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Any unfavorable or unintended sign, symptom,
or event associated with human subject research affecting
a participant’s physical, mental, social, financial,
legal, or psychological well-being. Included are all significant
deviations from IRB approved protocol and all adverse reactions
experienced by a subject. The occurrence need not have a clear
causal relationship with the individual’s participation
in the research.
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Anonymity |
Protection of the participants’ identity
whereby no identifying information is collected from subjects
(e.g., no name, social security number, or driver’s
license number).
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Approval |
The determination of the IRB that the research
protocol has been reviewed and may be conducted at an institution
within the constraints set forth by the IRB and by other institutional
and Federal requirements.
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Assent |
The agreement to participate in a research
study given by a child, or an adult who lacks full decision-making
capacity or authority to give legally valid informed consent.
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Assurance |
An agreement between a legal entity that is
engaged in research and the Office for Human Research Protections
(OHRP) that stipulates the method(s) by which the entity will
protect research participants. Purdue University has an assurance
with OHRP.
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At Risk |
To be placed in a position with greater potential
for physical, mental, social, or financial harm than would
be expected for that individual in his or her normal occupation
or daily activities.
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Cornerstone document of ethical principles
for human subjects research, written in 1979 and titled “Ethical
Principles and Guidelines for the Protection of Human Subjects
of Research.” The ethical principles identified are
respect for persons, beneficence, and justice.
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Beneficence |
An ethical principle based on doing no harm
and maximizing benefits while minimizing risks. Beneficence
is applied by conducting risk/benefit assessments to ensure
that risks associated with participation are justified.
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Certificate
of Confidentiality |
An advance grant of confidentiality issued
to a research study to the DHHS in certain circumstances which
is intended to provide protection against forced disclosure,
even against a subpoena of individually identifiable research
data. This procedure has received little legal testing and
it is not known if a Certificate of Confidentiality would
hold up if challenged.
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Certification |
The official notification by the institution
to the supporting Department or Agency that a research project
or activity involving human subjects has been reviewed and
approved by an IRB in accordance with an approved assurance.
If required, it includes documentation to funding agencies
that a PI has completed specific training in the ethical conduct
of human subjects research.
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| Classified Research |
Research, either whole projects or portions thereof, that
has a security classification established by a federal agency,
OR industrially sponsored proprietary research for which the
sponsor requires a delay in publication in excess of six months.
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Confidentiality |
Protection of the participants’ identity
whereby identifying information that is collected from subjects
(e.g., name, social security number, driver’s license
number) is safeguarded by the researcher (e.g., assigning
a pseudonym to each subject, using a unique code/number identification
known only to the researcher, randomly assigning a code not
known to the researcher).
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Code of Federal Regulations
(CFR) |
The codification of the general and permanent
rules published by the executive departments and agencies
of the federal government. It details the laws that govern
research with human participants.
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Conflict of Interest
(COI) |
A conflict of interest may take many forms,
but arises when a principal investigator or IRB member has
competing organizational interests, a stake in the outcome
of the research, or personal bias, or can claim direct or
indirect financial benefit from the product or idea being
developed from the research. Conflicts of interest must be
identified so that necessary precautions can be taken to protect
research participants (e.g., disclosing the conflict of interest
during the informed consent process) and to minimize these
conflicts (e.g., an IRB member recusing himself or herself
from the decision).
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Continuing Review |
The IRB review and renewal, suspension, or
termination of a prior approved protocol that occurs at least
once every 12-months for all active protocols.
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Department
of Health and Human Resources (DHHS) |
“Parent” federal agency that oversees
the implementation of assurances and the conduction of human
subject research.
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Research activities are those which are not
subject to the requirements of the federal regulations. However,
the IRB or its designee determines if the research is exempt
from the requirements of the federal regulations and qualifies
for one of the federally stipulated exemption categories.
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Expedited |
Level of review pertaining to research activities
that can be approved as conforming to the federal requirements
and institutional assurances without requiring review by the
full Committee.
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Food
and Drug Administration (FDA) |
A division of DHHS. Enforces the Food, Drug
and Cosmetics Act and related federal public health laws.
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Federal-Wide Assurance
(FWA) |
An agreement between a legal entity that is
engaged in research and OHRP that stipulates the method(s)
by which the entity will protect research participants. This
document formalizes the institution’s agreement with
the federal government to protect human subjects/participants.
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Full Board |
Level of review pertaining to research activities
that must be evaluated by the full IRB to ensure that the
rights and welfare of human subjects/participants are safeguarded.
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Human
Protections Administrator |
Purdue’s primary contact person for
human subject protection issues. He or she exercises operational
responsibility for Purdue’s program for protecting human
subjects in research and plays a key role in ensuring that
the institution fulfills its responsibilities under the FWA.
