HSR Cheat Sheet 2026

The 30 highest-yield HSR facts, distilled from real exam questions. Print it, save it as a PDF, or study it here — free, no sign-up.

1. How should a researcher ensure that participant data is secure throughout a study? → By using secure storage systems, encrypted communication, and access controls
2. How should challenges in industry best practices be addressed? → Apply systematic problem-solving, seek expert guidance when needed, and document decisions
3. For children who are too young or developmentally unable to provide meaningful assent, which approach is correct? → Parental permission alone is sufficient if the IRB determines assent is not meaningful
4. Under 45 CFR 46 Subpart C, which condition must be met for prisoner research to receive IRB approval? → Risks must be minimal or relate directly to their status as prisoners
5. Why is confidentiality a critical ethical principle in human subjects research? → To safeguard the privacy of participants' data
6. NIH policy generally requires a Data and Safety Monitoring Board (DSMB) for which type of study? → Multisite clinical trials involving interventions that entail potential risk
7. How often must an IRB registration with OHRP be renewed? → Every 3 years
8. When recruiting employees as research participants, the most significant ethical concern is: → Hierarchical coercion stemming from employer-employee relationships
9. How should an investigator handle a situation where the IRB denies approval for a study? → Revise the research proposal based on the IRB's feedback and resubmit for approval
10. What action is an expedited reviewer NOT permitted to take on their own? → Disapprove the research
11. What is required for the informed consent process to be valid? → Participants must be given all necessary information to make an informed decision
12. What is the purpose of informed consent in research? → To inform participants of their right to withdraw from the study at any time
13. A known side effect listed in the consent form and investigator brochure occurs at its expected frequency and severity. How is this typically handled? → It is an adverse event but generally not an unanticipated problem
14. What quality assurance measure supports safety and compliance? → Regular self-assessment, peer review, and adherence to established standards
15. How should challenges in core concepts and principles be addressed? → Apply systematic problem-solving, seek expert guidance when needed, and document decisions
16. What quality assurance measure supports applied methods and techniques? → Regular self-assessment, peer review, and adherence to established standards
17. What must be done if a research study's protocols change after IRB approval? → The changes must be reported to the IRB for approval before implementation
18. A Certificate of Confidentiality primarily protects researchers from: → Compelled disclosure of identifiable sensitive information in legal proceedings
19. How should challenges in communication and documentation be addressed? → Apply systematic problem-solving, seek expert guidance when needed, and document decisions
20. What quality assurance measure supports continuing education requirements? → Regular self-assessment, peer review, and adherence to established standards
21. Which characteristic is most important for DSMB members? → They are independent of the study and free of significant conflicts of interest
22. What ethical standard governs assessment and evaluation practice? → Adherence to the profession's code of ethics and applicable laws and regulations
23. Under 45 CFR 46 Subpart C, which category of research involving prisoners is explicitly permissible? → Research on conditions particularly affecting prisoners as a class
24. Under FDA IND regulations, a serious and unexpected suspected adverse reaction that is NOT fatal or life-threatening must be reported to FDA within: → 15 calendar days
25. Which ethical principle from the Belmont Report is most directly invoked when ensuring vulnerable populations are not exploited in research? → Justice
26. What is the foundational principle of industry best practices in the Human Subjects Research Certification field? → Maintaining competence, integrity, and service to stakeholders
27. What is the role of the Data Protection Officer (DPO) in research? → To monitor data security practices and ensure compliance with data protection regulations
28. How should sensitive participant data be stored? → In secure, encrypted storage systems that limit access
29. Under the Common Rule, who may carry out an expedited review of a research protocol? → The IRB chair or one or more experienced IRB members designated by the chair
30. Which is one of the required criteria for an IRB to waive informed consent under 45 CFR 46.116(f)? → The research involves no more than minimal risk to subjects