OMB Approval No: 0693-0009

 Approval Expires: November 30, 2003

ADVANCED TECHNOLOGY PROGRAM

GUIDELINES AND DOCUMENTATION

 REQUIREMENTS FOR RESEARCH INVOLVING

HUMAN AND ANIMAL SUBJECTS

NOVEMBER 2000

Under the Paperwork Reduction Act, no person is required to respond to a collection of information unless it displays

a valid OMB control number. Public reporting burden for this collection of information is estimated to range between

15 minutes and 12 hours depending on the requirement, including time for reviewing instructions, searching existing

data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

Send comments regarding the burden estimates or any other aspect of this collection of information, including

suggestions for reducing this burden to Director, Advanced Technology Program, National Institute of Standards and

Technology, Administration Building, Room A333, MS 4700, Gaithersburg, MD 20800-4700.
TABLE OF CONTENTS

TITLE PAGE

Research Involving Human Subjects 2

Appendix 1 "Human Subjects Checklist” 4

Appendix 2 “Human Subjects Documentation Requirements” 8

Timeline for Submission of NIST Required Human Subjects Documentation 11

Appendix 3 “Request for Determination of no Human Subjects Involvement 12

or Exemption from 15 CFR Part 27 for ATP Proposals 

Involving Information Technology Data, Manufacturing 

and Imaging Studies”

Appendix 4 “Request for Determination of no Human Subjects 14 

Involvement or Exemption from 15 CFR Part 27 for ATP 

Proposals 

Involving Biological Studies”

Research Involving Vertebrate Animals 15

Timeline for Submission of NIST Required Animal Subjects Documentation 17
2

Research Involving Human Subjects

This booklet outlines the regulations and policies NIST applies to research proposals that include the

use of human and animal subjects. This booklet should be used in conjunction with the ATP Proposal

Preparation Kit. Research involving human subjects sponsored by ATP must be in compliance with

applicable federal regulations and NIST policy. Before research that may involve human subjects may

begin, NIST will independently determine if your research proposal involves the use of human

subjects. The term “research” is often misunderstood. Research means “a systematic investigation,

including research, development, testing and evaluation, designed to develop or contribute to

generalizable knowledge.” Activities that fall within this definition constitute research whether or not

they are conducted or supported under a program that is considered research for other purposes. For

example, using medical databases/records, conducting employee surveys, human testing of computer

software or video quality, and collecting data from voice video, digital or image recordings that include

human subjects generally fall within the scope of this rule if the knowledge derived from the research

is generalizable. The purpose of the regulations and policies is to protect human subjects from risk or

harm resulting from the research activities themselves or publication of research results. Personal harm

may include placing a person at risk of criminal or civil liability or be damaging to the subjects’

financial standing, employability or reputation, in addition to the traditional concerns about personal

health and safety risks. To assist you in determining whether your research involves human subjects,

as defined by the regulations, a human subjects checklist is provided for you in Appendix 1 of this

booklet. Under no circumstance may human subjects be used in your research until NIST has made

an independent determination and reviewed and approved the use of human subjects in your

research project. 

If you have any questions regarding this information, please call the ATP Human and Animal

Subjects Advisor, Mr. Tryn Stimart at 301-975-8779 for additional guidance.

The information contained in this booklet is also available on the ATP website

http://www.atp.nist.gov.

Authorities

Presidential policies, statutes, regulations, and guidelines have been issued concerning many types of

research activities involving human subjects. The proposer is advised to read and comply with all

applicable authorities when submitting a research proposal. Although NIST may not be directly named

in these authorities, to assure that research involving human subjects funded by NIST is consistent with

national policy, NIST hereby declares that it will fully adhere to the above mentioned authorities.

Shown below is a list of the policies, statutes, regulations, and guidelines applicable to research

involving human subjects:

1. Department of Commerce (DOC) regulations entitled “Protection of Human Subjects,” found at

15 CFR Part 27 (http://www.doc.gov/oebam/gforms.htm).

2. Department of Health and Human Services (DHHS) regulations found at 45 CFR Part 46 Subparts

B, C and D for the protected classe s

(http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm).
3

3. Children’s Online Privacy Protection Act of 1998, 16 CFR Part 312 15 U.S.C. Section 6501 et

seq., and implementing regulations found at 16 CFR Part 312

(http://www.ftc.gov/opa/1999/9910/childfinal.htm).

4. Section 111 of the NIH Revitalization Act of 1993, 42 U.S.C. Section 289g-1, on transplantation

of fetal tissue into human subject s

(http://ohrp.osophs.dhhs.gov/humansubjects/guidance/publiclaw103-43.htm).

