The timeline for IRB approval depends on how well the proposal is written. The overall timeline 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 respond to exempt protocol submissions within 5 days and expedited protocols within 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 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 training completed/refreshed prior to submitting your protocol.
- Be sure to read the protocol form carefully.
- Answer all questions completely.
- Check all appropriate boxes.
- Additional information can be placed at the end of your protocol.
- Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
- If such research involves obtaining information about “a living individual” (45CFR46, 102(f)), then the activity is human subjects research. This definition follows:
- (f) Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains: (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.
When research is exempt, under federal regulation, the IRB can use less stringent review requirements. It does not mean it is is excused from any review, but rather exempt from a Full Board Review. The IRB must still determine whether the exempt review is exempt from federal regulation.
To qualify as exempt review (these protocols still require IRB oversight, please see the point above), the research must not be greater than minimal risk and must fall into at least one of the following categories as defined by federal regulations:
Summary of Exempt Categories
- Educational research (ex: research on instructional strategies or curricula)
- Use of educational tests, surveys, interviews, or observation
- Research involving existing data, documents, records
- Public benefit or service programs
- Involving taste and food quality evaluation or consumer acceptance studies
- Further details on exempt qualifications can be found at http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html
In addition, no personally identifiable information may be collected during research participation and the risks should be no more than the risk involved in daily life.
If your project does not meet any of these categories, please complete an Expedited or Full Board Proposal. The form will guide you to select the correct level of review.
- Yes, if you are collecting data at University of Lynchburg or if your research participants will be University of Lynchburg students, faculty, or staff. The collaborating institution may need a IRB Authorization Agreement.
- If you 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, LC’s IRB will need a copy of the approved proposal and the approval letter. Modifications to the approved documents may be required in order gain approval from the LC 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 Informed Assent Agreement (Google doc) as well as the Informed Parental Consent Agreement (Google doc) 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.
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 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 research plan, consent process and form, investigators, other research personnel, and/or methods of subject recruitment, 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 fill out the Research Study Closure Form (Google doc). This form must be shared to the IRB director. Once a study is closed, it cannot be reopened.
Please complete a Research Renewal Request Form (Google doc).
- Please contact the proposed individual/office mentioned in the informed consent under the Risks/Benefits immediately.
- Please also contact the IRB immediately at .