FAP Outreach Project IRB FAP Staff Application

HRP-594 Protocol for
Not Human Subjects Research Determination
Protocol Title:
Provide the full title of the study as listed in item 1 on the basic information page in CATS IRB (http://irb.psu.edu).
Evaluation of the Family Advocacy Program’s Outreach Campaigns through Feedback Sessions with FAP Staff

Principal Investigator:
Name: Dr. Daniel F. Perkins
Department: SSRI/Clearinghouse for Military Family Readiness
Telephone: 814-867-4182
E-mail Address: [email protected]

Version Date:
Provide the version date for this document. This date must be updated each time this document is submitted to the IRB
office with revisions. DO NOT revise the version date in the footer of this document.
02/08/2023

Important Instructions for using this protocol template:
1.
2.
3.

4.
5.

All human subject research must be reviewed by the IRB prior to initiation. If you have questions about whether
an activity is human research, contact the appropriate IRB office for guidance.
To request a written determination that an activity is not human research, add this completed protocol template
to your study in CATS IRB (http://irb.psu.edu) in the “Basic Information” page. Links to Penn State’s protocol
templates are available in the same location where they are uploaded and their use is required.
The IRB uses “HRP-310 – WORKSHEET - Human Research Determination” to determine whether an activity is
research and if so, uses “HRP-311 – WORKSHEET - Engagement Determination” to determine if the research
engages PSU. These worksheets can be found in the IRB Library in CATS IRB (http://irb.psu.edu). You may use
these worksheets to guide the information you provide in your description below.
This template is provided to help investigators prepare a protocol that includes the necessary information needed
by the IRB to make a not human research determination.
Information should be written in lay language. Do NOT copy and paste grant proposal information into the
protocol.

If you need help…
All locations:
Human Research Protection Program
Office for Research Protections
101 Technology Center
University Park, PA 16802-7014
Phone: 814-865-1775
Fax: 814-863-8699
Email: [email protected]
https://www.research.psu.edu/irb
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Table of Contents
1.0

Review of select activities that generally do not meet the definition of human subjects research......................3

2.0

Determining if activities meet the definition of human subjects research ..........................................................4

3.0

Description of Study Activities ...........................................................................................................................6

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1.0

Review of select activities that generally do not meet the definition of human subjects research
Review the select activities below. These activities generally do not meet the definition of research. If you are
conducting any of these activities, you do not need to submit anything to the IRB unless you need a written
determination that an activity is not human subjects research.
1.1

Program Evaluation/Quality Improvement or Quality Assurance Activities
The activities to be conducted are designed specifically to assess or improve performance within a
particular classroom, clinical setting, business, or department. The intention of the project and outcome
are not intended to contribute to generalizable knowledge and are designed specifically to be used
within the environment in which the activities are conducted. See
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/quality-improvement-activities/ for
OHRP information regarding such activities.

1.2

Case Reports
Clinical
Generally, the activities to be conducted consist of case reports of 3 or fewer patients (persons) that
describe a particular treatment, presentation or outcome. Most importantly, nothing was done with the
patient(s) with prior intent of conducting research.
Other
Report about experiences or observations associated with three or less individuals.

1.3

Student Course Assignments/Projects
The activities to be conducted are done so with the intent to satisfy the curriculum requirements of a
course, are not intended for use outside of the classroom, and are typically concluded at the end of the
relevant semester. The activities are not intended to create new knowledge or contribute to
generalizable knowledge.
Some student course assignments and projects may meet the definition of human participant research.
For example, a student may be conducting the activities with the intent to conduct further investigation
or analyses in order to contribute to generalizable knowledge. If this is the case, IRB review and approval
or determination is required prior to the conduct of such activities.
Studies intended to result in a dissertation or thesis are considered to be research and do not fall under
this description of student course assignments/projects.

1.4

The following have been deemed to not to be research in the 2018 Common Rule:
 Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal
research, and historical scholarship), including the collection and use of information that focus
directly on the specific individuals about whom the information is collected.


Public health surveillance activities, including the collection and testing of information or
biospecimens, conducted, supported, requested, ordered, required, or authorized by a public
health authority. Such activities are limited to those necessary to allow a public health
authority to identify, monitor, assess, or investigate potential public health signals, onsets of
disease outbreaks, or conditions of public health importance (including trends, signals, risk
factors, patterns in diseases, or increases in injuries from using consumer products). Such
activities include those associated with providing timely situational awareness and priority
setting during the course of an event or crisis that threatens public health (including natural
or man-made disasters).

