June

Research Conduct

1. Informed Consent

2. Human and Animal Rights

3. The Role of the IRB

4. HIPAA

5. Forms of Scientific Misconduct

6. Conflicts of Interest

7. Investigator/Co-Investigator Responsibilities

8. Responsibilities of a Valid Author

Content Outline Learning Objectives:

• Know the required components of an informed consent document

• Know the ethical issues that complicate obtaining informed consent in young children

• Know the ethical issues affecting informed consent in older children and adolescents (also see here) and how these may be addressed

• Know the issues raised by the Health Insurance Portability and Accountability Act (HIPAA) in the informed consent process

• Know the requirements for waiver of consent in emergency research

• Know the role of the institutional review board in approving research projects involving human subjects`

• Know the basic rights of humans participating in research

• Know the role of the investigator in monitoring of human subjects during a clinical trial

• Know the rights of animals used in research

• Know the issues raised by HIPAA in clinical research

• Know the common forms of scientific misconduct

• Know what constitutes an investigator conflict of interest during the course of a study

• Know the responsibilities of an investigator or co-investigator in the proper conduct of research

• Know the responsibilities required of a valid author in scientific publications

Classic Article:

https://emergency.cdc.gov/han/2020/han00432.asp