Ethical Research Practices

Dr. Bruce L. Pihlstrom, DDS, MS

Learn about the basic principles of ethical research practices involving human subjects.

1. Describe and understand the major historical events that led to the ethical standards, review and monitoring of clinical research.

  • Human experimentation that occurred in Europe and the United States that led to codes of ethical conduct of human subject research.Examples include WWII Nazi experiments and
  • Tuskegee syphilis study in the United States

2. Describe and understand the development of national and international ethical codes and standards for research involving human subjects

  • Good Clinical Practice (GCP)
  • International ethical guidelines
  • Research standards of various countries

3. Describe an understand how compliance with ethical guidelines and standards are reviewed and monitored in research involving human subjects

  • Ethics review committees or boards (IRBs)
  • Data and Safety Monitoring Boards (DSMBs)

Glossary – Definitions of Key Terms

  • Data Safety And Monitoring Board (DSMB)
    • A group of independent scientists who monitor the safety and scientific integrity of a clinical study. The group can recommend to the study sponsor that the study be stopped if it is not effective, is harming participants, or is unlikely to serve its scientific purpose. Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also referred to as a data safety and monitoring board (DSMB).
    • https://clinicaltrials.gov/ct2/about-studies/glossary#D
  • Informed Consent
    • For most research, informed consent is documented using a written document that provides key information regarding the research. The consent form is intended, in part, to provide information for the potential subject’s current and future reference and to document the interaction between the subject and the investigator. However, even if a signed consent form is required, it alone does not constitute an adequate consent process. The informed consent process is an ongoing exchange of information between the investigator and the subject and could include, for example, use of question and answer sessions, community meetings, and videotape presentations. In all circumstances, however, individuals should be provided with an opportunity to have their questions and concerns addressed on an individual basis.
    • The informed consent process involves three key features: (1) disclosing to potential research subjects information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether or not to participate in the research. Informed consent must be legally effective and prospectively obtained.
    • http://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/Informed-Consent/index.html