. For awards anticipated to be beyond these amounts, please contact Program staff. The NINDS will commit $3 million over FY04, 05, and 06 to fund applications for supplements submitted in response to this Notice. REVIEW CRITERIA Applications for submission will be reviewed administratively by the NINDS Project officer and NINDS Repository Committee. All funding decisions are final and are not subject to appeal. Applicants should provide the following information for consideration in review: o The sample collection strategy; o How the collection strategy will be incorporated into the parent project; o Justification for the anticipated number of samples; o Types of samples (sib pair sets, case control sets, or both types); o Track record of previous sample collection and repository submissions, if any. RECEIPT DATES (starting October 2003, ending June 2006): October 1 February 1 June 1 The supplemental award will take place approximately two months after favorable review and approval by NINDS staff. INQUIRIES Direct your inquiries about scientific /research issues to: Dr. Katrina Gwinn-Hardy Program Director, Neurogenetics NSC Rm 2142 6001 Executive Blvd Bethesda, MD 20892 (Regular Mail) Rockville, MD 20852 (Express Mail) Tel: (301) 496-5745 Fax: (301) 402-1501 Email: gwinnk@ninds.nih.gov Direct inquiries regarding fiscal and business administration matters to: Kathleen A. Howe Grants Management Branch National Institute of Neurological Disorders and Stroke NSC Rm. 3290-MSC 3597 6001 Executive Blvd., Bethesda, Maryland 20892 Tel: (301) 496-3291 Fax: (301) 402-0219 Email: howek@ninds.nih.gov
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
||||||||
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, RealPlayer, Video or Flash files, see Help Downloading Files. |