Guidelines & Policies for Investigators Requesting ADRC Resources

All requests for the use of ADRC resources (data, tissue, subjects, services) must be approved by the ADRC Executive Committee. Confirm meeting dates with the Executive Director, Dr. Virginia Buckles (314-286-2416; bucklesv@abraxas.wustl.edu, Campus Box 8111-ADRC).

SUGGESTED TIMELINE

Four (4) weeks prior to submitting your request: Contact Executive Director, Dr. Virginia Buckles regarding your request. Consult with appropriate Core Leader or Leaders.

Submit your request by the 15th of even-numbered months (Feb, Apr, Jun, Aug, Oct, Dec) to be considered at the committee meeting in even-numbered months.  Submit:  (1) Web form at http://alzheimer.wustl.edu/Research/ResourceRequest.htm  and (2) research description (max. 3 pages) in electronic form. See section I.A. for time table and section I.C. for review procedures.

IMPORTANT POINTS

Use of ADRC Human Subjects or their data – See section II.A and II.B. for detailed procedural requirements and contacts.

Tissue Requests: Whether banked in the ADRC Tissue Resource or in another laboratory, these materials (tissue, fluids, etc.) remain under the authority of the Executive Committee. Questions regarding tissue requests can be directed to the Neuropathology Core Leader, Dr. Nigel Cairns, 314-362-2386, cairnsn@neuro.wustl.edu. Disclaimer: No screening for infectious agents has been performed on tissues or bodily fluids provided by the Washington University School of Medicine Alzheimer’s Disease Research Center. The investigator must take appropriate precautions. See section III. for more details.

Neuroimaging Requests: The ADRC maintains a database of previously obtained scans that are potentially available to investigators. For questions, please contact the ADRC Neuroimaging Committee, Dr. Mark Mintun, 314-362-2316, mintun. See section IV. for more details.

Grant Applications – If you are submitting a grant proposal that will use ADRC resources, you must submit a letter of intent to the ADRC Executive Committee NO LESS THAN 30 DAYS PRIOR TO THE GRANT APPLICATION deadline. See VII. for more details.

 Guidelines and Policies for Investigators

REQUESTING ADRC Resources

 The ADRC encourages and facilitates research and publications by current and new investigators. The ADRC Administration is eager to help generate successful proposals, secure funding, and complete and publish study results. All requests for the use of ADRC resources must be approved by the Executive Committee. If you are in the planning stages of a grant application, pay particular attention to section VII.

ADRC Executive Committee Meeting Schedule: The ADRC Executive Committee meets the second Monday of January, March, May, July, September, and November each year. The schedule is subject to change; please check with the Executive Director, Dr. Virginia Buckles (314-286-2881; adrc@neuro.wustl.edu, Campus Box 8111-ADRC) to confirm dates. If your request involves tissue or body fluid (see III. below) or neuroimaging data (see IV. below), then it should be submitted to the ADRC for preliminary review by the respective committees (Tissue or Neuroimaging) prior to the Executive Committee Meeting (see due dates in I.A. below.)

I. Requesting use of ADRC resources (subjects, data, tissue)

A.           Due dates and time table: Please consider the following time table when planning your proposal.

o        2 months prior to submission of your request to Executive Committee: Consult with appropriate Core Leaders (See I.B. below).

o        4 weeks prior to submitting grant application to outside agency: Submit Letter of Intent to Executive Director (see paragraph VII. below)

o        2 weeks prior to the relevant committee meeting (Tissue or Executive), submit web form and research summary.

B. Discussion with and use of Cores prior to submitting requests

Prior to submitting any application making use of ADRC resources, it is CRITICAL that you consult appropriate Core Leaders. Failure to do so could delay approval of your request. If you have any questions on which Core is appropriate, contact Dr. Buckles.

o        Clinical Core: - Dr. John C. Morris at 314-286-2683; morrisj@abraxas.wustl.edu;

o        Psychometric Core – Dr. Martha Storandt, 314-935-6508, mstorand@artsci.wustl.edu

o        Neuropathology/Tissue Core – Dr. Nigel Cairns, 314-362-2386; cairnsn@neuro.wustl.edu

o        Biostatistics Core can be of substantial help regarding design, power estimations and analyses – Prof. Phil Miller, 314-362-3617, phil@wubios.wustl.edu

o        Neuroimaging Committee - - Dr. Mark Mintun, 314-3623316, mintunm@mir.wustl.edu, or Dr. Denise Head, dhead@artsci.wustl.edu.

