Read the following Risk Level Assessment Form (next page) and mark all items in each risk category that apply to your research. Record the totals from each category below:
No risk: _ Minimum risk: __
Moderate risk: _ High risk: __
Be sure your IRB Application thoroughly describes the following:
If your research involves vulnerable populations, include the following in the IRB application.
- If your subjects are MINORS: Describe how you will obtain each child’s verbal or written assent as well as written consent from the child’s legal guardian. Note: At ANY level of risk, informed consent must be obtained from both the parent or guardian AND the minor before data is collected. If consent is given by the minor, but not by the parent or guardian, data should not be collected. Describe the means to be taken to reduce risks and to safeguard the subjects. Describe why alternative, less risky methods of research would not be possible.
- If your subjects are VULNERABLE TO “UNDUE INFLUENCE”: For example, anyone over whom you have authority or anyone in your care is vulnerable to your influence (students, clients, parishioners, employees, etc.). Describe how the subject’s right to decline participation without negative consequences will be preserved. Describe the means to be taken to reduce risks and to safeguard the subjects. Describe why alternative, less risky methods of research would not be possible.
- Other “VULNERABLE POPULATIONS”: For example, those who are institutionalized or are unable to make their own decisions are vulnerable. Describe the vulnerability of the subjects and how the risk caused will be minimized. Describe actions to be taken to reduce risks and safeguard the subjects. Describe why alternative, less risky methods of research would not be possible.