IRB: Steps for Investigators

1. Discuss your project with the Director of Institutional Research, who serves as the IRB Chair, and complete a Grant Interest Form if the project involves submitting a proposal for funding
2. Review College policies and procedures and federal regulations on human subjects research
3. Complete investigator training and submit certification of training
4. Prepare your application for IRB review
   Form A for exempt projects or
   Form B (option B-1) for expedited review or
   Form B (option B-2) for full-board review
5. Prepare informed consent documents using the Pellissippi Form(s) for Informed Consent.
6. Submit Form A or Form B to the Director of Institutional Research/Chair of the IRB
   
   For research approved by the IRB on Form B (projects that the IRB certifies as exempt on Form A need no further IRB oversight unless the protocol changes):
   
   
7. Prepare for continuing review by the IRB. IRB approval does not extend past one year (minus 1 day) from the date of IRB approval. Submit Form C, Continuing Review Report, two months prior to the expiration date of IRB approval.
8. Submit Form D, Project Status Report: Changes and/or Close Out, before making any changes in protocol.
9. Maintain document for the research project, including copies of all signed informed consent forms, for 3 years after the project is closed out.
10. Report any non-compliance issues to the Director of IR/IRB Chair
11. Submit Form D to close out the project to the Director of IR/IRB Chair

See Steps for Investigators (.doc) for more detail on each of these steps.

Informed Consent

Informed consent is a core element of research participants' rights and welfare and is a legal requirement. See the IRB Policies and Procedures (Section 5.0) for the principles of informed and voluntary consent.

Using the Informed Consent Forms of the Pellissippi State IRB helps investigators meet all requirements of informed consent. There are four different forms: (1) a consent form for adult participants age 18 or older; (2) a parental permission form needed when children under age 18 are involved in a project; (3) a child/student assent form for participants under age 18 and able to read and understand the form; and (4) a recorded media addendum to informed consent for use with the general informed consent documents when studies involve audio, video, photographic, or any other recording of research subjects.

• Informed Consent Forms
• Informed Consent Procedures: Questionnaires and Surveys
• Informed Consent Checklist

Other Resources

• Timeline for IRB Review System