o        Genetics Core – Dr. Alison Goate, 314-362-8691, goate@icarus.wustl.edu

C. Executive Committee Review

1. Investigators who propose use of ADRC resources (including subjects, tissue samples, Core resources, etc.) submit a brief research summary (purpose, background and preliminary findings, methods, analytical plan) electronically to the ADRC Executive Committee for review. In addition, specific web forms appropriate to the resource (subject, data, tissue) can be found on our website. Although this review and approval need not precede submission of a grant application to an outside agency (See VII below regarding notifying us in advance of submission to a grant agency), it must precede initiation of the project. Proposals and questions should be addressed to the ADRC Executive Director at adrc@neuro.wustl.edu.

2. Student investigators (including postdoctoral and medical fellows) must include a letter of support from a faculty advisor who has reviewed the proposal and is responsible for supervising the student's research.

3. Executive Committee approvals expire 18 months from date of approval.

II. Procedures Required by the ADRC

A. Human Studies approvals

1. Studies using human subjects from the ADRC, their tissue or data derived from such subjects, must obtain Human Research Protection Office (HRPO) approval from the Washington University Medical School HRPO. (Forms for protocol submission can be obtained from the Washington University School of Medicine Human Research Protection Office Web site).  HRPO will not review the application until the ADRC administration has signed off on the proposal/consent form; therefore please be certain to submit this proposal early enough for ADRC review.

2. HRPO approval is not required for submitting your proposal to us for review, however, you must provide the ADRC office a copy of your WUMS Human or Animal Studies protocol and consent form approval prior to initiating your study. Multi-year studies should forward copies of renewed approval annually to the ADRC office. This can be easily accomplished by adding "ADRC, Box 8111" to the "Return approvals to:" line on your submission to Human/Animal Studies. FAILURE TO PROVIDE APPROVALS TO THE ADRC OFFICE WILL DELAY YOUR ACCESS TO ADRC RESOURCES.

3. Please include language In your consent form that permits the future use of the data you collect (e.g. "Your data may be used by the research team now and in the future to answer questions about health concerns, memory and thinking.")

4. If your request involves archival data or tissue, approval or exemption from the HRPO is still required (e.g., analyses of computerized images or re-analysis of previously collected data to answer a new question).

5. If any clinical information is to accompany autopsy tissue, HRPO approval may be required.  Please check with the Human Research Protection Office

B. Human studies rules regarding use of subject names

1. It is a violation of University policy, HIPAA and our ADRC Human Studies approval to link subjects' names and scores in any way. ALL INDIVIDUAL DATA MUST BE STORED BY ADRC SUBJECT ID NUMBER, not name or subject's initials. Should a second unique identifier be necessary as a cross-check, we recommend you use the subject's date of birth. Any communication (with the ADRC or anyone else) should use subject ID numbers, never names.

1.            All investigators must abide by the Human Research Protection Office guidelines regarding the securing of subject names. In the Human Studies application, indicate how you will preserve confidentiality; your approval is dependent on this.

2.            Deviations from the use of ADRC assigned subject ID numbers must first be discussed with the Biostatistics Core Leader. Such deviations create an inability to pair individual project's data with ADRC Core data.

C.           investigator orientation to use of ADRC subjects – Before any testing with ADRC subjects can begin, the investigator and any research assistant who may be in contact with subjects will receive an orientation to procedures for contact and interaction with subjects. This orientation includes how they will receive subject information, the "dos and don’ts" of scheduling and testing ADRC subjects, and reporting weekly schedules, etc.

D.           Animal Studies approvals - Studies using animal subjects in conjunction or association with ADRC investigations must obtain approval from the Animal Studies Committee of the Washington University Medical School. A copy of the approval must be sent to the ADRC.

E. Requests for data

1. Requests for data sets for secondary analysis require review by the ADRC.  Please complete the ADRC Data Only request form and provide a brief description of your project.

2. Requests for research subject data pursuant to an approved ADRC protocol, including summary statistics on our subject sample and individual subject details, must be made ONLY to the Biostatistics Core Data Manager (Betsy Grant, PhD, 314-362-3612). Other personnel do not have access to these data.  When requesting data from Dr. Grant, please provide your ADRC Protocol number.

