Submission Instructions and Forms

Important notes:

Research proposals involving an experimental design are only reviewed at the expedited or full board review levels.

Researchers may not utilize the CITI animal care and use course(s) to satisfy the human subject research training requirement. Follow the link to the Ethical Research Practices Policy for more information.

The IRB provides oversight for human subject research for researchers College-wide. As such, we communicate regularly with many individuals across campus and have numerous research study proposals under review at any given time. One way that researchers can work with us to facilitate the review process is to utilize the review and approval numbers assigned by the IRB when communicating with the IRB. Emails sent with insufficient details or content will result in a delay in the review process.

Instructions

Forms located at bottom of page.

  1. Make sure that all members of the research team have completed the CITI training. See Ethical Research Practices Policy for more information and instructions.  Proposals will not be assigned to a reviewer until successful CITI training completion is confirmed by the Chair of the IRB.
  2. Complete the Initial Request for Review and Proposal Form and Research Team Signature Page, found below in the forms section. Be sure to consult the files under the “Resources” heading (link to the left) if your study involves vulnerable populations. For class project submissions in which professors are seeking to gain approval for multiple projects from a single class in which all project fit under the same review type (exempt or expedited, only), the professor will substitute the Class Project Initial Request for Review and Proposal Form and Class Project Research Signature Page forms, which are found below.
  3. Prepare all support documents required for review.  See section two of the Initial Request for Review and Proposal Form for items that must be included in your proposal packet.  All of the forms you will need are found below in the “Forms” section of this page, including the ‘Guide to Completing Section Three’ document.
  4. Once all of the checked materials have been compiled, please scan all completed documents into one PDF file (which is considered to be your “proposal packet”) and submit via email attachment to irb-hs@lynchburg.edu. Scanners are available on campus in a variety of academic and administrative offices – check with your department/school administrative assistant for suggestions on locating a scanner. Hardcopy submissions will not be accepted.
  5. Once received, the IRB Chair looks at the basic components of the proposal materials to make sure that the proposal submission package is complete.  While the reviewer may determine that more materials are needed (i.e., letter of support from community organization where data are to be collected; invitation to participate script for questionnaire), the IRB Chair is looking for four basic things:
    1. Does the proposal have real signature(s) in the appropriate place(s)? (scanned signature with the understanding that the original is on file with the researcher in the event that it is needed in an audit.)
    2. Was the data collection instrument (i.e., questionnaire, observation log) submitted?
    3. Is the Principal Investigator (PI) a faculty member or a staff member at LC?
    4. Have all the LC affiliated members of the research team completed the required CITI training? All LC faculty, staff, and students seeking IRB approval for research proposals requiring full or expedited review must pass a basic training course on research ethics offered by the Collaborative Institutional Training Initiative (CITI). The IRB will only review proposals submitted by those who have passed the training. Instructions for completing the CITI training are available on the faculty/staff researcher or student researcher pages.*
  6. The review process occurs and revisions are completed as per request of the reviewer (exempt and expedited review) and/or IRB committee (full board review).  For more information, visit Frequently Asked Questions #7.
  7. Once all items are satisfied, the Chair will notify the PI (via email, and carbon copy additional research team members if their email addresses are available) to confirm that the study has been approved.  Approved proposals will be assigned an approval number and it is important that PIs keep this number for use in future communication with the IRB.
  8. Any change to an approved research project, including research plan, consent/assent process and form, co-investigators, other research personnel, and/or methods of subject recruitment, requires submission of a Research Modification Form, which can be found below in the forms section of this page.  See the Research Modification Policy for more information.
  9. At one month prior to the end of the approval period (one year, as stated in the approval notification letter), PIs must submit the Renewal or Closure Form, which can be found below in the forms section of this page.  See the Research Renewal or Closure Policy for more information.

*Once all of the items in #5 are confirmed, the proposal submission package is considered to be “under review.”  The Chair will notify the PI, via email, that the proposal submission package is under review and assign a proposal number.  It is important that PIs keep this number for use in future communication with the IRB.

Forms

The following forms and the Guide for Researchers document were updated in January 2014; old versions of forms will not be accepted for review. After piloting forms and instructions for review of class projects in Fall 2013, it was determined that the needs of these research activities are not significantly different than those of other research studies. Therefore, all research proposals will utilize the same forms. Contact the IRB Chair, Dr. Sharon Foreman Kready, at IRB-HS@lynchburg.edu for assistance with completing these forms.

Initial Request for Review and Proposal Form
Research Team Signature Page
Consent Form Template
NEW! Consent Form Sample with Notes for Researchers
Assent Form Template
NEW! Assent Form Sample with Notes for Researchers
Request for Waiver of Documentation of Consent Form (Oral Consent Request)
Research Modifications Form
Renewal and Closure Form
Guide for Researchers (PDF)