5. Section 498(b) of the Public Health Service Act, 42 U.S.C. Section 289g on the use of fetal tissue.

6. Section 513 of the Departments of Labor, DHHS, and Education, and Related Agencies

Appropriations Act of 1998, Public Law 105-78, 111 Stat. 1467 regarding research involving

embryos (http://grants.nih.gov/grants/guide/notice-files/not98-013.html).

7. The Food and Drug Administration (FDA) guidelines published at 61 FR 49919 (September 23,

1996) regarding research involving xenotransplantation into human subjects

(http://fda.gov/cber/gdlns/xeno.txt).

8. Presidential Directive, 33 Weekly Comp. Pres. Doc. 281 (March 10, 1997), prohibiting federal

conduct and funding of research involving human cloning

(http://grants.nih.gov/grants/policy/cloning_directive.htm).

Research Involving The Protected Classes

Research involving the protected classes of human subjects must be in compliance with the regulations

found at 45 CFR Part 46 Subparts, B, C and D. Protected classes include pregnant women, human in

vitro fertilization and fetuses (Subpart B), prisoners (Subpart C), and children (Subpart D). Some

examples of research involving protected classes may include: medical test data from children,

software usability test results involving prisoners, surveys with pregnant women as subjects, tissue and

cell donations custom collected from fetal sources. The proposer is advised that NIST will require

approval of all research involving the protected classes as described in Subpart B, before an initial

award is issued, regardless of when the research is proposed to begin. NIST will not accept

Institutional Review Board (IRB) deferred approvals of protocols for research that involves human

subjects defined under Subpart B. In addition, NIST applies 45 CFR Part 46, Subpart B to all types

of gestational tissue, regardless of the source. Thus, any project involving human gestational tissue

(including yolk sacs, non-full-term placentae, tissue or cells to be custom collected from a nonviable fetus or fetal tissues/cells by the applicant directly or through a third party) regardless of

the source must meet the requirements in 45 CFR Part 46, Subpart B.

General Information

Currently, ATP does not approve human subjects research that takes place in a foreign country as part

of an ATP project. In addition, ATP typically does not accept foreign sources of human tissue, cells

or data, even if the tissue, cells or data may qualify for an exemption under the 15 CFR Part 27.

However, ATP will consider foreign sources of tissue, cells and data on a limited basis if the source

is scientifically recognized as unique, an equivalent source is unavailable within the U.S., an alternative

approach is not scientifically of equivalent merit, and the specific use qualifies for an exemption under

the rule. In addition, proposers are reminded that ATP only rarely supports research as part of a Phase

I clinical trial, and this type of research must be judged to be consistent with the ATP scientific and

technological merit selection criterion.
4

Appendix 1: HUMAN SUBJECTS CHECKLIST

[This checklist may be used to determine if human subjects are involved in a research project and if

the research may be exempt under the regulations on protection of human subjects (15 CFR Part

27).]

A proposal may contain more than one research activity involving human subjects that require different

levels of review. This checklist should be used for each potential use of human subjects to help the

proposer identify the level of documentation to be submitted to ATP with the proposal.

1. Is there an intervention or an interaction with a living person that would not be occurring or would

be occurring in some other fashion, but for this research? Examples: video taping people,

observing children using new software, surveying manufacturing personnel during a pilot test of

new equipment, gathering tissue or cells from human donors, etc.

__ Yes - Human Subjects are involved. Go to Question 3.

__ No - Go to Question 2. 

2. a. Will data/information/specimens collected originally from people or about people be used in

this research? Examples: broadcast video, web use logs, medical information, cells or tissues,

survey questions.

__ Yes - Identifiable Human Subjects may be involved. Go to Question 2.b.

__ No - Go to item 6. It appears that human subjects may not be involved in the project.

However, an exemption determination may be required. Please review Question 3 for

additional information about research that may require an exemption determination.

b. Does that information contain private information in a form in which the identity of the subject

is or may readily be ascertained from the information? Examples: medical records, donor

name or address, sales transaction records.

__ Yes - Identifiable Human Subjects are involved. Go to Question 3 to see if an exemption

may apply. If you know that an exemption does not apply proceed to Question 5.

__ No - Go to Question 3. The research may not be within the scope of 15 CFR Part 27,

however, it may require an exemption determination to be made due to the use of data,

recordings, or specimens that could be linked to humans without appropriate safeguards.

3. Do you think the research may either not be within the scope of 15 CFR Part 27 or qualify for an

exemption under 15 CFR 27.101 (b)? The following questions will help you evaluate whether or

not to request an exemption determination by ATP, or provide documentation that the research

may not be within scope of 15 CFR Part 27:

a. Will the task involving human subjects only use existing data, recordings (audio or visual), or

specimens? Examples: patient records, a company’s customer data, web use logs, cells or
5

tissue.