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

Collection and analysis of information, biospecimens, or records by or for a criminal
justice agency for activities authorized by law or court order solely for criminal justice or
criminal investigative purposes.



Authorized operational activities (as determined by each agency) in support of intelligence,
homeland security, defense, or other national security missions.

Determining if activities meet the definition of human subjects research
If the activities to be carried out do not fall into one of the conditions listed in Section 1 above, review this
section carefully to determine if your proposed activities meet the definition of human subjects research.
IRB review or exemption determination is required only if the proposed activities meet the federal definitions of
research AND human subject. If, after reviewing the information in this section, the proposed activities meet the
federal definitions of research AND human subject, then:
 This template should not be used
 Access CATS IRB (http://irb.psu.edu)
 Navigate to the Library
 Choose an appropriate protocol template to complete and follow the instructions in the template
If, after reviewing the information in this section, the proposed activities do *not* meet the federal definition of
either research OR human subject, then:
 You are not required to submit anything, unless you need a written determination that an activity is not
human research to meet the requirements of a sponsor or other entity.
 Contact the HRPP if you need assistance – see contact information above on first page.
2.1

Definitions of Research
2.1.1

DHHS Definition of Research
According to The Department of Health and Human Services (DHHS) regulations, research is
defined as “a systematic investigation, including research development, testing and evaluation,
designed to develop or contribute to generalizable knowledge.”
 If ALL of the boxes below are checked “YES” the activities meet the DHHS definition of
research.


If ANY of the boxes below are checked “NO” the activities do not meet the DHHS
definition of research.
Yes
No
Yes
No
Yes
No
Yes
No

Is the activity an investigation?
(Investigation: a searching inquiry for ascertaining facts; detailed or careful
examination)
Is the investigation systematic?
(Systematic: having or involving a system, method, or plan)?
Is the systematic investigation designed to develop or contribute to
knowledge?
(Designed: done with purpose and intent. Develop: to elaborate or expand
in detail. Contribute: to be an important factor in; help to cause.
Knowledge: truths, facts, information.)
Is the knowledge generalizable?
(Generalizable: universally applicable)

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2.1.2

2.2

FDA Definition of Research
According to the Food and Drug Administration (FDA) regulations, a clinical investigation means
any experiment that involves a test article and one or more human subjects and that either is
subject to requirements for prior submission to the Food and Drug Administraiton under section
505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the FDA under
these sections of the act, but the results of which are intended to be sumitted later to, or held for
inspection by, the FDA as part of an application for a research or marketing permit.
 If Box 1 AND one or more of the second, third or fourth boxes below are checked “YES”,
the activities meet the FDA definition of clinical investigation.
1

Yes
No

2

Yes
No

3

Yes
No

4

Yes
No

Is the activity an experiment that involves a test article (drug,
device or biologic) and one or more human subjects? AND
Must the activity meet the requirements for prior submission
to the FDA under section 505(i) of the Federal Food, Drug
and Cosmetic Act meaning any use of a drug other than the
use of an approved drug in the course of medical practice?
OR
Must the activity meet the requirements for prior submission
to the FDA under section 520(g) of the Federal Food, Drug
and Cosmetic Act meaning any activity that evaluates the
safety or effectiveness of a device? OR
Are the results of this activity intended to be later submitted
to, or held for inspection by, the FDA as part of an application
for a research or marketing permit?

Definitions of Human Subject
2.2.1

DHHS Definition of Human Subject (Updated with 2018 Common Rule revisions)
According to DHHS regulations, human subject is defined 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.”
 If ALL of the boxes below are checked “YES” the activity involves human subjects.


If BOXES 1 and 2 below are checked “YES” the activity involves human subjects.



If BOXES 1, 3, and 4 below are checked “YES” the activity involves human subjects.
1

Yes
No

2

Yes
No

3

Yes
No

The investigator is gathering information or biospecimens
about living individuals.
The investigator will use, study, or analyze information or
biospecimens obtained through either of the following
mechanisms:
 Physical procedures or manipulations of those
individuals or their environment for research
purposes (“intervention”).
 Communication or interpersonal contact with the
individuals ("interaction”).
The investigator will gather data that is either:
 Data about behavior that occurs in a context in
which an individual can reasonably expect that no
observation or recording is taking place (i.e.,
“private information”).

