Glossary

CFR: Code of Federal Regulations

DHHS: U.S. Department of Health and Human Services, an agency of the federal government:
formerly the Department of Health, Education and Welfare (DHEW)

FDA: Food and Drug Administration; an agency of the federal government established by
Congress in 1912 and presently part of the Department of Health and Human Services.

IRB: Institutional Review Board (see definition below)

NIH: National Institutes of Health: a federal agency within the Public Health Service, DHHS.
Comprised of 21 institutes and centers, it is responsible for carrying out and supporting
biomedical and behavioral research.

OHRP: Office for Human Research Protection (see definition below)

A
Administrative Hold: a temporary hold on the ability investigators to enroll new human
subjects on a research protocol until the IRB Committee has determined that changes in
adequate safeguards for the protection of human subjects have been implemented.

Adverse Effect: an undesirable and unintended, although not necessarily unexpected, negative
result of participation in research (e.g., headache following spinal tap or intestinal bleeding
associated with aspirin therapy, or a panic attack following an emotional experience).

Adverse Event: any occurrence of an adverse effect; any adverse finding (including a sign,
symptom, or abnormal assessment (e.g., lab, EKG)); any report regarding the quality,
safety, or performance of a medical product; or any other unfavorable outcome that affects
a human subject detrimentally, or that worsens an existing condition, as a result of
participation in a study.

Anonymous: the state of being unknown and not identifiable in any way (different from
confidential identity, see below)

Assent: affirmative agreement by an individual not competent to give legally valid informed
consent (e.g., a child or person who is cognitively impaired) to participate in research.
Assent is always affirmative or active; mere failure to object should not be construed as
assent.

Assurance: a formal, written, binding commitment that is submitted to a federal agency through
which an institution promises to comply with applicable regulations governing research
with human subjects and stipulates the procedures through which compliance will be
achieved.

At-risk populations: Includes people identified as requiring special attention, such as pregnant
women, human fetuses, neonates, prisoners, children, individuals with cognitive or
emotional impairments.

Autonomy: Personal capacity to process information, consider alternatives, make choices, and
act without undue influence or interference of others.

B

Belmont Report: a statement of basic ethical principles governing research involving human
subjects issued by the National Commission for the Protection of Human Subjects in 1978.

Beneficence: an obligation to go beyond minimizing harm so as to maximize benefits for
research subjects

Benefit: a valued or desired outcome; an advantage, a consideration

C

Children: persons who have not attained the legal age for consent to treatments or procedures
involved in the research, under the applicable law of the jurisdiction in which the research
will be conducted.

CFR: See: Code of Federal Regulations

Clinical trial: controlled study involving human subjects designed to evaluate prospectively the
safety and effectiveness of new drugs or devices or of behavioral interventions.

Co-investigator: any individual who collaborates with the principal investigator in the design
and/or conduct of a research project, including those with access to data. For IRB purposes,
status as a co-investigator includes no presumption about authorship status; all members of
a research team are considered to be co-investigators.

Code of Federal Regulations: compilation of federal executive agency regulations organized
into 50 Titles and published in the Federal Register as they are promulgated. The relevant
code for human-subjects research is Title 45, Chapter 46, also known as 45 CFR 46

Cognitively impaired: Having either a medical disorder (e.g., psychosis, encephalopathies,
traumatic brain injury, or dementia) or a developmental disorder (e.g., mental retardation)
that affects cognitive or emotional functions to the extent that capacity for judgment and
reasoning is significantly diminished. The label includes, but is not necessarily limited to,
persons under the influence of, or dependent on drugs or alcohol, who may be
compromised in their ability to make decisions in their best interests.

Common Rule (The): see Federal Policy, specifically 45 CFR 46.

Compensation: payment, medical care, or other consideration provided to subjects injured in
research; does not refer to payment (remuneration) for participation in research (Compare:
remuneration).

