ACU IRB # ____________
Date of Approval __/__/____
Date of Expiration __/__/____
Abilene Christian University Institutional Review Board Committee &
Departmental Research Review Panel
Non-Research/Non-Human Research Determination Request
Complete the Request and send as an e-mail attachment to orsp@acu.edu. Include any
appendix materials, as applicable, including participant solicitation materials, consent forms,
and/or surveys.
Allow up to 3-4 weeks for the requests to be processed. Many members of the committee are
unavailable to review proposals during the summer and holiday months. Submission during the
fall or spring term is highly recommended.
Title of Proposed Project:
Date of Request:
Project Director/Principal Investigator:
Faculty Advisor (If PD/PI is a student):
Department / Affiliation:
Phone:
Degree/Credentials:
Email:
Address or ACU Box:
Point of Contact, if other than PD/PI (Name, phone, email):
Degree/
Credentials
Other Staff/Students on Project
Department / Affiliation
1.
2.
3.
The project will be conducted:
On Campus
Is this project being funded by an outside agency?
Off Campus
Yes
No
If yes, please specify which agency:
In the funding application, is the project described as human research?
If yes, then this application cannot be used.
####_PI_NonResNonHumRequest_########
Yes
No
ACU IRB # ____________
Date of Approval __/__/____
Date of Expiration __/__/____
Please complete the checklist below to confirm that your project can be classified as nonresearch/non-human research according to 45 CFR 46. (See DHHS Chart 1). Please begin in
box A by checking Yes or No and then following the instructions next to the check box. When
you reach a [STOP], you have completed the checklist and should follow the instructions
following the [STOP].
A. Is the activity a systematic investigation
designed to develop or contribute to
generalizable knowledge? [45 CFR
46.102(d)]
☐ Yes. This is research. Continue to part B.
☐ No. [STOP] This is not research. Complete
the Non-Research/Non-Human Research
Request form.
B. Does the research involve obtaining
information about living individuals?
[45 CFR 46.102(f)]
☐ Yes. Continue to part C.
☐ No. [STOP] This is not research involving
human subjects. Complete the Nonresearch/Non-Human Research Request
form.
☐ Yes. [STOP] The study is human research
and must comply with 45 CFR 46. Therefore,
you cannot use the Non-research/NonHuman Research Request form for this study.
☐ No. Continue to part D.
☐ Yes. Continue to part E.
☐ No. [STOP] This is not research involving
human subjects. Complete the Nonresearch/Non-Human Research Request
form.
☐ Yes. [STOP] The study is human research
and must comply with 45 CFR 46. Therefore,
you cannot use the Non-research/NonHuman Research Request form for this study.
☐ No. [STOP] This is not research involving
human subjects. Complete the Nonresearch/Non-Human Research Request
form.
C. Does the research involve interaction or
intervention with the individuals? [45 CFR
46.102(f)(1), (2)]
D. Is the information individually
identifiable (i.e., the identity of the subject
is or may readily be ascertained by the
investigator or associated with the
information)? [45 CFR 46.102(f)(2)]
E. Is the information private? (About
behavior that occurs in a context in which
an individual can reasonably expect that
no observation or recording is taking
place, or provided for specific purposes by
an individual and which the individual can
reasonably expect will not be made
public.) [45 CFR 46.102(f)(2)]
####_PI_NonResNonHumRequest_########
ACU IRB # ____________
Date of Approval __/__/____
Date of Expiration __/__/____
1.
Is the project minimal risk?
Yes
No
2.
Does the project involve exposing human subjects to interventions or procedures that
are not standard?
Yes
No
3.
Does the project fall under one of the following categories:
Not Research
Quality Improvement: in which all participants are expected to benefit, all receive at
least standard treatment, and the purpose is to evaluate process change in order to
immediately implement program improvements.
Quality Assurance
Program Evaluation: the purpose is to assess the program’s ability to meet objectives
Customer Service Experience: the purpose is to obtain feedback for use by the
program’s managers
Class Project: the purpose is to teach content, not contribute to generalizable
knowledge
Case Report: when the report is of a small sample (no more than 3) and the activity is
not a systematic evaluation of a hypothesis (not research).
Community Outreach: the purpose is to benefit participants or otherwise make
improvements in the community, not contribute to generalizable knowledge.
Not Human Research
Anonymous or coded data or specimens in which [OHRP Guidance]:
the private information or specimens were not collected specifically for the
currently proposed research project through an interaction or intervention with living
individuals; and
the investigator(s) cannot readily ascertain the identity of the individual(s) to
whom the coded private information or specimens pertain because:
the data are anonymous (there are no identifiers attached to the original data
or specimens)
the investigators and the holder of the key enter into an agreement prohibiting
the release of the key to the investigators under any circumstances, until the
individuals are deceased; or
there are other legal requirements or IRB-approved written policies and
operating procedures for a repository or data management center that prohibit the
release of the key to the investigators under any circumstances, until the individuals
are deceased
####_PI_NonResNonHumRequest_########
ACU IRB # ____________
4.
Date of Approval __/__/____
Date of Expiration __/__/____
Please provide a summary of the project below. Include sufficient detail that an IRB
reviewer may evaluate the above items and confirm that the project is not research or is
not considered “human research” requiring IRB monitoring.
####_PI_NonResNonHumRequest_########
ACU IRB # ____________
5.
Identify which items are included in the appendix
Participant Solicitation materials
Consent Form
Survey
Other: ______________________
####_PI_NonResNonHumRequest_########
Date of Approval __/__/____
Date of Expiration __/__/____