Form 3 Vanguard Specimen and Data Request Form

A.3 NCS Vanguard Specimen and Data Request Form OMB# 0925-XXXX

XX/XX/2016

National Children’s Study Vanguard Specimen and Data Request Form

* = Required Field

Request Identifier

*Project Name:

Create a nickname for your reference.

Requesting Investigator Information

*Name:

*Address:

Title:

*Institution:

*Email:

*Phone:

Department:

Fax:

Website:

Recipient Information

*Institution type:

Non-Profit Organization Commercial Organization Academic

Number of years in scientific research:

0-5 5-10 10+ Approximately how many years has the lead investigator been involved in scientific research?

*Is funding currently available for this research?

Yes No

If yes, please upload of documentation of primary funding:

If funding is not yet available, please indicate anticipated primary funding source. ---------

Upload Documents:

Specimen Shipping Information

*Will the results be used for a commercial purpose?

Yes No - the results will not be used for a commercial purpose. Applicant must agree to use the Human Material for teaching and non-profit research purposes only and will not use the Human Material for any commercial purposes, including selling, commercial screening, or transferring Human Material to a third party for commercial purposes.

Fedex Acct. #:

Shipping address:

Note: All specimens will be shipped to the above address. Specimens cannot be shipped to a post office box.

Shipping PO #:

Lab Contact Email:

Lab Contact Name:

Lab Contact Phone Number:

Request Details

*Number of Specimens:

Approximate count of specimens required for your study.

*Material type:

*Minimum volume (or mass if requesting DNA):

Please include units.

*Optimum volume (or mass if requesting DNA):

Please include units.

Specimen requirements:

Describe any additional requirements pertaining to the biospecimens themselves, such as anticoagulant used, additives, preservatives, etc.

Subject characteristics:

Describe the characteristics of the subjects to be searched for available specimens. Criteria might include gender, age, disease status, genotype, etc. Be as specific as possible.

*Research Plan: Describe this request, including a summary of the rationale, main hypothesis and proposed research aims:

A brief overview of your research needs.

Scientific background and rationale:

Provide the research protocol background, objectives and hypothesis.

Approved Users name and email:

1. 2. 3. 4.

*Analyte(s) or parameter(s) to be tested:

Describe the assay(s) to be performed and include any test volume requirements.

*Type of assay(s)/ platform(s) to be used:

Describe the assay kit(s)/platform(s) to be used, if applicable.

*Rationale for number of biospecimens requested, including power calculations, and describe the use of covariates, if applicable:

Also describe your intended use of covariates from study datasets, if applicable.

*Information Security: Please check the information security practices to be used:

Institute supported, controlled access server Institute supported, password protected desktop computer Encrypted, password protected laptop computer Encrypted portable media (encrypted external hard drive, encrypted thumb drive) Unencrypted portable media backup (CD, DVD, thumb drive) stored in locked file cabinet Study data must be maintained in a secure and controlled environment Upload for Institutional sign off or cover letter approving research

Comments:

Public reporting burden for this collection of information is estimated to average 30 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0647). Do not return the completed form to this address.

Privacy Act Notification: Information collected as part of the data use agreement, data request forms, and distribution agreement may be made public in part or in whole for tracking and reporting purposes. This Privacy Act Notification is provided pursuant to Public Law 93-579, Privacy Act of 1974, 5 U.S.C. Section 552a. Authority for the collection of the information requested comes from the authorities regarding the establishment of the National Institutes of Health, its general authority to conduct and fund research and to provide training assistance, and its general authority to maintain records in connection with these and its other functions (42 U.S.C. 203, 241, 289l-1 and 44 U.S.C. 3101), and Section 301 and 493 of the Public Health Service Act. These records will be maintained in accordance with the Privacy Act System of Record Notice 09-25-0156 09-25-0200 (https://oma.od.nih.gov/forms/Privacy%20Documents/PAfiles/0200.htm) covering “Clinical, Basic and Population-based Research Studies of the National Institutes of Health (NIH), HHS/NIH/OD.” The primary uses of this information are to document, track, and monitor and evaluate the submission of data from clinical, basic, and population-based research activities and to notify Submitters in the event a potential error in the dataset is identified or in the event of updates or other changes to the database. The Federal Privacy Act protects the confidentiality of the Submitter’s NIH records. The NIH will use the information collected for the purposes described above. In addition, the Act allows the release of some information in the Submitter’s records without the Submitter’s permission; for example, if it is requested by members of Congress or other authorized individuals. The information requested is voluntary, but necessary for obtaining access to data and samples in the NCS Archive.