Institutional Review Board (IRB)
The IRB functions under the auspices of the Academic Affairs Council. The IRB reviews research proposals to protect the rights and welfare of human research subjects who participate in research activities conducted under the authority of the graduate school.
IRB reviews are necessary to ensure the safety and protection of research subjects and the ethical conduct of research that involves human subjects. The IRB review determines that the following requirements are satisfied:
1. Informed consent is sought from each prospective participant.
2. Informed consent is documented under and to the extent required by HSS regulation 45 CFR 46.
3. The research design makes adequate provision for monitoring data collected to ensure the safety of participants.
4. The research design makes adequate provision for the monitoring of data collected to ensure the safety of participants.
5. Adequate provisions are made to protect participants’ privacy and maintain data confidentiality.
6. Additional safeguards are included in the study to protect the rights and welfare of participants vulnerable to undue influence.
7. OGS does not support research involving participants likely to be vulnerable to coercion or otherwise compromised is not permitted, such as children or teens under 18, prisoners, and persons suffering from mental disabilities.
At Omega Graduate School, the IRB reviews and responds to proposals considered to be at minimal risk. The review procedure addresses research determined to be of minimal risk to subjects, i.e., ‘poses no more risk to subjects than would be encountered by the average person in their daily activities and involves only procedures listed in the federally described categories of an expedited review.
Expedited reviews may be carried out by the IRB chair or by one of the more experienced reviewers designated by the chair from among members of the IRB.
Policy Statement: Doctoral students must take IRB Human Subjects Protections Training for human subjects research topics for social researchers and provide a certificate of completion to the IRB. OGS is committed to ensuring that all research involving human participants is conducted with the utmost integrity and per established ethical principles and regulatory and institutional requirements for protecting human subjects. Therefore, all student researchers must fulfill this education requirement, and a copy of the completion certificate must be included in the dissertation or research project appendices. Human Research Protection Training can be found at no cost through the federal Health and Human Services Agency.
OGS accepts using the Collaborative Institutional Training Initiative (CITI) program’s research ethics and compliance web-based human research courses to satisfy the requirements outlined in this Policy
Researcher collecting or receiving Protected Health Information (PHI) as part of their proposed research must complete HPPA training and provide evidence of completion. Under the Health Insurance Portability and Accountability Act (HIPAA), “protected health information” is considered to be individually identifiable information relating to the past, present, or future health status of an individual that is created, collected, transmitted, or maintained by a HIPAA-covered entity concerning the provision of healthcare, payment for healthcare services, or use in healthcare operations (PHI healthcare business uses).
OGS Informed Consent Template
- Describe the target population, inclusion and exclusion criteria, and recruitment methods.
- Ensure the recruitment process is fair, equitable, and free from coercion or undue influence.
- Develop a clear and comprehensive informed consent form that includes all relevant information.
- Explain the consent process and ensure that it allows participants to make an informed decision about their participation.
Risks and Benefits:
- Identify potential risks or harms to participants and describe how they will be minimized.
- Describe the anticipated benefits of the research for participants and the broader society or field of study.
Confidentiality and Privacy:
- Explain how participant data will be collected, stored, and protected to maintain confidentiality.
- Describe any measures to ensure participant privacy during data collection, such as de-identification, secure data storage, and restricted access to data.
- If applicable, detail any compensation or incentives provided to participants.
- Ensure that compensation is fair and appropriate and does not create undue influence on potential participants.
Procedures for Withdrawal:
- Clearly outline the process for participants to withdraw from the study at any time without penalty.
- Describe how data will be handled for participants who choose to withdraw.
- OGS does not support research with vulnerable populations (e.g., children, pregnant women, prisoners)
Data Monitoring and Safety:
- Describe any data monitoring or safety oversight plans, such as using a Data and Safety Monitoring Board or independent safety monitors.
- Explain how adverse events or unanticipated problems will be reported to the IRB and addressed to protect participants.