Ongoing education is required to ensure that IRB members, investigators, and co-investigators are aware of (a) the historical foundations that underscore the importance of protections for human subjects who participate in research; (b) the relevant codes and regulations that apply to government-supported human subjects research activities; and (c) the application of the guiding principles of respect, beneficence, and justice in human subjects research.
Proof of completion of education requirements is required prior to the approval of any human subjects research project.
Education requirements are described at the following tabs:
All investigators and co-investigators (i.e., those individuals who are collecting data or using data that has personally identifiable information as part of research studies) are required to complete an online course titled “Protecting Human Research Participants” before they begin working with human subjects.
The course contains seven modules, and is available at no cost via the National Institutes of Health (NIH) Office of Extramural Research. The required modules take up to 3 hours to complete and include the following topics:
- Codes and regulations
- Respect for persons
When you successfully complete the seven module course, you will have the opportunity to print an education certificate. Deliver a paper or electronic copy of this certificate to IRB secretary Jennifer Kozak, Building 6, Suite 750.
This training must be completed by investigators every two years. The IRB secretary maintains a database of investigators who have satisfied the education components noted above.
The IRB will not approve any research project where the principal investigator or a listed co-investigator does not have a current education certificate on file.
In addition to the requirements for investigators/co-investigators, all IRB members must complete the three Human Subjects Assurance Training modules available via the OHRP. These modules include the following topics:
- HHS regulations and institutional responsibilities
- Investigator responsibilities and informed consent
- Human research protections program
Deliver a paper or electronic copy of your certificate to IRB secretary Jennifer Kozak, Building 6, Suite 750.
IRB members are also encouraged to familiarize themselves with the following resources as needed:
- Table of Contents Supplemental Resources HS Course 2012 AERA
- Belmont Report 1979
- Declaration of Helsinki on human subject research
- FedReg45CFR46 Protection of ResearchParticipants
- FERPA December2011Revision
- Tri-Council Policy Statement – Ethical Conduct for Human Research
- AERA Code of Ethics (2011)
- Levine & Skedsvold Behav&SocScienceRes (OxfordHndbkChapter 2008)
- Expedited Review SBS Research NSTC 6-08
- Pritchard 2001 Searching for Research Involving Human Subjects
- Cauce & Nobles Vulnerable Adolescents (2006)
- Singer & Easton Ethnographic Research on Drugs and HIV-AIDS in Ethnocultural Communities 2006
- Nolen & Vander Putten Action Research ER 2007
- Pritchard Travelers & Troll-Practitioner Res & IRBs 2002 ER 2002
- Hemmings Ethical Divides IRBs-Researchers ER 2006
- Levine & Sieber Appendix B, Putting People on the Map 2007
- National Academies Bibliography Data Access & Confidentialty Protection 2011
- NRC Expanding Access 2005
- NCES Statewide Longitudinal Data Systems (SLDS) Confidentiality & Use Nov.2011
- DeVries et al. Ethics Review of SBER (Ethics&Behavior2004)
- Levine-Skedsvold Rubber Meets Road – IRBs & Research Practice PS2008