IRB Determination

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NIOSH IRB Determination Form
This form can be used by the NIOSH Division Official and the Human Research Protection Program (HRPP) to document IRB determinations.

New Request

✔

Amendment

Project Title:

Project Location/Country(ies):

Tests and Requirements for Certification and Approval of Respiratory Protective Devices

NIOSH Principal Investigator:

Division:
NPPTL

Jeff Peterson

NIOSH Primary Contact:

Division:

Jeff Peterson

NPPTL

Proposed Start Date (mm/dd/yyyy):

12/01/2017

Pittsburgh, PA

Telephone/email:
(412) 386-4014/[email protected]

Telephone/email:
(412) 386-4014/[email protected]

Proposed End Date (mm/dd/yyyy):

11/30/2020

Funding Type, if applicable
CoAg, Grant or contract #:
Title of CoAg, Grant, or Contract
Please check the appropriate category and subcategory. Definitions are available at the end of this document for italicized terms.

Research or Nonresearch Determination
I.

✔

The activity is research if it is a systematic investigation, including research development, testing and evaluation, designed to develop or
contribute to generalizable knowledge. (Continue to III.)

II. The activity is NOT research*. The purpose of the activity is to prevent or control disease or injury and improve health, or to improve a
public health program or service. (Check one and stop.)
A. Epidemic or endemic disease control activity
B. Routine surveillance activity*
C. Program evaluation activity
✔
D. Public health program activity**
E. Laboratory proficiency testing
F. Other

*See CDC Policy on Distinguishing Public Health Research and Public Health Nonresearch. Surveillance can be research or nonresearch, per CDC Policy.
**E.g., service delivery; health education programs; social marketing campaigns; program monitoring; electronic database construction and/or support;
development of patient registries; needs assessments; and demonstration projects intended to assess organizational needs, management, and human
resource requirements for implementation.

Human Subjects Determination
III. The activity involves human subjects because the investigator conducting research: (Continue to V.)
A. Obtains data about living individual(s) through intervention or interaction with the individual(s) or
B. Obtains identifiable private information* about living individual(s).
*See attached guidance on human subjects and coded private information.
IV. The activity does NOT involve human subjects because: (Check appropriate boxes and stop.)
A. The activity is research involving collection or analysis of data about health facilities or other organizations or units (NOT persons).
B. The activity is research involving data or specimens from only deceased persons.
C. The activity is research involving unlinked or anonymous data or specimens collected for another purpose.
D. Other

NIOSH Engagement Determination

V. NIOSH is engaged in the research involving human subjects because its employees or agents*, for the purposes of the research project:
A. Obtain data about the subjects of the research through intervention or interaction with them, or
B. Obtain identifiable private information about the subjects of the research, or
C. Obtain the informed consent of human subjects for the research.
*See attached guidance on engagement and NIOSH contractors.

If NIOSH is engaged, please submit the study for IRB review or request an exemption determination.
IRB Determination Form, Rev. 2.24.17

VI. NIOSH is NOT engaged in the research involving human subjects. IRB review and approval is not required.
However, non-CDC collaborators engaged in the research involving human subjects must have a valid Federalwide Assurance and IRB approval.
Non-CDC Collaborator:

FWA #:

IRB Approval Attached: Y/N

Non-CDC Collaborator:

FWA #:

IRB Approval Attached: Y/N

Suggested Review (HRPP Only)
The activity is research involving human subjects that requires submission to the NIOSH Human Research Protection Program. The following is
recommended:
A. Full Board Review (Use forms 0.1250, 0.1370-research partners)
B. Expedited Review (Use same forms as A above)
C. Exemption Determination (Use forms 0.1250X, 0.1370-research partners)
D. Reliance
1. Allow CDC to rely on a non-CDC IRB (Use same forms as A above, plus 0.1371)
2. Allow outside institution to rely on CDC IRB (Use same forms as A above, plus 0.1372)

Comments/Rationale for Determinations:
Respirator certification, application, and audit activities in 42 CFR part 84 constitute an established program that is not intended to contribute to
generalizable knowledge. Therefore, it does not meet the HHS definition of research. Human subjects may be involved but data collection and
analysis is not specifically about them.

