Institutional Review Board

Institutional Review Board

The review of human subjects research at Oakland City University (OCU) is a collaborative process intended to facilitate research while protecting the rights and welfare of research participants. 

The primary purpose of an Institutional Review Board (IRB) is to protect the rights and welfare of human subjects involved in research activities being conducted under its authority. Research activities conducted by OCU faculty, staff, and students that involve human subjects or their identifiable, private information or specimens must be determined exempt by an IRB administrator or coordinator or reviewed and approved by an Institutional Review Board (IRB). All research involving human subjects must be reviewed and approved by OCU's IRB before the commencement or recruitment of subjects and data collection.

The OCU IRB is federally registered with the Federalwide Assurance (FWA) for the Protection of Human Subjects with the U.S. Department of Health and Human Services and is empowered by the Provost to review all research protocols involving human subjects to be conducted at or supported by OCU. The OCU Compliance Officer provides general oversight of the IRB and regularly conducts audits of the IRB practices and records. The administrator and/or the chair of the IRB reports to the Provost.

What to Consider Before Completing a Request for New Research Project (IRB Application)

Determine whether your activities are focused on research or continuous improvement

Determining if an activity is Research or focused on Quality Improvement (QI) can be challenging. Federal regulations require human subject research to be reviewed and approved by an Institutional Review Board (IRB), while strictly QI activities do not require IRB oversight. Please review the document, Quality Improvement or Research: Do I Need IRB Approval? for assistance in making such a determination.

Determine whether activities are human subjects research

In some cases, an activity that involves human subjects may not meet the federal guidelines for IRB review of human subjects research. For example, a project such as a quality improvement survey or oral history documentary may involve human subjects, but is not considered "research." Alternatively, a project may be considered research, but the existing data being analyzed has no identifiers or codes linking to identifiers and therefore the research does not involve human subjects.

Funding

Many investigators choose to wait until they hear that a project will likely be funded before submitting an IRB protocol. This saves time for both the primary investigator or the student researcher and the IRB since many grant applications do not get funded the first time. Most grant applications will allow you to indicate that human subjects review is "pending" or "in process." 

Exempt vs. non-exempt research

Please check first to see if your study fits under an exemption. Certain categories of human subjects research are low-risk and exempt from IRB criteria for review.  For example, projects involving benign or anonymous surveys or normal classroom activities may be exempt. OCU IRB reviews exempt requests to determine whether your study meets the criteria for exemption. Once a study is determined exempt, the study is valid for the duration of the described research as written without having to be renewed. 

Researchers conducting exempt research are exempt from the regulations but must adhere to the ethical principles in the Belmont Report: Respect for persons (e.g., informing subjects they are in an OCU research study, describe what they are being asked to do, provide contact information, and tell them they can choose to participate or not, or refuse to answer any questions), Beneficence (minimize any harms including breach of confidentiality), and Justice (equitable selection of subjects).

External research involving OCU students as subjects

External researchers who are not collaborating with OCU researchers and who plan to conduct research involving OCUstudents are asked to notify the OCU IRB and provide their respective institution's IRB approval as a courtesy. Please contact irb@oak.edu. 

Research Participation

The Office for Human Research Protections (OHRP) in the U.S. Department of Health and Human Services provides a useful website, About Research Participation, with resources that are designed to help potential research subjects better understand research and ask for the information they need to decide whether or not to participate. The resources include a series of short videos about participating in research and a printable list of questions potential volunteers can ask researchers.

Current and potential research participants are encouraged to check out the links on About Research Participation to watch videos, view questions to ask researchers and find additional resources related to research participation.

How to Proceed

No human subjects research can begin until an IRB decision is reported to the primary investigator(s), co-investigator(s), student researcher(s), and faculty sponsor(s).

OCU requires that human subjects research training is mandatory for all researchers working with human subjects whose research protocol is subject to review by OCU's IRB. This requirement includes students conducting research that is subject to IRB review.

All researchers must prepare a New Research Project Request and any supplemental documentation that describes the proposed research project. All IRB forms are provided as MS Word documents and checklists and guides associated with the IRB forms are available to assist researchers in the preparation of the IRB application packet. 

If you have any questions prior to preparing any of the IRB forms, please feel free to correspond to the IRB through the following email account: irb@oak.edu.

After receiving your OCU IRB form(s) electronically, the IRB administrator/coordinator will conduct an initial screening to determine if your research fulfills the criteria for exemption from IRB review, and if it does your request will be reviewed so that you may proceed with your study. 

If your protocol does not qualify for exempt status, you will be supplied a complete IRB application packet, which will be sent to you and may be returned electronically to irb@oak.edu. The application will receive either "expedited review" or "full committee review" by the relevant subcommittee.  The IRB may request additional information in order to complete its deliberation.

Institutional Research Board Forms and Form Guides & Checklists

The following forms and associated guides and checklists are available to researchers at Oakland City University:

Human Subjects Research Submission Checklist

The checklist is intended for researchers and faculty sponsors to use when conducting their review of the New Research Project request (IRB application) prior to its submission to the IRB. [The checklist is available in the form to the right.]

New Research Project Request (Exempt and Limited Category)

The New Research Project Request form (IRB Application) should be completed by all principal investigators and students researchers wishing to conduct exempt and limited category research at Oakland City University.

