Читать книгу 100 Questions (and Answers) About Research Ethics - Emily E. Anderson - Страница 26

The federal research regulations require that institutional review boards (IRBs) determine that the “[r]isks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result” (45 C.F.R. § 46.111(2)) from the research. This means that participants should not be subjected to risks when participating in research without the prospect of some benefit. Research does not have to provide direct benefits to those who participate, but there must be some potential benefit to science and society.

While there is no magic formula for determining a reasonable balance between research risks and potential benefits, you must honestly consider the following:

 the anticipated risks of study participation;

 the likelihood and magnitude of those risks, and steps you will take to minimize those risks;

 the potential expected benefits of the research to participants; and

 the potential knowledge that will be gained by your study.

When designing your research study, you will want to make sure you have clearly thought through all these issues and that, from your perspective, the potential benefits outweigh the risks. You will also want to ensure that this information is clearly described in your protocol, so the IRB has sufficient knowledge to make their determination. It is important to keep in mind that IRBs may view the risks and benefits of a particular study differently from the researcher who designed the study. Perceptions of risks and benefits may also vary among the different members of an IRB.

More questions? See #11, #12, and #14.