The timeline for IRB approval depends on how well the proposal is written. The overall timeline from submission to approval will depend on how many revisions are requested. It is best to plan one month at a minimum for IRB approval to be granted. We typically provide initial feedback for a minimal-risk proposal within 7-10 days during the fall and spring semesters. Communication regarding full Board proposals is provided within 1 week of the full Board meeting. Revisions are typically reviewed within 3-5 days of submission. Response times may be longer during times of high volume, over holidays, or during the summer or semester break.

No. Students cannot submit their own protocols — they must be submitted by their faculty/staff research mentor.

• Have ethics training completed/updated (must be no longer than three years since the last training/update) for ALL research team members, and submit the certificates for all team members with the research protocol proposal.
• Be sure to read the protocol form carefully.
  • Answer all questions completely.
  • Check all appropriate boxes.
  • Include all supplemental information at the end of the protocol.

It depends on whether the goal is educational and not the dissemination of generalizable research. If the research is solely for the purpose of a class project (ie data will not be published nor will it be presented outside of the classroom) and the topic is benign (ie is not a topic that could potentially cause harm, such as rape, abuse, criminal behavior, etc.), then the projects do not need to be approved by the IRB. Instructors do, however, need to have students complete a Class Project Waiver of IRB form. This must be submitted by the instructor and then reviewed and approved prior to students engaging in any human subjects research-related activities.

Yes. All faculty, staff, and students who are part of a research team seeking approval from the University of Lynchburg IRB (Human Subjects Research) for research proposals must pass an online ethics training course offered by the CITI Program. The IRB will only review proposals submitted by those who have passed the training as evidenced by a certificate of completion within the past 3 years. A certificate of completion will be accepted by CITI or NIH. In order to complete the training, please see Instructions for Research Ethics Training.

If you (or your collaborators) have received IRB approval at another institution, the IRB at the other institution may agree to be the IRB of record. If that is the case, the University of Lynchburg’s IRB will need a copy of the approved proposal and the approval letter. The approved documents may be modified to gain approval from the University of Lynchburg IRB. You and the collaborating institution will need to complete an IRB Authorization Agreement. If the University of Lynchburg has the IRB of record, you will submit the proposal to the University of Lynchburg’s IRB.

Assent is a type of consent required for subjects under the age of 18. If working with any subjects under the age of 18, the Assent Form, as well as the Parental Informed Consent Form, must be completed. The template can be adjusted depending on the population. For example, the way the information is provided to a 14-year-old would be very different than the way the information is provided to a 4-year-old. Please contact the IRB Director for a copy of the Assent Form and/or Parental Informed Consent Form.

Yes, but the storage site must be password-protected. We also require the computer login to be password protected.

For internet-based research such as surveys, participants must still be presented with the consent information. internet-based surveys can include the consent form with “I agree” or “I do not agree” buttons at the bottom of the webpage (or something similar) for participants to click their choice of whether or not they consent to participate prior to completing the remainder of the study.

Any change to an approved research project, including a research plan, consent process, form, investigators, other research personnel, and/or subject recruitment methods, requires submission of a Research Modification Form. Modifications to research projects may not be initiated until IRB approval has been obtained.

When your study is completed, please complete the Research Study Closure Form (Google Doc). This form must be shared with the IRB director. Once a study is closed, it cannot be reopened.

• Please immediately contact the proposed individual/office mentioned in the informed consent under the Risks/Benefits.
• Please also contact the IRB immediately at [email protected].