Download New Research Project Request Form

Consent Form for Research Participation

The Consent Form for Research Participation should be used as the template for research participation consent when utilizing an electronic survey. Information on how to secure a waiver of informed consent from research participants completing electronic surveys is included in the guide and checklist for the New Research Project Request form.

Download Consent Form for Research Participation Form

Parental Permission Form for Child's Research Participation

The Parental Permission Form for Child’s Research Participation form must be used to gain the permission of parents and legal guardians so that their children (under 18 years of age) can participate in a research project.

Download Parental Permission Form for Child's Research Participation

Assent Form for Use with Minors

When children are involved in research, Federal regulations require Investigators to have the child’s agreement to take part in the study.  This is known as assent and means that the study has been explained to the child, and the child is willing to take part.  This is separate from getting a parent or guardian’s permission for the child to participate.  Generally, OCU’s IRB requires that the assent of a minor child be sought when the child is seven years of age or older unless the child’s decision-making capacity is impaired. Principal investigators and student researchers must obtain the assent from a minor in-person, and electronic consent is not approved by OCU.

Download Assent Form for Use with Minors

Confidentiality Agreement for Use with Research Assistance/Assistant

The form enables researchers to be assured that all research data and information will be handled so that confidentiality is maintained by persons assisting with the research efforts.

Download Confidentiality Agreement for Use with Research Assistance/Assistant

Confidentiality Agreement for Use with Transcription Services

The form enables researchers to be assured that all research data and information will be handled so that confidentiality is maintained by transcription services.

Download Confidentiality Agreement for Use with Transcription Services

Request for Modification / Amendment

The Request for Modification / Amendment form must be used when the principal investigator or student researcher wishes to modify or amend the research protocols of a previously approved research project.

Download Request for Modification / Amendment

Request for Renewal of an Approved Research Project

The Request for Renewal of an Approved Research Project form must be submitted to the IRB by principal investigators and student researchers when their research exceeds one year since it received IRB approval.

Download Request for Renewal of an Approved Research Project

Declaration for Determination of IRB Member Conflict of Interest

The Declaration for Determination of IRB Member Conflict of Interest form is intended to be completed by members of the OCU Institutional Review Board (IRB), the IRB administrator/coordinator, or others that directly support the IRB process upon the request of the IRB or the IRB administrator/coordinator (i.e., subject matters experts, research methods experts). Principal investigators, co-investigators, student researchers, and faculty sponsors do not need to complete this form.

Download IRB Member Conflict of Interest Form

 

 

Instititutional Review Board Frequently Asked Questions (FAQ)

What does the OCU Institutional Review Board do?

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.

 

Does my research need to be approved by the IRB?

If you are conducting research with human subjects, your research needs to be reviewed by the Oakland City University Institutional Review Board.

 

How long does the IRB approval process take?

A New Research Project Request Form can be submitted at any time. Research requests for exempt status research should be submitted at least 15 working days prior to the end of any academic term to ensure that the IRB has sufficient time to conduct the review. The IRB administrator/coordinator or one (1) member of the IRB will review the research request. A response by the IRB will generally be given within 15 working days (for the purposes of this policy, holidays and weekend dates are not considered working days).

Currently, the IRB is not accepting research applications for expedited or full research review. If any researcher would like to conduct research that will require an expedited or full research review, please contact the IRB at irb@oak.edu.

 

How can I determine if my research involves human subjects?

The Federal Regulations set up to protect human research subjects provides this definition: Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. (CFR 45, Part 46.102(f))

 

When can the researcher start on their research project and collect data?

No data or research on or with human subjects or animals may be collected or commenced until approval is received from the IRB.

 

Where can I get information that can help me whether to participate in a research project or not?

The Office for Human Research Protections (OHRP) in the U.S. Department of Health and Human Services provides a useful website, About Research Participation, with resources that are designed to help potential research subjects better understand research and ask for the information they need to decide whether or not to participate. The resources include a series of short videos about participating in research and a printable list of questions potential volunteers can ask researchers.

Current and potential research participants are encouraged to check out the links on About Research Participation to watch videos, view questions to ask researchers, and find additional resources related to research participation.

 

What should I do if there is an unanticipated event that may result in loss of data, physical harm, or emotional harm to participants?

Notify the Oakland City University IRB within 24 hours of becoming aware of any unanticipated events or problems. The IRB administrator or coordinator will provide information on how to formally report the unanticipated event to the IRB and to the Office of Compliance.

 

What should I do when the research is complete or when the approved time for research is going to expire?

Any research project that has exceeded a one-year period since IRB approval was received must submit a Request for Renewal of an Approved Research Project form. The form as well as a guide and checklist for the form are available on the IRB web page. Principal investigators can submit the form directly to the IRB at IRB@oak.edu while student researchers should submit the form to their faculty advisors.

 

Who are the IRB Committee members?

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 Provost and work with the Assistant Provost for Assessment and Institutional Effectiveness to accomplish the required tasks of the IRB.

 

Who does the research contact if they have questions?

Questions may be directed to the Institutional Review Board at irb@oak.edu or (812) 749-1431.

Institutional Review Board Registration

Institutional Review Board (IRB) Name: Oakland City University IRB #1
IRB Identification/Registration #: IRB00012529