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Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalized knowledge.

Human Subject means a living individual about whom an investigator conducting research obtains: 1) data through intervention or interaction with the individual, or 2) identifiable private information.

The IRB performs the review to protect the rights and welfare of human subjects involved in research and to assist the investigator and the University in the mutual obligation to comply with all federal, state and OCU policies with respect to these subjects. IRB approval must be obtained if any of the following circumstances apply:

• The research is sponsored by OCU;
• The research is conducted by or under the direction of any OCU employee or student in connection with his or her responsibilities;
• The research is conducted by or under the direction of any OCU employee or student using any subjects, property or facility at OCU or any location identified with the University; and
• The research involves the use of OCU’s non-public information to identify or contact human research subjects or prospective subjects. 

All research involving human subjects must be guided by the ethical principles set forth in the Belmont Report: 

1. Respect for Persons: Acknowledging autonomy and protecting those with diminished autonomy.
2. Beneficence: Maximizing possible benefits and minimizing possible harms.
3. Justice: Ensuring reasonable, non-exploitative, and equitable procedures and outcomes in the selection of research subjects. 

2026-27 Members

Dr. Sara Buster - Nursing, IRB Chair

Dr. Mark Davies - Philosophy

Dr. Cheryl Frutchey - Nursing

Dr. Paul Gebb - Dance

Dr. Melissa Hakman - Psychology

Dr. Joey Medina - Physician Assistant Program

Need to contact IRB at OCU?  Email us at [email protected]

 
The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and well-being of subjects involved in research.

U.S. regulations governing the protection of human subjects.

The report from the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research that establishes ethical principles and guidelines for the protection of human subjects of research.

Information about proposing and conducting NIH extramural research involving human subjects, including policies, regulations, training and resources.

Guidance and resources from the Department of Education on the protection of human subjects in research.

Information and guidance from the FDA on principles of good clinical practices and human subject protection.

Adverse Event is any untoward or unfavorable occurrence in a human subject, including any abnormal sign, symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research. Adverse events encompass both physical and psychological harms. 

• External adverse events: adverse events experienced by subjects enrolled by investigators at other institutions engaged in a multi-center study in which OCU is participating.
• Internal adverse events: adverse events experienced by subjects enrolled by an investigator at OCU whether as a part of a multi-center study or solely as a OCU study. 

Coercion (Undue Influence) occurs when an overt or implicit threat causes the participant to act in a way that is contrary to their own interest.

Clinical Trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. These studies may include drugs, biologics, devices, or behavioral interventions. 

Human Subject means a living individual about whom an investigator (whether professional or student) conducting research: 

• Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens;
• Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. 

Incident is an occurrence that may be considered an adverse event or unanticipated problem. 

Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. 

Interaction includes communication or interpersonal contact between investigator and subject.

Informed Consent is defined as a person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence. 

Minimal Risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. 

Noncompliance is the failure to comply with federal or state regulations, OCU policies and/or procedures governing research with human subjects, or requirements of the IRB. 

• Continuing Noncompliance is noncompliance that has been previously reported, or a pattern of ongoing activities that indicate a lack of understanding of human subjects’ protection requirements that may affect research participants or the validity of the research and suggest the potential for future noncompliance without intervention.
• Minor Noncompliance is a deviation from procedures that does not increase risks to research participants, compromise participants’ rights or welfare, or affect the integrity of the research/data or the IRB process.
• Serious Noncompliance is an act or omission that has the potential to increase risk to research participants, compromise participants’ rights or welfare, or affect the integrity of the research/data or IRB process. 

Multi-site means that the same research procedures (i.e., protocol) are being conducted at one or more domestic sites and that each site is under the control of a local participating investigator. 

Principal Investigator (PI) has primary responsibility for the research project. The PI may be an OCU faculty member, staff member, or student, depending on the nature of the project. All research in which a student is the PI must be supervised by a OCU faculty member with a current appointment.

Prisoner means any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing. Individuals are prisoners if they are in any kind of penal institution, such as a prison, jail, or juvenile offender facility, and their ability to leave the institution is restricted. Prisoners may be convicted felons or may be untried persons who are detained pending judicial action, for example, arraignment or trial. 

Private Information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record). 

• Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information. 

Protocol is the description of research or related projects presented to the IRB for review. Research projects may encompass several individual investigations using related techniques or common themes. The proposed projects must be presented in sufficient detail to enable the IRB to determine whether adequate provisions have been made for the protection of the subjects’ rights and welfare.

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. 

Risk is the probability of harm or injury occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. The risks to which research subjects may be exposed have been classified as physical, psychological, social, and economic. The determination of such risk is a matter of sound professional judgment and responsibility by the IRB as well as the investigators (see Evaluation of Risk section ). 

Unanticipated Problem is any incident, experience, adverse event, or outcome that meets the following criteria: unexpected given the described procedures, informed consent, and population characteristics; related or possibly related to participation in the research; suggests that subjects are placed at greater risk than previously known. 

Vulnerable Populations include special populations such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons for which special safeguards should be considered. 

Written (or in writing) refers to writing on a tangible medium (e.g., paper) or in an electronic format.