Online Request for Review form: Request for Review
The Hannibal-LaGrange University Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of Hannibal-LaGrange University. The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations (Code of Federal Regulations, Title 45, Part 46) and local institutional policy. The IRB makes its independent determination whether to approve or disapprove the research protocol based upon whether or not human subjects are adequately protected.
The IRB uses the following 3 types of review when evaluating research proposals:
If the research project involves any of the following, the project will receive a full review by the IRB Board:
If none of the above descriptors apply to the research proposal, the project may require a less rigorous, expedited review. The following criteria determine whether a project will receive expedited review:
Does the proposed research:
If none of the preceding descriptors for full or expedited review apply to the project, the research proposal falls under the category of exempt review. Such proposals still require IRB review. Exempt review means that the proposal only requires a review by one single IRB member to confirm that the proposal does not warrant a more in-depth review by the IRB. Some types of research proposals that may qualify for exempt review:
A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life (§46.102).
When making a decision about minimal risk of research:
Some minimal risk research is exempt from full IRB review. Exemption waives only the need for full IRB review and does not negate the need for the consent of subjects where applicable.
The authority to determine and confirm exempt status rests with the IRB and not with the investigator nor student advisor. Thus, an Application Form is required for your exemption to be confirmed and granted by the IRB.
Informed consent is a process in which a research participant learns the key facts about the research before he or she decides to participate in the study. In addition to talking about the facts of the study with the researcher, all information will be included in a written consent form. The participant will be able to take the consent form home to read and discuss with family members. Participants may continue to ask questions before, during and after the consent form is signed. The participant's agreement to be in a study after being fully informed about what participation will involve, length of the study, benefits and risks, confidentiality, purpose of the study, and withdrawal/discontinuation procedures is informed consent. Participants will receive a copy of the signed consent form (§46.117). (Refer to "Human Subjects Research Informed Consent Form Checklist.")
Regulations further provide that the following additional information be provided to subjects, where appropriate:
The plan for the research activity is submitted to the IRB for review before research begins. The IRB Review Form includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s) and the proposed methods of analysis that will be performed on the collected data. A cover letter to subjects and informed consent agreement for subjects must also be attached.
All student research involving human subjects must be supervised by a faculty member. In consultation with your faculty advisor, you must complete the IRB Review Form. Your advisor must be the one to initiate your IRB review by forwarding it to the chairperson of the IRB. By forwarding the form, your advisor indicates that he or she approves of the project as outlined in your research proposal and the IRB submission form.
For most research proposals (e.g., projects that do not involve vulnerable populations and that represent minimal risk to subjects), the IRB makes every attempt to return proposals within 10 to 14 days of submission. Normally the IRB does not review proposals during the summer or other school holidays.
If a project raises particular issues that the IRB feels are not adequately addressed in the proposal, the researcher may be asked to submit additional material, clarify a point, or rewrite a section of the proposal. To reduce delay, these changes are usually solicited electronically. However, on rare occasions, the researcher (and faculty supervisor, if appropriate) may be asked to appear before the IRB to resolve matters of procedure, etc.
When the IRB approves the research proposal, written notice will be provided to the student's faculty advisor. You may not begin to collect data from human subjects before you have received approval of the project from the IRB.
All research is subject to periodic review at the IRB's request.
You can complete the request for review online here: Request for Review
To ensure that research participants are fully informed about the research in which they will participate, they must read and sign a consent form. A copy of the signed consent form should be given to the participant. The consent form should be printed on school letterhead and include the following: