Institutional Review Board (IRB) (Procedure 1.5000)

Purpose

Research at the College sometimes involves human subjects for data collection and analysis. Consistent with federal mandates, the College's Institutional Review Board (IRB) will review and approve research proposals that involve human subjects and ensure the rights and safety of human subjects are protected.

Procedure

1. The responsibilities of an IRB are to safeguard the rights and welfare of human subjects involved in research. The responsibilities of the IRB shall include, but not be limited to, the following:
   1. Determining which research requests involving human subjects require review;
   2. Approving requests for research involving human subjects;
   3. Conducting initial and continuing reviews of human subjects research;
   4. Reporting findings and actions to the investigator and the institution;
   5. Ensuring reporting of changes and unanticipated problems involving risks or noncompliance.
2. Consistent with federal guidelines defined in Title 45 Code of Federal Regulations Part 46, the following research activities are EXEMPT from IRB review:
   1. Research conducted in established or commonly accepted educational settings involving normal educational practices, such as: a) research on educational instructional strategies; b) research on the effectiveness of 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: a) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and b) any disclosure of the human subjects' responses outside the research reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, 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 subjects cannot be identified directly or through identifiers linked to the subjects.
   4. Taste and food quality evaluation and consumer acceptance studies: a) if wholesome foods without additives are consumed, or b) if a food is consumed that contains a food ingredient at or below the level found to be safe by the U.S. Food and Drug Administration or approved by the U.S. Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
3. The above exemptions do NOT apply - and research activities will require IRB review - in any case when:
   1. Deception of subjects may be an element of the research;
   2. Subjects are under the age of eighteen;
   3. Subjects are elected or appointed public officials or candidates for public office;
   4. Subjects are under federal statutes which require, without exception, that the confidentiality of personally identifiable information will be maintained throughout the research and after;
   5. The activity may expose the subjects to discomfort or harassment beyond levels encountered in daily life; or
   6. Fetuses, pregnant women, human in vitro fertilization, children, or individuals involuntarily confined or detained in penal institutions are subjects of the activity.
4. The IRB shall review non-exempt research proposals involving human subjects to ensure that:
   1. The rights and welfare of human subjects used in research studies are protected;
   2. Risks have been considered and minimized;
   3. Benefits have been identified and maximized;
   4. All human subjects volunteer to participate in research after being provided with legally effective informed consent; and
   5. Research is conducted in an ethical manner and in compliance with established standards.
5. The membership of the IRB shall include the following:
   1. The Associate Vice President of Institutional Effectiveness and Research
   2. A full-time college credit Instructor from Biosciences, Physical Sciences, or Mathematics
   3. A full-time college credit Instructor from Social Sciences
   4. A member of the College's Executive Team
   5. An Academic Administrator from the College
   6. A representative from the University of Central Florida or a representative not affiliated with the College
6. The Associate Vice President of Institutional Effectiveness and Research will serve as IRB chair.
7. The chair will have the responsibility to forward reviews of research proposals involving human subjects and IRB determinations and decisions to the liaison member of the College's Executive Team for final review.
8. Except where membership is defined by position title, members shall serve two year terms, as appointed by the College's Executive Team.
9. The committee shall convene as required. Minutes of each meeting shall be recorded and notifications made to the originators of research proposals.
10. The College's IRB will follow guidelines and make determinations consistent with federal guidelines and mandates applied to Institutional Review Boards.
11. Exempting an activity from review does not absolve the investigator(s) of the requirement for ensuring that the welfare of subjects is protected and that methods used to gain subject consent are appropriate. Questions regarding whether a research activity may be exempt from IRB review should be directed to the Associate Vice President of Institutional Effectiveness and Research for determination.