Research Ethics
It is important to adhere to ethical principles in order to protect research participants, create a value-based environment to hold researchers accountable, and build public trust and support for research. Institutions need research integrity professionals to help ensure clinical research adheres to these principles.
The introductory online module covers the basics of ethical principles in clinical research and the unethical history that transformed the way clinical research was conducted. Upon completion, learners will be able to:
- Recognize why it is important to adhere to ethical principles while conducting clinical research
- Describe historical unethical research studies that led to the establishment of ethical guidelines and regulations governing clinical research
- Describe the main ethics principles in the context of human subjects research
Resources
Resources and literature related to research ethics
Resources:
Resources:
- Duke Office of Scientific Integrity
- Federal Office of Research Integrity
- DHHS Office for Human Research Protections (OHRP)
- Duke Health Institutional Review Board
- North Carolina State Law for Research
- World Health Organization: Ethical Standards and Procedures for Research with Human Beings
- National Institutes of Health: What is Ethics in Research and Why is it Important?
- The Nuremberg Code
- The Belmont Report
- Code of Federal Regulations: 45 CFR Section 46: Human Subject Protection
- Code of Federal Regulations: 21 CFR Section 50: Informed Consent
- Code of Federal Regulations: 21 CFR Section 56: Institutional Review Boards
- The Common Rule
- International Ethical Guidelines for Biomedical Research Involving Human Subjects
- Ezekiel J. Emanuel, David Wendler, Jack Killen, Christine Grady, What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research, The Journal of Infectious Diseases, Volume 189, Issue 5, 1 March 2004, Pages 930–937, https://doi.org/10.1086/381709
Terms and definitions related to research ethics
- Research Ethics: A set of accepted moral standards that govern scientific research and the conduct of scientific researchers.
- Clinical trials: According to NIH, clinical trial is “ A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”
- Institutional Review Board: “Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects.” (Link to Source)
- Human subjects research: According to 45 CFR 46, a human subject is "a living individual about whom an investigator (whether professional or student) conducting research:
- Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens." (Link to Source)
- Data Ownership: Both the possession of and responsibility for information. Ownership implies power as well as control. The control of information includes not just the ability to access, create, modify, package, derive benefit from, sell or remove data, but also the right to assign these access privileges to others (Loshin, 2002 - Link to Source). Data Sharing is a good research practice of making research data available to other investigators.
Interview
Emilia Chiscop-Head, PhD
Scientific Integrity Associate in the
Duke Office of Scientific Integrity
ASIST (Advancing Scientific Integrity Services and Training)