Competence: capacity to act on one’s own behalf; the ability to understand information
presented, to appreciate the consequences of acting (or not acting) on that information, to
make a choice, and have the ability to express that choice. (See also: incompetence,
incapacity)

Confidentiality: pertains to the treatment of information that an individual has disclosed in a
relationship of trust and with the expectation that it will not be divulged to others without
permission in ways that are inconsistent with the understanding of the original disclosure.
This is different from anonymity.

Consent: see: informed consent

D

Debriefing: Giving subjects previously undisclosed information about the research project
following completion of their participation in the research. This can include providing
written material to participants.

E

Emancipated minor: legal status conferred upon persons who have not yet attained the age of
legal competency as defined by state law (for such purposes as consenting to medical care),
but who are entitled to treatment as if they were “of age” by virtue of assuming adult
responsibilities such as being self-supporting and not living at home, marriage, or
procreation.

Embryo: early stages of a developing organism, broadly used to refer to stages immediately
following fertilization of an egg through implantation and very early pregnancy (i.e., from
conception to the eighth week of pregnancy). (See also: fetus.)

Equitable: fair or just; often, but not exclusively, used in the context of selection of subjects to
indicate that the benefits and burdens of research are fairly distributed; generally receiving
some consideration based on entitlement or earning, as opposed to receiving consideration
equally.

Ethics: the study of the general nature and purpose of morals and the process of specific moral
choices to be made by the individual in his/her relationship with others.

Exculpatory: clearing or tending to clear from alleged fault or guilt. Statements of informed
consent may not include exculpatory language that would justify, excuse, or clear an
investigator from alleged fault or guilt (in the case of an adverse event), or through which
the subject waives their legal rights

Exempt: more fully described as exempt from continuing review and refers to research as
defined in 45 CFR 46 in paragraph 46.101(b). Projects that meet these criteria in their
initial review by the IRB need not be reviewed further by the IRB, are exempt from the
continuing-review requirements, unless changes are made to the protocol or problems arise
during the conduct of the research.

Expedited Review: review of proposed research by designated IRB member(s) instead of the
entire IRB. Federal rules and SVSU policy permit expedited review for certain kinds of
research and for minor changes in previously approved research. This category of review is
described in 45 CFR 46 at paragraph 46.110. Generally, Expedited Review may be
employed for research that involves no more than minimal risk for participants and does
not include any special classes of participants, or for minor changes to approved projects.

Expiration date: date after which a protocol is no longer approved for use with human subjects.
No protocols are approved for more than one year; except for exempt (see above) projects,
renewal applications are required for projects that extend beyond one year from the initial
date of approval

F

Family member: defined to include spouses, parents, children (including adopted children),
siblings, spouses of siblings, and any individual related by blood or affinity whose close
association with the subject is the equivalent of a family relationship.

Federal Policy (The): policy that provides regulations for the involvement of human subjects in
research, 45 CFR 46. The Policy applies to all research involving human subjects
conducted, supported, or otherwise subject to regulation by any federal department or
agency that takes appropriate administrative action to make the Policy applicable to
research. Currently, sixteen federal agencies have adopted the Federal Policy. (Also known
as the “Common Rule” and 45 CFR 46.) SVSU has also adopted the Federal Policy.

Fetus: product of conception from the time of implantation until delivery. If the delivered or
expelled fetus is viable, it is designated an infant. The term "fetus" generally refers to later
phases of development; the term "embryo" is usually used for earlier phases of
development. (See also: embryo.)

Fieldwork: Behavioral, social, anthropological, or other research involving the study of persons
or groups in their own environment, often without manipulation for research purposes
(distinguished from laboratory or controlled settings).
45 CFR 46: See: Title 45 Code of Federal Regulations Part 46

Full Board Review: process that occurs during a formal meeting of the IRB. For a project to be
approved, it must receive the approval of a majority of those members present at the
meeting. This category of review applies to all research that does not fall into other
categories. In general, full board review will be required for all projects involving: a) more
than minimal risk to participants, b) the deception of subjects, c) sensitive behavioral
research (such as research relating to illegal or sexual activity), and d) at-risk populations
(e.g., pregnant women, human fetuses, neonates, prisoners, children, individuals with
cognitive impairments).

