INDEX
(Primary citations; not all inclusive)
A
Academy’s IRB: in all sections
Active Duty Military Personnel: IV-2, XVI-3
Administrative Issues and Support to the Academy’s IRB: VI-7, VIII-1
Adverse Event: II-6
Affected Populations: I-5
Amending an Approved Project: IX-2, XII-5
Amendments and Review Dates: XII-5
Appeals of “Not Approved” Recommendations: IX-16
Applicability: I-1, I-3, I-4
Approvals: I-7
Approval Citations in Public Release of Information: XIV-2
Approval Period: IX-14
Approval Numbers on Proposals: VIII-2, XIV-2
Assessment Activities: III-1, III-2
Assent: IV-7, IV-8
Audits: VII-5
B
Belmont Report: I-1, Encl-1;
Beneficence: I-1,
C
Capstone Courses and Projects: III-3, XV-1
Chief of Naval Research (CNR): VII-1
Classified Research: VII-3, IX-3, XIV-1
Closure Forms: XIII-1
“Common Rule”: XVII-1, Encl 1-1, Encl 2-1
Components of a Protocol Submission for a Meeting of the Academy’s IRB: X-3, X-4
Composition of the Academy’s IRB: VI-5, VI-6, VI-7
Concluding Projects: XIII-1, XIII-2, XIV-1
Conditions of Approval for All Projects: XVIII-5
Conflicts of Interest: VI-8
Consultants to the Academy’s IRB: VI-7
Continuing Projects: XII-1, XII-2
Continuing Review Dates: XII-3, XII-4
Course Evaluations: III-1
Course Instructors: XV-1, XVI-4
Index - 1
D
Data: I-4, I-5, VI-1, VII-14, IX-14, XVI-7
Data Destruction: VI-3, VIII-3
Data Protection and Uses: VI-3, IX-14, IX-15
Data Repository: VIII-3
Data Safeguards: VI-3
Debriefing Participants: IV-10
Deception: IV-9, IV-10, IX-5
Deferring IRB Approval: XVIII-2, XVIII-4
Definitions: II-1, Encl 2-1
De-identified Data: I-4, IX-6
Department Chairs, Office or Center Directors: XI-3
Design Courses and Projects: III-1, XV-1
Disputes: IX-15, IX-16
Division Directors: V-2, VII-13, VII-14, X-1, X-2, XI-1, XI-2, XV-4, XVI-7, XVIII-2
DoD Navy Addendum to an FWA: VII-6, X-4, XVIII-3, XVIII-4
DoD Navy Assurance: VII-1, VII-2, VII-6
E
Education: V-4
Educational tests: IX-5
Emancipated Minors: IV-1, XVI-3
Endorsements of Proposals: X-1, X-2
Ethical Principles: I-1, IV-1, V-2
Evaluation of Scientific Merit: XI-1, XI-2, XV-5, XVI-8
“Exempt”: II-3, VI-6, VII-3, IX-1, IX-2, IX-3, IX-6, X-1
“Expedited”: II-4, II-5, VI-6, VII-3, IX-1, IX-2, IX-7, IX-8, IX-9, X-1, XII-2
Extramural Collaborators: VII-5, VII-6, VII-15, XVIII-1, XVIII-3, XVIII-4
F
Faculty Involvement at NAPS: I-6
Faculty Involvement at USNA: I-6
Federal Funds: XIX-1
Federal Limitations: IV-3
Federalwide Assurance (FWA): VII-2, VII-6, X-4
Financial Issues: XIX-1
Focus Groups: II-1, III-1, XVI-3, XVI-4, XVI-6
Follow-up on Concluding Projects: IV-4
“Full”: IX-1, IX-10, IX-11, IX-12, IX-13, X-2, X-3
Fundamental Premise: V-1
Funding: I-3, IV-3, VII-12, IX-1, XIX-1
Index - 2
G
Glossary of Terms: II-1, Encl 2-1
Grace Periods on Review Dates: XII-5
Grant Applications: XVII-1
Greatest Protection: I-3, II-1
Guiding Principles: I-1, V-1, VI-1, VI-2, XX-1
H
Health Care Providers as Consultants to the Academy’s IRB: VI-7
High Risk: II-2
Human Research Protection Program (HRPP): in all sections
“Human Subjects” Definition: II-1, Encl 2-2
I
Identified Data: I-4
Incomplete Disclosure: IV-9, IV-10
“Information” Definition: XIV-1
Informed Consent: II-5, IV-1, IV-3, IV-4, IV-5, IV-8, IV-10, XVI-2
“Interaction”: II-2, IX-4
“Intervention”: II-2, IX-4
Interviews: II-1, III-1, IX-4, XVI-3, XVI-4, XVI-6
Institutional Review Board (IRB): I-3, VI-1, VII-2
