Podcast
Questions and Answers
What does IRB approval refer to?
What does IRB approval refer to?
Informed consent must be obtained from participants before involving them in research.
Informed consent must be obtained from participants before involving them in research.
True
What is the difference between fabrication and falsification in research?
What is the difference between fabrication and falsification in research?
Fabrication involves making up results, while falsification involves manipulating or omitting results.
Plagiarism can occur even if it is ___ intention.
Plagiarism can occur even if it is ___ intention.
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Match each type of plagiarism with its definition:
Match each type of plagiarism with its definition:
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Which of the following is NOT a form of plagiarism?
Which of the following is NOT a form of plagiarism?
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What are the responsibilities of an author in published work?
What are the responsibilities of an author in published work?
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Journals do not need to remind contributors about authorship guidelines.
Journals do not need to remind contributors about authorship guidelines.
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What is the main characteristic of predatory journals?
What is the main characteristic of predatory journals?
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Self-citation is the practice of citing someone else's work out of context.
Self-citation is the practice of citing someone else's work out of context.
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What should editors seek from all authors and peer reviewers?
What should editors seek from all authors and peer reviewers?
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In a ___________ peer review, the identity of both the reviewer and the author are not known to each other.
In a ___________ peer review, the identity of both the reviewer and the author are not known to each other.
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Match the following types of peer review with their advantages:
Match the following types of peer review with their advantages:
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What is the role of peer review in academic publishing?
What is the role of peer review in academic publishing?
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Peer review is a process limited to authors within the same institution.
Peer review is a process limited to authors within the same institution.
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What is the typical timeframe for reviewers to submit their comments?
What is the typical timeframe for reviewers to submit their comments?
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Publishing in predatory journals often involves a ______________ fee.
Publishing in predatory journals often involves a ______________ fee.
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Which type of blinding in peer review allows both reviewers and authors to know each other's identities?
Which type of blinding in peer review allows both reviewers and authors to know each other's identities?
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What is the primary goal of clinical research?
What is the primary goal of clinical research?
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Respect for autonomy means that participants should not have the ability to make their own decisions.
Respect for autonomy means that participants should not have the ability to make their own decisions.
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What historical study is known for its unethical treatment of participants suffering from untreated syphilis?
What historical study is known for its unethical treatment of participants suffering from untreated syphilis?
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The principle of __________ emphasizes doing no harm to research participants.
The principle of __________ emphasizes doing no harm to research participants.
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Match the following ethical principles with their explanations:
Match the following ethical principles with their explanations:
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Which code emphasizes the necessity of voluntary consent from research participants?
Which code emphasizes the necessity of voluntary consent from research participants?
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The Belmont Report includes principles of respect for persons, beneficence, and justice.
The Belmont Report includes principles of respect for persons, beneficence, and justice.
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What is the role of an Institutional Review Board (IRB)?
What is the role of an Institutional Review Board (IRB)?
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The practice of __________ involves using another person's work without giving proper credit.
The practice of __________ involves using another person's work without giving proper credit.
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What does the principle of justice in clinical research relate to?
What does the principle of justice in clinical research relate to?
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Scientific validity refers to the use of methods that do not produce reliable data.
Scientific validity refers to the use of methods that do not produce reliable data.
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What is one of the seven requirements of ethical research?
What is one of the seven requirements of ethical research?
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The __________ was created to govern federally funded research involving human subjects.
The __________ was created to govern federally funded research involving human subjects.
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What is one consequence of failing to obtain informed consent from participants?
What is one consequence of failing to obtain informed consent from participants?
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Study Notes
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.
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