Research Ethics Policies and Procedures
Human subject research is regulated by a series of foundational documents, state and federal laws and regulations, and relevant university policies. On this page, you will find links to and brief descriptions of foundational documents, laws and regulations, and university policies. In addition, you will also be able to access links to the IRB's standard operating procedures.
Guiding Documents and Regulations
All Institutional Review Boards are guided by several foundational documents. These documents are referenced in regulations for human subject research. They are also described in researcher ethics trainings (i.e., CITI Training) required by the university.
- Declaration of Helsinki: A statement developed by the World Medical Association that outlines ethical principles for medical research and research involving human material and data.
- The Belmont Report: The report published by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which identifies basic ethical principles and guidelines for human subject research
The Office for Human Research Protections (OHRP) within the United States Department of Health and Human Services (HSS) has developed extensive regulations governing the conduct of human subject research:
- Federal Policy for the Protection of Human Subjects ("Common Rule"; revised 2018)
- OHRP IRB Guidebook
Federal legislation may also be relevant to human subject research. The following list is not exhaustive, but includes legislation that is frequently important in the conduct of human subject research:
- Health Insurance Portability and Accountability Act (HIPAA): HIPPA is a federal law that resulted in the development of national standards to protect patient health information
- Federal Educational Rights and Privacy Act (FERPA): FERPA is a federal law that protects the privacy of student education records.
Finally, university policies are also a consideration in human subject research. Again, the list below is by no means exhaustive, but highlights frequently relevant policies related to human subject research:
Standard Operating Procedures
The IRB is currently in the process of developing written standard operating procedures. These procedures will outline and describe the day-to-day or typical procedures and processes of the IRB. Note that these procedures are subject to revision, especially as university policies--including the university's IRB policy--are revised.