G

Generalizable knowledge: knowledge "expressed in theories, principles, and statements of
relationships" that can be widely applied to our experiences [the Belmont Report]. The term
"generalizable knowledge" is used to distinguish the results of research from the results of
non-research activities such as "practice" activities. "For the most part, the term 'practice'
refers to interventions that are designed solely to enhance the well-being of an individual
patient or client. By contrast, the term "research" designates an activity designed to test an
hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to
generalizable knowledge [the Belmont Report]. Knowledge is generalized through
activities including, but not limited to, publication, presentation (including posters), posting on a
website, and/or generally disseminating a “white paper.”

Guardian: in the context of research, an individual who is authorized under applicable state or
local law to give consent and make other decisions on behalf of someone else.

H

Human Subject: defined in 45 CFR 46 at paragraph 46.102(f). Consistent with this definition,
“human subject” activity involves any interaction with humans, access to identified
samples obtained from humans, or existing archives that contain identifiable information
about or obtained from humans.

I

Identifiable private information: includes information about behavior that occurs in a context
in which an individual can reasonably expect that no observation is taking place, and
information that has been provided for specific purposes by an individual and for which the
individual can reasonably expect will not be made public (for example, a medical record).

Identifiers: characteristics about an individual (e.g. Name, Social Security Number, Hospital
Admission Number, Specimen Number, or codes linked to the research subject) that could
be used to connect the project to a specific research subject.

Incapacity: refers to a person's mental status; means inability to understand information
presented, to appreciate the consequences of acting (or not acting) on that information, to
make a choice, and to express that choice. Often used as a synonym for incompetence. (See
also: incompetence).

Incompetence: legal term meaning inability to manage one's own affairs. Often used as a
synonym for incapacity. (See also: incapacity.)

Information Sheet: written statement that contains the same elements as a written consent. It
differs only in that is does not require research subjects to provide a signature indicating
agreement to participate in a research study. It is used in a study for which a waiver of
documentation of consent has been granted. The SVSU IRB may approve the use of an
information sheet if either: 1) the only record linking the subject and the research would be
the consent document and the principal risk would be potential harm resulting from a
breach of confidentiality, or (2) the research presents no more than minimal risk of harm to
subjects and involves no procedures for which written consent is normally required outside
of the research context. Investigators must provide justification for a request to waive
written documentation of consent.

Informed Consent: a person’s voluntary agreement, based upon adequate knowledge and
understanding of relevant information, to participate in research or to undergo a diagnostic,
therapeutic, or preventative procedure. It is characterized by the provision of complete and
accurate information to potential research subjects, facilitating full and genuine
comprehension of this information by potential research subjects, and assuring the
voluntary nature of any consent obtained. In giving informed consent, subjects may not
waive or appear to waive any of their legal rights, or release or appear to release the
investigator, the sponsor, the institution or agents thereof from liability for negligence.
Note: Human subjects cannot be fully protected if they are not fully informed. Therefore,
the consent form becomes a major focus of scrutiny. In order to inform subjects fully,
consent forms must be clear and concise, in most cases in language understandable by a
person with no more than an eighth grade education. In particular, unambiguous
identification of procedure, objectives, and risks is an absolute requirement.

Institutional Review Board: a specially constituted review body established or designated by an
entity to protect the welfare of human subjects recruited to participate in human-subjects
research.

Interaction: includes any communication or contact between any member of the research team
and research participants

Intervention: includes "both physical procedures by which data are gathered, and manipulations
for the subject or the subject's environment that are performed for research purposes" [45
CFR 46.102(f)(2)].

Investigator: Any member of a research team. (See also: principal investigator.)

IRB: See Institutional Review Board

J

Justice: an ethical principle discussed in the Belmont Report requiring fairness in distribution of
burdens and benefits; often expressed in terms of treating persons of similar circumstances
or characteristics similarly. In the context of research, justice is often used to refer to the
questions of fairness in the selection of human subjects for study, such as whether or not
subjects are selected for study merely because they are conveniently available or unable to
protect themselves from potential exploitation, and the relative distribution of benefits of
research to subjects and society in general

K

Key Personnel: all individuals responsible for the design and conduct of the study. This includes
those individuals responsible for the recruitment and consent of potential study
participants.

