Graduate students completing a capstone project MUST submit an IRB application along with their approved capstone proposal BEFORE they begin their research. MLC needs to ensure that all student research respects the safety and rights of human subjects.
An IRB application needs to be submitted regardless of the type of research, but the detail will differ depending on whether human subjects are involved. The following guidelines will help direct the process.
- Students must receive approval of the capstone project proposal from the capstone committee.
- Students must complete an application for IRB approval and all informed consent materials.
- The advisor must review, approve, and sign the proposal and IRB application as complete.
- Two copies of the proposal, the IRB application, and all consent or assent forms are submitted to the director of graduate studies for initial review by the following individuals:
i. IRB chairman and
ii. Director of graduate studies. - The application will be screened by the IRB chairman with input from the director of graduate studies to determine if the proposed activity
i. involves no risk to the subject according to exempt criteria in 45 CFR 46.101, and so is exempt from full IRB review, or
ii. requires full IRB review because it involves greater than no risk or non-exempt research. - If required, the full IRB will meet to make a determination regarding the proposed activity.
- After review, the IRB may:
i. approve the proposal as submitted,
ii. approve with minor suggestions for changes,
iii. approve with stipulations to be met before final approval is given, or
iv. not approve. - Complete documentation of IRB action will be sent to the researcher and a copy kept on file.
- All non-exempt research is subject to continuing review at least annually, but possibly more frequently as determined by the level of risk to the subjects.
Tips for Students
• Carefully plan the ethical aspects of your study from the very beginning.
• Submit your IRB application and research proposal at least six weeks prior to the start of research.
• Include your capstone proposal with special attention to human subject interactions to demonstrate clearly how anonymity, confidentiality, and informed consent will be obtained.
• Ask yourself if you would honestly want someone you love to participate in your study.
• Work hard to ensure that recruitment materials yield equitable and noncoercive results.
• Write consent forms at an eighth-grade reading level.
• Overestimate risks and underestimate benefits in your consent forms.
• Educate and debrief subjects on the nature, purpose, and findings of your study.
• Establish procedures to delink identifying information from main data sets and sources.
• Establish procedures to encrypt any and all identifying information and destroy it as soon as possible.
• Remember that research is not a right but a privilege and IRB’s are peer review groups.
