CITI Program Training
Lawrence University provides human subjects research certification through the CITI Program. The required Human Subjects Research course takes approximately 5 hours to complete, but can be completed over several days and at your own pace.
The only course you are required to take is the Human Subjects Research course. However, the IRB strongly encourages students to complete of the Responsible Conduct of Research course as well.
To begin training you must first register for an "Organizational Affiliation" account with the CITI Program. Your organizational affiliation is Lawrence University.
Once you have an account and log in you will be asked a series of questions about the research you plan to conduct.
- Do not choose continuing education credits when asked.
- Do not enroll in any courses other than Human Subjects Research (Question 2) and Responsible Conduct of Research (Question 3). The latter is optional.
If you need additional assistance registering for the program and/or navigating the CITI website, visit CITI's guide to get started.
The Belmont Report
The National Commission for the Protections of Human Subjects of Biomedical and Behavioral Research was formed as one of the outcomes of the Syphilis Study at Tuskegee. The Commission drafted the Belmont Report, which is the foundation for the ethical principles and U.S. Department of Health and Human Services (HHS) regulations for the protection of research subjects. The three basic ethical principles are:
- Respect for persons
Declaration of Helsinki
“The World Medical Association drafted the first international agreement recommending ethical standards for clinical research. Like the Nuremberg Code, the Declaration makes informed consent a central requirement for ethical research. The Declaration does, however, allow for surrogate consent when the research subject is incompetent, physically or mentally incapable of giving consent, or a minor. The Declaration, which has undergone multiple revisions, also states that research with these groups should be conducted only when the research is necessary to promote the health of the population represented and when this research cannot be performed on legally competent persons.”
The verdict from the Nazi Medical War Crimes Tribunal at Nuremberg included a section titled “Permissible Medical Experiments”, otherwise known as the Nuremberg Code. The Code provides ten Directives for Human Experimentation and was the first international code of research ethics:
- Voluntary consent of the human subject is absolutely essential
- The experiment must yield generalizable knowledge that could not be obtained in any other way and is not random and unnecessary in nature
- Animal experimentation should precede human experimentation
- All unnecessary physical and mental suffering and injury should be avoided
- No experiment should be conducted if there is reason to believe that death or disabling injury will occur
- The degree of risk to subjects should never exceed the humanitarian importance of the problem
- Risks to the subjects should be minimized through proper preparations
- Experiments should only be conducted by scientifically qualified investigators
- Subjects should always be at liberty to withdraw from experiments
- Investigators must be ready to end the experiment at any stage if there is cause to believe that continuing the experiment is likely to result in injury, disability or death to the subject