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4

2.2.2

FDA Definition of Human Subject
According to FDA regulations, human subject is defined as “an individual who is or becomes a
participant in research, either as a recipient of the test article or as a control.”
 If EITHER is checked “YES” the activities meet the FDA definition of human subject.
Yes
No
Yes
No

2.2.3

Yes
No

Data individuals have provided for specific purposes
in which the individuals can reasonably expect that
it will NOT be made public, such as a medical record
(i.e., “Private information”).
Individuals’ identities can be readily ascertained or
associated with the information by the investigator (i.e.,
“identifiable information”) and/or with the biospecimens by
the investigator (i.e., “identifiable biospecimen”).

An individual will be a recipient of any test article (i.e., drug, medical device
for human use, human food additive, color additive, electronic product, or
any other article subject to regulation under the Food, Drug, and Cosmetic
Act) or as a control.
An individual on whose specimen, whether identifiable or not, an
investigational medical device will be used.

Coded Data and/or Biospecimens
According to DHHS guidance, coded means that (1) identifying information (such as name or
social security number) that would enable the investigator to readily ascertain the identity of
the individual to whom the private information or specimens pertain has been replaced with a
number, letter, symbol, or combination thereof (i.e., the code); and (2) a key to decipher the
code exists, enabling linkage of the identifying information to the private information or
specimens. DHHS considers coded data to be identifiable.
Yes
No
Yes
No
Yes
No
Yes
No

The provider of the data and/or biospecimens will remove the code before
sending the data and/or biospecimens to the researcher (therefore no link
exists between data received and the identifiable information); OR
The holder of the key and investigator enter into an agreement prohibiting
the release of the key to the investigator under any circumstances, until
the individuals are deceased; OR
The investigator has documentation of written policies and operating
procedures from a repository or data management center that prohibits
the release of the key to the investigators under any circumstances, until
the individuals are deceased; OR
There are other legal requirements prohibiting the release of the key to the
investigator, until the individuals are deceased.

Once you have reviewed the definition questions in Sections 2.1 and 2.2, please re-review the instructional text
provided in Section 2.0 to determine if a submission to the HRPP is necessary before proceeding with the remainder
of this form.
3.0

Description of Study Activities
Provide a brief description of the activities to be conducted by answering the questions below. The information
should supplement and not contradict the answers provided in section 2 above.

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3.1

Purpose
Describe the purpose, specific aims or objectives of the study or activities to be conducted. If
activities do not meet the definition of research according to sections 1 and/or 2.1 above, please
clearly outline the purpose of the activities.
The purpose of this project is to conduct program evaluation for the Department of Defense (DoD) by
evaluating the Family Advocacy Program’s (FAP) Domestic Violence Awareness (DVA) and Child Abuse
Prevention (CAP) campaigns. This project will evaluate the implementation of the campaigns by
conducting program improvement feedback sessions with FAP staff.

3.2

Procedures
Describe the procedures used to obtain information (e.g., communication or interpersonal contact
with individuals, manipulation of individual’s environment, or physical procedures).
Clearinghouse staff will conduct 60-minute online feedback sessions with FAP staff involved in the
implementation of the campaigns with the purpose of program improvement. Feedback sessions will
occur online using Zoom or Microsoft Teams. These sessions will be recorded to aid in the coding
process.

3.3

Data and/or specimens
Describe the data and/or biospecimens that will be gathered or used about individuals without
interaction or intervention with subjects including any names and sources of datasets, links to provider
websites, etc.
N/A
3.3.1

Data Collection and Analysis
Describe the data and/or biospecimens that will be collected or used and how and by whom the
data and/or biospecimens will be analyzed.
Information collected during the feedback sessions will include a description of campaign
activities, strengths and challenges experienced with implementation, and lessons learned.

3.3.2

Method of Collection
Describe how the data and/or biospecimens were originally gathered from individuals (e.g.,
obtained as part of another IRB approved protocol at this institution/another institution or as a
part of routine clinical practice).
N/A

3.3.3

Identifiability of Data and/or Biospecimens
Indicate whether the collected data and/or biospecimens can be directly or indirectly
associated/link with individual identities by you, or by others if you are receiving coded data.
N/A

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