Institutional Research Board FAQ
Answers to frequenty-asked questions about OCU institutional research and policies are included here. For additional information, contact the OCU Director of Institutional Research.
Oakland City University's Institutional Review Board (IRB) has as its mission and function to review and approve all proposed research involving human subjects and animals that is conducted under the University's auspices through its Schools. Approval is required, regardless of whether the research is funded status or sponsored status. The code of federal regulations guiding IRB policy can be found here: 45 CFR 46.
Further, Oakland City University's IRB fully intends to follow the intent and purpose of the law. The IRB believes that the law is designed to protect the rights and safeguard the welfare of human research subjects and/or animals utilized in research activities. Since the law provides guidelines for establishing a local peer-review process, the IRB believes that this review process will help students or researchers better understand the nature of research and the importance of ethical approaches in conducting research.
The IRB must review any and all research that will be conducted by students or faculty that involves human subjects or animals. For the purposes of this review, the term research is defined by federal law 45 CFR §46.102 as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." All activities that meet the foregoing definition of research need to be reviewed by the IRB, including activities that may or may not be conducted or supported under a program which is considered research for other purposes. (Please note that some demonstration and/or service programs may include research activities.) For the purposes of this policy, a systematic investigation is any data collection method. This includes interviews, surveys, tests, observations, or other experiments, regardless of content area, including pilot studies.
As additional criteria, the IRB further defines research as a project designed to "contribute to generalizable knowledge," when it adds to a field of knowledge (e.g., the field of education, the field of religion, the field of management), and when the research results become publicly available, either through a presentation or publication.
For the purposes of this policy, the IRB considers a research project to involve human subjects if the research activity involves "a living individual about whom an investigator . . . obtains data through intervention or interaction with the individual or identifiable private information," as defined by 45 CFR §46.102. This definition is interpreted broadly, therefore, even if a student or researcher is just interviewing people or conducting a survey, human subjects are involved in the research and the research must be reviewed by the IRB in accordance with this policy.
The following research projects/activities are subject to prior review and approval by Oakland City University's IRB: any documentation of information from an identifiable person or any collection of information about an identifiable person that is not publicly available, when the results of the research activity will be made public (for example, through oral presentations or written articles for publication). Such research projects include any qualitative and quantitative research that involves human participants. If there is any doubt as to whether a proposed project should be reviewed by the IRB, a member of the IRB board should be contacted for assistance.
Which application form should the student or researcher use to have his or her research proposal reviewed?
In order for a student or researcher to conduct any type of research activity involving human subjects and/or animals, the student or researcher must fill out the appropriate sections of the Universal Research Application. The sections of the Universal Research Application that will be required to be completed and the documentation that will need to be included with the application depend on the applicable review level for the application. There are three tiers of IRB review into which research activities involving human subjects and/or animals could fall. The three tiers are:
- Exempt status
- Expedited review status
- Full review
The student or researcher is to initially determine the type of IRB review for which his or her project would qualify. (The IRB will make the final determination.) The student or researcher needs to understand that irrespective of the level of review that he or she determines is appropriate for his or her research activity, any research project may be submitted to the IRB for full review at a regularly convened meeting upon the election of the IRB. If the student or researcher has questions about the type of review for which the research activity will qualify, he or she should call the Chair of the IRB or any one of its members.
If a student or researcher desires to conduct research activities that involve animals, then, in addition to the policies and procedures outlined in this policy, the student or researcher should be familiar with and prepared to follow the Oakland City University polices and guidelines and the Federal regulations with regard to care and use of animals. The Animal Welfare Act of 1966 (P.L. 89-544, as amended) and the Health Research Extension Act of 1985 (P.L. 99-158) provide guidelines and requirements for the care and husbandry of animals utilized in research activities. In addition to the Universal Research Application (completed for Full Review Status) required for research activities involving human subjects and animals, the student or researcher will be required to complete an Animal Care and Use Application. The Animal Care and Use Application must be submitted at the same time as the Universal Research Application, so that the IRB can conduct a Full Review of both applications.
The appropriately completed Universal Research Application and the necessary supporting documentation, must be submitted electronically to email@example.com as an attachment, along with any necessary other attachments. After the Universal Research Application form has been reviewed and approved by the appropriate level of the IRB, the student or researcher must submit an original, signed copy of all signature pages in the Universal Research Application to the Oakland City University IRB in Murray Administration Center prior to commencing any activities.
A current copy of the curriculum vita of the Primary Investigator (PI) (faculty member) must be on file in the Academic Affairs office. If the PI has submitted a current vita during the current academic year, he or she will not need to include it with his or her research application.
An Exempt Status Universal Research Application may be submitted at any time. Only one (1) member of the IRB needs and/or will be assigned to review this level/type of application. In the event the IRB member assigned to review the Exempt Status Universal Research Application has questions about the Universal Research Application that need to be answered prior to approving or disapproving the research activity, the student or researcher will be contacted for clarification. A response by the IRB will generally be given within ten (10) working days. (For the purposes of this policy, holidays and weekend dates are not considered working days.)
An Expedited Review Status Universal Research Application may be submitted at any time. Only one (1) member of the IRB needs and/or will be assigned to review this level/type of application. In the event that the IRB member assigned to review the Expedited Review Status Universal Research Application has questions about the Universal Research Application that need to be answered prior to approving or disapproving the research activity, the student or researcher will be contacted for clarification. A response by the IRB will generally be given within ten (10) working days. (For the purposes of this policy, holidays and weekend dates are not considered working days.)
