Institutional Review Board

An objective of the Milligan University Mission is the practice of sound scholarship, which includes scholarly research. Milligan’s Institutional Review Board (IRB) assures the ethical conduct of all Milligan University research involving human study participants. The purpose of the IRB is to protect the rights and welfare of the human participants who engage in research conducted by Milligan faculty, staff, or students.

The IRB is composed of individuals who are charged with the task of reviewing research involving human participants. All proposed research conducted on behalf of Milligan shall be evaluated by the IRB, which has the authority to approve or disapprove research, or to request modifications prior to approval.

The members of the IRB are guided by the federal requirements defined in Title 45 of the Code of Federal Regulations Part 46 (the Common Rule), which is based on the ethical principles outlined in the Belmont Report. The nature and content of proposed research are evaluated according to Milligan’s IRB policies and procedures as defined in Milligan’s Faculty Handbook.  Milligan’s IRB meets regularly during the Fall and Spring semesters.  Refer to the meeting schedule for submission deadlines listed below.

 

Milligan IRB Membership (AY 2021-22)

Trini Rangel (CHAIR)

Adam Bean

Joy Drinnon

David Gibbons

Bruce Gibson

David Hampton

Landon Holbrook

Kristen Mudrack

Community member (PENDING)

 

IRB Process Overview

Steps to Complete the IRB Process (Initial/New Research)

  1. Complete the Human Research Protections Program course in Canvas.

a. Request enrollment in this course by submitting an email request to IRB@Milligan.edu.
b. Complete Modules #1, #2, and #3.

  1. Review and understand the submission deadlines listed below.
  2. Draft a Research Study Plan (and related informed consent) using the Research Study Plan template. (NOTE:  Full completion of this Study Plan is optional for Exempt Research that does not require an IRB Limited Review.)
  3. Exempt Research Evaluation. Using the research study plan, determine if the proposed research is exempt research using the Human Subjects Regulations Decision Charts (pdf) and by completing the Exempt Research Evaluation and IRB Verification form.
  4. For Exempt Research, submit to the IRB (via IRB@Milligan.edu) the Exempt Research Evaluation and IRB Verification form (plus the Research Study Plan if exempt research requires a Limited Review) for IRB verification and review.
  5. For Non-Exempt Research, obtain the Non-Exempt Research Application form.

a. Determine if the research qualifies for IRB Expedited Review using the Expedited Review Guide (pdf).
b. Submit the Non-Exempt Research Application along with the Research Study Plan to the IRB at IRB@Milligan.edu.

  1. Review timelines:
    • Limited and Expedited Reviews will be reviewed on a rolling basis between the regularly convened, monthly IRB Meetings. Review decisions may be expected within 2 weeks of receipt.
    • Full Reviews for non-exempt research applications received by the submission deadlines will be reviewed only at regular convened, monthly IRB Meetings held during the Fall and Spring semesters. Review decision may be expected within 3 business days following the IRB Meetings.
    • Under no circumstances may research begin prior to written IRB approval for the conduct of human research.

Steps For the Conduct of IRB Approved Research

  1. Conduct research as approved by the IRB.
  2. Continuing Review. For research requiring an IRB Continuing Review, submit a summary report to the IRB per the schedule required by the IRB for the approved research.
  3. Change Notification. Any changes necessary to the research study plan must be reviewed and approved by the IRB prior to the change. Submit requests for changes to IRB@Milligan.edu using the Human Research Change Request form.
  4. Prompt Reporting. During the conduct of research, promptly report the following to the IRB Chair at IRB@Milligan.edu:

a. Any serious or continuing non-compliance with the IRB approved research study plan
b. Any serious or continuing non-compliance with the IRB requirements
c. Any unanticipated problems involving risks to participants or others related to the research

  1. Adverse Events. During the conduct of approved research, if any research participant has been, or is suspected of being, physically or psychologically harmed during the course of the research, promptly suspend the research, and promptly and directly inform the IRB Chair of the adverse event.  Promptly follow notification to the IRB Chair with written documentation of the event and the measures taken to rectify or reduce the harm.  Promptly inform the research participants of their right to submit a statement directly to the IRB.

The IRB Chair will promptly inform all IRB members and the VP for Academic Affairs of any adverse events or outcomes resulting from research conducted at or on behalf of Milligan, in addition to any other required regulatory authorities.

  • The IRB will promptly conduct a review of the adverse events/outcomes and the study’s research study plan.
  • If the IRB finds that the study was not conducted in accordance with its requirements or ethical guidelines, the IRB has the authority to suspend or terminate approval of the research.
  • Any suspension or termination of approval will include a statement of the reasons for the IRB’s action, and will be reported promptly to the investigator and the Academic Dean.
  1. Reporting Research. Upon completion of the research, report research per the IRB Approved research protocol.  Retain research data per the IRB approved research study plan for 3 years, maintaining privacy and confidentiality.
  2. Data/Information Retention. All research data, specimens, and related reports generated according to a Milligan IRB approved research plan are the property of Milligan University, unless otherwise authorized for faculty per the Faculty Handbook.

At the completion of the retention period, securely destroy retained research data and specimens.  Data and specimens should not be retained longer than the authorized retention period.

  • Electronic records should be permanently deleted from the secured storage locations described in the approved research protocol. Milligan IT should be consulted as necessary.
  • Paper records (such as informed consent, other raw research data, study correspondence) should be returned to Milligan’s Office of Institutional Research and Effectiveness for secure destruction.
  • Specimens should be securely discarded in collaboration with Milligan faculty in the School of Sciences and Allied Health, ensuring all private identifying information has been destroyed.

A copy of the completed final research report may be retained indefinitely by the Investigator.

 

IRB Meeting Schedule and Submission Deadlines

2021-22 IRB Monthly Meetings

Application Deadline Meeting Date/Time
September 7

By 5:00 pm

September 21

11:00 am – 12:00 pm

October 5

By 5:00 pm

October 19

11:00 am – 12:00 pm

November 2

By 5:00 pm

November 16

11:00 am – 12:00 pm

January 11

By 5:00 pm

January 25

11:00 am – 12:00 pm

February 8

By 5:00 pm

February 22

11:00 am – 12:00 pm

March 15

By 5:00 pm

March 29

11:00 am – 12:00 pm

April TBD

By 5:00 pm

April TBD

11:00 am – 12:00 pm

 

Resources

 

Forms

 

Contact

IRB@milligan.edu