Policy and Procedure

Hutchinson Community College's Institutional Review Board (IRB) ensures the safety and well-being of human subjects (as defined by the U.S. Department of Health and Human Services Office of Human Research Projections) participating in research studies being conducted by Hutchinson Community College (HutchCC) students, faculty, and staff. Those conducting research projects involving HutchCC students, faculty, and/or staff but are not currently affiliated with the institution must also complete the IRB process even if the research has been approved by an external IRB.

The HutchCC IRB must review and grant approval (or exemption) for the project before the research begins. HutchCC's IRB monitors research studies to ensure the human, civil, and legal rights of human research participants are respected and that researchers are adhering to the highest ethical standards.

IRB approval can only be given for up to one calendar year. Ongoing projects must seek reapproval, especially if any changes have been made to the research protocol.

Class projects that involve systematic collection of data for which the design or objective is to develop or contribute to generalizable knowledge are considered research. In other words, if the student or instructor plans to use the data outside of the class, the project is considered research and requires review. Projects that may constitute research include:

• Theses that may be presented in a professional venue (conference, publication, etc.)
• Projects that deal with protected populations (children/minors, prisoners, people with diminished capacity to give consent, etc.)
• Projects dealing with sensitive information

Only projects that are affiliated with HutchCC investigators (HutchCC students, faculty, or staff) or that utilize HutchCC students/faculty/staff as subjects or HutchCC property in the course of the research are eligible for HutchCC IRB review. If a researcher or instructor is unsure whether their project requires review, they should contact the Chair of the IRB.

IRB Membership

The HutchCC IRB will consist of a minimum of five members with varying backgrounds to promote complete and adequate review of the research activities commonly conducted by the institution. Membership will include the following:

• At least one member whose primary concern is in scientific areas
• At least one member whose primary concern is in nonscientific areas
• At least one member not otherwise affiliated with the institution and not part of the immediate family of a person affiliated with the institution.

No member will participate in the initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. For situations like this that may occur, the HutchCC IRB will have an identified alternate member with experience, expertise, background, professional competence, and knowledge comparable to that of the primary IRB member whom the alternate would replace.

IRB Process

Relevant Terms

External applicant: an applicant with no current affiliation with HutchCC

Internal applicant: an applicant with a current affiliation with HutchCC (as student, faculty, or staff)

IRB Application Consideration

1. Applicant submits an IRB Application or an amended IRB Application to Learning Zone.
2. If the project takes place at HutchCC or on HutchCC property, or if project subjects include HutchCC students, faculty, and/or staff, the IRB Chair will consult with the President’s Council.
3. The IRB Chair(s) assigns the application to a level of review--exempt, expedited, or full—based on the criteria below. Once assigned a level of review, the IRB Chair(s) will send the project to the appropriate IRB members and, once review is completed, will communicate IRB findings to the applicant.

Projects Exempt from IRB Review

Projects that are exempt from the IRB review process will satisfy at least one of the following criteria.

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 obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
   2. Any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal liability or be damaging to the subjects’ financial standing, employability or reputation.
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) survey procedures, interview procedures or observation of public behavior that is not exempt under category (b) of this section, if:
   1. The human subjects are elected or appointed public officials or candidates for public office; or
   2. Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
4. Research involving the collection or study of existing data, documents, records, pathological specimens or diagnostic specimens, if these sources are publicly available or if information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. (Please be aware that in order to qualify for this exemption, the date, documents, records or specimens must be in existence before the project begins.)
5. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate or otherwise examine:
   1. Public benefit or service programs;
   2. Procedures for obtaining benefits or services under those programs;
   3. Possible changes in or alternatives to those programs or procedures; or
   4. Possible changes in methods or levels of payment for benefits or services under those programs.
6. Taste and food quality evaluation and consumer acceptance studies:
   1. If wholesome foods without additives are consumed; or
   2. 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.

The designation of a project as “Exempt from IRB Review” will be communicated to the applicant by the IRB Chair via Learning Zone (for internal applicants) or via email (for external applicants).

Projects Appropriate for Expedited Review

Projects that are appropriate for expedited IRB review will satisfy at least one of the following criteria.

1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met:
   1. Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
   2. Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
   1. From healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 500 ml in an 8-week period, and collection may not occur more frequently than 2 times per week; or
   2. From other adults and children, considering the age, weight and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8-week period, and collection may not occur more frequently than 2 times per week.
3. Prospective collection of biological specimens for research purposes by noninvasive means:
   1. Hair and nail clippings in a non-disfiguring manner;
   2. Deciduous teeth at the time of exfoliation or if routine patient care indicates a need for extraction;
   3. Permanent teeth if routine patient care indicates a need for extraction;
   4. Excreta and external secretions (including sweat);
   5. 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;
   6. Placenta removal at delivery;
   7. Amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
   8. Supra- and subgingival dental plague and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth, and the process is accomplished in accordance with accepted prophylactic techniques;
   9. Mucosal and skin cells collected by buccal scraping or swab, skin swab or mouth washings;
   10. Sputum collected after saline mist nebulization.
4. 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. (Studies intending to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)
   1. 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;
   2. Weighing or testing sensory acuity;
   3. Magnetic resonance imaging;
   4. Electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow and echocardiography;
   5. Moderate exercise, muscular strength testing, body composition assessment and flexibility testing where appropriate given the age, weight, and health of the individual.
5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the Health and Human Services regulations for the protection of human subjects [45 CR 46.101(b)(4)]. This listing refers only to research that is not exempt.)
6. Collection of data from voice, video, digital or image recordings made for research purposes.
7. 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. (NOTE: Some research in this category may be exempt from the HHS regulations for the protections of human subjects [45 CFR 46.101(b)(2) and (b)(3)]. This listing refers only to research that is not exempt.)

Projects identified as appropriate for expedited IRB review will be evaluated in an email meeting (initiated by the Chair), consisting of two IRB Committee Members and the Chair. The Chair will communicate the decisions of the meeting to the applicant via Learning Zone (for internal applicants) or via email (for external applicants).

Projects Appropriate for Full Review

For projects that are neither assigned as exempt nor expedited, the Chair will initiate an email meeting with the entire IRB Committee to review the project. The Chair will communicate the decision of the committee to the applicant via Learning Zone (for internal applicants) or via email (for external applicants). Decisions will be communicated within one month of the application being received.