Resources
UMassD Resources
IRB Guidance Documents
External Resources
- OHRP: Human Subject Regulations Decision Charts
- OHRP: International Compilation of Human Research Standards
- CIOMS: International Ethical Guidelines for Health Research Involving Humans
- WHO: Guidance for Ethics Review of Health Research with Human Participants
- NIH: Clinical Trial Definition
- NIH: Clinical Trial Decision Tool
- NIH: Human Subjects - Frequently Asked Questions
- DOE: Ferpa Guidance
- DHHS: Code of Federal Regulations
- DHHS: GDPR Compilation of Guidances
- DHHS: International Research Guidance
- DHHS: Social-Behavioral Research Standards
- FDA: Decisions for Investigational Device Exemption
- FDA: General Wellness Devices
- FDA: Payment to Research Subjects
- FDA: Recruiting Research Subjects
- FDA: Software as a Medical Device
Training
The institutional policies require faculty researchers (as well as student investigators) who participate in a project involving the use of human subjects must complete the minimum institutional requirements for education to demonstrate knowledge of human subject research, including ethics. Certification must be renewed every three years.
The CITI Training (note: results are linked to UMass Dartmouth) is a comprehensive course that will take several hours to complete and is highly recommended for faculty who routinely perform human subject research, as well as for IRB members. Various modules are available, including ones for international research and renewal certificates.