The following is a list of resources and forms commonly used throughout the Human Research Protection Program at Michigan Tech.
IRB Submission Resources and Forms
- eIRB Protocol Submission
- eIRB Submission Walkthrough document
- Informed Consent Template
- Child Assent Template
- Compensation Procedures for Research Subjects
Additional Resources on Common IRB Topics
- Obtaining Consent/Permission/Assent
- Waiving Consent or Documentation of Consent
- Recruiting Subjects
- Reporting Incidents
- Common Ethical Issues in Human Subjects Research
Rules and Regulations
The primary Federal regulations for protection of human research subjects (45CFR46) can be found on the Department of Health and Human Services (HHS) website, on the page for the Office for Human Research Protections (OHRP):
- The Common Rule (i.e. the basic regulations since 2018)
- Subpart B (covering pregnant women, human fetuses, and neonates)
- Subpart C (covering prisoners)
- Subpart D (covering children)
The following are a selection of regulations that may be relevant to specific research.
NOTE: researchers must be aware of the relevant federal and sponsor regulations for their respective research.
- Food and Drug Administration rules protecting human subjects
- FERPA regulations concerning education information
- PPRA regulations concerning K-12 research funded by the Department of Education
- Department of Defense additional rules
- Department of Energy additional rules
- Department of Veterans Affairs rules
Research involving data from hospitals and other healthcare organizations must also consider the regulations covering identifiable personal health information (PHI):