Determining if IRB Approval is Needed

Before submitting an IRB application, first determine if IRB review is actually required for your project.

IRB review and approval is required for projects that:

• Meet the definition of research
• Involve human subjects and
• Include any interaction or intervention with human subjects or involve access to identifiable private information

IRB approval is required before you start your research.

Federal regulations require that research projects involving human subjects be reviewed by an Institutional Review Board (IRB). The IRB must approve or determine the project to be exempt prior to the start of any research activities. The IRB cannot provide approval or determinations for research that has already been concluded.

Does your project meet this definition of Research?

Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

A Systematic Investigation follows a predetermined plan for looking at a particular issue, testing a hypothesis or research question, or developing a new theory that may include:

• Collection of quantitative 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
• Observation of individual or group behavior

Contribute to Generalizable Knowledge means that the purpose or intent of the project is to test or to develop scientific theories or hypotheses, or to draw conclusions that are intended to be applicable and/or shared beyond the populations or situations being studied. This may include one or more of the following:

• Presentation of the data at meetings, conferences, seminars, poster presentations, etc.
• The knowledge contributes to an already established body of knowledge
• Other investigators, scholars, and practitioners may benefit from this knowledge
• Publications including journals, papers, dissertations, and master’s theses

If the project does not meet the definition of research (i.e. is not a systematic investigation or does not contribute to generalizable knowledge), as described above, then the project does not require IRB review and an IRB application is not required.

A Human Subject is defined by OHRP as - a living individual about whom an investigator (whether professional or student) conducting research obtains:

 

• Data derived through intervention or interaction with the individual, or 
• Identifiable private information.

Identifiable information as defined by OHRP - means information that is individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information).

Protected Populations
Some research may involve protected population groups. Research involving these populations who for various reasons cannot freely grant informed consent, must generally go through a Full Review.

Protected population includes these groups:

• Prisoners

• Minors (younger than 18)

• Experiencing diminished capacity

• Mentally or physically challenged

• Pregnant (particularly for those projects where physical procedures, exercises, etc., will be performed).

All research involving protected populations must undergo a Full Review. The IRB must ensure research involving these population groups is ethical and legal.

 

Interaction—Any communication or interpersonal contact between the investigator(s) and the subjects. This includes in-person, mail, telephone, etc. Online surveys (even if anonymous) involve interaction.

Intervention—Physical procedures or manipulations of the subject or his/her environment (e.g. taking blood samples, exercise studies, use of devices, cognitive tasks, etc.)

Private Information—Information about behavior that occurs in a context in which the individual can reasonably expect that no observation or recording is taking place (e.g. person’s home, exam room, public restroom, etc.) OR has been provided for specific purposes with a reasonable expectation that it will not be made public (e.g. medical records, student records, employee file, etc.)

Identifiable Information—The identity of the individual is or may be readily ascertained by the investigator or others either directly or indirectly through the use of codes or a combination of data points.

If the project does not include any interaction or intervention with human subjects or include any access to identifiable private information, then the project does not require IRB review. If even one of the above categories are met (intervention, intervention, access to identifiable private information), an IRB application is required.

Informed Consent- No research involving a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.

Basic elements of informed consent:

1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
    
2. A description of any reasonably foreseeable risks or discomforts to the subject.
    
3. A description of any benefits to the subject which may reasonably be expected from the research.
    
4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
    
5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
    
6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
    
7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and
    
8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled (45 CFR 46.116).