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Some kinds of projects are not considered research and do not require IRB review. Below you will find information to help you determine if your project is considered research and, if so, what type of interaction with the IRB is needed (Exempt, Expedited Review, Full Board Review). 

Note: All application material can be found on the Application Forms and Templates Page.

You are only required to submit to the IRB if your project is research conducted on human participants (aka human subjects)

Step 1: The first step is to determine if your project is “research” 

Research is defined by the federal government as "a systematic investigation...designed to develop or contribute to generalizable knowledge."  [45 CFR 46.102(l)]

Your project is likely not research if you are only:

  • Carrying out a class project that won't be presented beyond your class or archived/published
  • Engaging in a personal interest Venture Grant project that has no academic component
  • Carrying out scholarly and journalistic activities that include the collection and use of information in which the focus is on the specific individuals about whom the information is collected and is not intended to contribute to generalizable knowledge; these activities include oral history, journalism, biography, literary criticism, legal research, and historical scholarship; some documentary projects may be included

More information is available in the

Quick "research" test (answer YES/NO):
  1. Will you present or publish results outside this course or archive results for reuse?
  2. Do you intend the findings to be used beyond this class to inform others or draw generalizable conclusions?

If your answer was NO to both questions your study is not considered research so no IRB submission is needed. If you answered Yes for either question your study is research, and you should proceed to Step 2.

Step 2: If your project is "research" then you need to determine if it is research with "human participants/subjects" 

A "Human Subject" is defined by the federal government as "a living individual about whom an investigator ...conducting research (i) obtains information or biospecimens through intervention or interaction with the individual and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens" [45 CFR 46.102(e)]

“Identifiable private information" means information about a person that was given or observed in a setting where the person reasonably expects privacy, and the researcher can readily learn who the person is (because the data include names, contact details, medical record numbers, or combinations of details that allow identification).  

Based on this definition, you do not need to go through the IRB if:

  • You talk to people for background information, but the people are not the subject of the research (e.g., asking an expert about technical methods)
  • You are not interacting with living people (e.g., if you are  analyzing texts or carrying out ecological research)
  • You carry out non-participant observation of people people in public without recording identifiers or interacting with the people and the observation would not place people at risk of harm

In all other cases, you need to interact with the IRB. 

Quick "human subject" test (answer YES/NO):

  1. Will your data come from interacting with or intervening on living people? (e.g., interviews about their own experiences, surveys, experiments)
  2. Will you collect or access identifiable private information or identifiable biospecimens?
  3. Will you observe behavior in contexts where people reasonably expect privacy (e.g., homes, private offices) or record identifiers (names etc.)?

If you answered NO to all three questions your project likely does NOT involve human‑subjects research. If you answered YES to any questions your project likely involves research on human subjects, and you will need to submit an application to the IRB. 

NOTE: If your participants include vulnerable populations (e.g., prisoners, children, pregnant women) or are outside the U.S., contact the IRB early as additional protections or approvals may be required.

Additionally, know that even if your project does not require IRB review, you still must assure that your project addresses ethical and legal concerns about harm, informed consent, and the other categories of IRB concern. If your project does not require IRB review but you want to make sure that your project is legally and ethically appropriate, please contact the IRB chair. 

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Exempt research requires relatively minimal interaction with the IRB in order to determine whether the research meets the criteria for exemption. There are four types of exemption relevant to research at 今日吃瓜:
  1. Educational Exemption - research conducted in established or commonly accepted educational settings, involving normal educational practices.
  2. Interaction Exemption - research including interactions involving educational tests, survey procedures, interview procedures, or observation of public behavior.
  3. Benign Behavioral Intervention Exemption - research involving benign behavioral intervention and collection of information from adults with their agreement.
  4. Secondary Research Exemption - secondary research use of identifiable private information or identifiable biospecimens.

Importantly, if your project includes any non‑exempt activity, the whole project is not exempt.

 

Quick Test - Exemptions (answer YES/NO) (*see the for more details)

Educational Exemption ()

  • Is the activity conducted in an established or commonly accepted educational setting (e.g., classroom)?
  • Does it involve normal educational practices (e.g., typical classroom teaching, curriculum, or assessment methods)?
  • Will participation or the activity NOT adversely affect a student’s learning opportunities or assessment of instructors?