__ Yes - Go to 3.d.

__ No - Go to 3.b.

b. Will the research plan involve normal educational practices such as instructional strategies or

comparison of instructional techniques, curricula, or classroom management methods?

Examples: observation of student-teacher interactions, video of instruction.

__ Yes - Go to 3.d.

__ No - Go to 3.c.

c. Will the research plan involve educational tests (cognitive, diagnostic, aptitude, achievement),

survey procedures, interview procedures or observation of public behavior. Examples:

broadcast video, software usage testing.

__ Yes - Go to 3.d.

__ No - Go to 5, this research is probably not exempt and will need an IRB review.

d. Do any of the data, recordings, specimens, or practices/procedures involve or come from a

protected class? Protected classes include: Prisoners, children, pregnant women, human in

vitro fertilization, fetuses, and non-viable fetus or fetal sources of data, cells or tissue.

Examples: testing educational software with children, surveys of obstetric patients.

__ Yes - Go to 5, this research is probably not exempt and will need an IRB review.

__ No - Go to 3.e.

e. Are the data, recordings (audio or visual), or specimens publicly available? Note: Publicly

available may include items for sale, items that are freely available to the public, or items that

reside in the public domain. Examples: customer data sets, catalog orders of cells or tissues,

donations of pathological specimens, shareware.

__ Yes - Go to 4, this research may be exempt under 15 CFR 27.101(b).

__ No - Go to 3.f.

f. Will the data, recordings (audio or visual), or specimens be stripped of all identifiable

information that could be linked to a human subject prior to being received by the investigator?

__ Yes - Go to 4, this research may not be within the scope of 15 CFR Part 27, or it may be

exempt under 15 CFR 27.101(b).

__ No - Go to 3.g.

g. Will information be recorded by the investigator in such a way that it can be linked to the

human subject? Examples: web use logs tied to e-mail address, patient records or specimens
6

that include patient identifiers.

__ Yes - Go to 5, this research is probably not exempt and will need an IRB review.

__ No - Go to 4, this research may be exempt under 15 CFR 27.101(b).

4. __ Yes, an exemption under 15 CFR 27.101(b) may apply to the task, or the task may not be

within the scope of 15 CFR Part 27. If the task is expected to take place during the first year

of the project, follow the documentation requirements in Appendix 2 of this booklet in order

to request an evaluation by ATP. If the task is expected to take place during the out years of

the project, follow the documentation requirements in Appendix 2 of this booklet in order to

request a deferred evaluation by ATP. The following areas are the most common exemptions

typically granted for ATP proposals, additional exemption categories are listed in the

regulation. 

a. Fill out Appendix 3: “Request for Determination of No Human Subjects Involvement

or Exemption from 15 CFR Part 27 for ATP Proposals Involving Information

Technology Data, Manufacturing and Imaging Studies” for the following possible

exemption categories or other exemption categories that you believe apply:

1) Normal educational practices in an established or commonly accepted educational

setting (15 CFR 27.101 (b) (1)).

2) Educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures,

interview procedures or observation of public behavior (15 CFR 27.101 (b)(2)). 

NOTE: Data in the form of video or other images may fit into observation of public

behavior if pre-existing publicly available video is used or the video is collected in a

public setting. 

3) Collection or study of existing data, documents, or records that are publicly available

or stripped of all identifiers linked to the human subject (15 CFR 27.101 (b)(4)).

NOTE: This includes materials used as research controls. Data (e.g. video images,

medical records, retail sales transactions etc.) from human sources that are not preexisting DO NOT qualify for an exemption under 15 CFR 27.101 (b) (4). Existing

means collected (i.e. on the shelf) prior to the research for a purpose other than the

proposed research or excess material obtained through a procedure not related to the

proposed project. (OPRR 10/1/98 Human Subjects Regulation Decision Charts).

b. Fill out Appendix 4: “Request for Determination of No Human Subjects Involvement

or Exemption from 15 CFR Part 27 for ATP Proposals Involving Biological Studies”

for the following possible exemption category or other exemption categories that you

believe apply:

Collection or study of existing data, documents, records, human cells, human tissues that

are publicly available or stripped of all identifiers linked to the human subject (15 CFR

27.101 (b)(4)). NOTE: This includes materials used as research controls. Data (e.g. video

images, medical records, retail sales transactions etc.) or specimens (e.g., cells, tissue,

blood etc.) from human sources that are not pre-existing DO NOT qualify for an exemption
7

under 15 CFR 27.101 (b) (4). Existing means collected (i.e. on the shelf) prior to the

research for a purpose other than the proposed research or excess material obtained

through a procedure not related to the proposed project. (OPRR 10/1/98 Human Subjects

Regulation Decision Charts).

