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Institutional Review Board Policy Brief

Online Request for Review form: Request for Review

Institutional Review Board Policy: Click to open PDF document

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.

Types of Review

The IRB uses the following 3 types of review when evaluating research proposals:

Full Review

If the research project involves any of the following, the project will receive a full review by the IRB Board:

  • Support from non-university sources (e.g., government agencies) that requires full IRB approval before they will release funds.
  • The likelihood of risk or substantial stress or discomfort to the subject.
  • Personality tests, inventories or questionnaires of a personal and sensitive nature where subjects' identities will not be anonymous to the researcher.
  • Sensitive aspects of a subject's behavior that could reasonably place a subject at risk of criminal/civil liability or be damaging to a subject's financial standing or employability.
  • Sensitive aspects of a subject's behavior such as illegal conduct, drug use, sexual behavior, or use of alcohol.
  • Diagnostic or therapeutic assessments, interventions, or measures that are not standard, generally acceptable, or common practice.
  • Deception or procedures that are not known to the subject (e.g., the subject will not be fully informed about study objectives.)
  • Special populations (e.g., children, prisoners, pregnant women, or individuals who are mentally or psychologically ill, or incompetent.)
  • Greater than minimal risk to subjects.

Expedited Review

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:

  • Involve minimal risk? (If more than minimal, it needs full review.)
  • Involve recording data from subjects 18 years of age or older using noninvasive procedures routinely employed in clinical practice?
  • Involve analysis of voice recordings made for research purposes?
  • Involve moderate exercise by healthy volunteers?
  • Involve research on individual or group behavior, or characteristics of individuals, without manipulation of a subject's behavior and in a manner that does not cause stress to subjects?

Exempt Review

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:

  • Investigations of commonly accepted educational practices in established or commonly accepted settings (e.g., a faculty member or teacher is examining a new method of teaching instruction to determine educational effectiveness).
  • Analysis of information from educational tests that will be recorded in such a manner that subjects cannot be identified.
  • Surveys or interviews in which responses will be recorded in such a manner that a subject cannot be identified directly or through identifiers linked to a subject. To qualify for exempt status, the surveys would not involve vulnerable populations (e.g., juveniles) or ask questions about sensitive aspects of a subject's behavior (e.g., criminal behavior).
  • Observations of public behavior (participant observation).
  • Collection or study of publicly available existing data, documents, records or specimens.
  • Collection or study of existing data, documents, records or specimens in which information will be recorded or reported in such a manner that a subject cannot be identified directly or through identifiers linked to a subject.

Minimal Risk

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:

  1. Consider both magnitude and likelihood of risk; A more serious event may be permissible if its probability is extremely low. Example: Airplane flight carries a risk of death, but it occurs only once in some millions of passenger miles.
  2. Risks of ordinary, non-invasive diagnostic tests are permitted. Examples: pen-and-paper tests
  3. Minimal risk may be age- or context-dependent. Example: Certain procedures may be minimal risk for someone old enough to give consent, but not for a small child.
  4. Remember that risks need not be "physical" in order to be "more than minimal." Examples: A serious privacy risk, confidentiality risk, informational risk or risk of embarrassment may be enough to push a study into the "greater than minimal risk" category and thus to full committee review.

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

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." and "Sample Informed Consent Letter" below)

Regulations further provide that the following additional information be provided to subjects, where appropriate:

  1. A statement that the particular treatment or procedure may involve risks to the subject (or to an embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
  2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
  3. Any additional costs to the subject that may result from participation in the research;
  4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
  5. A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and
  6. The approximate number of subjects involved in the study.

Procedures for IRB Review

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.

IRB Request for Review

You can complete the request for review online here: Request for Review

Human Subjects Research Informed Consent Form Checklist

To ensure that research participants are fully informed about the research in which they will participate, they must read and sign a consent form (Sample Informed Consent Letter). 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:

  • Invitation to participate and alternative procedure, if needed
  • Clear description of the purpose and procedures of the research
  • Statement that participation is voluntary and refusal to participate or early withdrawal will involve no penalty
  • Description of potential risks, if any
  • Description of potential benefits to subjects and society
  • Assurance of confidentiality which clearly describes how it will be maintained
  • Offer to answer all questions concerning the research now and at a later date
  • Researcher's name and phone number
  • Advisor's name and phone number
  • Signature and date blanks for researcher and participant

Contact Information

Dr. Jill Arnold
Online
573-629-3103