NCS Vanguard Data and Sample Request Form

OMB# 0925-0730
2/28/2019

The National Children’s Study Vanguard Data &
Sample Request Form
Request Identifier

Request Name (required)

Create a brief title for your research plan:

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
(0925-0730). 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
f
CS

1

Requesting Investigator Information
Name:

Address:

Title:

Institution:

Phone (Required):

Email:

Fax:

Department:

Website:

2

Recipient Information
Institution type (required)
o Non-Profit Organization
o Commercial Organization
o Academic
o Government
Is funding currently available for this research?
(required)
If yes, please upload documentation of primary
funding

Number of years in scientific research
Approximately how many years has the lead
investigator been involved in scientific research?
o
o
o

0-5
5-10
10+

If no and funding is not yet available, please
indicate anticipated primary funding source:

o Yes
o

3

Specimen Shipping Information
Will the results be used for a commercial purpose? (required)
o
o

Yes
No

Shipping Address

FedEx Acct. #

Note: All specimens will be shipped to the
account holder's address unless specified
below.

Shipping PO #

Lab Contact Name:

Lab Contact Email:

Lab Contact Phone Number:

Request Details
Number of Specimens (required)
Approximate count of specimens required for your study.

Material Type (required)

Minimum volume (or mass if requesting DNA)
(required)

Optimum volume (or mass if requesting DNA)
(required)

Please include units

Please include units.

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

4

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 (required)
A brief overview of your research needs

Scientific background and rationale
Provide the research protocol background, objectives and hypothesis.

Analyte(s) or parameter(s) to be tested (required)
Describe the assay(s) to be performed and include any test volume requirements.

Type of assay(s)/ platform(s) to be used (required)
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 (required)
Also describe your intended use of covariates from study datasets, if applicable.

5

Approved Users
Approved User #1
Name

Email

Approved User #2
Name

Email

Approved User #3
Name

Email

Approved User #4
Name

Email

6

Information Security: Please check the information security practices to be used (required)
Study data must be maintained in a secure and controlled environment
o
o
o
o
o

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)
Encrypted portable media (encrypted external hard drive, encrypted thumb drive)

Comments

Upload checklist
o
o

I have uploaded Institutional sign off or a cover letter approving research
I have uploaded documentation of primary funding

7