All research done by those affiliated with Lynchburg College falls into one of three categories. The research is either exempt from review, qualifies for expedited review, or necessitates full formal review. These three classes of research are defined by the Federal Protection of Human Subjects Regulations and are further specified below. Human subject research may begin only after the Human Subject Research Committee has approved it. Any reviewed project which will have a duration exceeding one year must reapply for approval each year. If the IRB decides that a shorter interval between reapplication is necessary, this will be noted in the initial response to a request for review.
Any research involving human subjects and conducted, in whole or in part, by members of the Lynchburg College community should be considered as a possible object to review under this policy. Faculty sponsors advising student research share in the responsibility for making certain that student research complies with Lynchburg College's formal policy.
Procedures for Review of Research
1. Decide whether the project is exempt from review, qualifies for expedited review, or requires a full review. Use the guidelines listed below to make your decision.
2. If you believe an expedited or full review is needed, please click on the appropriate link to the left (Request for Expedited Review or Request for Full Review) to access the forms needed for a review. Complete the forms and submit them along with supporting materials (informed consent, surveys, etc.) electronically to the chair of the committee.
3. The committee will review submitted applications and notify applicants of the decision via e-mail. If concerns about the proposed study arise, the chair may request more information or revisions to the proposed study prior to giving approval. Normally, expedited reviews will be reviewed and a response given with 7-10 days whereas full reviews may take up to 2-3 weeks.
Exemptions from Review
Please note: Research with children (under age 18), pregnant women, prisoners, and mentally disabled individuals do not qualify for an exemption and may require a full review.
A project is exempt from review on the following conditions:
1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
• research on regular and special educational instructional strategies, or
• research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
• information is recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects; and
• any disclosure of the human subject's responses outside the research could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability, or reputation.
3. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that the subject cannot be identified, directly or though identifiers linked to the subjects.
4. Taste and food quality evaluation and consumer acceptance studies.
Expedited Review
Please note: Research that involves children (persons under the age of consent) as subjects cannot qualify for expedited review (such studies require a full review).
If the study does require review it may qualify for an expedited review. Research activities involving no more than minimal risk and in which the only involvement of human subjects will be in one or more of the following categories (carried out through standard methods) may (as determined by the IRB) qualify for an expedited review.
1. Collection of body fluids, etc., or the collection of data from subjects 18 years of age or older using noninvasive procedures routinely employed in clinical practice. This includes the use of physical sensors that are applied to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the subject's privacy. It also includes such procedures as weighing, testing sensory acuity, electocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (for example, x-rays, microwaves).
2. Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and no more often than two times per week, from subjects 18 years of age or older and who are in good health and not pregnant.
3. Voice recordings made for research purposes such as investigations of speech defects.
4. Moderate exercise by healthy volunteers.
5. The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
6. Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate subjects' behavior and the research will not involve stress to subjects.
7. Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.
Full Review
Research which is neither exempt from review nor qualifies for expedited review must go through full review. Necessary forms for full review may be found by clicking on the link titled "Request for Full Review." Complete all forms /questions and include all supporting materials when requesting a full review. Please submit all materials electronically to the chair of the committee. If you are unable to submit the materials electronically, please submit five complete sets of materials to the chair of the IRB. After the review is complete, the proposal will be returned as soon as possible to the principal investigator. For student projects, formal approval or other decisions/comments will be sent to the student and the faculty sponsor. If the committee does not approve a project, it will provide justification and suggest ways in which the project might be revised to meet approval. In this case, the revised proposal must be submitted with a new form, following the procedures above. If a project is approved conditionally, those responsible for the project must provide the IRB with a letter which states specifically how the conditions have been (or will be) met before the project begins. The IRB will respond as to whether the conditions have been satisfied. Normally, in this case, a resubmission of the original proposal will not be required.