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Ethical Codes and Regulations
Box 3.3 in the textbook provides links to several resources on ethics, including the Belmont Report, Code of Federal Regulations (“Common Rule”), professional codes of several organizations, and the NIH free online tutorial on the rights and welfare of research participants.
This checklist gleaned from the DHHS Code of Federal Regulations outlines the essential elements and documentation necessary to acquire informed consent.
Certificates of Confidentiality Kiosk
This site provides information about Certificates of Confidentiality issued by the National Institutes of Health (NIH) to prevent the forced disclosure of confidential research information. The Certificates allow the investigator to refuse to disclose identifying information on research participants in any legal proceedings. They may be granted for studies collecting sensitive information (e.g., drug use or other illegal activities) that, if disclosed, could have adverse consequences for participants such as by damaging their reputation or employability.
The U.S. Office of Research Integrity and Office for Human Research Protections has created an excellent video, The Research Clinic, which educates viewers “on the importance of appropriately protecting research subjects and avoiding research misconduct.” After an introduction to the scenario, viewers are given the opportunity to play one of four characters: a principal investigator, a clinical research coordinator, a research assistant, and IRB chair. Each character faces a series of ethical dilemmas for which the role-player must make a decision-making choice.
Research Subject’s Bill of Rights
Several websites such as this one at Vanderbilt University provide a list of the rights of research participants. The list is valuable for anyone who is asked to participate in a research study and, for the researcher, provides a perspective on ethics from the perspective of the participant.