Approvals/Signatures:

Christopher C. Coffey -S

Digitally signed by Christopher C.
Coffey -S
Date: 2017.12.04 12:50:26 -05'00'

Date:

Remarks:

12/4/2017

Tracking number: 17-NPPTL Division-04D-nr

1/8/2018

Signed by IRB Chair as acknowledgement of determination
issued by Dr. Coffey

Division Official
signed by Angela Morley -S
Angela Morley -S Digitally
Date: 2018.01.08 08:21:36 -05'00'

NIOSH Institutional Review Board Chair or Co-Chair
Note: Although IRB review is not required for certain projects under this determination, CDC investigators and project officers are expected to adhere
to the highest ethical standards of conduct and to respect and protect to the extent possible the privacy, confidentiality, and autonomy of participants.
All applicable country, state, and federal laws must be followed. Informed consent may be appropriate and should address all applicable elements of
informed consent. NIOSH investigators should incorporate diverse perspectives that respect the values, beliefs, and cultures of the people in the
country, state, and community in which they work.

IRB Determination Form, Rev. 2.24.17

Definitions, Guidance and Additional Resources
Definitions
Agent – A nonemployee of CDC who conducts research under CDC’s FWA. This generally includes all persons cleared for access to CDC
networks and who use CDC networks or physical facilities for human research activities.
Epidemic disease control (aka, emergency response) – A public health activity undertaken in an urgent or emergency situation, usually
because of an identified or suspected imminent health threat to the population, but sometimes because the public and/or government
authorities perceive an imminent threat that demands immediate action. The primary purpose of the activity is to document the existence
and magnitude of a public health problem in the community and to implement appropriate measures to address the problem (Langmuir,
Public Health Reports 1980; 95:470-7).
Identifiable private information
Private information – 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).
Interaction – Communication or interpersonal contact between the investigator and the subject.
Intervention – 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.
Obtains – Using, studying or analyzing for research purposes identifiable private information or identifiable specimens that have been
provided to investigators by any source or were already in the possession of the investigator.
Program evaluation – The systematic collection of information about the activities, characteristics, and outcomes of programs to make
judgments about the program, improve program effectiveness, and/or inform decisions about future program development. Program
evaluation should not be confused with treatment efficacy which measures how well a treatment achieves its goals which can be considered
as research.
Surveillance – The ongoing systematic collection, analysis and interpretation of health data, essential to the planning, implementation and
evaluation of public health practice, closely integrated to the dissemination of these data to those who need to know and linked to
prevention and control.
Guidance
Human Subjects and Coded Private Information or Specimens: Research involving only coded private information or specimens does
not involve human subjects if: (1) the private information or specimens were not collected specifically for the currently proposed research
project through an interaction or intervention with living individuals; and (2) the investigator(s) cannot readily ascertain the identity of the
individual(s) to whom the coded private information or specimens pertain because, for example: a "data use agreement" or institutional
policy prohibits release of the code key to investigators. (NIOSH is not engaged when NIOSH is prohibited from receiving the identifying
key to coded private information (see CDC Form 0.1375B TITLE)).
Human Subjects, Non-CDC Collaborators and Coded Private Information: Suppose a collaborator has the key to coded private
information collected for a different purpose. Assume the collaborator plans to provide the coded private information to NIOSH and be
involved in: (1) the study, interpretation or analysis of the data resulting from the coded specimens or (2) authorship of presentations or
manuscripts related to the research. The collaborator is an investigator because the collaborator is involved in conducting the research. The
project involves human subjects because the investigator has obtained identifiable private information.
Requirements for Engaged Institutions: Institutions that are engaged in non-exempt human subjects research are required to: (1) hold or
obtain an applicable OHRP-approved Federalwide Assurance (FWA); and (2) certify to the HHS agency conducting or supporting the
research that the research has been reviewed and approved by an IRB designated in the FWA, and will be subject to continuing review by
an IRB.
Engagement and NIOSH Contractors: Suppose a NIOSH contractor has applied for and been awarded HHS funds for an activity. The
Statement of Work indicates that the activity includes research involving human subjects. The contractor is engaged in human subjects
research because the contractor is either: (1) obtaining data about the subjects of the research through intervention or interaction with them;
(2) obtaining identifiable private information about the subjects of the research; or (3) obtaining the informed consent of human subjects for
IRB Determination Form, Rev. 2.24.17

