Guidelines for Determining Type of Review

Please review the guidelines below to determine what type of review your research project will require.

The following website may also be helpful in making this determination:

http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html

Research activities conducted solely for academic assessment data purposes and intended only for internal dissemination (within Lynchburg College and potentially with accrediting bodies) are not subject to oversight by the Human Subject IRB. This includes items such as student opinion surveys ("course evaluations"); focus groups/interviews/surveys for development of courses, programs, and service; and other assessment research tasks that are focused solely on improving and refining the delivery of curricular and extra-curricular services and are only intended for internal audiences.

Plans for the external dissemination of academic assessment data shall necessitate that the IRB approval take place.

The IRB suggests that researchers conducting institutional assessment research ask the following question prior to collecting data: "If I/we learn something very interesting or extremely helpful, would I/we wish to disseminate externally to non-LC audiences?" If the answer is "yes," then your research study does need to go through the IRB approval process.

This policy applies only to academic assessment research conducted by individuals on the department, school, or college level. Individual faculty researchers and student researchers who wish to conduct research on these sorts of topics but who are not officially doing so at the behest of an academic or administrative unit must go through the IRB for approval.

If data have already been collected and a researcher, academic or administrative unit wishes to re-analyze the data for the purpose of dissemination to external audiences, then the research study proposal does need to go through the IRB approval process and would be treated as secondary data analysis through the procedures for verification of exempt status.

Exempt from Review Status

A project may be exempt from review on the following conditions:

  1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
    1. Research on regular and special educational instructional strategies, or
    2. 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:
    1. Information is recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects; and
    2. 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 through identifiers linked to the subjects.
  4. Taste and food quality evaluation and consumer acceptance studies.

Materials to be completed for possible exempt from review status may be found on the Request for Exempt from Review Status page. Complete the request for review form and proposal and include data collection instruments as well as any other supporting materials when requesting exempt from review status. Please submit all materials via Moodle to the chair of the committee. 

Expedited 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.

Materials to be completed for an expedited review may be found by clicking on the Request for Expedited Review page. Complete the request for review form, proposal, informed consent agreement, and informed assent agreement (if subjects are under the age of 18) and include data collection instruments as well as any other supporting materials when requesting an expedited review. Please submit all materials via Moodle to the chair of the committee. 

Full Review

Research which is neither exempt from review nor qualifies for expedited review must go through full review. Materials to be completed for a full review may be found by clicking on the Request for Full Review page. Complete the request for review form, proposal, informed consent agreement, and informed assent agreement (if subjects are under the age of 18) and include data collection instruments as well as any other supporting materials when requesting an expedited review. Please submit all materials via Moodle to the chair of the committee.