Institutional Review Board
Mercer University's Institutional Review Board (IRB) and the Office of Research Compliance (ORC) are responsible for making final decisions regarding what constitutes human subject research and the implementation of human subject's research protections. The purpose of IRB review of research is to assure the protection of the rights and welfare of human subjects.
Any research conducted using Mercer facilities or property, financially supported with Mercer funds, or performed by Mercer faculty, staff, or students MUST be reviewed and approved by the Mercer University Institutional Review Board.
To learn more about human subject research and IRB review and approval, use the following links to quickly jump to a specific section of information.
Is IRB Review Necessary for my Study?
A study requires IRB Review if it meets both of the following definitions:
- It is research and
- It directly involves human subjects or their private or identifiable information from biological samples, the review of medical records, or deception of research
What Constitutes Research?
Mercer adheres to the Code of Federal Regulation, 45 CFR 46.102 (d), which states:
Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Systematic investigation is an activity that may include:
- Collection of observational or qualitative data;
- Collection of data using surveys, testing or evaluation procedures, interviews, or focus groups;
- Collection of data using experimental designs such as clinical trials; or
- Some demonstration and service activities
Contribution to generalizable knowledge is the public presentation of the study data through any of the following:
- Meetings, conferences, seminars, poster presentations, etc; or
- Publications including journal articles, papers, dissertations, and Master's Theses
- Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship);
- Public health surveillance activities;
- Collection and analysis of information, biospecimens, or records for criminal justice or criminal investigative purposes; and
- Certain activities in support of intelligence, homeland, security, defense, or other national security missions. [§___.102(l)]
Are Human Subjects Involved?
According to the Final Rule, 45 CFR 46.102 (e):
- obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
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;
- Applications of procedures or treatments such as drugs, devices, or biologics by which data are gathered; or
- Administration of psychological therapies or counseling to change behavior or promote well-being
Interaction includes:
- Communication or interpersonal contact between investigator and subject; or
- Deception of the subject; or
- Interpersonal contact with the subject; or
- Physical procedures to collect data, such as taking blood samples
Studies that use bodily materials such as cells, blood, urine, tissues, organs, hair, or nail clippings may be research, even if you did not collect these materials. However, such research may be exempt if materials are not personally identifiable (Only the IRB has the authority to determine exemptions).
If you are sure that your proposed project is research involving human subjects and requires IRB review, please continue to My Research Requires IRB Review – What is Next? as you must comply with Federal Regulations and Mercer's policies for the protection of human subjects.
If you believe that your project does not meet the above definitions, please contact the Office of Research Compliance for further assistance.
NOTE: Graduate students planning a thesis or dissertation in a social/behavioral study typically require IRB review in order to conduct their research.
My Research Requires IRB Review - What is Next?
Complete IRB Education and Training Requirements
ALL Mercer University faculty, staff, and students who are involved in research using human subjects (all research personnel listed on the application including both the Principal Investigator and any Co-Principal Investigators) must complete approved education in Human Subjects Protection. Mercer University uses a web-based training provided by the Collaborative IRB Training Initiative (CITI) that provides basic training in human subject research. All investigators conducting research involving human subjects through Mercer University must have on file with the ORC a valid CITI Training certificate of completion.
In accordance with Mercer University’s policy on the conduct of research with Protected Health Information (PHI), HIPAA requirements must be met for research conducted using active or inactive medical records.
Apply for Approval
Researchers proposing to use human subjects are required according to University policy to submit an application to the IRB for review and approval before initiating each project. Mercer University’s IRB reviews applications for two types of human subject research: Minimal Risk Research and Clinical Trials (Greater than Minimal Risk Research).
Download the appropriate protocol forms for the type of research you are conducting and submit a complete application with all necessary supporting documents. Investigative research for a study may not begin until the Principal Investigator (PI) receives a formal letter of approval or exemption from the IRB.
Seek Funding
If you are seeking funding for your study, please contact the Grants and Contracts Office for further assistance. For research sponsored by NIH agencies, IRB approval may be delayed until notification of award. However, research may not be initiated in any case until IRB approval is obtained.