A Full Review Status Universal Research Application may be submitted any time. The entire IRB must review a Full Review Status Universal Research Application. The IRB will generally meet within ten (10) working days after the Full Review Status Universal Research Application has been submitted. (For the purposes of this policy, holidays and weekend dates are not considered working days.) In the event that the IRB has questions about the Universal Research Application that need to be answered prior to approving or disapproving the research activity, the student or researcher will be contacted for clarification. A response by the IRB will generally be given within ten (10) working days after the IRB meets to discuss the Full Review Status Application. Please note that the IRB may require that a student or researcher provide written clarifications to questions the IRB may have with regard to the Full Review Status Universal Research Application prior to approving or disapproving a research activity.
In addition to the forgoing outline of the application process, Federal Certification forms will need to be provided if the research proposal is being submitted for federal or state funding that requires such forms. Please note that while Oakland City University and the IRB are committed to expediting the application process for all research involving human or animal subjects, the foregoing outline and timeline is an estimate only and particular circumstances may require more or less time to render a decision on whether research activities are approved or disapproved.
No data or research on or with human subjects or animals may be collected or commenced until approval is received from the IRB.
Federal law requires that the IRB make certain that the student or researcher understands each of these ethical issues:
- Potential research-related risks to human subjects are minimized in the areas of physical, psychological, social, legal, and economic status.
- The risks to human subjects are reasonable in relationship to the anticipated benefits to the subject.
- The selection of human subjects is equitable and no group is excluded without justifiable reason based on gender, race, religion, or economic status.
- Confidentiality of human subjects is protected as required by law.
- Informed consent of human subjects in the research study is demonstrable.
- Evidence of understanding of any special problems that may potentially exist in the research is explored.
- Treatment and care of animals is appropriate.
The IRB acknowledges that the above list is not complete and that it is to serve as a basis for the student or researcher to understand the ethical issues involved in research that must be addressed, and the importance of those issues.
For further understanding of ethical issues involved in ethics and human subject research, the IRB recommends online resources and the following ethics books, available in the OCU library:
Title: How good people make tough choices
Author: Kidder, Rushworth M.
Year/Format: 1995 / Book
Oakland City Univ. Library / Main: 658.4 K533
Title: Constructing a life philosophy: opposing viewpoints
Author: Bender, David L., 1936-
Year/Format: 1993 / Book
Oakland City Univ. Library / Main: 140 C713
Title: Plato. Ethics, politics, religion, and the soul
Author: Fine, Gail.
Year/Format: 1999 / E- BK
Oakland City Univ. Library / EBooks:
Title: Ethics: selections from classical and contemporary writers
Author: Johnson, Oliver A.
Year/Format: 2004 / Book
Oakland City Univ. Library / Main: 170.22 J64e
Title: Ethics, the heart of leadership
Author: Ciulla, Joanne B.
Year/Format: 1998 / E- BK
Oakland City Univ. Library / EBooks:
Title: An inquiry concerning human understanding
Author: Hume, David, 1711-1776.
Year/Format: 199u / E- BK
Oakland City Univ. Library / EBooks:
Title: Ethics in plain English: an illustrative casebook for psychologists
Author: Nagy, Thomas F.
Year/Format: 2000 / Book
Oakland City Univ. Library / Main: 174.915 N39e
Title: Ethics & organizations
Author: Parker, Martin.
Year/Format: 1998 / Book
Oakland City Univ. Library / Main: 174.4 E855
Title: Ethics and the professions
Author: Appelbaum, David.
Year/Format: 1990 / Book
Oakland City Univ. Library / Main: 174 E835
Title: Ethics and social concern
Author: Serafini, Anthony.
Year/Format: 1989 / Book
Oakland City Univ. Library / Main: 170 E864
Author: Wekesser, Carol, 1963-
Year/Format: 1995 / Book
Oakland City Univ. Library / Main: 174.4 E845
The Federal regulations and University policies concerning human subject involvement in research activities exist to ensure, among other items, that each human subject enters into the research voluntarily and with adequate information. Therefore, consent must be obtained from all human subjects and such consent must be informed and voluntary. The requirement and circumstances for obtaining informed consent are specific and must be followed by all students and researchers. Federal regulations require that all informed consent forms contain certain elements. If the research project requires a more comprehensive form for informed consent, an IRB member can assist the researcher in developing such a form. Researchers should read the Basic Elements of Informed Consent to become familiar with the appropriate principles of informed consent.
Any member of the IRB is able to answer questions with regard to the application process and application requirements. Questions may be directed to the Institutional Review Board at firstname.lastname@example.org.
The IRB is composed of Oakland City University faculty members, as well as one external member of the community. The law requires that IRB have at least five members. The law also requires that each IRB include both males and females, people from varying cultural backgrounds, and people from varying professions—at least one member whose primary concerns are scientific, at least one member whose primary concerns are nonscientific, and at least one member who is not affiliated with the institution.
The Oakland City University IRB has a self-imposed goal of having a representative from each of the schools that conduct or may conduct human subject research. Members are appointed by the Vice President of Research and Planning or designee for two-year terms.
The committee presently includes the following individuals:
- Jordan Mays, Institutional Researcher
- Dr. Linda Marley, Education
- Dr. Michael Atkinson, Life Sciences
- Dr. Mary Jo Beauchamp, Education
- Dr. Norman Reynolds, Business
- Dr. Steve Etherton, Family Medical Practice