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Core Curriculum

Rationale and Objectives

Scholarly activity, which may include research, is now a required element of resident training. In addition, residents are required to participate in a systems-based practice or quality improvement project. Residency programs are expected to provide training for these endeavors but may lack the necessary resources. This work is intended to provide a core curriculum in research ethics for radiology residents to help fulfill that need.

Materials and Methods

The material was developed through discussion and collaboration of the authors, review of pertinent literature, and consultation with experts in the field.

Results

This work includes a brief introduction to the topic, followed by cases designed to highlight the issues inherent in informed consent, privacy, the disclosure of results, authorship, study subjects, and health services research.

Conclusion

Radiology residents are expected to learn about the design, performance, reporting, and critical evaluation of research. All of these elements can potentially raise ethical issues. Understanding the underlying ethical issues is critical for the future of radiology research.

For research to provide useful results, it is critical to maintain strict adherence to a carefully designed research protocol, keep meticulous records, and use rigorous logic in drawing conclusions from the data. It is easy for researchers to become so deeply engaged in obtaining useful results that they allow ethical concerns to recede from their attention. The following is intended to introduce residents to principles of ethics as they pertain to the design, performance, and reporting of radiology research.

In 1974, the National Research Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research ( ). A charge of this commission was to identify the underlying ethical principles that should govern the treatment of research subjects and to develop guidelines for researchers on the basis of these principles. These principles were summarized in a report, issued in 1979, titled The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research ( ). The three basic principles provided by the Belmont Report —respect for persons, beneficence, and justice—were arrived at to achieve a consensus. They were considered to be comprehensive, but much more detail is needed for the principles to provide guidance for the ethical conduct of research.

Respect for Persons

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Beneficence

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Justice

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Specific issues addressed in this report

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Subject Privacy

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Early Disclosure of Trial Results

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Authorship

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Radiologists as Study Subjects

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Health Services Research

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The IRB

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Conclusion

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Case 3: Conflict of interest

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Case 4: De-identification of study records

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Case 5: Authorship

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Case 6: Radiologists as study subjects

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Case 7: Health services research

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Acknowledgments

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References

  • 1. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: The Belmont report: ethical principles and guidelines for the protection of human subjects of research. http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm Accessed May 6, 2008

  • 2. Centers for Disease Control and Prevention: US Public Health Service syphilis study at Tuskegee: the Tuskegee timeline. http://www.cdc.gov/tuskegee/timeline.htm Accessed May 6, 2008

  • 3. IRB membership. 45 CFR §46.107 http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.107 Accessed September 8, 2008

  • 4. Brennan T.A., Rothman D.J., Blank L., et. al.: Health industry practices that create conflicts of interest: a policy proposal for academic medical centers. JAMA 2006; 295: pp. 429-433.

  • 5. Ehringhaus S.H., Weissman J.S., Sears J.L., Goold S.D., Feibelmann S., Campbell E.G.: Responses of medical schools to institutional conflicts of interest. JAMA 2008; 299: pp. 665-671.

  • 6. AAMC-AAU Advisory Committee on Financial Conflicts of Interest in Human Subjects Research: Protecting patients, preserving integrity, advancing health: accelerating the implementation of COI policies in human subjects research. https://services.aamc.org/Publications/showfile.cfm?file=version107.pdf&prd_id=220&prv_id=268&pdf_id=107 Accessed May 6, 2008

  • 7. Miller F.G., Emanuel E.J.: Quality-improvement research and informed consent. N Engl J Med 2008; 358: pp. 765-767.

  • 8. Baily M.A., Bottrell M., Lynn J., Jennings B.: The ethics of using QI methods to improve health care quality and safety. http://www.thehastingscenter.org/publications/reports.asp Accessed May 6, 2008

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