the research. As an engaged institution, the contractor must hold or obtain an OHRP-approved FWA and certify to NIOSH that the human
subjects research will be/has been approved by an IRB designated in the FWA and will be subject to continuing review by an IRB – and the
Statement of Work states these responsibilities. Generally, NIOSH does not become engaged in non-exempt human subjects research solely
because a contractor is engaged in non-exempt human subjects research. If the contractor is on-site (physically at NIOSH, has an SEV #
and user-ID), the IRB Chair or ADS must determine if the contractor is acting on behalf of NIOSH. If the contractor is acting on behalf of
NIOSH, then NIOSH is engaged (usually, if the contractor is onsite and acting on NIOSH's behalf, there is also an FTE working with the
contractor who will serve as the PI on the activity). If the contractor is not acting on behalf of NIOSH but on behalf of the contractor, then
NIOSH is not engaged.
Newborn Dried Blood Spots
If the activity involves any newborn dried blood spots collected after March 17, 2015, please note the Newborn Screening Saves Lives
Reauthorization Act of 2014 applies the following provisions until HHS updates the Common Rule: (1) requires federally funded research
on newborn dried blood spots to be considered research on human subjects, and (2) eliminates the ability of an Institutional Review Board
to waive informed consent.
Table: Distinguishing Public Health Research from Nonresearch±

Definition

Primary Purpose
Methodology

Examples
Surveillance
Projects

Research
“...systematic investigation, including research
development, testing, and evaluation, designed to
develop or contribute to generalizable
knowledge.” (ref. 45 CFR 46)

Practice (nonresearch)
The purpose of the activity is to identify and control a health
problem or improve a public health program or service; intended
benefits of the project are primarily or exclusively for the
participants (or clients) or the participants’ community; data
collected are needed to assess or improve the program or
The purpose of the activity is to develop or
service, the health of the participants or the participants’
contribute to generalizable knowledge to improve community; knowledge that is generated does not extend
public health practice; intended benefits of the
beyond the scope of the activity; and project activities are not
project can include study participants, but always experimental. May use scientific methods to identify and control
extend beyond the study participants, usually to a health problem with benefits for the study participants or their
society; and data collected exceed requirements communities.
for care of the study participants or extend beyond
the scope of the activity.
To generate new or generalizable knowledge
To benefit study participants or the communities from which
(information that can be applied in other settings) they come
Scientific principles and methods used
Scientific principles and methods may be used.
Hypothesis testing/generating
Hypothesis testing/generating
Knowledge is generalizable
Knowledge may be generalizable
Requested data are broad in scope (and may
involve as yet unproven risk factors)
Comparison of different surveillance approaches
Hypothesis testing
Subsequent studies planned using cases identified

Regular, ongoing collection and analyses to measure occurrence
of health problem
Scope of data is health condition or disease, demographics, and
known risk factors
Invokes public health mechanisms to prevent or control disease
or injury
Samples stored for future use
Solves an immediate health problem
Emergency
Additional analyses performed beyond immediate No testing of methods or interventions
Response
problem
Investigational drugs tested
Assess success of established intervention
Program Evaluation Test an untried intervention
Systematic comparison of standard and
Evaluation information used for feedback into program
nonstandard interventions, in any combination
(management)
± Adapted by CDC’s Human Research Protection Office from the 2010 CDC Policy on “Distinguishing Public Health Research and Public Health Nonresearch”

Additional Resources
CDC Human Research Protections Policy (2010): http://aops-mas-iis.cdc.gov/Policy/Doc/policy556.pdf
CDC Policy on Distinguishing Public Health Research and Public Health Nonresearch (2010): http://aops-mas-is.cdc.gov/policy/Doc/

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policy557.pdf

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CDC Scientific Ethics Verification # database (intranet): http://scientificethics.cdc.gov/reprint/reprintmenu.asp
HHS Title 45 Code of Federal Regulations Part 46, Protection of Human Subjects (Revised 2009):
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
OHRP Guidance on Engagement of Institutions in Human Subjects Research: http://www.hhs.gov/ohrp/policy/engage08.html
OHRP Guidance on Research Involving Coded Private Information or Biological Specimens: http://www.hhs.gov/ohrp/policy/cdebiol.html
OHRP FederalWide Assurance number database: http://ohrp.cit.nih.gov/search/search.aspx?styp=bsc

IRB Determination Form, Rev. 2.24.17