5. ___ No, an exemption probably does not apply to the proposed research. 

a. If research is expected to take place during the first year, the proposer should pursue

obtaining an IRB review and approval. Follow the documentation requirements in

Appendix 2 of this booklet to request NIST institutional review of an IRB approval.

b. If the research is expected to take place during the out years of the project follow the

documentation requirements in Appendix 2 of this booklet to request a deferred NIST

institutional review of an IRB approval. This option does not apply to projects in which

tasks in any year of the project involve the specific protected classes that are governed

by 45 CFR Part 46, Subpart B (see item 5.a above) – NO EXCEPTIONS.

6. It appears that human subjects are not involved in this project. This checklist is only a tool for

general guidance and does not constitute a final legal opinion from NIST on whether or not human

subjects are involved, or whether or not an exemption determination under the regulations is

needed. If upon ATP/NIST review of your proposal we believe additional documentation is

needed to reach a final determination, and your proposal is selected as a semifinalist, you will be

asked to provide the additional documentation prior to an oral review.
8

Appendix 2: Human Subjects Documentation Requirements

If you answered “yes” on the form, NIST-1262 or 1263, item 14.E.vi found in the ATP Proposal

Preparation Kit or if you are unsure whether or not the research tasks proposed involve human

subjects, human tissue, data, or video collected about human subjects, you must submit one of the

following types of documentation for each use of human subjects in the project. If you answered “no”

on the form, NIST-1262 or 1263, item 14.E.vi., you are not required to submit any of the following

documentation with the proposal. However, NIST reserves the right to make an independent

determination of whether or not human subjects are involved in the research protocol and NIST may

request documentation to complete the review process. A Timeline for Submission of NIST Required

Documentation is provided at the end of Appendix 2 to aid in the submission of documentation. A

proposal may contain more than one use of human subjects requiring different types of documentation

for NIST review. For example, a project may have multiple exemptions, or one exemption and several

deferrals, or an IRB review, a deferral and several exemptions. It is strongly recommended that the

proposer complete Appendix 1 of this booklet to determine if human subjects are involved in the

research proposal. Projects with human subjects research in the first year must supply item 1. Projects

with human subjects in the out years of the project must supply item 3. Projects with protected

classes subject to Subpart B in ANY year of the project MUST provide item 2. by the time of the

oral review; the other items do not apply.

1. Documentation for No Human Subjects Involvement or Exempt Research. To allow NIST to

determine if there are any identifiable human subjects, human tissue, cells/cell lines, data or

recordings involved in the proposed research that may not be within the scope of 15 CFR Part 27

or that may qualify for an exemption from 15 CFR Part 27, the proposer should provide specific

responses to Appendices 3 and/or 4 in this booklet and submit the responses with the proposal.

If an IRB has reviewed the research project and made a determination that the research qualifies

for an exemption, the proposer must provide a copy of the IRB approval of the exemption with the

proposal. In most cases, exemptions do not apply to research involving protected classes of human

subjects. NOTE: Data (e.g., video images, medical records, retail sales transactions etc.) or

specimens (e.g., cells, tissue, blood etc.) from human sources that are not pre-existing DO NOT

qualify for an exemption under 15 CFR 27.101 (b) (4). Existing means collected (i.e. on the shelf)

prior to the research for a purpose other than the proposed research or excess material obtained

through a procedure not related to the proposed project (OPRR 10/1/98 Human Subjects

Regulation Decision Charts). If NIST questions the determination provided, NIST will request

appropriate documentation to complete the review process.

2. Documentation for Non-Exempt Research. If NIST determines that the research project involves

human subjects and does not qualify for an exemption, and the tasks involving human subjects are

anticipated to begin in the first year of the project, the documentation outlined below is required.

a. IRB Assurance Documentation

SPECIAL REQUIREMENTS FOR PROTECTED CLASSES: Research projects involving

 protected classes of human subjects as defined in 45 CFR Part 46, Subparts B, C, and D

 including pregnant women, human in vitro fertilization, fetuses, prisoners, and
9

children) MUST be reviewed and approved by an IRB that possesses a current MPA

appropriate for the research in question, or another type of assurance that has been approved

by Office of Human Reseach Protection (OHRP)/ DHHS for federal- wide use. No award

involving protected classes as defined under 45 CFR Part 46, Subpart B, will be issued until

the proposer has certified that an appropriate IRB has made the determinations required

under Subpart B, and all other NIST approvals have been completed. This applies to

involvement of protected classes under Subpart B in ANY year of the project, not just the

first year. Therefore, IRB approval for any tasks involving protected classes of human subjects

under Subpart B at any time during the proposed ATP award period must accompany the

proposal, or be supplied at oral review if the proposal is selected as a semifinalist. Research

activities regulated under Subpart B will not be added to any proposal once the award is

issued. 

