Q1: Does your proposed activity involve the use of “Human Subjects”?
1. Will You Collect or Utilize Data:
a) Physically gathered from a person?
b) By manipulating a person or their environment?
c) By communicating with a person (e.g., via verbal or written survey/interview)?
2. Will you collect or utilize privately identifiable information (i.e., the identity of the subject can be readily obtained by the investigator or from the information) from/about a person?
– Medical records/tests (including previously archived test data),
– Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place,
– Any information provided by an individual which was/is reasonably expected to not be made public.
3. Is there an intervention or interaction with a living person that would not be occurring, or would be occurring in some other fashion, but for your activity?
If you answered “No” to every question, your activity does not need IRB approval. You do not need to contact the IRB.
If you answered “Yes” to any question above, your activity requires action by the IRB. Proceed to Question 2.
Decision Tree: Formal Review
Q2: Does your proposed human studies activity require formal IRB review?
Since your activity involves human subjects, some form of IRB action is required. YOU MUST CONTACT THE IRB. Please continue reading.
1. Does your proposed activity include a systematic investigation, (including research development, testing and evaluation) designed to develop or contribute to generalizable knowledge?
Example activities likely not designed to develop or contribute to generalizable knowledge:
– Course projects used to explore, teach “textbook” knowledge.
If you answered “No”: Inform the IRB that approval is not required.
Example activities likely designed to develop or contribute to generalizable knowledge:
– Project whose results might be published in a scientific journal/conference.
– Most federally-sponsored investigations; most investigations sponsored by not-for-profit agencies; most industry-sponsored projects (even if the results may be held proprietary).
If you answered “Yes”: Your activity requires IRB review. Proceed to Question 3.
Decision Tree: Exemption
Q3: Should you apply to the IRB for an “Exemption”?
The government exempts human studies activities for one of six specific reasons. To apply for an exemption, your activity must be contained within one or more of these categories. The categories are summarized in the Exemption from IRB document.
1. Do You Believe That Your Activity Is Contained Within One Or More of the Exemption Categories?
If you answered “Yes”: Apply for an IRB exemption for your activity using the IRB Application Form to apply for an IRB Exempt Review.
If you answered “No”: Your activity is not exempt. Proceed to Question 4.
Decision Tree: Expedited Review
Q4: Since your research does not qualify for an exemption, should you apply to the IRB for an “Expedited Review”?
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.
Example activities likely to be considered “minimal risk”:
- Written or verbal surveys on non-controversial topics or on topics not likely to evoke strong emotion.
- Non-invasive physiologic recordings (e.g., ECG, EEG).
Example activities likely not to be considered “minimal risk”:
- Written or verbal surveys on controversial topics or on topics likely to evoke strong emotion (e.g., incidents of assault, sexually transmitted diseases).
- Invasive physiologic recordings.
1. Is your activity of “minimal risk” to all human subjects involved?
If you answered “Yes”: Submit a completed IRB Application Form to apply for an IRB Expedited Review.
If you answered “No”: Submit a completed IRB Application Form to apply for an IRB Full Review.