PRC key terms

The voluntary agreement of a competent participant to take part in research after receiving and understanding information about its purpose, procedures, risks, benefits, and alternatives. It must normally be documented and can be withdrawn.

A minor's or cognitively impaired person's own agreement to participate, obtained in addition to permission from a legally authorized representative. It should be sought whenever the individual can understand information at an age-appropriate level.

An independent committee that reviews research involving human participants to ensure ethical standards, regulatory compliance, and protection of participants' rights and welfare before, during, and after a study.

A committee that oversees animal research programs, reviewing protocols and facilities to ensure humane care, appropriate use of animals, and compliance with animal welfare regulations and guidelines.

Groups whose ability to give free and informed consent is limited or at elevated risk of harm, such as children, prisoners, pregnant women, cognitively impaired persons, economically disadvantaged persons, and students or employees under authority.

The use of threats, force, or excessive incentives to obtain participation or compliance, undermining voluntary choice. In research, it can arise from power imbalances such as teacher-student or supervisor-employee relationships.

An offer of payment or benefit so large or attractive that it distorts judgment and prompts participation against a person's better interests. Payments should compensate time and burden without becoming an improper incentive.

The researcher's obligation to protect participants' identifiable information from unauthorized access or disclosure, using safeguards such as de-identification, secure storage, restricted access, and agreed limits described during consent.

A condition in which the researcher cannot link data or responses to any individual's identity, including through codes or indirect identifiers. It is stronger than confidentiality and cannot always be guaranteed in practice.

The process of removing or masking direct and indirect identifiers from data so that individuals are not readily identifiable. Residual re-identification risk must still be assessed and managed.

The ethical principle of acting to promote participants' welfare by maximizing anticipated benefits and minimizing possible harms. It underlies the risk-benefit assessment required in research review.

The principle of avoiding unnecessary harm, often expressed as primum non nocere. In research it requires that procedures pose no more than minimal risk relative to the knowledge to be gained.

The principle requiring fair distribution of research burdens and benefits, so that groups are not systematically excluded from benefits or disproportionately selected to bear risks.

The ethical principle that individuals are autonomous agents whose choices must be honored, and that those with diminished autonomy are entitled to protection. It grounds informed consent and assent requirements.

A level of risk where the probability and magnitude of harm are no greater than those ordinarily encountered in daily life or during routine physical or psychological tests.

An assessment weighing the probability and severity of potential harms to participants against the expected benefits to them, to science, or to society. Favorable ratios are a precondition for approval.

A category of IRB determination for research involving minimal risk in specified categories, such as anonymous surveys or analysis of existing de-identified data. Exemption is determined by the IRB, not the researcher.

A review procedure for research posing no more than minimal risk and falling within federally defined categories, conducted by the IRB chair or an experienced reviewer rather than the full board.

Review by a convened quorum of the IRB, required for research involving more than minimal risk or vulnerable populations not otherwise eligible for expedited review. A majority of members must approve.

Periodic IRB re-evaluation of an ongoing study, typically at least annually, to confirm that risks remain acceptable and that approved procedures are followed. Amendments and adverse events are also reviewed.

A formal change to an approved research protocol or consent document. It must be submitted to and approved by the IRB before implementation, except when needed to eliminate immediate harm to participants.

The required notification to the IRB and sponsors of unanticipated problems or harms involving risk to participants. Serious events are usually reported promptly, with follow-up documentation.

Intentional or reckless fabrication, falsification, or plagiarism in proposing, performing, or reporting research. It excludes honest error and differences of opinion.

Making up data, results, or records and presenting them as real. It is a form of research misconduct distinct from altering genuine data or copying others' work.

Manipulating, altering, or selectively omitting data, equipment, or processes so that results are misrepresented. Unlike fabrication, it starts from real observations that are then distorted.

Presenting another person's ideas, words, data, or images as one's own without appropriate attribution. It includes self-plagiarism and misuse of unpublished or AI-generated material without disclosure.

Credit for substantive intellectual contributions to a study, including conception, design, analysis, or drafting and approval of the work. It carries accountability for the published content.

Omission from the author list of someone who made substantial contributions, often a professional writer or industry employee. It conceals conflicts of interest and violates authorship criteria.

Listing as an author someone who did not make a substantive contribution, such as a supervisor, department head, or funder. It dilutes accountability and misrepresents credit.

A situation where financial, personal, or professional interests could improperly influence research judgments or reporting. It must be disclosed to institutions, journals, and participants as appropriate.

The transparent reporting of relevant interests, funding, methods, data, and limitations so that others can evaluate the work. In ethics review it also refers to revealing risks to participants.

Independent evaluation of a manuscript by experts in the field before publication. Reviewers must keep submissions confidential, avoid using ideas before publication, and recuse themselves when conflicted.

A formal withdrawal of a published article, usually because findings are unreliable due to misconduct, error, or other serious problems. It is distinct from a correction or expression of concern.

A published notice fixing errors in an article that do not invalidate its conclusions, such as mislabeled figures or wrong citations. It preserves the integrity of the scholarly record without removing the paper.

The practice of making underlying data accessible for verification and reuse, through repositories or on-request arrangements. It supports reproducibility and is increasingly required by funders and journals.

The ability of independent researchers to obtain consistent results using the same data and methods, or to replicate a study with new data. It depends on transparent methods, code, and materials.

Publicly documenting a study's hypotheses, design, and analysis plan before data collection to reduce selective reporting and hindsight bias. Deviations should be reported transparently.

Actions that distort the research record without meeting formal misconduct definitions, such as selective outcome reporting, p-hacking, or inappropriate exclusion of data. They erode credibility and are increasingly sanctioned.

The framework for ethical animal research: replace animals with alternatives where possible, reduce numbers to the minimum needed, and refine procedures to minimize pain and distress.