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Vulnerability and Risk Level

Determining Participant Vulnerability.

Vulnerable populations require a higher level of protection, thus a higher level of scrutiny for the research procedures. Prisoners, mentally disabled persons, and children are considered vulnerable because their ability to give truly voluntary and informed consent may be limited. Pregnant women are considered vulnerable in the case of research procedures that pose any hazard to the fetus. Research considered to be less-than-minimal-risk for nonvulnerable adults is considered as minimal-risk for vulnerable populations, thus only research on nonvulnerable adults qualifies for the exempt category.

Non-vulnerable participants are age 18 or older, who are not mentally disabled or in prison. If pregnant, the research cannot pose a risk to the fetus.

Determining Level of Risk.

Researchers should make every effort to minimize the amount of risk involved in the research design. The IRB will evaluate the risk and determine if the risks are reasonable in relationship to the anticipated benefits of the research to the subjects, if any, or the knowledge that may reasonably be expected to result.

Less-than-minimal-risk is research in which there is no known physical, emotional, psychological, or economic risk. This research can qualify as exempt if it does not involve a vulnerable population.

Minimal-risk is research that presents only the kind of risks encountered in daily life by most people (e.g., moderate exercise testing, minor stress from psychological tests, or surveys involving sensitive topics). This research can qualify as expedited if it does not involve a vulnerable population.

Greater-than-minimal-risk is research procedures that may include risk beyond that ordinarily encountered by participants (e.g., maximal exercise testing, stressful psychological testing, questions about illegal activities). This type of research requires a full review.

Assessment of Research Level

Exempt Review

Research projects that the principal researcher (and faculty research supervisor in the case of a student research) believes meet the qualifications for exempt status must be submitted to IRBNet before the researcher begins contacting participants or collecting data. The researcher should upload the application and associated documents to the IRBNet system the same way they would for any other review level. The IRB manager will select a review panel member and forward the application and materials on the IRBNet system. If the reviewer confirms that the research is exempt, the researcher will receive an approval letter on IRBNet. If the reviewer determines that the project does not meet the exempt criteria, the researcher will be notified on the IRBNet system with a recommendation for modification or resubmission for expedited or full review. Researchers should allow three days in their planning for the review process. The researcher must not begin collecting data until the written IRB approval is received.

Expedited Review

Research projects that the principal researcher (and faculty research supervisor in the case of a student research) believes meet the expedited review criteria must be reviewed by a member of the researcher's Departmental Review Panel (not the faculty research supervisor) and an IRB reviewer outside of the researcher's department. The researcher should create a package on IRBNet and upload their Human Subjects Review Application and associated documents to IRBNet. The researcher and research supervisor will be notified via IRBNet if the project is approved, or revision or full review is recommended and file the application. Researchers should allow one week in their planning for the review process. The researcher must not begin collecting data until the written IRB approval is received.

Full Review

If a research project requires a full review, the researcher must submit the Human Subjects Review Application and associated documents to IRBNet requesting a full review on the application. The IRB manager will send the application and materials to the IRB members for consideration at their next meeting. Proposals should be submitted at least five working days prior to a scheduled meeting. The IRB will meet for applications requiring full review on the second, sixth, tenth, and fourteenth week of the fall and spring semester, and the fourth week of the 8-week summer session. A majority of the IRB members must be Human Subjects Protections Policy present for research to be reviewed. Approval of a proposal by the IRB requires a majority vote of the members present at the meeting. The IRB manager will inform the researcher or research supervisor in writing of the IRB decision on IRBNet.