Form 1 CRU Form Sample w screenshots

Chimpanzee Research Use Form

Attach 9_CRU Form Sample w screen shots (6)

attach 9 CRU Form Sample with screen shots

OMB: 0925-0705

Document [pdf]
Download: pdf | pdf
THE CHIMPANZEE RESEARCH USE FORM – NO REVISIONS PROPOSED

Chimpanzee Research Use Form

This document presents the Chimpanzee Research Use Form
Part 1: Chimpanzee Research Use Form displayed as Screen Shots
Part 2: Text only of the Chimpanzee Research Use Form

1

THE CHIMPANZEE RESEARCH USE FORM – NO REVISIONS PROPOSED

Part 1: Chimpanzee Research Use Form displayed as Screen Shots
First Screen After Login—Assignments
User sees assignments and clicks on CRU Report # (hotlink) to access the form. User submits one form
per research application or proposal that involves use of chimpanzees or chimpanzee biomaterials.
User sees only his/her research proposals. He/She cannot access proposal by other investigators.
Project-level information has been redacted from the image below.

2

THE CHIMPANZEE RESEARCH USE FORM – NO REVISIONS PROPOSED
Second Screen—Initiate CRU Report — NO REVISIONS

3

THE CHIMPANZEE RESEARCH USE FORM – NO REVISIONS PROPOSED
Third Screen—Project Information – NO REVISIONS
For grant applicants (external to NIH), the information on this screen is pre-populated with information
they submitted in the applicant’s grant application. Note: On this screen the users see the icon
that
allows them to access additional information about the item. The text can be found in the revised CRU
Report Guidance.

4

THE CHIMPANZEE RESEARCH USE FORM – NO REVISIONS PROPOSED
Sample Certification Letter – Completed by the Signing Official – NO REVISIONS
The investigator also uploads a letter completed by the signing official that certifies the accuracy of the
information in the CRU system. A template is located in the Third Screen (previous page) to reduce time
to complete the entry.

5

THE CHIMPANZEE RESEARCH USE FORM – NO REVISIONS PROPOSED

Fourth Screen—Project Information for Noninvasiveness Determination – NO REVISIONS
This screen allows the user to assess whether his/her proposed research is noninvasive.

6

THE CHIMPANZEE RESEARCH USE FORM – NO REVISIONS PROPOSED
Fifth Screen—Attachments – NO REVISIONS
The screen allows the user to attach supplemental information, e.g., images. Attachments are optional.

7

THE CHIMPANZEE RESEARCH USE FORM – NO REVISIONS PROPOSED
Sixth Screen—Final Certification by the Investigator – NO REVISIONS
Upon hitting “Submit” the Investigator is presented with the following certification.

8

THE CHIMPANZEE RESEARCH USE FORM – NO REVISIONS PROPOSED

Part 2: Text only of the Chimpanzee Research Use Form
First Screen After Login—Assignments
User sees assignments and clicks on CRU Report # (hotlink) to access the form. User submits one form
per research application or proposal that involves use of chimpanzees or chimpanzee biomaterials.
User sees only his/her research proposals. He/She cannot access proposal by other investigators.

