Institutional Review Board

• All proposals should be sent to the Chair of the IRB electronically. kckccirb@kckcc.edu
• Proposals must be received twenty-one calendar days prior to the second Thursday of the month, excluding June, July and December, for review during the regular IRB meeting.
• A quorum of 51% is required for approval of research proposals.
• The Principal Investigator/Researcher may be asked to attend the KCKCC-IRB meeting to address questions.
• The Principal Investigator/Researcher will be informed of the IRB’s decision within seven business days of the Board’s decision.
• No Principal Investigator/Researcher will have access to KCKCC email addresses.
• If a proposal is sent back for further information, it may go to the back of the line after it is returned to the IRB.
• The Principal Investigators/Researchers will be required to view a FERPA/Human Subjects podcast. If a similar exercise was done at another institution, the KCKCC-IRB will take it under consideration provided documentation is provided and it was done with the last 12 months of the proposal’s submission.

• KCKCC students, staff and faculty will adhere to all the General Guidelines listed above.
• KCKCC students, staff and faculty must sign a statement stating that they will not solicit members of our KCKCC community to do research outside of the guidelines of the KCKCC–IRB.

• Timeline: The College is conducting a global study around the same time.
• Timeline: A similar study is going on or was just completed within the last twenty-eight calendar days, or a study has been approved prior to this to be conducted within the next twenty-eight calendar days. This applies only if it is the same cohort of students.
• It is fourteen calendar days before midterm exams or fourteen calendar days before final exams. These restrictions/parameters apply to all course schedules (e.g., 16-weeks semesters, eight weeks semesters, etc.) and modalities (e.g., face-to-face, virtual, online, etc.).
• It is the view of the majority of the KCKCC-IRB members that the research being proposed is not a productive use of time for KCKCC students, staff, and faculty. This could be the case even though the research was approved by another institution.

1. The determination of Human Subjects Research is enshrined within the definitions provided by the Department of Health and Human Services 45 CFR 46.101(a); FDA 21 CFR 56.101; and AAHRPP I1.3.C. Research is a methodical inquiry intended to contribute generalizable knowledge.
2. The Principal Investigator (PI) should make this initial determination based upon the definitions above; and communicate this in their proposal. If in doubt, inquire of the KCKCC-IRB Chair.
3. The Chair and two members of the IRB will make the final determination based upon the definitions above. This will be communicated to the PI via email. If there is a difference of opinion between the PI and the Chair and two IRB members, the full KCKCC-IRB will be asked to weigh in and make a final decision.
4. There are three levels of KCKCC-IRB Review: Exempt, Expedited and Full Board.

1. The decision for granting exempt status at KCKCC is completely the jurisdiction of the KCKCC-IRB; that is irrespective of whether another institution’s IRB has granted approval and or exemption.
2. Research may be granted an exemption if ALL of the activities involve procedures in one or more of the specific categories under CFR 46.104.
3. Exempt will be given after a review by the Chair and two other IRB members.
4. They do not apply to studies involving prisoners.
5. There are six exempt criteria:

A proposal can be approved as “Expedited” if it is no more than “minimal risk” and fits in one of the federally designated expedited review categories. Expedited reviews are conducted by any three members of the KCKCC-IRB. Expedited Reviews are not granted where the participants may be identified and or they can be reasonably subjected to risks (e.g., employability, civil or criminal liability, stigmatizations, etc.). 

Minimal risk is defined by the federal regulations as the likelihood and degree of physical or psychological harm that is normally encountered in the daily lives of healthy persons.

There are seven Expedited criteria:

1. Clinical studies of drugs and medical devices only when certain conditions are met (21 CFR Part 312 and 21 CFR Part 812 are not required).
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture in certain populations and within certain amounts.
3. Prospective collection of biological specimens for research purposes by noninvasive means.
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.
5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes {(45 CFR 46.104(d) may be exempt from expedited review}.
6. Collection of data from voice, video, digital, or image recordings made for research purposes.

Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. {45 CFR 46.101(b) (2) and (b) (3) may be exempt from expedited review}.

All other research (those that do not fit the exempt and expedited categories) will receive review at a fully convened KCKCC-IRB. KCKCC-IRB obligations are defined in the Federal Regulation for Protection of Human Subjects (45 CFR 46).