F. Data Sharing

1. Data from ADRC research projects "belong" to the individual investigators, but the principle of data sharing is endorsed. Such sharing requires mutual trust and cooperation.

2. Data from the ADRC Cores should be easily available to all ADRC investigators. When data from a Core are to be used by an investigator not in that Core, the Core Leader must give approval, the contribution of the Core should be acknowledged in resulting publications, and co-authorship from the Core should be considered when appropriate by reason of intellectual contribution. Discuss concerns or ambiguous situations with the ADRC Director.

G. Data Retention, Archiving, and Access

1. Archiving of data from research projects and Cores in the ADRC is the responsibility of the Biostatistics Core. The nature of the data to be included in the archive will be determined for each project individually after discussion between the investigator and the Biostatistics Core Leader.

2. Data in the archive must have adequate documentation from the original investigator or Core Leader. In addition to the definition of measures, documentation should include, but is not limited to, such information as how missing data are handled, nature and date of changes made in measurement procedures, special hardware or software requirements for use of the data.

3. Data and tissue are archived indefinitely.  A research participant may withdraw permission to use tissue or data per the HRPO policies.

4. Problems with archived data should be publicized so that later users of the same data can be alerted.

III. REQUESTS FOR USE OF BIOLOGICAL MATERIALS

A. AUTHORITY -These materials (tissue, fluids, etc.) remain under the authority of the Executive Committee who must approve their usage with input from the Tissue Committee by any investigator (including Cores) who wishes to use the material, whether the samples are banked in the Core or in another laboratory. For any questions regarding tissue requests, please contact the Neuropathology Core Leader, Dr. Nigel Cairns, 314-362-2386, cairnsn@neuro.wustl.edu No third party sharing is permitted without approval of the ADRC.

B.           FORM: Please use the "Tissue Request" form enclosed with this document to be submitted with the 4 copies of your complete proposal.

C.           Determine if HUMAN STUDIES APPROVAL is required for use of archival material.

D.           TIME Limitation on requests: Unless approved for a longer period of time, all requests are "active" for a maximum of 18 months or until the number of approved samples have been provided, whichever comes first.

E.           Tissue archived by the ADRC is held indefinitely.  If a research participant requests removal of tissue or data from the ADRC archive, HRPO policies will be followed.

F.            The following requirements apply to utilization of ADRC resources:

    1. Provide a copy of any publication which contains experimental results obtained from the use of the Material

2.    Agree to protect the confidentiality of research participants by not attempting to identify them.

3.    Acknowledge your Center and Program Project grants in any presentation or publication that may result from this research: P50AG05681 and P01AG03991. 

    1. Should funding result from this research now or in the future, please notify the Alzheimer’s Disease Center with details so we may report productivity derived from our resources to NIA.

 F. COMMON OBSTACLES TO APPROVAL

1. Inadequate background/justification

2. Poor description of sample requested (the "Diagnostic Impression" sheet may help to define our human subject characteristics and descriptors).

 Disclaimer: No screening for infectious agents has been performed on tissues or bodily fluids provided by the Washington University School of Medicine Alzheimer’s Disease Research Center. The investigator must take appropriate precautions.

IV. NEUROIMAGING STUDIES

A.           The Neuroimaging Committee reviews requests for studies involving neuroimaging (see appropriate form). For questions regarding the ADRC Neuroimaging Committee, please contact Dr. Mark Mintun, 314-362-3386, mintunm@mir.wustl.edu.

1.            When recruiting subjects for neuroimaging studies, please specify whether remuneration will be provided and at what rate ($ per hour) and detailed information about the subject’s experience (time in scanner, risks and discomforts). Whenever possible, we ask that the scans be archived with the ADRC.

2.            The ADRC maintains a database of previously obtained scans that are potentially available to investigators.

V. Reporting and publishing results

A. Case Studies and Case Series Reports- Any publication (abstract, journal article, chapter) that includes either case studies or case reports should have attached to your electronic reprint to the ADRC (see IV E, below) a cross reference of subjects identified in the publication by case number and the ADRC registry number ("subject number").

B. Subject Description - Please report that CDRs are obtained "from assessments by experienced clinicians trained in the use of the CDR."