Documentation of an applicable IRB assurance is REQUIRED as outlined below:

1) An IRB With a Multiple Project Assurance (MPA). If your organization uses an IRB

with an MPA on file with OHRP to approve your research projects, the proposer must

provide the IRB's MPA number (or the number and type of assurance approved for federalwide use) and its associated expiration date with the proposal. A listing of institutions that

have an MPA on file with OHRP can be found at http://ohrp.osophs.dhhs.gov/polasur.htm.

2) An IRB Within an Organization Without an MPA. If the proposing organization is using

an IRB that has been created by and within the proposing organization and does not have

an MPA on file with OHRP, a Single Project Assurance (SPA) granted by NIST is required.

An SPA is required by NIST to document that the proposing Organization’s IRB was

created according to the requirements of 15 CFR Part 27 and that all research involving

human subjects will comply with the requirements of 15 CFR Part 27 and the ethical

principles set forth in the report of the National Commission for the Protection of Human

Subjects of Biomedical and Behavioral Research entitled, “Ethical Principles and

Guidelines for the Protection of Human Subjects of Research,” which is commonly referred

to as the “Belmont Report ”

(http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm)). NIST will not grant

an SPA for research that involves any of the following categories:

a) Any research involving the protected classes as defined at 45 CFR Part 46 Subparts B,

C and D.

b) Any research involving pre-clinical or clinical trials, 

c) Any research that involves invasive administration of any drug or agent, 

d) Any research that involves invasive surgical procedures, 

e) Any research that NIST determines may place research subjects at greater than minimal

risk.

On a case by case basis, NIST will determine whether or not the proposed research falls

within one of the categories mentioned above. For all categories of research not mentioned

above, NIST will determine, on a case by case basis, whether or not an SPA will be
10

granted. If NIST determines that an SPA will not be granted, NIST will require that an IRB

with an MPA on file with OHRP review and approve the research protocol.

Information on drafting an SPA, submitting an SPA and other SPA-related issues may

be found on the ATP website http://www.atp.nist.gov.

NOTE: For research involving protected classes, the IRB reviewing and approving

the research protocol MUST have an MPA on file with OHRP. NIST will not accept

IRB approval for research involving protected classes from any IRB without an MPA

on file with OHRP.

b. IRB Protocol. A signed copy of the final approved IRB protocol for each of the specific

research tasks in the ATP proposal must be submitted to NIST. 

c. Informed Consent Forms. All informed consent forms reviewed and approved by the IRB

must be submitted to NIST. All informed consent forms must clearly state that the cognizant

IRB, NIST, and other appropriate Federal officials may review any records associated with the

protocol.

d. IRB Approval Documentation. A signed and dated approval letter from an IRB with an

appropriate assurance for each approved protocol, along with any pertinent comments from

the IRB concerning interim review requirements or other restrictions must be submitted to

NIST.

e. IRB Education Documentation. A signed and dated letter is required from the Organizational

Official who is authorized to enter into commitments on behalf of the organization

documenting that appropriate IRB education has been received by the Organizational Official,

the IRB Coordinator or such person that coordinates the IRB documents and materials if such

a person exists, the IRB Chairperson, all IRB members and all key personnel associated with

the proposal. The NIST requirement of documentation of education is consistent with NIH

notice OD-00-039 (June 5, 2000). Although NIST will not endorse an educational curriculum,

there are several curricula that are available to organizations and investigators which may be

found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

3. Documentation for Deferrals. (This option does not apply to research governed by 45 CFR

Part 46, Subpart B, see item 2.a. above.) If there are no research tasks involving human subjects

or tissue in the first year, but some are anticipated beyond the first year of the project, the proposer

should provide a detailed request for a deferred IRB approval or exemption as appropriate under

15 CFR 27.118. The documentation as outlined in items 1. and 2. above must be submitted for

review and written approval by the NIST Grants Officer prior to releasing funds for the research

tasks requiring an exemption determination or an IRB approval for tasks involving human subjects

in the out-years of the project. It is strongly encouraged that this documentation be provided well

in advance (3-6 months) of the planned start of the tasks involving human subjects. Deferral

requests should include the following documentation:
11

a. A projected date when the research tasks involving human subjects, tissue, data or recordings

involving human subjects are planned. For example: second quarter of Year 3.

b. A schedule of when documentation is expected to be submitted to NIST for either an

exemption determination, item 1. above, or for documentation of an IRB approval for nonexempt research, item 2. above. NOTE: The NIST IRB is not authorized to perform IRB

reviews for ATP proposers or funded projects.
12

Timeline for Submission of NIST Required Human Subjects Documentation (Before submitting any

documentation to NIST, the proposer is advised to read this booklet and the ATP Proposal Preparation

Kit in their entirety). NOTE: As required in Exhibit 2 of the ATP Proposal Preparation Kit, please

incorporate the required documentation listed below in the initial proposal (see GATE 1 column below) and

submit the required 16 copies, i.e., an original signed bound and 15 copies (1 unbound and 14 bound).

