Ethical Terminologies and Research Ethics Flashcards

A complete list of vocabulary definitions extracted directly from the lecture notes on health research ethics.

Autonomous Person

An individual capable of deliberation about personal goals and of acting under the direction of such deliberation.

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.

Clinical Trial

A prospective biomedical or behavioral research study of human subjects designed to answer specific questions about interventions by comparing results from a study arm and a control arm.

Coded Data

Data from which identifiers are removed in exchange for codes that correspond to the identifiers, with the identifiers maintained separately from the rest of the dataset.

Coercion

Influencing an individual's decision about whether or not to do something by using explicit or implied threats, such as loss of job standing, poor grades, or loss of community support.

Compensation

Payment provided to research participants which may include money, other material compensation such as coupons or gift certificates, or non-monetary rewards.

Deception

Misleading research participants about the research purpose or procedures.

Diminished Autonomy

An individual with restricted capability of deliberation about personal goals and of limited ability to act under the direction of their deliberations.

Anonymized Data

Data lacking identifiers or codes that can link a particular sample to an identified specimen or a particular human being.

Assent

Affirmative agreement to participate in research, typically given by those unable to grant legal consent due to legal restriction or perceived incompetency.

Equipoise

Substantial scientific uncertainty about which treatments will benefit subjects most, or a lack of consensus in the field that one intervention is superior to another.

Featus

The product of conception from implantation until delivery.

Incomplete Disclosure

Withholding some information in order to conduct an unbiased study, with the understanding that the information could be material to a prospective participant's decision to participate.

Informed Consent

A legally-effective, voluntary agreement given by a prospective research participant following comprehension and consideration of all relevant information pertinent to the decision to participate.

Investigator

Anyone involved in conducting research, excluding individuals who solely provide coded private information or specimens without collaborating on research design, data analysis, or manuscript authorship.

Legally Authorized Representative (LAR)

An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective study participant to their participation in research procedures.

Minimal Risk

A level of risk where the probability and magnitude of harm or discomfort anticipated in research are not greater than those ordinarily encountered in daily life or during routine physical or psychological examinations.

Neonates

A newborn.

Permission

The agreement of parent(s) or guardian to the participation of their child or ward in research.

Placebo

An inactive intervention designed to resemble, as much as possible, its active counterpart in clinical research.

Pregnancy

The period encompassing implantation until delivery, assumed if a woman exhibits presumptive signs such as missed menses until a pregnancy test is negative.

Prisoner

Any individual involuntarily confined or detained in a penal institution or held under commitment procedures alternative to criminal prosecution.

Therapeutic Misconception

The tendency for research participants to downplay or ignore risks to their well-being due to a conviction that every aspect of participation is designed for their individual benefit.

Undue Burden

The systematic selection of research populations simply because of easy availability, compromised position, or manipulability, rather than reasons directly related to the research problem.

Undue Influence

An offer of an excessive, unwarranted, inappropriate, or improper reward or other overture to obtain compliance.

Beneficence

An ethical obligation to secure the well-being of research participants through two rules: do no harm, and maximize possible benefits while minimizing possible harms.

Privacy

The state of being free from unsanctioned intrusion.

Confidentiality

Holding all information relating to an individual in a way that is inaccessible by unauthorized persons, unless the individual gives consent permitting disclosure.

Individual Justice

The moral requirement that investigators do not offer potentially beneficial research only to favored patients or select only undesirable persons for risky research.

Social Justice

The moral requirement that distinctions be drawn between classes of participants based on their ability to bear burdens and avoiding placing further burdens on already burdened persons.

Health Research Ethics Committees (HREC)

Specialized committees required by the National Code for Health Research Ethics to safeguard the rights and welfare of human participants through initial review, approval, and continuing oversight.

Data and Safety Monitoring Board (DSMB)

An independent committee of experts without bias toward the research permitted to periodically view unblinded data and conduct interim analyses to ensure subject safety.

Back-Translation

A consent form translation validation process where a second translator translates the local language informed consent form back to English to compare side-by-side for accuracy.