Institutional Signatory Official (ISO): I-7, II-6, VII-2, VII-3, VII-4, VII-5
Instructor Evaluations: III-1
Investigations of Non-compliance or Research Misconduct: XX-3
IRB Chair: I-7, VI-3, VI-4, VI-5, VII-7, VII-8, IX-6, IX-9
IRB Vice Chair: I-7, VI-6, VII-7
J
Justice: I-1
K
L
Legal Experts as Consultants to the Academy’s IRB: VI-8
Legal Effectiveness of Informed Consent: IV-8
Limited Assurance: II-4, VI-6, VII-1, VII-8
Index - 3
M
Membership of the Academy’s IRB: VI-5, VI-6, VI-7
Midshipman or Midn Candidates Involvement: I-5, I-6, VI-1, IX-4, XVI-1, XVI-6, XVI8
Midshipmen as Co-investigators and Student-Researchers: V-3, VII-13, XV-1, XVI-5
Midshipman Candidate Involvement: I-5, I-6, VI-1, VII-13, XI-1, XVI-1
Minimal Risk: II-2
Minutes of the Academy’s IRB Meetings: VIII-8, XII-2
Misconduct: VII-4, XIX
Moderate Risk: II-2
N
Naval Academy (USNA) definition: I-2
Naval Academy Preparatory School (NAPS): I-2, XI-1
Naval Academy Promise: I-2
Navy Surgeon General (SG): I-7, II-4, II-5, VI-6, VII-1, VII-4
New Projects: IX-1
Non-compliance: II-6, VII-4, VII-5, VII-9
O
Office of Institutional Research (IR): I-6, IV-3, VI-7, XVI-1, XVI-2, XVI-8
P
Permission: IV-7
Populations: I-5, VI-1, XVI-1, XVIII-2, XVIII-4
Presentation of Results: X-4, XIV-1
Principal Investigator (PI): in all sections
“Private Information”: II-2, IX-4
Process Improvement: III-1
Protected Populations: I-5, IV-2, VI-1, VII-3
Protocol Submissions: IV-8
Publication of Results: X-4, XIV-1
Publicly Available Data: IX-5
Q
Quality Assurance: III-1
Quorum of the Academy’s IRB: VI-9
Questionnaires: II-1, III-1, XVI-3, XVI-4, XVI-6
R
Index - 4
Records Maintenance & Retention: VI-1, VIII-1, VIII-2, VIII-3, XIV-2, XV-5, XVI-7,
XVIII-5
Recruiting and Selecting Participants: IV-1, XII-6, XVI-1
Regulations: I-2, VI-1, VI-2, VII-2, XV-2, XVIII-3, Encl 1-1, Encl 1-2
Research Approvals: I-6
Research Collaborations: XVIII-1
“Research” Definition: II-1
Research Fatigue: I-6, IV-3, XVI-2
Research Project Courses: III-1, XV-1, XVI-5
Research Overload: I-6
Respect for Persons: I-1
Restricted Assurance: II-4, VI-6, VII-1, VII-8
“Risk” Levels: II-2
S
Scientific Merit: XI-1, XI-2, XV-5, XVI-8, XVIII-4
Scope: I-4, II-4
Secretary of Defense Approval: IX-3
Secretary of the Navy-level Approval: IV-2, IV-3, IV-6, IV-7
Senior Leadership Team (SLT): V-2, VII-13, VII-14, X-1, X-2, XI-1, XI-2, XV-4, XVI7,
XVIII-2
Staff Involvement at NAPS: I-7
Staff Involvement at USNA: I-6
Statement of Work (SoW): XVIII-1
Submissions of Protocols: X-1
Superintendent as ISO: I-7, VII-2, XX-1
Superintendent as Researcher: VII-4
Superior to Subordinate: IV-2, XVI-2
Surveys: II-1, III-1, XVI-3, XVI-4, XVI-6
T
Technical Experts as Consultants to the Academy’s IRB: VI-8
Tracking Numbers on Proposals: VIII-2
Training: V-1, V-4, V-5, X-4, XV-2, XVIII-1, XVIII-3, XVIII-4
Training, Academy Responsibility: V-3
Training of Individuals: V-1, V-2, V-3
Training, Initial: V-3
Training, changing roles: V-2
Training, Continuing: V-3
Training Midshipmen: V-3
Training of non-USNA Collaborators: V-1, V-2
Training, timing of: V-1
Trident Scholar Program Projects: XV-1, XVI-5
U
Index - 5
Unanticipated Problems: VII-4, VII-9, XII-1
Use of Data: VI-3, VII-14, IX-14, IX-15
V
W
Waiver of the Documentation of Informed Consent: IV-6
Waiver of Informed Consent: IV-6, IV-7
X
Y
Z
Index - 6