Frequently Asked Questions
All research involving human subjects requires prior review by the IRB. However, the federal regulations have very technical definitions for 'human subjects' and 'research'. If you question the necessity of your project needing IRB review, please consult the IRB Chair at firstname.lastname@example.org.
At CSU Maritime Academy, the IRB meets regularly so that applications can be reviewed in a timely manner. It is the goal of the IRB to review applications for exempt and expedited research as quickly as possible of the receipt of a complete application (during the academic year). Applications that require a full Board review can take longer to review. Applications submitted during the summer may take longer to review.
Human subject is defined by the Code of Federal Regulations (CFR), section 46.102f, as "a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information." The regulations extend to the use of human organs, tissue, and body fluids from individually identifiable human subjects as well as to graphic, written, or recorded information derived from individually identifiable human subjects.
Research is defined in the CFR (section 46.102d) as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." Some examples of activities that constitute research include:
- Any study intended to result in publication or public presentation
- Any activity resulting in publication or public presentation, even though it involves only review of existing data that was collected with no intent to publish
- Any use of an investigational drug or device
Thus, research with human subjects includes survey and interview research, as well as evaluation studies.
Informed Consent is intended to allow all human subjects, prior to their participation, the opportunity to understand the nature and scope of the research, issues related to confidentiality, and risks associated with their voluntary decision to participate in the research.
Vulnerable populations include children, pregnant women, ethnic minorities or those who are unable to speak English, people with mental impairment, and prisoners. For more information see 45 CFR 46.107, 111 and 116, as well as explicitly in subparts B, C and D at https://www.hhs.gov/ohrp/sachrp-committee/recommendations/attachment-a-consideration-of-the-principle-of-justice-45-cfr-46.html
Minimal risk involves no more risk than what is normally encountered in the daily lives of healthy individuals.
Voluntary participation means that all subjects freely choose to participate in the research (without coercion or undue influence), and understand that it is their right to withdraw from the study at any point without consequence.
For a study to be carried out at another institution, the Principal Investigator must seek a written permission letter from a person from the institution with authority to approve the recruitment of human subjects and to conduct research at the institution.
Exempt research designation may not be determined by the Principal Investigator. Only the IRB, upon review of the application, may grant the exempt designation.
A Classroom project that will be used for teaching and learning the research tools in the classroom or for pedagogy and will not be published or presented beyond the classroom does not require IRB review and approval.
Identifiable information is any type of information that can reveal the identity of a participant. This includes, but is not limited to, name, job title, age, fingerprints, biometric data, gender, birth date, ethnicity or race, medical records, and the zip code for a location with a small population. Confidentiality of the participants’ identity must always be maintained.
A complete IRB application includes a completed and signed application form and any additional materials that will be used in the project, e.g., informed consent forms, recruitment flyers/posters, interview questions and/or a copy of survey(s) to be used, the institutional permission letter, and the Principal Investigator training certificate. Please note that the characteristics of each project will dictate what additional items are needed. Some projects will not need all items listed above.
Human Subjects training is required of all project personnel who will be interacting with human subjects or who will have access to the data and/or are involved in the analysis. This includes completing CITI training on the Training and Compliance page.
Disclosure of the scope of the project must be described clearly and in plain language in the informed consent forms. Disclosure must also communicate that participation is voluntary with no consequences for the participant who may not want to participate or may stop participating at any time they decide to.
Deception of the scope or nature of the project must not be used for the project. However, in some instances, it may be necessary for objective research. In those cases, the IRB will carefully evaluate the need and extent of deception and the risks and rewards associated with it in approving the application.
- Continuation of research on a project that extends beyond the IRB approved period requires IRB approval. IRB approvals are for one year, and any extension of the research beyond this period requires filing a Research Continuation Form for IRB’s review and approval. Approvals for projects that are deemed exempt or are reviewed on an expedited basis do not expire.