20 FAQs about Human and Animal Research

What is 45 CFR 46?
This refers to the Department of Health and Human Services (DHHS) regulations for the protection of human subjects, containing four subparts: A, B, C and D. Subpart A is "The Common Rule" or the Federal Policy for the Protection of Human Subjects (regulations agreed to by 17 agencies on protection of human subjects).
What is 32 CFR 219?
This refers to Title 32, Part 219 of the Code of Federal Regulations. These regulations are the Department of Defense’s implementation of 45 CFR 46, Subpart A (“The Common Rule”).
What are the major requirements of 32 CFR 219?
These regulations require all research involving human subjects to be reviewed by an Institutional Review Board (IRB), requires an institutional assurance of compliance and informed consent of subjects.
Are there other parts of 45 CFR 46 that the Navy follows?
Yes, it is policy to follow Subpart B, C and D of 45 CFR 46. Subpart B – provides additional protections for pregnant women, human fetuses, and neonates involved in research; Subpart C – provides additional protections pertaining to biomedical and behavioral research involving prisoners as subjects; Subpart D – provides additional protections for children involved as subjects in research.
What is SECNAVINST 3900.39D?
This instruction from the Secretary of the Navy establishes policy and assigns responsibility for the protection of human subjects in research conducted by, within, or for the Department of Navy.
What is the Belmont Report and how does it relate to human subject research?
The Belmont Report is a statement of basic ethical principles and guidelines that assists in resolving ethical problems that surround the conduct of research with human subjects.
What are the ethical principles that guide human subjects protection?
As put forth in the Belmont Report, three basic principles are relevant to the protection of human subjects in biomedical and social/behavioral research: respect for persons, or recognition of the personal dignity and autonomy of persons and the need for special protection for persons with diminished autonomy, such as children or prisoners; beneficence, or the obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks; justice to ensure fairness in the distribution of the benefits and the burdens of the research.
How is "research" defined?
A systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalizable knowledge [32 CFR 219].
What is a "human subject?"
A living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or obtains identifiable private information [32 CFR 219].
What are some examples of activities NOT considered human subject research?
Generally, activities that pursue quality improvement, process improvement (Lean Six Sigma) or performance improvement, quality assurance, or program evaluation are not considered human subject research.
How do you know if you are "engaged" in research?
An institution becomes "engaged" in human subjects research when its employees or agents (i) intervene or interact with living individuals for research purposes; or (ii) obtain individually identifiable private information for research purposes [45 CFR 46].
What is "minimal risk?"
A minimal risk research study means that for participants, the probability and magnitude of harm or discomfort anticipated in the research is not greater…than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests [32 CFR 219].
Who must complete the required human subjects training?
All personnel involved in reviewing, approving, supporting, conducting, managing, or overseeing research involving human subjects must complete initial and ongoing research ethics and human subject protections training appropriate to each individual’s level of involvement, duties and responsibilities [SECNAVINST 3900.39D].
When is a medical/research monitor required?
For research involving more than minimal risk (as defined in 32 CFR 219.102(i), reference (c)) to subjects, an independent medical monitor shall be appointed by name. Medical monitors shall be physicians, dentists, psychologists, nurses, or other healthcare providers capable of overseeing the progress of research protocols, especially issues of individual subject/patient management and safety. Medical monitors shall be independent of the investigative team and shall possess sufficient educational and professional experience to serve as the subject/patient advocate. Depending on the nature of the study, the medical monitor may be assigned to assess one or more of the following phases of a research project: subject recruitment, subject enrollment, data collection, or data storage and analysis. [DoDD 3216.02]
What is the primary responsibility of an Institutional Review Board (IRB)?
The primary responsibility of the IRB is to protect the rights and safeguard the welfare of human subjects involved in research.
How do I obtain a Federal-wide Assurance (FWA)?
The Department of Health and Human Services (DHHS), through the Office of Human Research Protections issues new FWA. For information please visit the DHHS site.
What is a DoD Navy Assurance?
The SECNAVINST 3900.39D defines an Assurance as “a document originated by the institution engaged in human subject research that states it will comply with federal, DoD and Department of Navy (DON) requirements for human subject protections.” Navy institutions are required to obtain a DoD Navy Assurance from the DON Human Research Protection Program (HRPP) if they are conducting, supporting, reviewing, approving or managing research with human subjects.
What is a DoD Navy Addendum to Federal-wide Assurance?
Non-Navy institutions engaged in DON-supported research with human subjects must have an FWA for the Protection of Human Subjects in accordance with 32 CFR 219 approved by the Department of Health and Human Services’ Office for Human Research Protections. A DoD Navy Addendum identifies and covers the unique DoD and DON requirements that are not specifically included in the FWA.
What is an Institutional Agreement for IRB Review (IAIR)?
If an engaged institution does not have an IRB appropriate for review of Navy-sponsored research, the institution may designate IRB(s) outside of the institution. The IAIR is signed by both the engaged institution as well as the external IRB, and outlines the roles and responsibilities for the institution and the IRB.
What is an Individual Investigator Agreement (IIA)?
Any individual who is engaged in human subject research and is not an employee of an institution holding an Assurance can enter into an agreement with an assured institution by means of a DON Individual Investigator Agreement. For example: Institution A has a DoD-Navy Assurance. Investigator B has a specialized skill that is essential for the research being conducted with Institution A but is not affiliated with an assured institution. In order to perform research with Institution A, Investigator B must obtain an IIA in order to conduct the research. Either the investigator or the institution may initiate the IIA.