Study Design
Considerations
Researchers should minimize risks to study participants by utilizing procedures that are consistent with sound study design. Whenever appropriate, risks to study participants should be minimized by designing studies that include procedures already performed on the participants for diagnostic or treatment purposes. Studies should be designed to ensure the research will likely develop or contribute to generalizable knowledge. In addition, researchers should document in their IRB application and support materials that the potential risks of participation are reasonable in relation to anticipated benefit and that the expected results of the research justify proceeding.
Refer to the following links for additional information to consider when designing a research project:
Ethical Guidelines
Federal Regulations
How to Demonstrate Design
Researchers must demonstrate and document clearly that they have considered the risks of the research and potential benefits of the research when they submit an application for review. Researchers must also provide the IRB Committeee with enough detail in the IRB application to verify whether the study design meets ethical and federal guidelines.
How Design is Evaluated
Federal research regulations require the IRB to ensure risks to subjects be minimized by using procedures that are consistent with a sound study design and risks to participants are reasonable in relation to benefits. In addition, the proposal will be evaluated to ensure that the study is designed to decrease risks to participants. As researcher, you must design your study to ensure that risks to participants are reasonable in relation to benefits and verify for the IRB the importance of the knowledge that may be reasonably expected to result.
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