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Human Subject or Human
Participant |
Individuals whose physiologic or behavioral
characteristics and responses are the object of study in a
research project. Under federal regulations, human subjects
are living individuals about whom a researcher obtains (1)
data through intervention or interaction with the individual
or (2) identifiable private information.
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An agreement to participate in research that
is made voluntarily by an individual with legal and mental
competence and the capacity to understand the information
transmitted and its implications, after having been informed
of the physical, psychological, and personal risks and potential
benefits entailed by a research protocol. Note: Informed consent
is more than acquiring the necessary signatures; rather, it
is a process by which potential participants are informed
of the study and voluntarily agree to participate.
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| Interaction |
Any form of communication or interpersonal contact between
an investigator and a human subject.
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| Intervention |
Physical procedures by which data are gathered and manipulations
of the individual or the individual’s environment that
are performed for research purposes, including using individuals
to evaluate or test devised products or materials developed
through research.
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Institutional Official |
The individual legally authorized to represent
the institution for signing assurances and other legal documents
and responsible for ensuring that human subjects research
is appropriately conducted.
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IRB Administrator |
An employee or agent of the university who
exercises operational responsibility, on a day-to-day basis,
for the institution’s program for protecting human research
subjects.
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Institutional Review
Board (IRB) |
A committee that reviews research protocols,
consent forms, and related documents to ensure that the rights
and welfare of human subjects are protected and that research
complies with applicable federal, state, and local regulations,
as well as university policies.
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The ethical principle based on fairness in
distribution of both harm (e.g., undue imposition of burden)
and reward (e.g., access to benefits). Justice is applied
by ensuring that (1) participants will benefit from the study
and (2) there is a fair and equitable selection of study participants.
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For non-prisoner studies: The probability
and magnitude of harm or discomfort anticipated in the research
are not greater in and of themselves than those ordinarily
encountered in daily life or during the performance of routine
physical or psychological examinations or tests. For studies
involving prisoner(s): The probability and magnitude of physical
or psychological harm that is normally encountered in the
daily lives, or in the routine medical, dental, or psychological
examination of healthy persons.
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Office
for Human Research Protections (OHRP) |
A division of the Department of Health and
Human Services that acts as a compliance oversight entity
for DHHS-funded research and issues assurances to institutions
conducting federally-funded research.
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Principal
Investigator (PI ) |
The scientist or scholar with primary responsibility
for the design, conduct, and analysis of a research project
and the protection of the human participants enrolled in his
or her study.
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Private Information |
Information about behavior that occurs in
a context in which an individual can reasonably expect that
no observation or recording is taking place, as well as information
which has been provided for specific purposes by an individual
and which the individual can reasonably expect will not be
made public (e.g., medical records).
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Protected Health Information
(PHI) |
Any individually identifiable health information
that is created or received by a health care provider, health
plan, public health authority, employer, life insurer, school,
university, or health care clearinghouse and that relates
to the past, present, or future physical or mental health
or condition of an individual; the provision of health care
to an individual; or the past, present, or future payment
for the provision of health care to an individual. PHI refers
to both data that is explicitly linked to a particular individual
and health information with data items which reasonably could
be expected to allow individual identification.
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A systematic investigation, including research
development, testing and evaluation, designed to develop or
contribute to generalizable knowledge or a larger body of
discipline-specific knowledge. Proposed activities may be
determined by the IRB to be research, regardless of the source
of support and regardless of whether they are classified by
other entities as non-research.
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Research Protocol |
Documentation of a research study’s
objective, design, methods of data collection and analysis,
statistical methods, and organization, particularly with regard
to the use of human participants (subjects) and their respective
information. The research protocol is both a component of
the application to the IRB for approval of a proposed project
(including any amendments made to the original document after
the project is approved by the IRB) and a term used to describe
the study as a whole.
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Respect for Persons
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The ethical principle based on the belief
that humans should be treated as autonomous agents and that
persons with diminished autonomy are entitled to increased
protection (e.g., children, developmentally disabled, prisoners).
Respect for persons is applied by the use of informed consent.
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Any occurrence that results in death, a life-threatening
situation, hospitalization, disability, incapacity, a congenital
anomaly/birth defect, or other significant outcomes.
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Standard Operating
Procedures (SOPs) |
A document issued by the ORA/HRPPP and/or
the IRB that identifies the processes and procedures by which
the IRB and associated staff conducts protocol reviews, conducts
day-to-day operations, and handles particular matters.
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Individuals who cannot give informed consent
because of limited autonomy (e.g., children, mentally ill,
prisoners). Also, human subjects/participants who are likely
to be vulnerable to coercion or undue influence (e.g., students,
subordinates, patients).
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