One objective of the Milligan College Mission is the application of sound scholarship. The Institutional Review Board was established to advance the goal of conducting research with diligence and integrity. The purpose of this committee is to protect the rights and welfare of the human subjects who participate in research conducted by students and/or faculty affiliated with Milligan College. This committee is composed of diverse individuals who are charged with the task of reviewing research involving human participants. All research conducted on behalf of or by affiliates of Milligan College shall be evaluated by this committee, which may request modifications to, approve, or reject proposed research. The members of the IRB will be guided by the ethical principles outlined in the Belmont Report and the federal requirements (45 CFR Part 46) as they relate to the mission of the college. The nature and content of proposed research will be evaluated according to the specific policies and procedures outlined below.
Membership and Jurisdiction of the IRB
The IRB is an administrative committee established by the Academic Dean to review research conducted under the auspices of Milligan College. Research that has been reviewed and approved by the IRB may be subject to review and disapproval by officials of the college. However, those officials may not approve research if it has been disapproved by the IRB. The IRB functions independently of but in coordination with other committees. The IRB will be composed of between 5 and 7 members who are appointed by the Academic Dean. Members will serve staggered terms of three years. The chair of the committee will also be replaced after serving three consecutive years. At least one member will represent each area of the college that is actively involved in research. Furthermore, at least one member of the committee will not be employed or related to an employee of the college. The IRB may, at its discretion, invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the IRB. However, these individuals may not vote. No IRB member may participate in the review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. The IRB will meet once a month at a regularly scheduled time during the fall and spring semester.
What research projects need to be reviewed by Milligan's IRB?
All research involving human subjects that is conducted and/or supported by Milligan students or faculty. It also includes research conducted by outside individuals or agencies with MilliganCollege Faculty, Staff or Students. The Milligan College IRB retains final judgment as towhether a particular activity must be reviewed by this committee.
What research projects require additional approval?
Research conducted or supported by any federal agency must receive additional approval by federal regulatory boards. In addition, some research activities may require additional review including: school systems, universities, and medical facilities. It is the responsibility of the principle investigator to obtain appropriate approval from both the Milligan IRB and all participating agencies before starting the research.
What activities do NOT need to be reviewed by Milligan's IRB?
Unless otherwise required by faculty or instructors, the following activities are exempt from review by this committee:
- 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.
- Research and demonstration projects (e.g., opinion surveys used for instructional purposes and confined to the classroom), which are conducted during the course of regular college courses. However, if the results are to be presented publicly (e.g., thesis or conference) the research must be approved by the IRB prior to data collection.
- Educational or therapeutic activities that are conducted during regular internships or field work.
- Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed, or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use 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.
What is the procedure for reviewing a project?
With the exception of the aforementioned types of study, the Institutional Review Board must review and approve all research projects before they are started. It is the responsibility of the principal investigator(s) to submit a research proposal to the Milligan IRB committee. Investigators should refer to the attached document, Checklist for Proposed Research Involving Human Subjects , for proposal guidelines. The IRB has two levels of review.
Expedited Review Process
Projects involving minimal risk to participants and traditional forms of assessment may be considered for expedited review. A list of the criteria for expedited review can be found in the Checklist for Proposed Research Involving Human Subjects. Projects reviewed under the expedited process, however, may at the discretion of the reviewer be subjected to full review.
The principal investigator must write a research proposal with an attached cover sheet before seeking approval. The content of the proposal must follow the guidelines outlined in the Checklist for Proposed Research Involving Human Subjects. If the principal investigator is a faculty or staff member, the proposal must be reviewed and approved by a member of the IRB. If the principal investigator is a student, the proposal must be reviewed and signed by a faculty advisor before seeking IRB approval. All proposals must be submitted to the Chair of the IRB who will either review the proposal or forward it to another member of the committee. Members of the IRB will review proposals on a rotating basis, and the Chair of the IRB will determine who will review each submitted proposal. No committee member will be allowed to review proposals if there is a conflict of interest (e.g., faculty advisor to the student researcher). A decision will be made within two weeks after receiving the proposal. A copy of the proposal and board decision will be returned directly to the faculty advisor. If the project has been approved, then the research may proceed immediately. A copy of the approved proposal will be placed on file where it will remain active for a period of five years.
Full Review Process
Projects that involve any of the following must be reviewed by a majority of the IRB: (a) physical or psychological risk, (b) psychological or physiological intervention, (c) deception, (d) surveys on sensitive topics, or (f) research with special populations (e.g., homeless). A detailed research proposal with attached cover sheet must be submitted at least 10 days before the regular monthly meeting of the IRB. The meeting dates will be set at the beginning of each fall and spring semester. The principal investigator must attend the meeting to present the proposal and be prepared to answer questions about his or her research. When the committee members are satisfied that they have the necessary information to make a decision they will call a vote in the absence of the principal investigator. The final decision will be based on the majority of votes. Although the Chair of the IRB must be in attendance, his or her vote will not carry additional weight. Any board members, including the Chair of the IRB, who have a conflict of interest, will be asked to abstain from the vote. If the research is approved, the study may begin immediately. A copy of the proposal and the board's decision will be placed on file and remain active for five years.
Modifications to Approved Research
Minor changes in the forms or administrative details (e.g., room location, phone numbers) may be changed at the discretion of the faculty researcher or with the approval of a faculty advisor. However, a revised proposal must be submitted to the IRB if any substantive changes are made in the methodology of the research. It is the responsibility of the faculty researcher/advisor to determine if changes in the study warrant resubmission to the IRB. Modifications that should be resubmitted include changes such as increased risk for participants, additional assessments or interventions, changes in the types or number of participants, etc. The revised proposal should be submitted directly to the Chair of the IRB for approval prior to changing the protocol.
Informed consent assures that prospective participants will understand the nature of the research nd can knowledgeably and voluntarily decide whether or not to participate. It is an on-going process, not a piece of paper or a discrete moment in time. Informed consent is a critical part of conducting ethical research and the IRB will consider very seriously the manner in which informed consent is provided and obtained. The IRB recognizes, however, that informed consent may not be feasible or warranted in every study. In the case of expedited research, the final decision will be left to the discretion of the faculty researchers and faculty advisor. In the case of full review , informed consent will be mandatory. The required elements of an informed consent form or protocol are listed on the Checklist for Proposed Research Involving Human Subjects. If full informed consent is impractical or would alter the results of the study, the principal investigator may request modifications to or a waiver of this requirement. To do so, the principal investigator must provide the IRB with sufficient written justification for excluding this step. If full informed consent is to be waived the principal investigator must , at a minimum, provide information about how to contact the investigators for additional information.
Unexpected Harm to Participants
If any participants are suspected of being physically or psychologically harmed during the course of a study, it is the responsibility of the principal investigator to suspend the research and inform the Chair of the IRB. The principal investigator must submit written documentation of the incident and the measures taken to rectify or reduce the harm. The participant(s) will also be informed of their right to submit a statement directly to the IRB. The Chair of the IRB will inform all members of the IRB, as well as the Academic Dean, of any adverse outcomes or incidents resulting from research conducted at or on behalf of Milligan College. If the IRB finds that the study was not being 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.