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4 Training Requirements
7 Not Human Subjects Research Form
8 Researcher Instructions - Activities Submitted to DoD IRB
9 Researcher Instructions - Activities Submitted to Non-DoD IRB or HRPP
10 Procedures Full Protocol Research No Non-USAFA
11 Guidelines for Applying the Exempt Categories
12 Procedures for Exempt Research
13 Procedures to Obtain Resources and Survey Approval
14 Procedures Full Protocol Research Non-USAFA Investigator
15 Researcher Procedures for Amending Research
16 Researchers Procedures for Continuing or Final Review
18 Not Human Subjects Errors
19 Exempt Research Most Frequent Errors
20 Most Frequent Errors for Full Protocol Human Subjects Research
21 Amendments Most Frequent Errors
22 Most Frequent Errors for Continuing or Final Reports
23 When Do Activities Need IRB Approval
25 How to Submit a Protocol Deviation or Problem to the USAFA IRB
Researcher Instructions-No Human Subjects
Researcher Instructions-Human Subjects Not Affiliated with USAF Surgeon General
Researcher Instructions-Human Subjects Affiliated with USAF Surgeon General in Past 365 Days
Researcher Instructions-Human Subjects Affiliated with USAF Surgeon General in Past 2-3 Years
Researcher Instructions-Human Subjects Affiliated with USAF Surgeon General in More Than 3 Years
Initial Human research Protection Program (HRPP) Submission
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23 When Do Activities Need IRB Approval
When do activities need Institutional Review Board (IRB) review and approval?
(If there are any questions regarding what does or does not require USAFA IRB review contact Human Research Protection Program (HRPP) support personnel @ 719-333-6593 or
usafa.irb@usafa.edu
).
Any activity that may meet the definition of both “research” and “human subjects” [
32 CFR 219.102
] requires review and approval by an IRB. Further, a Principal Investigator (PI) is not authorized to make such determinations for their own activity [
DoDI3216.02_AFI40-402, Enclosure 2, 11.c
]. USAFA excludes customer satisfaction and post program feedback directly solely at improving activities within a program [USAFA local policies/procedures].
Research: “A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” [
32 CFR 219.102(d)
]
Human Subjects: “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” [
32 CFR 219.102(F)
].
• Intervention and Interaction: “An intervention includes both physical procedures by which data are gathered and manipulations of the subject or subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator or subject. See CFR 219.102(f) of Reference (c) for more information. Examples include, but are not limited to, a physical procedure, a drug, manipulation of the human subject or subject’s environment, the withholding of an intervention that would have been undertaken if not for the research purpose, or communication such as a survey or interview.” [
DoDI3216.02_AFI40-402, Part II
]
• Identifiable 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 or 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 the information to constitute research involving human subjects.
[32 CFR 219.102(f)(2
)
AFMSA/SGE-C Guidance Memorandum 2016-0002G: Guidance on Activities that may be Research Involving Human Subjects
AFMSA/SGE-C Guidance Memorandum 2016-0002G Attachment
Submission Types and Instructions
Initial Submission
Amendments
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Protocol Violations and Adverse Events
HRPP Information
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When do activities need IRB review?
Contact Us
HQ USAFA/A9N
2304 Cadet Drive,
Suite 3800
USAF ACADEMY, CO 80840-5002
Email Address:
usafa.irb@usafa.edu
Telephone Number, HRPP Administrator
Commercial: 719-333-6593 DSN: 333-6593
Telephone Number, Exemption Determination Official (EDO) for Educationally Exempt Research
Commercial: 719-333-3277 DSN: 333-3277
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