Education, Training Guidance
All investigators and research staff are required to complete human subject research protections education. Each individual research protocol must follow the reviewing IRB's requirements for training education. If your IRB requires other types of education, please contact the appropriate site personnel for further instructions (IRB information links). Please follow your individual site’s requirement for providing certificates of completion for required training modules.
OHRP offers no-cost online Human Research Protection Training, with available completion certificates, providing foundational knowledge on protecting human subjects in research funded by the U.S. Department of Health and Human Services (HHS). Check out the training on OHRP’s website: https://www.hhs.gov/ohrp/education-and-outreach/human-research-protection-training/index.html
If you have questions regarding the specifics of the training modules at your site, please contact your individual IRB Administrator/IRB Office.
Collaborative Institutional Training Initiative (CITI) Modules
For those sites who use the CITI training modules, click on the following link:
http://www.citiprogram.org/
Login by entering your username and password. First time users, click ‘Register Here’, choose your participating institution from the dropdown box and complete the required fields to register as a user of the CITI modules.
OHRP Topics for investigators:
- Overview of New NIH Policies on Human Subjects Research and Clinical Trials
- OHRP Policy Guidance by Topic
- Adverse Events
- Biological Materials and Data
- Conflicts of Interest
- For Investigators
- Investigator Responsibilities-FAQs
- When HHS Regulations Apply
- What is Human Subjects Research?
- What are IRBs?
- IRB Review of Research
- Educational Resources for Investigators
IRB Review Requirements and Process:
- Human Subject Regulations Decision Charts
- Continuing Review
- Expedited Review Categories
- Informed Consent
- Prisoner Research:
- Research Involving Children:
GDPR Presentations:
These presentations were prepared by the Council on Governmental Relations (COGR). COGR is an association of Research Universities and Affiliated Medical Centers and Independent Research Institutes.
- European Union General Data Protection Regulation - Effects on Research
- The EU GDPR: Implications for U.S. Universities and Academic Medical Centers