Institutional Review Board

Participants

IRB review request process

To request an IRB review, send an electronic copy of the completed IRB Review Request form, the Project Description - Consent form, and all supporting documents to irb@millikin.edu. The Review Request and Consent forms are in rich text format and file copies can be obtained by clicking on the links:

• Review Request Form
• IRB Guidelines
• Research Continuation Review Request Form
• Exempt Application
• Consent Form Guidelines
• Research Closure Form
• Adverse Event and Ethics Complaint Form
• Research Amendment Request Form

NOTE: If you are having issues opening up one of these forms and filling them out, try saving it onto your own computer first. If that does not work, please contact us at irb@millikin.edu and we will send a form to you. Thank you!

Fall 2024 Meeting Dates: 

• October 10, 2024
• November 14, 2024
• December 12, 2024

The Millikin IRB reviews all non-exempt research using human participants conducted at Millikin University, or under its auspices or control, by faculty, staff, and students. IRB review ensures that the rights and welfare of human participants are adequately protected, and that legally effective informed consent has been obtained from participants. The Millikin IRB uses the ethical guidelines established in The Common Rule (45 CFR 46), professional organizations, and policies set forth in the Faculty Policies & Procedures Manual Section 6.12 Research Involving Human Participants and Animals.

Please remember to have all IRB Review Requests with supporting documents to the IRB 2 weeks prior to the scheduled meeting dates in case your proposal requires a Full IRB Board Review. This will allow time for a preliminary review and action on the proposal, and if necessary, distribution of IRB materials so that all IRB members may review proposal documents prior to the scheduled meeting. Timely submission of complete IRB documents enables the IRB to respond quickly and appropriately to the needs of researchers.

IRB educational assistance

IRB members are available individually or in teams to provide assistance to researchers and classes to help provide advice and guidance on completing IRB Review Request forms, answering questions about ethical concerns that arise in research, or guidance in revising proposals to conform to ethical standards. For assistance, contact a member of the IRB to request an individual meeting or a presentation to your class.

CITI Program Ethics Training and Certification

The CITI Program provides a review course for all Millikin individuals including board members and researchers planning a study involving human participants. To register, select the institution (Millikin University) and provide the requested information. Next select Millikin Human Subjects Researchers, Supervisors, and IRB Members and Chairs. Once you have successfully completed the one 7-module basic CITI course, you can print your ethics certificate. Please include your ethics certificate with your IRB Research Review Request.

Review categories and criteria

Research activities are classified according to 1 of 3 categories as as set forth in the Common Rule (45 CFR 46) and described below: (I) Exempt from IRB review, (II) Non-Exempt - Expedited IRB review, or (III) Non-Exempt - Full IRB review.

Category I - Research Exempt From IRB Review:

Unless research is covered by other parts of this policy, research activities using human participants is exempt from IRB review if it falls into one of the following categories:

• Research conducted in established or commonly accepted educational settings, involving normal educational practices such as (a) research on regular and special education instructional strategies, or (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods, or
• Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), IF information taken from these sources is recorded in such a manner that participants CAN NOT be identified, directly or through identifiers linked to the participants, or
• Research involving survey or interview procedures, EXCEPT where ALL of the following conditions exist: (a) responses are recorded in such a manner that the human participants can be identified, directly or through identifiers linked to the participants, (b) the participant's responses, if they became known outside the research, could reasonably place the participant at risk of criminal or civil liability or be damaging to the participant's financial standing or employability, AND (c) the research deals with sensitive aspects of the participant's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol. ALL research involving survey or interview procedures is exempt, without exception, when the respondents are elected or appointed public officials or candidates for public office, or
• Research involving the observation (including observation by participants) of public behavior, EXCEPT where ALL of the following conditions exist: (a) observations are recorded in such a manner that the human participants can be identified, directly or through identifiers linked to the participants, (b) the observations recorded about the individual, if they became known outside the research, could reasonably place the participant at risk of criminal or civil liability or be damaging to the participant's financial standing or employability, AND (c) the research deals with sensitive aspects of the participant's own behavior such as illegal conduct, drug use, sexual behavior, or use of alcohol, or
• 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 participants CAN NOT be identified, directly or through identifiers linked to the participants.

Category II - Research Eligible for Expedited Review:

Reviews of Minimal Risk Research: Expedited reviews of research proposals, that involve no more than minimal risk of physical or psychological harm or discomfort, are conducted by the IRB Chair, and one or more IRB members, with the stipulation that the subcommittee consists of persons from both scientific and non-scientific disciplines. The IRB subcommittee exercises all of the authority of the full IRB, except that the subcommittee may not reject a research proposal. If the IRB subcommittee recommends rejection of the research proposal, then the subcommittee must present their rationale to the full IRB at a regularly scheduled meeting, during which time a review of the research proposal will be conducted by the full IRB.

Renewals of Previously Approved Research: Expedited reviews of research proposals, previously approved by the Millikin IRB, are conducted by the IRB Chair as long as the research covered by the renewal request is an ongoing, previously approved project that has not changed, or has changed in a way that will not affect confidentiality or risk of harm to participants, or has had no adverse events reported. One month prior to the study's anniversary approval date, the IRB will contact the Principal Researcher to determine if the study has ended (researcher will be sent a research closure form) or if the study needs to be renewed (researcher will be sent a request for continuation form). These completed forms will be filed with the original IRB Review Request forms.  All continuing research must be annually reviewed to certify that no evidence of risk to human participants has surfaced (e.g., literature, debriefing feedback, participant complaints) since the initial review. The IRB always reserves the right to use a full IRB board review, if there are any concerns that changes in research procedures may compromise confidentiality or place the participant at more than minimal risk.

Category III - Full Review: All research involving human participants that falls into the categories of Non-Exempt review and may exceed minimal risk, is required to undergo a complete review by the full IRB at one of its regularly scheduled meetings. Full IRB board reviews of research proposals, previously approved by the Millikin IRB, are conducted by the IRB Chair as long as the research covered by the renewal request is an ongoing, previously approved project that has not changed, or has changed in a way that will not affect confidentiality or risk of harm to participants, or has had no adverse events reported. One month prior to the study's anniversary approval date, the IRB will contact the Principal Researcher to determine if the study has ended (researcher will be sent a research closure form) or if the study needs to be renewed (researcher will be sent a request for continuation form). These completed forms will be filed with the original IRB Review Request forms. All continuing research must be annually reviewed to certify that no evidence of risk to human participants has surfaced (e.g., literature, debriefing feedback, participant complaints) since the initial review. The IRB always reserves the right to use a full IRB board review, if there are any concerns that changes in research procedures may compromise confidentiality or place the participant at more than minimal risk.