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. Which of the following best illustrates undue influence in the enrollment of vulnerable participants? → Offering reduced prison sentences to incarcerated individuals who enroll in a study
5. 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
6. Why is confidentiality a critical ethical principle in human subjects research? → To safeguard the privacy of participants' data
7. When recruiting employees as research participants, the most significant ethical concern is: → Hierarchical coercion stemming from employer-employee relationships
8. 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
9. What is required for the informed consent process to be valid? → Participants must be given all necessary information to make an informed decision
10. What is the purpose of informed consent in research? → To inform participants of their right to withdraw from the study at any time
11. What quality assurance measure supports safety and compliance? → Regular self-assessment, peer review, and adherence to established standards
12. How should challenges in core concepts and principles be addressed? → Apply systematic problem-solving, seek expert guidance when needed, and document decisions
13. What quality assurance measure supports applied methods and techniques? → Regular self-assessment, peer review, and adherence to established standards
14. 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
15. How should challenges in communication and documentation be addressed? → Apply systematic problem-solving, seek expert guidance when needed, and document decisions
16. What quality assurance measure supports continuing education requirements? → Regular self-assessment, peer review, and adherence to established standards
17. What ethical standard governs assessment and evaluation practice? → Adherence to the profession's code of ethics and applicable laws and regulations
18. Under 45 CFR 46 Subpart C, which category of research involving prisoners is explicitly permissible? → Research on conditions particularly affecting prisoners as a class
19. When an IRB reviews research targeting students recruited by their own instructor, the primary concern should be: → Addressing the potential for implicit coercion in the teacher-student power dynamic
20. Which ethical principle from the Belmont Report is most directly invoked when ensuring vulnerable populations are not exploited in research? → Justice
21. What is the foundational principle of industry best practices in the Human Subjects Research Certification field? → Maintaining competence, integrity, and service to stakeholders
22. What is the role of the Data Protection Officer (DPO) in research? → To monitor data security practices and ensure compliance with data protection regulations
23. How should sensitive participant data be stored? → In secure, encrypted storage systems that limit access
24. What ethical standard governs safety and compliance practice? → Adherence to the profession's code of ethics and applicable laws and regulations
25. What is the foundational principle of safety and compliance in the Human Subjects Research Certification field? → Maintaining competence, integrity, and service to stakeholders
26. Who is responsible for submitting a research proposal to the IRB? → The researcher or principal investigator
27. What does participant autonomy refer to in the context of informed consent? → Participants are given full control over their decision to participate or withdraw
28. What ethical standard governs core concepts and principles practice? → Adherence to the profession's code of ethics and applicable laws and regulations
29. What is the significance of documentation in the informed consent process? → It serves as proof that the participant was informed and consented
30. What quality assurance measure supports core concepts and principles? → Regular self-assessment, peer review, and adherence to established standards