Some types of research include issues that can increase the risk to participants. If issues of special concern are present, even exempt protocols may warrant more scrutiny than usual. These issues include:
This doesn’t mean such research cannot take place. It means that the reviewers will confirm that the researcher has taken these issues into account by mentioning them in the risks section, and by taking steps to lessen the risk. One way to lessen the risk is to let the participants know there will be no penalty if they decline to participate.
For instance, a teacher’s student assent for members of her own class would assure the students that their grade in the class would not be affected by their decision whether or not to participate in the research. A researcher in the workplace would assure employees that their manager would see only aggregated results of a survey, not the original data, so their responses would be kept confidential.
In the health examples, maintaining the confidentiality of the data will be of great importance: how will the data will be coded, stored, accessed, analyzed and disposed of? How will the participants’ privacy be best protected?
In non-exempt research, the office will make sure that all steps have been taken to protect the participants in:
The presence of issues of special concern does not mean the research cannot be conducted. Rather, the IRB will confirm that the investigator is aware of the issues and is willing to correct any bias that he/she has not considered. In these cases, the subject’s privacy becomes even more important, and the confidentiality of the data must be maintained even more rigorously. Contact the office if you have questions.