Exempt Review (2018)

Final Revisions to the Common Rule are effective January 19, 2018.  After this time, older versions of exempt guidance/forms are no longer valid.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 on the HRPO web site.

Introduction to Exempt Review

  • 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 guidance on International Research.  If you are student or plan on conducting research in a foreign country, you are strongly encouraged to schedule a consultation early in your planning stage by emailing askirb@pitt.edu (include PI name).
  • Prior scientific review by a School or Departmental review committee is not required for exempt protocols.
  • No annual 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.

 

Contents:

Introduction to Exempt Review
IRB determination that a study is either Not Research or Does Not Involve Human Subjects
Support Services
Privacy & Confidentiality
Other Important Definitions
Exempt Categories
Additional Resources
OSIRIS - Online Submission for Institutional Reviews
Archiving of Exempt Studies
 

IRB determination that a study is either Not Research or Does Not Involve Human Subjects

The federal regulations include a very specific definition for what constitutes “research” and for what is meant by a “human subject”.

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). The IRB will not provide a formal written determination after the project has been initiated.  If a study likely does not meet the definition of human subject research or otherwise likely does not require review, contact askirb@pitt.edu before creating a protocol.

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.

The following activities are deemed not to be research:

(1) 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.
(2) 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).
(3) 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.
(4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.


Support Services

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 askirb@pitt.edu 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.  

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Privacy & Confidentiality

  • 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.

 

Other Important Definitions

  • 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.

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Exempt Categories

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 in question E2.0 in OSIRIS. Contact an IRB staff member or email us at askirb@pitt.edu for additional information.

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Additional Resources

OSIRIS - Online Submission for Institutional Reviews

  • Instruction Sheet for Exempt Applications

 

Archiving of Exempt Studies

The approval date for exempt studies indicates that the IRB has determined that the project meets all the necessary criteria for an exemption and does not have an expiration date. This approval differs from other IRB reviews where an expiration date may be displayed and the study may be required to be submitted for IRB review at least yearly.

All exempt studies will be archived 3 years from the date of approval unless the principal investigator extends the approval for an additional 3 years.  An email notification will be sent to the principal investigators 6 weeks prior to the archive date and if no action is taken, the exempt study will be archived.

All exempt studies are approved without an expiration date and do not expire but the archive process was initiated to manage the IRB database of active studies. When an exempt study is completed or if the principal investigator is leaving the institution, it is important for investigator to submit to the IRB a termination notification, as well as a summary of the outcomes of their study.
 

If you have any questions, email the support team at askirb@pitt.edu.  

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