Conflict of Interest
| 1. What are your institution's requirements for financial disclosure before or during the conduct of a human research proposal? |
| 2. What is the importance of disclosing financial conflicts of interest in the conduct of human research? |
Study Design
| 3. Give an example of how you design your research proposal to detect harm promptly. |
| 4. What is a sound study design? |
| 5. What type of research design characterizes the majority of your studies? |
| 6. What is your IRB reporting requirements for reporting deaths that may be related to study participation? |
Risk Evaluation
| 7. Is there anything different about risks that research subjects undertake compared to risks that patients undertake when receiving care? |
| 8. Can you implement a change in your study without having IRB approval? |
| 9. Where would I look in your research protocol if I was looking for how you minimize risk in your studies? |
Subject Recruitment
| 10. How do you determine whether the inclusion and/or exclusion criteria are equitable? |
| 11. What is an example of a recruitment procedure that you employ that maintains equitable selection of subjects in your study(ies)? |
| 12. What do you do if one of your subjects becomes incarcerated after they are enrolled into your study? |
| 13. Can you recruit your own employees into your studies? |
| 14. How do you determine if a subject is decisionally-impaired? |
| 15. What information do you normally put in a recruitment ad for your studies? |
| 16. Explain what type of incentives are allowed to be given to your fellows or staff that assist in recruiting patients into your studies. |
Study Resources
| 17. How do you determine whether you have enough study personnel to assist in your studies? |
| 18. How do you fund your research? |
| 19. Do you have protected time to conduct your research activities? |
| 20. Do you use any special physical (ex. space, hospital services) resources in the conduct of your study, and how do you obtain them? |
| 21. What are your institution's policies on obtained informed consent for human research subjects? |
Informed Consent
| 22. Who administers informed consent to potential subjects in your studies? |
| 23. How do you determine whether an individual that you delegate authority to conduct the informed consent process is qualified? |
| 24. How do you train your study personnel? (Element III.1.E and F) |
| 25. How do you assess decision-making capacity in potential subjects whose decision-making capacity is in question? |
| 26. What do you do when a study coordinator calls you and tells you that a prospective subject does not understand the information he or she is being given? |
| 27. What signatures are required to be documented on your informed consent forms? |
| 28. Who can serve as the legally authorized representative if a potential subject is decisionally-impaired? |
Subject Questions and Complaints
| 29. What is an example of a subject complaint? |
| 30. What do you instruct your study staff to do if they receive a complaint from one of your subjects? |
Study Personnel Training
| 31. What is your training requirements to conduct human research at this institution? |
| 32. How do you consult if you are unsure whether an activity is human research? |
Unanticipated Problems
| 33. What is an example of an unanticipated problem involving risks to subjects that you would have to report to the IRB? |
| 34. What is the reporting requirement at this institution if a non-serious adverse event occurs that is not related to the study? |
Investigator Oversight
| 35. How do you oversee the activities of research staff? |
| 36. What are the qualifications required to be a study coordinator for this study? |
| 37. How does the investigator have oversight of the studies (study coordinator question)? |
Data Safety and Monitoring Plans
| 38. Do all of your studies require a data safety and monitoring plan? |
| 39. Is there a difference between a data safety and monitoring plan and a data safety and monitoring board? |
| 40. Do studies classified as minimal risk require a data safety and monitoring plan? |