Determinatio

n of Human

Subjects Use 

Gate 1

(Initial Proposal)

Gate 3

(Prior to Oral Review )

Year 1

No Human

Subjects or

Exempt

Completed Appendix 3, “Request for

Determination of No Human Subjects

Involvement or Exemption from 15 CFR Part

27 for ATP Proposals Involving Information

Technology Data, Manufacturing and

Imaging Studies,” and/or Appendix 4,

“Request for Determination of No Human

Subjects Involvement or Exemption from 15

CFR Part 27 for ATP Proposals Involving

Biological Studies,” as required

All other NIST required

materials or clarifications as

requested in pre-orals

questions

Year 1

Non-exempt; 

IRB with

MPA

The name of the IRB that will be reviewing

the protocol; the MPA number of the IRB

and the expected date of IRB review

A protocol summary of the

research approved by the

IRB; a signed and dated

approval letter from the

IRB; all IRB approved

consent forms and a signed

and dated letter

documenting appropriate

IRB education

Year 1

Non-exempt;

IRB without

MPA

The approved IRB protocol; all approved

consent forms; a roster of the IRB; a

completed and signed SPA and a signed and

dated letter from the organization

documenting appropriate IRB education

All other NIST required

materials or clarifications as

requested in pre-orals

questions

After Year 1

Deferred

No documents are required to be submitted

with the initial proposal

A projected date of human

subjects usage and a

schedule of when NIST

required materials will be

submitted in accordance

with the categories listed

above
13

NOTE: For research involving the protected classes under 45 CFR Part 46, Subpart B, in ANY

year of the project, IRB approval is required for each involvement of human subjects in the

project BEFORE an award can be issued.
14

Appendix 3: Request for Determination of No Human Subjects Involvement or Exemption

from 15 CFR Part 27 for ATP Proposals Involving Information Technology

Data, Manufacturing and Imaging Studies

Responses to the following questions must be supplied along with the initial proposal submission (Gate

1) to allow NIST to perform an independent determination if no human subjects are involved in the

research proposal or to determine if the use of human subjects qualifies for an exemption from 15 CFR

Part 27. Proposers are reminded that the term data includes collection of data from voice, video,

digital or image recordings made for research purposes. For proposals involving biological studies,

please complete Appendix 4. If a question is not applicable, please indicate “NA.”

1. What is the time frame (start and end dates) for human subject/data/image involvement?

2. State the technical justification for human subject/data/image involvement (i.e. No other way to

achieve equivalent technical outcome? Why?).

3. Are the data/images stripped of any identifiable information (e.g. personal identifiers such as names

or codes which can be traced back to the human donor or source)? Explain.

4. Are the data/images publicly available from a named source? Explain and name the source(s)

being considered or planned, if appropriate. NOTE: An answer of “no” to either question #3 or

#4 may disqualify the project from an exemption. In those cases, an appropriate IRB approval may

be required, and should accompany the proposal if the work is within the first year of the project.

5. Are the data/images/recording pre-existing, being collected for the express purpose of the research,

or obtained by some combination of the two?

6. What is the source of the data/image/recording (e.g. video archives, proprietary database, security

systems/records, medical records, video conference records, etc.)?

7. What is the extent of data/image/recording handling by the Principal Investigator: collecting,

receiving, and/or sending data/images?

8. What is the extent of contact by the Principal Investigator with human subjects: personal

observation, image recording, survey questions, etc.?

9. What is the extent of control by the Principal Investigator of the environment in which the human

subjects will be monitored?

10. Do the data/images/recording come from individuals who may need special safeguards (i.e. minor

children, pregnant women, human in vitro fertilization, fetuses, or prisoners)? NOTE: An answer

of “yes” to question #10 disqualifies the project from exemption under 15 CFR Part 27. In these

cases, the proposal protocol/task descriptions MUST be reviewed and approved by an IRB that

possesses a current assurance, appropriate for the research in question, on file with the OHRP, and

which has been approved by OHRP for federal wide use. This IRB approval MUST be submitted

by the time of oral review (Gate 3). Please follow the instructions for research involving the

protected classes in Appendix 2.