[At the time of enrollment in the ADRC, subjects with dementia of the Alzheimer type (DAT) fulfill certain inclusionary criteria; they and control subjects also meet exclusionary criteria. (Inclusionary and exclusionary criteria are cited in publications given below). These strict criteria are followed at entry. However, in these longitudinal studies, subjects are not dropped because of later development of various exclusionary criteria. Some have developed evidence for depression, stroke or Parkinson’s disease, as examples. It is incumbent on investigators to work with the clinical and Biostatistics Cores to specify how "clean" the subject sample must be for their studies. Subjects being tested at some period after enrollment may no longer fulfill all the criteria listed in citations below.]

B.                           Citations - When preparing manuscripts for publication, the following references will be useful for clinical diagnostic criteria, their validation, and for staging criteria.

 (1) Berg L, McKeel DW Jr, Miller JP, Storandt M, Rubin EH, Morris JC, Baty J, Coats M, Norton J, Goate AM, Price JL, Gearing M, Mirra SS, Saunders AM. Clinicopathologic studies in cognitively healthy aging and Alzheimer’s disease: Relation of histologic markers to dementia severity, age, sex, and APOE genotype. Arch Neurol 55:326-335, 1998.

(2) Morris JC: The Clinical Dementia Rating (CDR): Current version and scoring rules. Neurology 43:2412-2414,1993.

 VI. REPORTING REQUIREMENTS

A. Acknowledgement of the ADRC contribution and listing of our grant number (P50 Ag05681) in publications and grant proposals is expected.  Such acknowledgments assist in documenting our success in enhancing and supporting research, a major criteria for evaluation in future ADRC grant renewals.

B. Reporting of submitted publications and abstracts: For work using ADRC resources, one copy of EVERY MANUSCRIPT (journal or book) OR ABSTRACT SUBMITTED FOR PUBLICATION with the cover letter to the Editor should be sent to the ADRC Executive Director, Virginia Buckles, and to the Biostatistics Core Leader, Phil Miller.

C. Receipt of final publications and abstracts - For work using ADRC resources, PLEASE SEND AN ELECTRONIC VERSION OF THE REPRINT OF EVERY ABSTRACT, JOURNAL ARTICLE, OR BOOK CHAPTER is to BE SUBMITTED to the Executive Director, to be held in our ADRC library. These reprints are vital to grant reporting, documenting ADRC productivity and aiding us in seeking financial support for our investigators.

D. When human subjects are tested, weekly/monthly reports of your testing schedule to the Biostatistics Core are required.

E. After 1 year from receipt of sample (data, tissue, etc.) a brief progress report on utilization is required.

VII. GRANT APPLICATIONS - Planning and preparation of grant applications

A. Mandatory letter of intent to submit an application - Any effort that plans to make use of ADRC resources (including subjects, data, tissue samples, etc.) must submit to the ADRC Executive Committee a "letter of intent to request financial support from an outside agency NO LESS THAN 30 DAYS PRIOR TO THE GRANT APPLICATION deadline. The letter of intent should include a brief description of the proposed project and the ADRC resources that will be used. This letter and questions should be addressed to the ADRC Executive Director, Campus Box 8111 (314-286-2882). LETTERS OF SUPPORT OBTAINED FROM ADRC FACULTY DO NOT ELIMINATE THE NEED TO SUBMIT A LETTER OF INTENT TO THE EXECUTIVE DIRECTOR.

B. Without such letter, no assurance can be given that ADRC resources (including ADRC subjects) will be available should the project be funded. THIS LETTER OF INTENT DOES NOT REPLACE THE NEED TO MAKE A FULL PROPOSAL TO THE EXECUTIVE COMMITTEE FOR REVIEW.

C. Approval by the ADRC Executive Committee need not precede submission of your grant application. However, if you wish us to provide a letter of support from the ADRC to accompany your application stating that the resources you have requested are available, then a stronger support letter stating that your request for ADRC resources has been approved can be generated instead of one stating the resources are available to you should your application be approved.

D. Proposals not seeking financial support from outside agencies need not submit a letter of intent prior to submitting their proposal to the Executive Committee.

E. Please remember to consult the appropriate Core Leaders when writing your proposal, as they may be able to assist in developing your proposal. They must also evaluate the availability of resources. When a significant amount of resources of a Core will be required, investigators should discuss with the Core Leader including support for these resources in their proposal.

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