With your IR team, make a list of possible ethical issues or challenges related to your study and discuss the following questions:

• For each challenge, what steps will your IR team take steps to mitigate risks or safeguard against risks for your participants?
• Does your study require ethical clearance from an IRB? If so, which IRB will you apply to? What are the timelines for doing so? For example, how often does the IRB meet? When is the next opportunity to apply?
• What documents will you need to develop to support your IRB application, such as informed consent forms? How, when and by whom will these be developed?