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The Anderson University Human Subjects Committee is responsible for making decisions about what constitutes human subject research and the implementation of human subject’s research protection. Institutional Review Board (IRB) review of research serves to assure the protection of rights and welfare of human subjects.
Any research involving human subjects conducted using Anderson facilities or property, financially supported with Anderson funds, or performed by Anderson faculty, staff, or students MUST be reviewed and approved by the Anderson University Human Subjects Committee.
The following links are provided to guide you as you learn more about human subject research and the IRB review process.
→ Do I need IRB review?
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
○ Am I conducting research?
Anderson University 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
○ Does my research involve human subjects?
According to the Code of Federal Regulations, 45 CFR 46.102 (f):
A Human Subject is any living individual about whom an investigator (whether professional or student) conducting research obtains:
- Identifiable private information through observation of an individual including information about behavior that occurs in a context in which an individual can reasonably expect that no observation is taking place, or
- Data through intervention or interaction with the individual, or
- Private information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).
- Manipulations of the subject or the subject’s environment that are performed for research purposes; or
- 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
- 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 Anderson'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-what do we want here??] 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.
→ What do I do if I need IRB review? (My research requires IRB Review- What is next?)
○ How do I become an investigator?
Complete IRB Education and Training Requirements
ALL Anderson 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. Anderson 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 Anderson University must have on file with the HSC a valid CITI Training certificate of completion.
In accordance with Anderson 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. **??**
○ How do I get my research approved?
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. Anderson University’s HSC 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 from the IRB.