9

THE CHIMPANZEE RESEARCH USE FORM – NO REVISIONS PROPOSED
Second Screen—Initiate CRU Report — NO REVISIONS
OMB No: 0925-0705, Expiration date: 10/31/2017
Privacy Notice
This collection of information is authorized by 42 U.S.C. 241, 282, 282b, 284a, and 48 CFR Subpart 15.3. Certain
information provided through this form may be used by National Institutes of Health (NIH) to identify and contact the
submitter about the proposed research. Unless otherwise specified in a written agreement between NIH and the
submitter, all information, including proprietary information, submitted through the form, attached to it, or
referenced in it may be accessed by the NIH and/or the Council. NIH staff and contractors who have signed
confidentiality and non-disclosure statements will use the information for administrative purposes, e.g.,
reviewing materials for completeness, routing materials and managing subsequent steps related to
discussions about the proposed research.
Burden Disclosure Statement
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 (0925-0705). Do not return the completed form to this address.
Purpose
The purpose of this form is to obtain information needed by the NIH to assess whether the proposed research
satisfies the NIH’s policy for research involving chimpanzees, as announced in the Federal Register and NIH Guide.
These announcements inform the research community that NIH will support only “noninvasive” research involving
chimpanzees.
The NIH will consider the information submitted through this form prior to the agency making funding decisions or
otherwise allowing the “noninvasive” research to begin. Completion of this form is a mandatory step toward receiving
NIH support or approval for such research. Failure to complete this form by the due date may delay consideration by
the NIH.
Who Can Submit the Form
Only applicants and offerors notified by the NIH are required to complete this form. If the NIH has contacted you
about completing this form, it is because you have requested that the agency support or otherwise approve a grant,
contract, intramural project, or 3rd party research activity involving chimpanzees or chimpanzee biomaterials, and the
agency requires additional information before making funding decisions or otherwise allowing the research to begin.
The NIH requires applicants and offerors to complete the form when the proposed research:
1.
2.

Requests the use of chimpanzees (Pan troglodytes) or chimpanzee biomaterials in research, and
Is being considered for funding (grants), is in the competitive range (contracts), is scientifically meritorious and
fundable (NIH intramural research), or was otherwise submitted for consideration (3rd party projects).

The form may be submitted by the Signing Official for an organization or his/her designee. The Signing Official is the
individual, named by the applicant or offeror’s organization, authorized to act for the applicant or offeror and to
assume the obligations imposed by applicable Federal laws, regulations, requirements, and conditions.

10

THE CHIMPANZEE RESEARCH USE FORM – NO REVISIONS PROPOSED
What Information Gets Considered
Applicants and offerors are required to describe their proposed research and how it satisfies the agency
announcement in NIH Guide NOT-OD-16-095. Depending on the nature of the research, the NIH will determine if the
activity is “noninvasive” (e.g., observational research or research involving stored biospecimens), or if the research is
“invasive.” Consideration is based solely on the information provided in the Noninvasive Determination section of this
form. Although attachments may be submitted, they are optional. The NIH may consult attached materials at its
discretion. All information pertinent to their consideration must be entered into the Noninvasive Determination text
boxes.
How and When to Submit the Form and How to Revise Submitted Information
Unless otherwise specified by the NIH, applicants and offerors have 15 calendar days to submit the completed report
after they have been contacted by the NIH. Information must be submitted electronically via the Chimpanzee
Research Use Reporting System.
Questions about the online form can be emailed to the [email protected]. If the applicant or offeror notices that the
report requires a change after it has been submitted, contact the NIH’s Division of Program Coordination, Planning,
and Strategic Initiatives at [email protected]. Submissions that are incomplete by the due date may delay
consideration by the NIH.

11

THE CHIMPANZEE RESEARCH USE FORM – NO REVISIONS PROPOSED
Third Screen—Project Information – NO REVISIONS
For grant applicants (external to NIH), the information on this screen is pre-populated with information
they submitted in the applicant’s grant application. Note: On this screen the users see the icon
that
allows them to access additional information about the item. The text can be found in the revised CRU
Report Guidance.

Submitting Organization

Complete only if the submitter is not the Signing Official and attach a certification letter signed by the Signing Official.
Use the following template to create the SO Certification Letter.

