Untitled Quiz

Ethical Principles in Clinical Research

• Goal of clinical research: Generate useful knowledge about health and illness, benefiting society and future patients.
• Ethical principles: Focus on respecting participants, promoting benefits (beneficence), minimizing harm (non-maleficence), and ensuring fair distribution of risk and benefit (justice).
• Respect for autonomy: Recognizing a person's ability to make their own decisions, linked to privacy, confidentiality, truth-telling, and informed consent.
• Beneficence: Promoting the well-being of research participants and society.
• Non-maleficence: Minimizing harm to research participants.
• Justice: Equal distribution of risks and benefits, especially crucial for vulnerable groups.
• Vulnerable groups: Children, pregnant women, students, employees, prisoners, socioeconomically disadvantaged, ethnic minorities, patients with limited education or mental disabilities require special protection.

History of Bioethics

• Hippocratic oath: Early ethical principles, including non-maleficence.
• Tuskegee study: Unethical study of syphilis in African American men, lacking informed consent and withholding treatment.
• Nuremberg code: Emphasized voluntary consent, avoiding unnecessary harm, and weighing risks vs. benefits.
• Declaration of Helsinki: Guiding principles for medical research involving human subjects, weighing potential benefits and risks against current standards.
• Belmont report: Establishes three ethical principles (respect for persons, beneficence, justice) and required IRB review for federally funded research.
• Common Rule: Basis for oversight of human subjects research in the US, derived from the Belmont report.

Institutional Review Board (IRB)

• Purpose: Ensuring ethical research practices by minimizing risks and maximizing benefits for participants, ensuring equitable subject selection, and providing informed consent.
• Responsibilities: Reviewing research protocols before implementation and providing safeguards for vulnerable populations.

International Conference on Harmonisation - Good Clinical Practice (ICH/GCP)

• Principles: Based on the Nuremberg Code and the Declaration of Helsinki, and the Belmont Report.
• Requirements: Standards for ethical research involving human subjects to ensure quality, validity, and protection of participants' rights and safety.

Ethical Requirements of Research

• Social/scientific value: Must improve understanding or health related conditions
• Scientific validity: Research must adhere to accepted scientific methods and standards to improve reliable data.
• Fair subject selection: Vulnerable populations must not be targeted for disproportionate risk.
• Favorable risk-benefit ratio: Risks must be minimized as proportionate to anticipated benefits.
• Independent review: Unbiased review of research proposals by an independent body, like an IRB.
• Informed consent: Providing participants with clear information about the study to make informed decisions.

Unethical Research Examples

• Research on vulnerable populations (newborns, pregnant women etc..) with unproven safety in adults

Research Misconduct

• Fabrication: Creating fake data.
• Falsification: Manipulation of data to present false results.
• Plagiarism: Using another person's work or ideas without credit.

Publication Ethics

• Authorship: Defined by contributions to research, including conceptualization, data collection, analysis, and manuscript development. Authorship should be agreed upon early.
• Simultaneous submission: Presenting the same manuscript to different journals simultaneously, an ethical violation.
• Self-citation: Improper or excessive citation of one's own work.
• Predatory journals: Journals that publish without proper peer review, misleading information, and/or aggressive solicitation.
• Conflicts of interest: Factors that might compromise objectivity in research, publication, or peer review processes.

Peer Review Ethics

• Disclosure of interests: Financial and non-financial interests must be declared to prevent bias.
• Peer review process: The process of rigorous review of manuscripts by subject-matter experts, ensuring quality and validity.
• Anonymity in peer review is best practice.