Guidelines
and Documentation Requirements for Research Involving Human and Animal
Subjects
I. Research Involving Human
Subjects
A.
Introduction
The Advanced
Technology Program (ATP) will fund research involving human subjects.
Research involving human subjects must comply with all applicable federal
statutes, Executive Orders, federal regulations, and policies. Applicable
authorities are listed in Appendix 1.
For certain types
of research involving human subjects, the National
Institute of Standards and Technology (NIST) has procedures that require
NIST as an institution to approve documentation in addition to ATP review
and approval.
The Federal Policy
for the Protection of Human Subjects (the Common Rule), adopted by the
Department of Commerce (DOC) at 15 C.F.R.
Part 27, sets forth the appropriate policies and procedures for the protection
of human subjects in research. The Common Rule is available at http://www.access.gpo.gov/nara/cfr/cfr-table-search.html.(1)
The Common Rule defines
human subject as a living individual about whom an investigator
conducting research obtains (1) data through intervention or interaction
with the individual or (2) identifiable private information. The term
research means a systematic investigation, including research development,
testing, and evaluation, designed to develop or contribute to generalizable
knowledge.
The Common Rule provides
a systematic means, based on established, internationally recognized ethical
principles, to safeguard the rights and welfare of individuals who participate
as subjects in research activities. An awardee institution bears the responsibility
for safeguarding the rights and welfare of human subjects in DOC-supported
research.
To help you determine
whether your research includes the use of human subjects, you are encouraged
to review the Human Subjects Determination Checklist in Appendix
2 before submitting your proposal to ATP.
B.
Assurance of Compliance
Applicant organizations
proposing to involve human subjects in nonexempt research must have on
file a written assurance approved for federalwide use from the Office
for Human Research Protections (OHRP) within the Department of Health
and Human Services (DHHS).
The Common Rule at
section 27.103(a) requires that each institution engaged in federally
supported human subject research file an assurance of compliance. An assurance
formalizes the institution's commitment to protect human subjects.
Under the Common Rule
at section 27.102(f), awardees and their collaborating institutions become
engaged in human subject research whenever their employees or agents (1)
obtain data through intervention or interaction with living individuals
for research purposes or (2) obtain identifiable private information for
research purposes.
Awardee institutions
are considered to be engaged in human subject research whenever they receive
a direct DOC award to support such research, even when all activities
involving human subjects are carried out by a joint venture partner, subcontractor,
or formal collaborator. In such cases, the awardee institution bears ultimate
responsibility for protecting human subjects under the award.
Awardees are also
responsible for ensuring that each joint venture partner, subcontractor,
and formal collaborating institution that is engaged in human subject
research hold an assurance approved for federalwide use from OHRP.
ATP will accept either
a current Federalwide Assurance (FWA) or a current Multiple Project Assurance
(MPA) from OHRP. ATP does not grant or accept a Single Project Assurance
(SPA). Information regarding the FWA process can be found at http://ohrp.osophs.dhhs.gov/humansubjects/assurance/fwas.htm.
C.
Protected Classes
Research involving
pregnant women, human fetuses, neonates, prisoners, or children must comply
with 45 C.F.R. Part 46 Subparts B, C, and D, respectively, which describe
additional protections required for these human subjects.
NIST considers all
custom collection of gestational tissues (e.g., yolk sac) or cells to
be covered by subpart B.
The regulations for
research involving the protected classes identified in subparts B, C,
and D can be found at http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm.
The use of cadaveric
materials is governed by applicable state and local laws and is not directly
regulated by the Common Rule.
D.
Clinical Trials
On a case-by-case
basis, ATP may support research as part of a Phase I clinical trial. ATP
expects requests to support Phase I clinical trials to be rare. If the
research proposed includes all or any portion of a Phase I clinical trial,
the research must be deemed consistent with all ATP requirements for scientific
and technological merit selection criteria. Although the criteria may
be met, ATP reserves the right not to fund the Phase I clinical trial,
and ATP may ask the proposer to describe the impact on the project if
that activity is removed from the project.
