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A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Association for the Accreditation of Human Research Protection Programs
Adverse Event (AE)
Any harm or untoward medical occurrence in a research participant administered a medical
product, medical treatment or procedure even if it does not necessarily have a causal
relationship with the product, treatment, or procedure. An adverse event can be any
unfavorable and unintended sign (including an abnormal laboratory finding, for example),
symptom, or disease temporally associated with the use of a medical product, medical
treatment or procedure whether or not considered to be related.
[FDA: 21 CFR 312.32]
Adverse Reaction (AR), Adverse Drug Reaction (ADR)
Pre-Approval Clinical Use of a Product
All noxious and unintended responses to a medicinal product related to any dose.
Marketed Medicinal Product
A response to a drug which is noxious and unintended and which occurs at doses
normally used in man for prophylaxis, diagnosis, or therapy of disease or for
modification of physiological function.
[FDA: Guideline for Industry, Clinical Safety Data Management: Definitions and Standards for
IRB members are considered affiliated if they, their spouse, domestic partner, or dependent
children are an employee, contractor, student, board member, or have any other similar
affiliation with Fred Hutch, UW, SCCA, or Seattle Children's.
Allegation of Noncompliance
An assertion that noncompliance has or may have occurred that requires further investigation
to determine whether noncompliance has in fact occurred.
Alteration of HIPAA
A request to change or omit one or more of the research-related HIPAA requirements. The
most common use of an alteration is to omit the HIPAA signature requirement.
Demonstrating that the "research could not practicably be conducted without the waiver or
alteration" is the main obstacle to approving an alteration. If the participant is physically
present, it is usually practicable to obtain written HIPAA Authorization.
45 CFR 164.512(i)(2)(ii)
Glossary of Terms and Acronyms
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Affirmative agreement by an individual not competent to give legally valid informed consent
(e.g., a child or cognitively impaired person) to participate in research. Mere failure to object
should not, absent affirmative agreement, be construed as assent.
See Federalwide Assurance.
The internal routing and approval form submitted along with a proposal for an activity to be
performed at Fred Hutch under a grant, contract or other sponsored agreement.
The internal routing and approval form submitted along with a funding proposal for an activity
to be performed at Fred Hutch funded by Center funds, discretionary funds, royalties, or other
non-sponsored funding source.
The internal routing and approval form for commercial and non-commercial research
Authorized Institutional Official
An officer of an institution with the authority to speak for and legally commit the institution to
adherence to the requirements of the federal regulations regarding the involvement of human
subjects in biomedical and behavioral research.
Personal capacity to consider alternatives, make choices, and act without undo influence or
interference of others.
The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of
Research of the National Commission for the Protection of Human Subjects of Biomedical
Behavioral Research is a statement of basic ethical principles governing research involving
human subjects issued by the National Commission for the Protection of Human Subjects in
An ethical principle discussed in the Belmont Report that entails an obligation to protect
persons from harm. The principle of beneficence can be expressed in two general rules: (1) do
not harm; and (2) protect from harm by maximizing possible benefits and minimizing possible
risks of harm.
A valued or desired outcome; an advantage.
Under the 2018 requirements of the Common Rule, a type of informed consent that allows for
the storage, maintenance, and secondary research uses of identifiable private information and
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identifiable biospecimens. Broad consent is less specific than consent for each use, but
narrower than open-ended permission without any limitations.
A research partnership between the institutions of Fred Hutch, the University of Washington,
Seattle Cancer Care Alliance, and Seattle Children’s Hospital. Also called the Fred
Hutch/University of Washington Cancer Consortium.
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. [HHS: 45 CFR 46.402(a)]
In most states, including Washington state, the legal age at which a person is able to consent
to participate in research is 18 years. Investigators should check appropriate State laws and
regulations before conducting research to determine the definition of a child for the purposes
of participation in research studies. In the case of research studies conducted outside the
United States, the relevant laws and regulations of the research participants’ country of
residence should be applied.
Collaborative Institutional Training Initiative (www.citiprogram.org), an online provider of
research ethics, compliance, and professional development education. Fred Hutch, University
of Washington, and SCCA have subscriptions for a number of CITI courses available to
researchers, including Human Subjects and Good Clinical Practice training.
Any experiment that involves a test article and one or more human subjects and that is either
subject to requirements for prior submission to the FDA, or is not subject to requirements for
prior submission but the results are intended to be submitted later to, or held for inspection
by, the FDA as part of an application for a research or marketing permit. [FDA: 21 CFR 50.3(c)]
This term is used by the FDA to describe research that is subject to FDA regulations relating to
informed consent and review by an IRB. Additional information regarding FDA clinical
investigation definitions for drug or device studies is found at 21 CFR 312.3(b) and 21 CFR
Clinical Research Support (CRS)
The Fred Hutch Office that promotes, supports, and facilitates research trials within the
Cancer Consortium. CRS supports the Cancer Consortium Data and Safety Monitoring
Committee and the Scientific Review Committee. (See: Data and Safety Monitoring Committee
and Scientific Review Committee.)
A research study in which one or more human subjects are prospectively assigned to one or
more interventions (which may include placebo or other control) to evaluate the effects of
those interventions on health-related biomedical or behavioral outcomes.
[HHS 2018: 45 CFR 46.102(b); NIH Policy: Notice of Revised NIH Definition of “Clinical Trial”]
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Clinical Trial Staff
Individuals, identified by the investigator, who are responsible for study coordination, data
collection and data management. The central focus of clinical trial staff is to manage
participant recruitment and enrollment, to maintain consistent study implementation, data
management, and to ensure integrity and compliance with regulatory and reporting
requirements. These individuals may also seek informed consent from prospective
participants, enroll and meet with research participants, and collect and record information
from research participants. Clinical trial staff may also be called the research coordinator,
study coordinator, research nurse, study nurse or sub-investigator.
[NIH Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-Funded
A study is closed when accrual of research participants is complete and all research activities
have ceased. This means no interaction/intervention is planned for the purpose of research
with research participants and no long-term follow-up. Data collection and analysis are
When identifying information (such as name or social security number) that would enable the
investigator to readily ascertain the identity of the individual to whom the private information
or specimens pertain has been replaced with a number, letter, symbol, or combination
thereof (i.e., the code) AND a key to decipher the code exists, enabling linkage of the
identifying to the private information or specimens.
[OHRP Guidance: Coded Private Information or Specimens Use in Research]
A group of subjects initially identified as having one or more characteristics in common who
are followed over time. In social science research, this term may refer to any group of persons
who are born at about the same time and share common historical or cultural experiences.
See Federal Policy.
The treatment that must be afforded to individually identifiable information about research
participants or potential research participants. Confidential treatment of information in the