Signing Official
Signing Official is the individual, named by the applicant or offeror organization authorized to act for the applicant or
offeror and to assume the obligations imposed by applicable Federal laws, regulations, requirements, and conditions.
Signing Official Name

Chris Ji

Chris

Signing Official Phone
Signing Official e-mail
Certification Letter

Add Certification Letter …
This field is required if the person submitting is not the Signing Official.
Sample SO Certification Letter [SEE PAGE 14]

Organization
Organization Name

UNIVERSITY OF

Organization DUNS Number
Organization Address

00211545641516

Office of Researc

Organization Work Phone
Organization Email

12

THE CHIMPANZEE RESEARCH USE FORM – NO REVISIONS PROPOSED

Research Project Information

PI Name
PI Name

Lora PI

Lora PI

Research Funding Mechanism
Funding Type
Project Number

Contract Proposa
test

Project Title
test

Project Summary/Abstract, Specific Aims, and Public Health Relevance
A project summary or abstract summarizes the proposed research activity. It should be a self-contained description
of the project and should contain a statement of objectives and methods to be employed. It should be informative to
other persons working in the same or related fields and insofar as possible understandable to a scientifically or
technically literate lay reader.
Specific aims provides the research with the broad, long-term objectives and the goal of the specific research
proposed, for example, to test a stated hypothesis, create a novel design, solve a specific problem, challenge an
existing paradigm or clinical practice, address a critical barrier to progress in the field, or develop new technology.
Public health relevance describes the relevance of this research to public health. In this section, be succinct and
use plain language that can be understood by a general, lay audience.

10000 Characters Remain.

13

THE CHIMPANZEE RESEARCH USE FORM – NO REVISIONS PROPOSED
Sample Certification Letter – Completed by the Signing Official – NO REVISIONS
The investigator also uploads a letter completed by the signing official that certifies the accuracy of the
information in the CRU system. A template is located in the Third Screen (previous page) to reduce time
to complete the entry.
Sample Certification Letter for Signature by the Signing Official
Updated: 06/22/2016
The following should be on institutional letterhead and signed by the Signing Official (Authorized
Organizational Representative).
[Date]
Dear NIH DPCPSI,
I certify that:
(1) I understand that I will receive a "Submission Received on [Date]" verification screen showing the
date and time NIH received the submission. If I do not receive a verification screen after clicking
"Confirm", I may contact [email protected] to confirm receipt by NIH.
(2) I understand that consideration by the NIH to affirm its status of “noninvasive” is based on the
assumption that a Scientific Review or other Evaluation Group (for grants and contracts) or the Scientific
Director (for Intramural projects) has reviewed the project and already determined it to be scientifically
meritorious.
(3) The statements herein are true, complete, and accurate to the best of my knowledge. I am aware
that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or
administrative penalties.
(4) The information provided herein is materially consistent with the research methods proposed in the
grant application, contract proposal, intramural protocol, or 3rd party research protocol to which this
information supports.
(5) I am the Signing Official with all rights, authority, and responsibilities appropriate to that role for the
organization provided above. As the Signing Official, I am the individual, named by the applicant or
offeror organization, who is authorized to act for the applicant or offeror and to assume the obligations
imposed by applicable Federal laws, regulations, requirements, and conditions.
(6) The applicant or offeror gives permission for the NIH to share its contents with the NIH and
applicable advisory councils. In addition, the applicant or offeror gives permission for NIH staff and
contractors to use the information for administrative purposes, such as reviewing materials for
completeness, routing materials, and managing subsequent steps related to discussions of the proposed
research.
14

THE CHIMPANZEE RESEARCH USE FORM – NO REVISIONS PROPOSED
(7) If I indicated that the research is “noninvasive” based on NIH Guide Notice NOT-OD-16-095, I
understand that NIH will consider the submitted information to validate that determination. If the NIH
disagrees with the organization’s assessment that the research is ”noninvasive,” NIH will notify the
organization of its decision and recommend the organization contact the program official or other
federal official to discuss the proposed research.
(3) I acknowledge that NIH will not fund “invasive” research involving chimpanzees, and research that
proposes such research may delay further consideration by NIH. There is no process to appeal NIH’s
determination on whether research is “noninvasive” or “invasive.”
____________________________________________
Signing Official/Scientific Director Signature and Date

15

THE CHIMPANZEE RESEARCH USE FORM – NO REVISIONS PROPOSED
Fourth Screen—Project Information for Noninvasiveness Determination – NO REVISIONS
This screen allows the user to assess whether his/her proposed research is noninvasive.

