Final Revisions to the Common Rule were effective starting on January 21, 2019. After this time, older versions of exempt guidance/forms are no longer valid. Always ensure that you are using the most current guidance and exempt forms available in the PittPRO library and via the links at the bottom of this page.
Introduction to Exempt Review
IRB determination that a study is either Not Research or Does Not Involve Human Subjects
Privacy & Confidentiality
Other Important Definitions
Tips on Entering Exempt Submissions in PittPRO
- The Code of Federal Regulations identifies several different categories of minimal risk research as being exempt from Federal Policy for the Protection of Human Research Subjects. This does not mean that they are exempt from IRB review.
- The IRB does not "approve" an exempt study but instead makes a determination that the project meets at least one of the federal exempt categories criteria.
- Faculty mentors are responsible for oversight of student projects and should ensure that studies are completed and closed before the student leaves the University.
- When studies are conducted in foreign countries, refer to the Guidance on International Research. If you plan on conducting research in a foreign country, you are strongly encouraged to schedule a consultation early in your planning stage by emailing firstname.lastname@example.org (include PI name).
- Prior scientific review by a School or Departmental review committee is not required.
- No annual continuing review is required and no expiration date will be listed on your approval letter.
- It is very important that you close your project when completed or if you leave the University.
The federal regulations include a very specific definition of what constitutes “research” and of what is meant by a “human subject”. Note that all studies involving human specimens require IRB review.
Human subject means a living individual about whom an investigator (whether professional or student) 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.
Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Although the federal regulations do not require official IRB review of studies that do not involve human subjects research, investigators may be required to obtain documentation that their project either is not research and/or does not involve human subjects (e.g., as may be required by a student’s doctoral dissertation committee, a funding agency, or a journal editor). If a study likely does not meet the definition of human subject research or otherwise likely does not require review, contact email@example.com before creating a protocol. The IRB will not provide a formal written determination after the project has been initiated.
The following activities are deemed not to be research:
- Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
- Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
- Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
- Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
The IRB provides a consultation service to the research community and we strongly encourage you contact the IRB with any questions or concerns. Email us at firstname.lastname@example.org to schedule a consultation with a member of the IRB staff. Be sure to include the PI name. If a protocol has been started, even if very little information has been entered, include the protocol number in the email.
- Anonymous means that no one can identify the subject at any time.
- Recorded Anonymously means that recorded data are not linked to the identity of the individual subjects in any way. If there are linkage codes, data is not anonymous.
- Coded means that identifiers are recorded, but data are labeled with a code without identifiers. Linkage information is kept in a separate, secure location.
- Data should typically be recorded anonymously or at least coded.
- When identifiers are recorded, and information is of a sensitive nature, exempt review may not be appropriate.
- Sensitive information is information that has the potential to damage participants’ reputation, employability, financial standing, educational advancement, place them at risk for criminal or civil liability, etc.
- Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., 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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
- Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
- An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
The IRB has developed guidance documents and application forms for the most commonly requested exemptions as noted below. You will be required to download one of the exempt forms, save to your computer, complete and then upload the form on the Basic Information page, question 8 in PittPRO. Exempt forms and category-specific guidance can be found at the links below and can also be found in the Library section of PittPRO. If you are unsure which form to complete, contact an IRB staff member or email us at email@example.com for additional information.
- Educational Strategies, Curricula, or Classroom Management Methods
- Tests, Surveys, Interviews, or Observations of Public Behavior
- Research Involving Benign Behavioral Interventions
- Secondary Research with Data and/or Specimens
- Research and Demonstration Projects Conducted or Supported by a Federal Department or Agency
- Determination that Research Does Not Involve Human Subjects or is Not Research
- Request for an Exception to Informed Consent Requirements: Studies Using In Vitro Diagnostic Devices with Speciments that are NOT Individually Identifiable
- Exempt Data Coordinating Center
- Sample Introductory Script can be found in the A-Z Guidance (PDF)
- Archiving of Exempt Studies
- PittPRO Getting Started Guide
Item 8 prompts you to “Attach the protocol”. Upload a completed Exempt form only.
- Click on “Exempt Application form” (4th bullet point).
- Select the appropriate Exemption form (see Exemption items under the “Document” header).
- Complete the appropriate form for your study and upload it.
Study Team members:
If PI is a Student, Resident or Fellow, a mentor must be listed by name, mentor role and faculty qualification. Mentor approval is required prior to IRB review
- Item 2, Waivers. Enter N/A for all waivers of consent. Exempt medical record review studies ONLY require a Waiver/Alteration of HIPAA.
- Item 6, Scientific Review. Choose the Exempt option (no scientific review is required)
Note: Secondary data analysis studies should respond “No” in this section. If subjects are recruited for this study, respond “Yes” and complete Items 1 -5.
- Item 3. Indicate how individuals will be informed about this study and how they will indicate agreement to participate.
- Item 5. Upload the Introductory script and other recruitment items, e.g. flyers, e-mail text.
Enter “N/A” for items 1-4. Enter “No” for item 5. If subjects are recruited, address how they will agree to participate in the recruitment section.
Leave this section blank. Exempt studies do not require a written consent form.
Data and Safety Monitoring
- Item 1. Enter N/A
- Item 2. Provide information only if data may be shared with persons who are not a part of this study team. Even if not planned, it is recommended to allow for sharing of de-identified data for future research.
Risks and Benefits
- Items 1 & 2. Enter any risks, if applicable. Be consistent with risks listed in any recruitment materials and the introductory script. Typically, the risk of breach of confidentiality is applicable.
- Items 3 –6 are not required fields; however, a response should be entered if applicable
If you have any questions, email the support team at firstname.lastname@example.org.