Under no circumstances
will ATP support research included in a Phase II, Phase III, or Phase
IV clinical trial.
E.
Human Subjects in Foreign Countries
Generally, ATP does
not fund research involving human subjects in foreign countries. ATP will
consider, however, the use of tissue, cells, or data from a foreign source
on a limited basis if all of the following criteria are satisfied:
- the scientific
source is considered unique,
- an equivalent
source is unavailable within the United States,
- an alternative
approach is not scientifically of equivalent merit, and
- the specific use
qualifies for an exemption from the Common Rule.
F.
Transplantation of Fetal Tissue
Research involving
the transplantation of human fetal tissue must meet all of the requirements
set forth at section 498A(b) and (c) of the Public Health Service Act,
42 U.S.C. §§ 289g(b) and (c), and section 111 of the NIH Revitalization
Act of 1993, 42 U.S.C. § 289(g)1. Guidance can be found at http://ohrp.osophs.dhhs.gov/humansubjects/guidance/publiclaw103-43.htm.
G.
Research Involving Embryos and Embryonic Stem Cells
ATP adheres to all
federal statutes, Executive Orders, federal regulations, and policies
regarding the use of human embryos and human embryonic stem cells.
Although other federal
agencies may permit the use of human embryonic stem cells in federally
funded research, ATP will not consider any proposal that intends to create,
destroy, derive, characterize, or use human embryonic stem cells.
H.
Research Exempt From the Regulations
Certain research activities
may qualify for an exemption from the requirements of the Common Rule.
The categories of research that qualify for an exemption can be found
at 15 C.F.R. § 27.101(b). The exemptions most commonly cited in ATP
awards are the following:
- Research conducted
in established or commonly accepted educational settings, involving
normal educational practices such as (i) research on regular and special
education instructional strategies, or (ii) research on the effectiveness
of or the comparison among instructional techniques, curricula, or classroom
management methods. [15 C.F.R. § 27.101(b)(1)]
- Research involving
the use of educational tests (cognitive, diagnostic, aptitude, achievement),
survey procedures, interview procedures, or observation of public behavior,
unless (i) information obtained is recorded in such a manner that human
subjects can be identified, directly or through identifiers linked to
the subjects, and (ii) any disclosure of the human subjects' responses
outside the research could reasonably place subjects at risk of criminal
or civil liability or be damaging to the subjects' financial standing,
employability, or reputation. [15 C.F.R. § 27.101(b)(2)]
- Research involving
the collection or study of existing data, documents, records, pathological
specimens, or diagnostic specimens, if these sources are publicly available
or if the information is recorded by the investigator in such a manner
that subjects cannot be identified, directly or through identifiers
linked to the subjects. [15 C.F.R. § 27.101(b)(4)]
Exemptions are not
available for research involving the protected classes identified at 45
C.F.R. Part 46 Subpart C (prisoners). Also, the exemption at 15 C.F.R.
§ 27.101(b)(2) for research involving survey or interview procedures
or observation of public behavior does not apply to research with children,
except for research involving observations of public behavior when the
investigator or investigators do not participate in the activities being
observed.
To determine whether
your research qualifies for an exemption from the Common Rule or 45 C.F.R.
Part 46 Subparts B or D, please see the Human Subjects Determination Checklist
in Appendix 2.
I.
Required Documentation
You are required to
indicate on Form NIST-1262 or Form NIST-1263,
at item 13.D in the ATP Proposal Preparation
Kit, whether your research involves human subjects.
The Human Subjects
Determination Checklist in Appendix 2 will
assist you in determining whether your research involves human subjects.
You are strongly encouraged to review the authorities found in Appendix
2 before submitting your Gate 1 proposal.
NIST and ATP reserve
the right to make an independent determination of whether your research
involves human subjects. If NIST or ATP determines that your research
project includes human subjects, you will be required to provide additional
information for review and approval.
The documentation
requirements for the use of human subjects are listed below. In addition,
a timeline for the submission of required documents is presented in Appendix
5.