Noninvasive Determination

The following types of research involving chimpanzees or chimpanzee biomaterials are considered “noninvasive”:

•
•

•

•
•
•
•

Visual observation.
Behavioral studies designed to improve the establishment and maintenance of social groups. These activities may
cause stress as a result of novel interactions between chimpanzees and caregivers, but they are not considered
invasive as long as they are intended to maximize the well-being of the chimpanzees.
Medical examinations as deemed necessary to oversee the health of the chimpanzees, in the least invasive
manner possible. Collection of samples routinely obtained during a physical examination for processing during this
time is also considered noninvasive since a separate event is not required.
Administration and evaluation of environmental enrichment used to promote the psychological well-being of the
chimpanzees.
Actions taken to provide essential medical treatment to an individual chimpanzee exhibiting symptoms of illness.
This applies only to serious illness that cannot be treated while the chimpanzee remains within the colony.
Observational studies and collection of biomaterial in the wild without interfering with the chimpanzee.
Collections of biological materials (e.g., saliva, oral or other cavity specimens, urine, feces, or hair) obtained
voluntarily from a chimpanzee that has been trained through positive reinforcement to cooperate in the collection.
This excludes venipuncture or other more invasive methods.
If any portion of the proposal fails to satisfy the description of “noninvasive” research involving chimpanzees, contact
your program officer or other federal official responsible for administering the award.

Additional Information

If the organization believes the entire research project is “noninvasive,” provide sufficient detail about the proposed
research to allow NIH to verify this designation. If the agency agrees with your designation, then the proposed
research may be considered for funding. If NIH disagrees with the designation, the project will be considered
“invasive” and the investigator will be directed to consult with the program officer or other appropriate federal official.
Complete the text box with sufficient detail about the research project for agency officials to verify that the proposed
research is “noninvasive”:

This field is required. 7000 Characters Remain.

16

THE CHIMPANZEE RESEARCH USE FORM – NO REVISIONS PROPOSED
Enter response above or attach a document with your response (maximum of two pages at 12pt type, equations may
use smaller type).

Attach File …

17

THE CHIMPANZEE RESEARCH USE FORM – NO REVISIONS PROPOSED
Fifth Screen—Attachments – NO REVISIONS
The screen allows the user to attach supplemental information, e.g., images. Attachments are optional.

Attachments

Although NIH allows you to submit attachments, consideration of these materials by the NIH is
discretionary. All pertinent information must be entered into the Noninvasive Determination tab. All
information must be in English and attachments should be in pdf, image, or MS Word file types.
Applicants and offerors are strongly discouraged from resubmitting their grant application, contract
proposal, or protocols as an attachment to the Chimpanzee Research Use Form.
Add…

18

THE CHIMPANZEE RESEARCH USE FORM – NO REVISIONS PROPOSED
Sixth Screen—Final Certification by the Investigator – NO REVISIONS
Upon hitting “Submit” the Investigator is presented with the following certification.

I Certify that:

* I understand that I will receive a "Submission Received on [Date]" verification screen showing the date and
time NIH received the submission. If I do not receive a verification screen after clicking "Confirm", I may contact
[email protected] to confirm receipt by NIH.
By indicating that the research is noninvasive, I understand that NIH will consider the submitted information to
validate that determination. If the NIH disagrees with the organization’s assessment that the research is noninvasive,
NIH consider the project to be invasive and suggest the investigator contact the program officer or other appropriate
federal official. I acknowledge that NIH will not fund invasive research involving chimpanzees.

Cancel Confirm

19


File Typeapplication/pdf
AuthorSmith, James (NIH/OD) [C]
File Modified2017-05-22
File Created2017-05-22

© 2024 OMB.report | Privacy Policy