There are three application forms used by Heartland Institutional Review Board, a commercial IRB, for human subjects research or program evaluation:
- Standard application (to be used whether a research project or program evaluation)
- Application for oral-history/field research
- Application for research using existing or secondary data
Submit the form appropriate to your project. These forms are fillable Microsoft Word/PDF files. All forms are located under the Forms tab.
The Heartland Institutional Review Board Secretary initially examines all applications for completeness. The Secretary will send the proposal to the Heartland Institutional Review Board Administrator who then reviews all proposals and makes the final determination as to the level of review that will be needed for each proposal (Level 1 or Level 2). The Secretary maintains a database and a hard copy file for each project, including all correspondence between the researchers and Heartland IRB. After a project has been approved and the work begun, the researcher must file a request to continue the research as indicated by Heartland IRB, which will be required at least once a year.
Under federal regulations, certain types of research are exempt from review unless the funding agency or the researcher’s institution requires a review. Research with human subjects will be reviewed and should be approved prior to the gathering of any data, including those projects that fall within the federal “exempt” category. These projects involve little risk beyond that which a person encounters in daily life. The Heartland IRB Administrator and Associate Administrator will select 2 additional members for the review committee based upon the discipline involved.
Research or program evaluation activities in which the only involvement of human subjects will be in one or more of the following areas will be reviewed as Level 1 applications.
A. Research conducted in established or commonly accepted educational settings (this includes both formal and informal educational settings), involving normal educational practices, such as research on regular and special education instructional strategies, or research on the effectiveness of or comparison among instructional techniques, curricula, or classroom management methods.
B. Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior, unless:
directly or through identifiers linked to the subjects; and
ii. any disclosure of the human subjects' responses outside the research could reasonably place the
subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
C. 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 subjects cannot be identified directly or through identifiers linked to the subjects.
D. Taste and food quality evaluation and consumer acceptance studies, if wholesome foods without additives are consumed, or if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
If proposals meet certain criteria that are clearly defined in the federal guidelines, a subcommittee of the commercial IRB will be assigned to review the proposals as a Level 2 proposal. The subcommittee reviewers consist of the Associate Administrator and three additional members from the appropriate discipline(s). The detailed guidelines for Level 2 review are as follows.
A. Research activities that present no more than minimal risk to human subjects, and involve only procedures listed in one or more of the following categories. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the Level 2 review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
B. The categories in this list apply regardless of the age of subjects, except as noted.
Categories 1 - 3 below pertain to both initial and continuing Heartland IRB review.
- Prospective collection of biological specimens for research purposes by noninvasive means. Examples:
- a. Hair and nail clippings in a nondisfiguring manner.
- b. Deciduous teeth at time of exfoliation.
- c. Excreta and external secretions (including sweat).
- d. Uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue.
- e. Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings.
- f. Sputum collected after saline mist nebulization.
- Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. Heartland IRB does NOT review studies intended to evaluate the safety and effectiveness of a new or emerging medical device, including studies of cleared medical devices for new indications. Examples of noninvasive procedures that would be reviewed by Heartland IRB:
- a. Physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy.
- b. Weighing or testing sensory acuity.
- c. Moderate or low-impact exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
- d. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected, solely for non-research purposes (such as medical treatment or diagnosis).
- e. Collection of data from voice, video, digital, or image recordings made for research purposes.
- f. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
- Continuing review of research previously approved by Heartland IRB as follows:
- a. where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
- b. where no subjects have been enrolled and no additional risks have been identified; or
- c. where the remaining research activities are limited to data analysis.