- Research Exempt
From the Common Rule
If your use of human subjects qualifies for an exemption from the Common
Rule, you are required to submit a completed exemption request form
(see Appendix 3 or 4,
as applicable) with your Gate 1 proposal.
- Research Not Exempt
From the Common Rule
If your use of human subjects does not qualify for an exemption, and
the research is scheduled to begin during the first year, you are required
to submit the following at Gate 3:
- a signed copy
of the final Institutional Review Board (IRB) approved human subjects
research protocol for each of the specific research tasks;
- a copy of all
IRB approved consent forms and advertisements;
- a signed and
dated approval letter from the IRB that indicates the start and end
dates for the approved research; and
- if applicable,
any IRB required interim reporting requirements.
- Research Beginning
After Year 1 of the Proposal
If there are no research tasks involving human subjects in the first
year of the proposal, but there are tasks anticipated beyond the first
year, a detailed request for deferred IRB approval or exemption as appropriate
under 15 C.F.R. § 27.118 must be submitted to ATP at Gate 1. A
deferral request must include the following information:
- an outline
of the tasks that will be performed using human subjects;
- the projected
start date for the use of human subjects (e.g., second quarter of
year 3);
- an outline
of when the ATP and NIST required documentation will be submitted
to ATP for review and approval; and
- if the research
requires IRB review and approval, the name of the institution housing
the IRB and the assurance number on file with OHRP.
J.
Contact Information
If you have any questions
regarding the use of human subjects in research, please call the ATP Human
and Animal Subjects Advisor at 301-975-8779.
The information contained
in this booklet is also available on the ATP website at http://www.atp.nist.gov/atp/helpful.htm.
K.
Definitions
Terms used in this
booklet are defined in the Common Rule at 15 C.F.R. Part 27.
The regulations under
15 C.F.R. Part 27 can be found at http://www.doc.gov/oebam/gforms.htm.
Clinical Trial:
A prospective biomedical or behavioral research study of human subjects
that is designed to answer specific questions about biomedical or behavioral
interventions (drugs, treatments, devices, or new ways of using known
drugs, treatments, or devices).
Custom Collection:
The collection or gathering of organs, tissues, cells, or data for the
purpose of research that would have otherwise not been collected or gathered.
Human Subject:
A living individual about whom an investigator (whether professional or
student) conducting research obtains (1) data through intervention or
interaction with the individual or (2) identifiable private information.
[15 C.F.R. § 27.102(f)]
The regulations governing
human subjects extend to the use of human organs, tissues, cells, and
bodily fluids from individually identifiable human subjects as well as
to graphic, written, or recorded information derived from individually
identifiable human subjects.
Intervention:
Includes both physical procedures by which data are gathered (for example,
venipuncture) and manipulations of the subject or the subject's environment
that are performed for research purposes. [15 C.F.R. § 27.102(f)]
Phase I Clinical
Trial: A clinical trial done to test a new biomedical or behavioral
intervention in a small group of people (e.g., 20-80) for the first time
to evaluate safety, efficacy, and effectiveness (e.g., determine a safe
dosage range and identify side effects).
Private Information:
Includes information about behavior that occurs in a context in which
an individual can reasonably expect that no observation or recording is
taking place and information which has been provided for specific purposes
by an individual and which the individual can reasonably expect will not
be made public (for example, a medical record). Private information must
be individually identifiable (i.e., the identity of the subject is or
may readily be ascertained by the investigator or associated with the
information) in order for obtaining the information to constitute research
involving human subjects. [15 C.F.R. § 27.102(f)]
Research: A
systematic investigation, including research development, testing, and
evaluation, designed to develop or contribute to generalizable knowledge.
Activities which meet this definition constitute research for purposes
of this policy, whether or not they are conducted or supported under a
program which is considered research for other purposes. For example,
some demonstration and service programs may include research activities.
[15 C.F.R. § 27.102(d)]
____________________
(1) Websites listed in this publication are accurate as of the publishing
date. Check www.atp.nist.gov/atp/helpful.htm
for updates to websites.
Return to Table
of Contents or go to Section 2.
Date created: February
3, 2004
Last updated:
February 23, 2004
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