L

Legally authorized representative: an individual or judicial or other body authorized under
applicable law to consent on behalf of a prospective subject to the subject’s participation in
the procedure(s) involved in the research. In the case of children, this would most likely be
a parent or legal guardian. For adults, a legally authorized representative would have
durable power of attorney or some other court order authorizing him/her to be the legal
representative.

M

Major modification: A significant change to a protocol where subjects would be engaging in
activities not previously approved during the review process or where there is an increased
level of risk to the physical, emotional, or psychological well-being of participants,
including loss of confidentiality.

Mental disability(ies): See: cognitively impaired.

Mentally disabled: See: cognitively impaired

Minimal Risk: 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.
Minors: persons who have not attained the legal age for consent to treatments or procedures
involved in the research, under the applicable law of the jurisdiction in which the research
will be conducted

Minor modification: Protocol modifications that might include minor wording changes in the
consent form, small changes in compensation, time of participation, or subject recruitment,
or the use of a new investigation site that is not materially different from a previously
approved site. There may also be changes to other parameters whereby the investigator
provides the subjects with more accurate information as a result of additional experience
with the protocol.

N

National Commission: National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research. An interdisciplinary advisory body, established by
Congressional legislation in 1974, which was in existence until 1978, and which issued a
series of reports and recommendations on ethical issues in research and medicine, many of
which are now embodied in federal regulations.

O
Office for Human Research Protections (OHRP): New name for the OPRR after it was moved
out of the NIH and directly under the purview of the DHHS in June 2000; this office is
currently responsible for implementing and enforcing DHHS regulations governing human
subjects research, including the imposition of sanctions on institutions not in compliance
with the regulations.

Office For Protection From Research Risks (OPRR): The office that, until June 2000, was
within the National Institutes of Health, an agency of the Public Health Service,
Department of Health and Human Services, and responsible for implementing DHHS
regulations (45 CFR Part 46) governing research involving human subjects.

Oral Assent: an affirmative verbal agreement by an individual not competent to give legally
valid informed consent to participate in a research study.

Oral Consent: When the research is of minimal risk, (e.g. research involving telephone surveys
or interviews), the IRB may approve the use of oral consent. In research projects that
involve greater than minimal risk, documentation of oral consent must involve three
individuals: the subject, the research staff member obtaining consent, and a witness (who
may also serve as the translator).

Outside IRB Purview: category of research that includes activities not subject to IRB oversight.
This category will be applied by the IRB to activities that do not meet either the definition
of human subject or the Common Rule definition of research

P

Parent: a child's adoptive or biological parent [45 CFR 46.402(d)].

Passive consent: Consent that is deemed to have been provided when a subject voluntarily
participates in or allows their child to participate in a research protocol without actively
agreeing (in writing or verbally) to participation. For example, when parents do not return a
signed statement disallowing their child’s participation in a study, they are deemed to have
provided passive consent. Passive consent cannot be approved under any circumstances.

Permission: the agreement of parent(s) or guardian to the participation of their child or ward in
research[45 CFR 46.402(c)].

Pregnancy: encompasses the period of time from implantation until delivery. A woman shall be
assumed to be pregnant if she exhibits any of the pertinent presumptive signs of pregnancy,
such as missed menses, until the results of pregnancy test are negative or until delivery.

Principal Investigator (PI): The individual with primary responsibility for the design and
conduct of a research project.

Prisoner: An individual involuntarily confined in a penal institution, including persons: (1)
sentenced under a criminal or civil statue; (2) detained pending arraignment, trial, or
sentencing; and (3) detained in other facilities (e.g., for drug detoxification or treatment of
alcoholism) under statutes or commitment procedures providing such alternatives to
criminal prosecution or incarceration in a penal institution [45 CFR 46.303(c)]

Privacy: control over the extent, timing, and circumstances of sharing oneself (physically,
behaviorally, or intellectually) with others.