If YES to all the project may qualify for the Educational Exemption. Submit the Educational Research Exemption Determination Form found on the Application Forms and Template Page.

 

Interaction Exemption ()

  • Does the study involve only educational tests (e.g., cognitive, aptitude), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recordings)?
  • Are the subjects adults, or if subjects are children, is the activity limited to educational tests or observation of public behavior in which the investigator does not participate? 
  • Will you record data so that participants cannot be identified or if the data are identifiable, would disclosure of responses not place subjects at risk of criminal/civil liability or other harms (financial, reputational, employability, education)?

If Yes to all the project may qualify for the interaction exemption. If identifiers are recorded and disclosure could cause harm, limited IRB review is required to determine adequacy of privacy/confidentiality protections. Submit the Interaction Research Exemption Determination Form found on the Application Forms and Template Page.

 

Benign Behavioral Intervention (with Adults) Exemption ()

  • Are all of your participants adults?
  • Are you conducting a benign behavioral intervention (that is, is the intervention brief, harmless, painless, not physically invasive, not likely to have a lasting impact, and not likely to be offensive or embarrassing)?
  • Will data be collected only via verbal/written responses or audiovisual recording?
  • Will subjects consent to the intervention and information collection?
  • Will you record data so that participants cannot be identified or if the data are identifiable, would disclosure of responses not place subjects at risk of criminal/civil liability or other harms (financial, reputational, employability, education)?

If Yes to all the project may qualify for the Benign Behavioral Intervention exemption. If identifiers are recorded and disclosure could cause harm, limited IRB review is required to determine adequacy of privacy/confidentiality protections. This exemption does not apply if the research uses deception about nature/purpose except in narrow circumstances. Submit the Benign Behavioral Intervention Exemption Determination Form found on the Application Forms and Template Page

 

Secondary Research Exemption ()

  • Are you using only existing (already collected) private information or biospecimens?
  • Are the materials publicly available, or will the investigator record the information so subjects cannot be readily identified?
  • Will you NOT contact the subjects as part of this secondary use?

If Yes to all the project may qualify for the Secondary Research exemption. Submit the Secondary Research Exemption Determination Form found on the Application Forms and Template Page

Other important note for any exemption:

  • Does the study involve children, prisoners, pregnant women, or other vulnerable groups? Some exemptions cannot be applied to research on these populations.

Next Steps: If you think your research falls into one of these categories, submit the Exempt Application found on the Application Forms and Template Page. Note, to submit you will need your consent form (for the first three categories). For the Interaction Exemption you will need  a copy of any materials you will use (i.e., educational tests, surveys, interview questions, or a description of the research taking place in a public setting) for the Interaction Exemption. 

If not, read below for information on non-exempt studies. 

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Expedited research requires a regular review but this review can be carried out by a single member of the IRB. The IRB Chair carries out all expedited reviews at present on a rolling basis. Expedited review may be used for certain categories of research involving no more than minimal risk (see the subpage on harm for more discussion of minimal risk research). Examples include collection of data from voice, video, digital, or image recordings made for research purposes, research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

Expedited research requires that the regular IRB application be filled out and sent to the IRB chair with all relevant attachments, including a consent process.

Continuing review: under the revised Common Rule, continuing review is generally not required for many studies eligible for expedited review unless the IRB determines otherwise.

Next Steps: If you think your research falls into this category, submit the Full IRB Application found on the Application Forms and Template Page.

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Full-Board Review Research consists of research that is not exempt and cannot be reviewed on an expedited basis, most often because of the likelihood that it will cause more than minimal harm. Full-Board research requires all members of the IRB to meet and determine whether the research can be approved, needs to be modified first, or must be rejected on legal and/or ethical grounds. 

The application process is the same for expedited and Full-Board research, and all researchers doing non-exempt research are encouraged to send the application and attachments to the IRB chair with the expectation that their research is likely to be reviewable on an expedited basis. If this turns out not to be the case, the IRB chair will inform the researcher.

Next Steps: Submit the Full IRB Application found on the Application Forms and Template Page.

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