UC Irvine – Human Research Protections/Institutional Review Board
Determining Whether a Proposed Activity is Human Research
According to DHHS, FDA, or Other Regulatory Definitions
Activity is “Human Research” according to DHHS regulations if BOTH of the following first two
situations are true. 1 See Exceptions 1 and 2 below.
1. The activity involves research because all of the following are true:

The activity is a systematic investigation, including research development, testing and evaluation, and
Systematic: Having or involving a system, method, or plan
Investigation: A searching inquiry for facts; detailed or careful examination

Either of the following is true:
The activity is designed to develop generalizable knowledge, or
The activity is designed to contribute to generalizable knowledge.
Generalizable: Universally or widely applicable
Knowledge: truths, facts, information
2. The activity involves human participants because both of the following are true:
 Activity is “Human Research” according to DHHS regulations if the data the researcher
is planning to obtain are about living individuals, and
 Either of the options are true:
The investigator plans to obtain the data through one or more of the following:

Physical procedures performed on those individuals

Manipulation of those individuals

Manipulation of those individuals’ environments

Communication with those individuals

Interpersonal contact with those individuals
O
O OR
The information to be obtained is both:
 Private, because either of the following is true:
o The information is about behavior that occurs in a context in which an individual
can reasonably expect that no observation or recording is taking place, or
o The individual has provided the information for specific purposes and can
reasonably expect that the information will not be made public (for example, a
medical record)
AND

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Individually identifiable, because either of the following is true:
o The identity of the participant is or may readily be ascertained by the
investigator
o The identity of the participant is or may readily be associated with the
information
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EXCEPTION 1: If the activity is funded by the Department of Justice and conducted within the Bureau
of Prisons, the activity is not “Human Research” if the following is true:
 The activity is a pilot project designed for implementation of the Bureau’s programmatic or operational
initiatives.
EXCEPTION 2: If the activity involves accessing state issued death records (certificates and indices)
the activity is “Human Research.” See the CA Health and Safety Code, Sections 102231-102232 for more
information.
1
Activities that meet this definition are subject to DHHS regulations when a Federalwide Assurance is in effect indicating that the
institution applies the protections of 45 CFR 46 when the research is conducted or funded by DHHS, or is otherwise subject to
regulations by DHHS.
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Activity is “Human Research” according to FDA regulations if ANY of the three situations are true.
1. DRUG - All of the following must be true:

The activity will involve the use of a drug, meaning one of the following:
 An article recognized in the official United States Pharmacopoeia, official Homoeopathic
Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them
 An article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in
humans or other animals
 An article (other than food) intended to affect the structure or any function of the body of humans or
other animals
 An article intended for use as a component of any article specified in the above items

Either of the following is true:
The activity is conducted in the United States and will involve the use of a drug in one or more persons
that is NOT the use of an approved drug dispensed in the course of medical practice.
Data regarding subjects or control subjects will be submitted to or held for inspection by FDA as part of
an application for a research or marketing permit.
2. MEDICAL DEVICE - All of the following must be true:

The activity will involve the use of a medical device, meaning an instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory
which is one of the following:
 Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement
to them
 Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or
prevention of disease, in humans or other animals
 Intended to affect the structure or any function of the body of humans or other animals, and which does
not achieve any of it's primary intended purposes through chemical action within or on the body of
humans or other animals and which is not dependent upon being metabolized for the achievement of
any of its primary intended purposes
Any of the following are true:
The activity is conducted in the United States and will evaluate the safety or effectiveness of a device
in one or more persons.
Data regarding subjects or control subjects will be submitted to or held for inspection by FDA as part
of an application for a research or marketing permit.
Data regarding the use of a device on human specimens will be submitted to or held for inspection by
FDA as part of an application for a research or marketing permit.

3. FDA REGULATED PRODUCTS - All of the following must be true:

The activity will involve one or more of the following:
 Foods or dietary supplement that bears a nutrient
content or a health claim
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

Medical device for human use
Biological product for human use



Infant formula
Food or color additive for human consumption
Drug for human use


Electronic product for human use
Any other article subject to regulation under
the FD&C Act

The activity in the United States and will involve one or more human participants, and

Data regarding subjects or control subjects will be submitted to or held for inspection by FDA as part of an
application for a research or marketing permit.
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Activity is “Human Research” according to Department of Defense Regulations and Addendum if
BOTH of the following two situations are true (required if research is funded by DOD entity):
1. The activity involves research because all of the following are true:

The activity is a systematic investigation, including research development, testing and evaluation, and

Either of the following is true:
The activity is designed to develop generalizable knowledge, or
The activity is designed to contribute to generalizable knowledge.
2. The activity involves Human Beings as “Experimental Subjects” because all of the following are
true:
 There is an intervention or interaction with a human being for the primary purpose of obtaining data
regarding the effects of the intervention or interaction and
 The following are true:
The investigator plans to obtain the data through one or more of the following:

Physical procedures performed on those individuals

Providing a drug to the individuals

Manipulation of those individuals

Manipulation of those individuals’ environments

Withholding of a research intervention

Communication with those individuals

Interpersonal contact with those individuals
O
O AND
The activity does not include:
 Activities carried out for the purposes of diagnosis, treatment, or prevention of injury and
disease in members of the Armed Forces and other mission essential personnel under Force
Health Protection programs of the DOD; or
 Authorized health and medical activities as part of the reasonable practice of medicine or
health professions; or
 Monitoring for compliance of individuals and organizations with requirements applicable to
military, civilian, or contractor personnel or to organizational units. This includes such
activities as drug testing, occupational health and safety monitoring, and security clearance
reviews.
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