11. Is the image/recording being recorded in fact “public behavior”? Some indicators of public

behavior would be:

a. Image of behavior does NOT give rise to any cause of action under ANY legal theory

protecting personal privacy;

b. There are NO trade secrets or OTHER CONFIDENTIAL INFORMATION of any person

contained in the image or recording;

c. There are NO copyright restrictions OR, the copyright holder has granted written
15

permission to the proposer;

d. Any other matter the proposer deems germane to this issue.

12. If answer to #11 is “yes”:

a. Can the human subjects be identified directly or through identifiers?

b. If the human subjects can be identified, any disclosure would NOT reasonably place the

subjects at risk of criminal or civil liability, standing, employability or reputation.

13. Has the research been reviewed by an IRB? If yes, attach a copy of the review.

The following signed statement must accompany the answers to the above questions:

This is an accurate description of the proposed research involving human subjects. Any changes in

protocol or task descriptions will be submitted in advance to the IRB as appropriate, and to ATP prior

to notification of ATP award decisions. 

 

Name and Signature of Principal Investigator Date
16

Appendix 4: Request for Determination of No Human Subjects Involvement or Exemption

from 15 CFR Part 27 for ATP Proposals Involving Biological Studies

Responses to the following questions must be supplied along with the initial proposal submission (Gate

1) to allow NIST to perform an independent determination if no human subjects are involved in the

research proposal or to determine if the use of human subjects qualifies for an exemption from 15 CFR

Part 27. Proposers are reminded that the term data includes collection of data from voice, video,

digital or image recordings made for research purposes. For proposals involving the collection of

data or other uses of informatics, please complete Appendix 3. 

1. What is the time frame (start and end dates) for human tissue/subject involvement?

2. State the technical justification for human tissue/subject involvement (i.e. No other way to achieve

equivalent technical outcome? Why?).

3. Are the samples stripped of any identifiable information (e.g. personal identifiers such as names

or codes which can be traced back to the human donor or source)? Explain.

4. Is the tissue publicly available from a named source? Explain and name the source(s) being

considered or planned, if appropriate.

NOTE: An answer of “no” to either question #3 or #4 may disqualify the project from an

exemption. In those cases, an appropriate IRB approval may be required, and should

accompany the proposal if the work is within the first year of the project.

5. What is the anatomical source of the cell or tissue? (e.g. liver, skin, etc.)

6. What is the extent of tissue handling by the Principal Investigator: collecting, receiving, and/or

sending specimens?

7. Are the samples pre-existing, being collected for the express purpose of the research, or obtained

by some combination of the two?

8. Do the samples come from individuals who may need special safeguards (i.e. minor children,

pregnant women, human in vitro fertilization, fetuses, or prisoners)?

NOTE: An answer of “yes” to question #8 disqualifies the project from exemption under 15

CFR Part 27. In these cases, the proposal protocol/task descriptions MUST be reviewed and

approved by an IRB that possesses a current assurance, appropriate for the research in

question, on file with the OHRP, and which has been approved by OHRP for federal wide use.

This IRB approval MUST be submitted by oral review (Gate 3). Please follow the instructions

for research involving the protected classes in Appendix 2.

9. Has the research been reviewed by an IRB? If yes, attach a copy of the review.

The following signed statement must accompany the answers to the above questions:

This is an accurate description of the proposed research involving human subjects/tissues. Any

changes in protocol or task descriptions will be submitted in advance to the IRB as appropriate, and

to the ATP prior to notification of ATP award decisions. 
17

 

Name and Signature of Principal Investigator Date
18

Research Involving Vertebrate Animals

This part of the booklet outlines the regulations and policies NIST applies to research proposals that

intend to use live vertebrate animals. Research involving live vertebrate animals under an ATP project

must be in compliance with the Animal Welfare Act (7 U.S.C. §§ 2131 et. seq.) and the National

Research Council's "Guide for the Care and Use of Laboratory Animals" (http://www.nap.edu.) In

addition, NIST requires certain assurances or institutional certifications depending on the type of

research proposed as described below. If institutional assurances or certifications are not obtainable

for research proposed to begin within the first year, the proposer is advised that it is unlikely that an

award can be issued. NIST requires Institutional Animal Care and Use Committee (IACUC) approval

of any live vertebrate animal research prior to beginning the research. The IACUC associated with the

organization(s) where animals will be manipulated, housed and cared for must approve all Animal

Study Proposals (ASPs) detailing all research involving vertebrate animals. NIST will also make an

independent review of the ASP before the NIST Grants Officer approves release of funds for animal

studies. 

