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For Research Participants - Report a Concern

The foremost concern of ¾Ã²Ý¹ú²ú¸£Àû's IRB is ensuring the health. safety and rights of all individuals participating in research conducted by OCU faculty, staff, and students.  

To resolve a minor issue with a study, it is best to contact the Principle Investigator (PI) of the study listed in the contact information given during the Informed Consent process.  If your concern is more serious, please contact the IRB chair at [email protected].  

For Researchers

Reporting a Protocol Deviation

Researchers are required to promptly report proposed changes in research activities to the IRB. Such changes during the period for which IRB approval has already been given may not be initiated without IRB review and approval, except when necessary to eliminate apparent immediate hazards to the participant .  Researchers must complete a modification submission to propose changes in a research activity.

Adverse Event or Unanticipated Problems

An 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 (see Definitions). 

An unanticipated problem is any incident, experience, adverse event, or outcome that meets all of 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 (see Definitions). 

Adverse events and unanticipated problems are not mutually exclusive. An adverse event is not necessarily an unanticipated problem and vice versa. The IRB makes the final determination on categories of incidents. 

• OCU investigators shall report adverse events or unanticipated problems to the IRB within two (2) working days of knowledge of the incident. Researchers must submit a completed Incident Report Form for Legacy Studies to the IRB Office within five (5) working days.
• The incident report shall include at a minimum: name of PI, title of research project, award information (if applicable), a detailed description of the incident, a detailed description of actions or plans to address the incident, and the outcome.
• When reviewing reports of unanticipated problems and adverse events, the IRB shall consider whether the affected research protocol continues to satisfy the requirements for IRB approval, whether risks to participants continue to be minimized and reasonable in relation to the anticipated benefits to the participants, and the importance of the knowledge that may be reasonably expected to result.
• The IRB Chair may call an emergency meeting of the IRB or suspend research activities if necessary to prevent immediate threat to the safety and well-being of research subjects. Notification of suspensions or terminations will include the rationale for the IRB’s action and will be sent by the IRB to investigators, faculty advisors of student investigators, the academic unit administrator, appropriate institutional officials, and the funding agency head if applicable.
• The IRB is authorized to require additional information from the investigator and/or require any modifications necessary to ensure the safety and wellbeing of research subjects and ensure that such incidents will not happen again, either with the investigator or the protocol in question. Changes to a research study proposed by the investigator in response to an unanticipated problem must be reviewed and approved by the IRB Chair and another member before being implemented, except when necessary to eliminate apparent immediate hazards to participants. If the changes are determined to be more than minor, the changes must be reviewed and approved by the convened IRB. 

IRB Reporting Requirements

The IRB shall promptly report unanticipated problems or incidents to the provost. The time frame for reporting will be based on the nature and severity of the incident and be in accordance with applicable  regulations or the OHRP Guidance on Reporting Incidents to OHRP at . 

When required, reports to OHRP, supporting personnel, and the Provost on unanticipated problems shall include: name of the institution, name of PI, title of the research project, award information (if applicable), a detailed description of the incident, actions OCU is taking or plans to take to address the problem (e.g., protocol revision, suspension of participant enrollment, termination of research).