Research Ethics - NAPLEX

Consent provided by a parent or legal guardian. It serves as a substitute for the child's informed consent, ensuring legal and ethical protection when the child cannot fully consent.

Affirmative agreement of a child to participate. In pediatric research, assent respects the child's developing autonomy by requiring their agreement in addition to parental permission.

Voluntariness. This element protects autonomy by ensuring decisions are made freely, without pressure or incentives that could unduly influence participation.

Comprehension (understanding). This element requires that information be presented in a way that matches the participant's capacity to understand risks, benefits, and procedures.

Voluntary, informed agreement to participate. It upholds respect for persons by providing participants with sufficient information to make an autonomous decision about involvement.

Ghost authorship. Excluding contributors denies proper recognition and breaches ethical standards like those from ICMJE, compromising transparency in research.

Protect human subjects by reviewing research ethics. IRBs are mandated by federal regulations to evaluate study protocols, ensuring ethical compliance and safeguarding participant rights and welfare.

Compensation must not be so large that it is coercive. Ethical guidelines require payments to reimburse without coercion, preserving voluntariness and preventing undue influence on participation.

Genuine uncertainty about which intervention is superior. Equipoise justifies randomization ethically by ensuring no known superior treatment exists, balancing beneficence and scientific validity.

Harm not greater than daily life or routine exams. Federal regulations define it as risks comparable to everyday activities or standard medical exams, guiding IRB approvals for low-risk studies.

Promptly report to the IRB/sponsor per protocol. Reporting ensures participant safety and regulatory compliance, allowing oversight bodies to assess and mitigate ongoing study risks.

Stop study procedures; honor withdrawal per consent terms. Respecting autonomy requires immediate cessation of interventions and adherence to withdrawal protocols to protect participant rights.

The Belmont Report. Published in 1979 by the National Commission, it established the foundational ethical principles for protecting human subjects in research.

Falsification (selective data reporting). Selective omission manipulates data to misrepresent outcomes, constituting falsification under research misconduct definitions.

Justice. This Belmont Report principle ensures fairness in selecting subjects and distributing research burdens and benefits equitably across populations.

Beneficence. This Belmont Report principle mandates researchers to do no harm and maximize potential benefits while minimizing risks to participants.

Using others’ ideas or words without proper attribution. It undermines intellectual honesty by appropriating others' work, violating ethical norms of originality and proper credit in scholarship.

Manipulating methods or data so results are misrepresented. This misconduct distorts scientific truth by altering processes or results, leading to inaccurate representations in research reporting.

Making up data or results and recording/reporting them. It violates research integrity by inventing false information, which can mislead scientific progress and erode public trust in findings.

Gift (honorary) authorship. This practice violates authorship guidelines, such as ICMJE criteria, which require substantial contributions for legitimate authorship credit.

Fabrication, falsification, or plagiarism (FFP). U.S. policy, including from the Office of Research Integrity, defines misconduct strictly as these intentional acts that undermine scientific validity.

Secondary interest that could bias professional judgment. COIs arise when external influences, like financial ties, could compromise the integrity and objectivity of research decisions.

Disclose the COI and follow the management plan. Disclosure promotes transparency, and a management plan mitigates bias, ensuring research integrity and compliance with ethical standards.

Respect for persons (autonomy). This principle from the Belmont Report emphasizes autonomy by ensuring participants can make informed, voluntary choices without coercion.