If you answered “yes” on form, NIST-1262 or 1263, item E.vii. found in the ATP Proposal Preparation

Kit, and there are research tasks proposed that involve animal subjects, the proposer must submit the

following documentation for each use of animal subjects in the project. If you answered “no” on the

form, NIST-1262 or 1263, item 14.E.vii., you are not required to submit any of the following

documentation with the proposal. A timeline for Submission of NIST Required Documentation is

provided at the end of this part of the booklet to aid in the submission of documentation. The

documents described below do not apply to proposed research using pre-existing images of animals

(e.g. a wildlife documentary, or pictures of animals in newscasts, etc.), or to research plans that do not

include animals that are being cared for, euthanized, or used by the project participants to accomplish

research goals, teaching, or testing. These documents also do not apply to obtaining animal materials

from commercial processors of animal products, or to animal cell lines or tissues from tissue banks.

If you have any questions regarding research projects involving vertebrate animals, please contact

the ATP Human and Animal Subjects Advisor, Mr. Tryn Stimart at 301-975-8779 for additional

guidance.

Documentation Requirements

1. For research involving vertebrate animals during the first year of the research proposal, a copy of

the following documentation is required. 

a. Certifications/Assurances (NIST will require at least one of the following in order to approve

the use of animal subjects)

1) The U.S. Department of Agriculture (USDA) Animal Welfare Act registration

certificate. A USDA registration is required for large animal studies (e.g. bovine).

General information about applying for this registration is available at

http://www.aphis.usda.gov/ac/awainfo.html. 
19

2) The Animal Welfare Assurance issued by the Office of Laboratory Animal Welfare

(OLAW), National Institutes of Health (NIH). An assurance from OLAW can only be

obtained if your organization is receiving funding from the NIH. General information

regarding animal welfare policies and regulations is available at

http://grants.nih.gov/grants/olaw/olaw.htm.

3) The Association for Assessment and Accreditation of Laboratory Animals Care

International (AAALAC) accreditation. Applicable to organizations using only rodents,

birds, or fish. AAALAC accreditation alone is insufficient for large animal studies. General

information about applying for this accreditation is available at

http://www.aaalac.org/html/application.html.

b. Animal Study Proposals (ASP). A copy of all approved ASPs including all signatures as

required by the organizational IACUCmust be submitted to NIST. In addition to the necessary

information required by the organizational IACUC, NIST requires that all approved ASPs

contain the following information:

1) The name, degree and experience of all personnel involved with the care and use of the

animals. 

2) A determination of the pain category for all animals associated with the research.

3) Certification by the Principal Investigator of the ASP that a literature search has been

completed to determine if the there are any alternative procedures which would involve

less pain or distress to the animals proposed in the research and that the research proposed

is not unnecessarily duplicative.

An example of an ASP or a similar ASP to what may eventually be submitted to an IACUC

for review is NOT acceptable. If the ASP includes tasks not applicable to

the ATP project, or if the ASP is supported by multiple sources of funding,

include a brief description of what portions of the ASP apply specifically to the ATP

project.

c. IACUC Approval Memos. A copy of all approval memos issued by the organizational

IACUC for the animal study proposals in item 1b. above must be submitted to NIST. The

approval memos must be signed by the approving official for the IACUC approving the ASP

and include expiration dates and interim reporting requirements or restrictions for each study.

2. For research involving live vertebrate animals beginning after the first year of the proposal, the

following information is required by the time of oral review: 

a. The name of the organization(s) that may be performing the animal studies.

b. An indication whether or not the organization(s) has certifications or assurances as described

in 1.a. If the organization(s) does not have the required certifications or assurances, provide

a time line anticipated for obtaining certification or assurance prior to performing the animal

studies.

c. A time line for when the ASPs will be submitted to the appropriate IACUC, and when NIST
20

can expect to receive all required documentation as outlined above for each ASP.
21

Timeline for Submission of NIST Required Animal Subjects Documentation: (Before submitting any

documentation to NIST, the proposer is advised to read this booklet and the ATP Proposal Preparation

Kit in their entirety). 

NOTE: As required in Exhibit 2 of the ATP Proposal Preparation Kit, please incorporate the required

documentation listed below in the initial proposal (see GATE 1 column below) and submit the required 16

copies, i.e., an original signed bound and 15 copies (1 unbound and 14 bound).

Date of

Animal

usage

Gate 1

(Initial ATP Proposal)

Gate 3

(Prior to Oral review)

Year 1 The name of the IACUC that

will be reviewing and approving

each ASP; the location of use

and housing for ALL animals;

the appropriate USDA, OLAW,

AAALAC assurance or

certification number

An IACUC approved ASP; a signed and

dated approval letter for the ASP from

the approving official for the IACUC

and a copy of the appropriate assurance

or certification document

After Year 1

Deferred

No documents are required to

be submitted with the initial

proposal

The name of the IACUC that may be

reviewing and approving each ASP; a

copy of the appropriate assurance or

certification document for the IACUC,

or a timeline for obtaining such an

assurance; a timeline for submission of

the approved ASP to NIST for review