From the Guidelines
The correct answer is C. Failure to protect human research subjects is considered research misconduct. This is based on the principles outlined in the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines, which emphasize the protection of human research subjects as a fundamental ethical principle of research 1. Research misconduct specifically refers to fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. While options A, B, and D represent issues in research, they don't constitute formal misconduct.
- Unintentional errors (option A) lack the deliberate intent required for misconduct.
- Differences of opinion (option B) are normal in scientific discourse.
- Authorship disputes without plagiarism (option D) are ethical issues but not formal misconduct. However, failure to protect human research subjects violates fundamental ethical principles of research, including respect for persons, beneficence, and justice, as highlighted by guidelines such as those from the Committee on Publication Ethics (COPE) 1. This represents a serious breach of Good Clinical Practice (GCP) guidelines, which prioritize participant safety and rights above all research objectives. Researchers have an ethical and legal obligation to ensure participant protection through proper informed consent, risk minimization, and adherence to approved protocols, as emphasized in recent statements by the European Association of Cardiovascular Imaging (EACVI) 1.
From the Research
Research Misconduct
The following options are considered in the context of research misconduct:
- Unintentional errors in data entry: This is not typically considered research misconduct, as it is an honest mistake rather than a deliberate attempt to falsify or manipulate data.
- Differences of opinion: This is also not typically considered research misconduct, as it is a normal part of the scientific process and can be resolved through discussion and debate.
- Failure to protect human research subjects: This is considered research misconduct, as it violates the ethical principles of respect for persons, beneficence, and justice 2, 3, 4, 5.
- Authorship dispute not involving plagiarism: This is not typically considered research misconduct, as it is a matter of professional etiquette and can be resolved through discussion and negotiation.
- None of the above: This option is incorrect, as failure to protect human research subjects is indeed considered research misconduct.
Relevant Studies
Studies have shown that failure to protect human research subjects is a serious issue that can have severe consequences 2, 3, 4, 5. The importance of protecting human research subjects is emphasized in various guidelines and regulations, including the Belmont Report and the Common Rule 2, 4. Good Clinical Practice (GCP) is also essential in protecting human research subjects, and includes principles such as informed consent, respect for persons, and beneficence 5. Retrospective review of human subjects research can also help improve the efficiency and effectiveness of oversight 6.
Correct Option
Based on the evidence, the correct option is C. Failure to protect human research subjects, as this is considered research misconduct 2, 3, 4, 5.