Private: affecting or belonging to private individuals rather than to the general public for public
use or consumption.

Protocol: the formal design or plan of an experiment or research activity; specifically, the plan
submitted to an IRB for review and to an agency for research support. The protocol
includes the purpose of the research, a description of the research design or methodology to
be employed, the eligibility requirements for prospective subjects and controls, the
treatment regimen(s), and the proposed methods of analysis that will be performed on the
collected data.

R

Remuneration: payment or consideration for participation in research. (Note: It is wise to
confine use of the term "compensation" to payment or provision of care for research-related
injuries.) (Compare: compensation.)

RPA: Request for Project Approval (RPA) is the form through which investigators request that
the IRB review a proposed project

Research: is defined in 45 CFR 46 at paragraph 46.102(d). Consistent with this definition,
“research” involves systematic investigation designed to develop or contribute to
generalized knowledge, regardless of other purposes or designs that may attend the
investigation.

Research Supervisor (RS): faculty or staff member who has qualifications and expertise
sufficient to oversee the conduct of research and who has adequate supervisory capacity for
ensuring that all individuals involved in the research will conform to all federal and
institutional requirements for protecting human subjects. Research conducted by students at
SVSU must have an individual designated as Research Supervisor.

Risk: the probability of harm, injury, or loss (physical, psychological, social, or economic)
occurring as a result of participation in a research study. Both the probability and
magnitude of possible harm may vary from minimal to significant.
a. Physical risks may arise from the use of test agents such as chemicals or therapeutic
drugs, devices, physical agents (including radiation), and clinical procedures.
b. Psychological risks may arise from the utilization of behavioral questionnaires or
surveys, interview interactions, the collection of sensitive data, or the emotional stress
of study participation.
c. Social risks may arise from actual or potential breaches of confidentiality such as
harm to interpersonal relationships, damage to reputation or social standing, or
exposure to legal sanctions.
d. Economic risks may affect an individual's financial status, employability or
insurability.

S

Special Groups (of Human Subjects): The Office for Human Research Protections (OHRP) has
identified populations in need of special protections in research. IRBs must apply
additional regulations and criteria and give special consideration to recruitment, subject
selection, informed consent, privacy, and confidentiality issues before approving research
involving these populations.

Subjects: See: human subjects

V

Viable: As it pertains to a neonate, able to survive after delivery to the point of independently
maintaining heartbeat and respiration. The Secretary may, from time to time, take in
account medical advances and publish in the Federal Register guidelines to assist in
determining whether a neonate is viable for purposes of 45 CFR 46. If a neonate is viable,
then it may be included in research only to the extent permitted and in accordance with the
requirements of 45 CFR 46.

Voluntary: free of coercion, duress, or undue inducement. Used in the research context to refer
to a subject’s decision to participate (or to continue to participate) in a research activity.

Vulnerable: see “at risk”


W

Waiver of Consent: consent may be waived by the IRB if the following four conditions are met:
1) the risk to the subject is not more than minimal; 2) the waiver will not adversely affect
the rights and welfare of the research participants; 3) the research could not practicably be
carried out without the waiver; and 4) the subjects will be provided with additional
pertinent information after participation when appropriate. Note that waiver of consent is
different from a waiver of written documentation of consent, in which consent is required
but no written record of consent is maintained.

Waiver of Consent in Emergency Situations: in acute medical emergency research, situations
may arise in which neither the patient can give consent, nor can his/her legally authorized
representative be contacted in time to consent to the investigational therapy. Waiver of
written informed consent must be pre-approved by the IRB prior to enrollment of patients
under these conditions.

Ward: A person placed by the court under the care of a guardian [Black's Law Dictionary, 5thed.].

Written Assent: a signed document used to record the agreement by an individual not competent
to give legally valid consent (e.g., a child or cognitively impaired person) to take part in a
research study.

Written Consent: a signed document used to record the agreement by an individual competent
to give legally valid consent to take part in a research study.