IRB Determination Form

What type of IRB Review does my project require?

To assist us in making a determination of whether your project constitutes Human Subject Research, please complete this short questionnaire. You should also consult with your faculty advisor/dissertation chair/faculty project chair/scholarly project advisor, etc. before completing this form.

Note: All EdD students should complete this form to determine level of review but will be expected to complete the IRB application process. 


Human Subject Determination Form

NOTE: HUMAN SUBJECT DETERMINATION FORM DOES NOT CONSTITUTE IRB APPROVAL. YOU MUST OBTAIN OFFICAL IRB APPROVAL PRIOR TO BEGINNING ANY DATA COLLECTION.

Definitions: 45 CFR 46.102

Human subject - a living individual about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information.

Intervention includes both physical procedures by which information is gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.

Interaction includes communication or interpersonal contact between investigator and subject.

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and 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 information). Private information must be individually identifiable.

Identifiable is where the identity of the subject is or may be ascertained by the researcher, or will be associated with the information. The research could involve the use of coded data/specimens.

Coded means a living individual's identifiable information such as name or social security number has been replaced by a code, such as a number, letter, or combination thereof and there is a key to link the code to the identifiable information of that individual. Coded data are considered identifiable under the Common Rule.

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

Minimal Risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

IRB Approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

Explanation of Review Levels:

Exempt (45 CFR 46.104) - Research may be considered exempt if it falls within one of the below categories:

  1. Educational research
  2. Surveys, interviews, educational tests, and public observations (that do not involve children)
  3. Benign behavioral interventions
  4. Secondary research uses of identifiable private information or identifiable biospecimens
  5. Federal research or demonstration projects
  6. Taste and food quality evaluation studies

Research is not exempt if it:

is greater than minimal risk
or;
involves administration or use of drugs or devices

Expedited (45 CFR 46.110) – Research involves no more than minimal risk, and for minor changes in previously approved research. Research may qualify for expedited review if it falls within one of the below categories:

  1. Clinical studies of drugs and medical devices only when certain conditions are met
  2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture in certain populations and within certain amounts
  3. Prospective collection of biological specimens for research purposes by noninvasive means
  4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.
  5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes
  6. Collection of data from voice, video, digital, or image recordings made for research purposes
  7. Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies

Full Board (45 CFR 46.110) - The probability and magnitude of harm or discomfort anticipated in the research are greater in and of themselves from those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests, or are not in a category allowed for Expedited Research. Research that does not qualify for exempt or expedited (presents more than minimal risks to subjects) will require review at a fully convened IRB committee meeting.

Note: A project that is considered exempt must still be submitted to the IRB and the IRB will certify exemption from expedited or full-board review.


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