Which components should be included in an IRB application?

Including study protocols, informed consent documents, and risk assessments in an IRB application is essential to ensure that the research being proposed adheres to ethical standards and safeguards the rights and welfare of participants.

The study protocols outline the research design, objectives, procedures, and the involvement of human participants, giving the IRB a clear understanding of what the study entails. Informed consent documents are crucial as they explain the nature of the study to participants, ensuring they are fully aware of what their participation involves before agreeing to take part. Risk assessments are also vital, as they identify potential risks to participants and describe how the research team plans to mitigate those risks. This comprehensive approach helps the IRB evaluate the study’s safety and ethical considerations effectively before approval.

Other components, such as funding sources or detailed literature reviews, may be relevant but do not encompass the primary ethical considerations required for a thorough assessment by the IRB.