University of Minnesota
Institutional Review Board
http://www.research.umn.edu/irb
612-626-5654

Institutional Review Board home

Guidance & FAQs

IRB Review of Exempt Research

Determine if your activity is research, involves human subjects, and exempt from full IRB review.

Definitions and Best Practices (click to open/close)

Research subject to regulation, and similar terms are intended to encompass those research activities for which a federal department or agency has specific responsibility for regulating as a research activity, (for example, Investigational New Drug requirements administered by the Food and Drug Administration). It does not include research activities which are incidentally regulated by a federal department or agency solely as part of the department's or agency's broader responsibility to regulate certain types of activities whether research or non-research in nature (for example, Wage and Hour requirements administered by the Department of Labor).

Human subject means a living individual about whom an investigator, whether professional or student, conducting research obtains either

  1. Data through intervention or interaction with the individual
  2. Identifiable private information.

Intervention includes both physical procedures by which data are 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). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

Public Use Data Files are data files prepared by investigators or data suppliers with the intent of making them available for public use. The data available to the public are not individually identified or maintained in a readily identifiable form. Public use data files are data files that have been reviewed under the jurisdiction of an IRB with the intent of making them available for public use. In the case of Federal statistical data collections, the Federal government has responsibility for that review. Producers and suppliers of public use data files are responsible for having public use data files appropriately reviewed by IRBs before making them available to the public.

 

Exemption Doesn't Mean You Don't Apply

DHHS Guidelines (45 CFR Part 46.101(b) and (c)) define research as exempt from further IRB review when the research involves no risk to the subject. Research that is considered exempt from Committee review must still be filed with the IRB and screened for exempt status.

Some minimal risk research is exempt from full IRB review. Exemption waives only the need for full IRB review and does not negate the need for the consent of subjects where applicable.

The authority to determine and confirm exempt status rests with the IRB and not with the investigator nor student advisor. Thus, an Exempt Screening Application Form is required for your exemption to be confirmed and granted by the IRB.

Examples of Exempt Research

Survey interview research with adult subjects; the use of nonidentifiable laboratory specimens; review of nonidentified existing records; observation of the public behavior of subjects where there is no manipulation of the subject; and some educational testing and classroom activity. Be sure to note the category specific advice in the right column.

Category 1

  • Evaluating the use of accepted or revised standardized tests
  • Testing or comparing a curriculum or lesson
  • A program evaluation of pharmacy continuing education

Category 2

  • Surveying teachers, nurses, or doctors about a technique or an outcome
  • Interviewing managers about a management style or best practice
  • Conducting a focus group about an experience or an opinion of a community program
  • If you are completing evaluation project for graduation/academic requirement, then IRB review is needed

Category 3

  • Interviewing public officials about a local or global issue

Category 4

  • Analyzing de-identified tissue samples or data set
  • Analyzing de-identified national test scores
  • Analyzing census data about aging or housing

Category 6

  • Taste testing whole grain food products
  • Comparing taste or smell of molasses, cheese or milk
  • Sampling texture of ice cream

Examples of Non-Research Activities

  • Quality assurance activities or evaluation projects designed for self-improvement or program evaluation, not meant to contribute to "generalizable" knowledge.
  • Interviews of individuals where questions focus on things not on people (eg. questions about policies, general facts about an organization or business).
  • Searches of existing literature or analysis of aggregate or public data that cannot be linked to a living individual (e.g. data sets available on the web that do not require any sort of privacy/confidentially agreement or special request procedure, newspaper accounts, census data held in public libraries, published school test scores). However, if access to the data is limited to researchers, and not publicly available, then IRB review is needed.
  • Single case studies in which all data already exists. However, if this includes medical record review, there may be obligations under HIPAA privacy law.

Common Issues with Exempt Submissions

  • Always submit an appendix J as they are required with every exempt application, regardless of category. This appendix can be sent by student if advisor is cc’d or sent directly from advisor.
  • Remember to submit your supplemental materials along with your application and appendices (common are A, M, K). The materials often include recruitment scripts/flyers/letters of invitation, consent forms, interview questions, focus group questions, surveys, documentation of approval from other IRBs or overseeing committees.
  • Be sure to send your submission by email, including all materials as attachments from your University of Minnesota email account and cc your advisor.
More Information

Reports and Articles

Recomended Reading for Exempt Researchers

Category Specific Advice

There are few common areas that researchers need to address for each type of exempt research. Here are a few common points of emphasis provided from an exempt study reviewer.

TIP: click on the title bars to open and close the topics.

Category 1

  • Research must be conducted in normal educational settings, involving normal educational practices, such as implementing a new curriculum.
  • Investigators must seek approval from specific school or school district before applying to the IRB. If the district does not have their own IRB or research evaluation committee, then the investigator should seek permission from a principal or superintendent. Documentation of approval or permission must be submitted with your University IRB application.
  • If your study involves research subjects under 18, parental consent and student assent are both required. The IRB may waive the need for a signature on the parental consent form, if this is requested and approved by the school, but active assent is always required.
  • Be sure to submit your Appendix M.

Categories 2 & 3

  • Minors cannot be included under this category unless observation only. No interaction or contact with the child is allowed.
  • If at all possible, make surveys anonymous
  • Sensitive or personal topics can not be exempt
  • If you are using a private list for recruitment you must have permissible access to make initial contact yourself. If you do not have permissible access to the list you must ask the custodian of the record to make initial contact for you. Potential subjects then must contact you if they are interested.
  • Consent form signatures are not required, but consent is. Consent can be obtained verbally or by participation as completion of the survey implies consent. This detail must be clarified in the form.

Category 4

  • Pathological or diagnostic specimens must be considered waste tissue or must be previously stored by the Tissue Procurement Facility. Waste tissue used cannot have any patient identifiers attached.
  • If you do not normally have access to data, the data must be stripped of all identifiers including:
    • Name
    • All geographic subdivisions smaller than a state (street address, city, county, precinct)  Note:  zip code or equivalents must be removed, but can retain first 3 digits if the geographic unit to which the zip code applies if the zip code area contains more than 20,000 people
    • For dates directly related to the individual, all elements of dates, except year. (date of birth, admission date, discharge date, date of death)
    • All ages over 89 or dates indicating such an age
    • Telephone number
    • Fax number
    • Email address
    • Social Security Number
    • Medical Record Number
    • Health Plan Number
    • Account Numbers
    • Certificate or license numbers
    • Vehicle identification/serial numbers including license place numbers
    • Device identification/serial numbers
    • Universal Resource Locators (URL’s)
    • Internet Protocol addresses (IP’s)
    • Biometric Identifiers
    • Full face photographs and comparable images
    • Any other unique identifying number, characteristic or code
  • If you have legitimate access to the data, through an internship, job, medical resident, then you may access private information, but you may not record any identifiers or maintain a link to identifiers.
  • If you will access PHI (medical records, databases), then you must complete Appendix H to fulfill HIPAA obligations.
  • Public use data includes sets posted on the internet that include a responsible use statement or other confidentiality agreement for authors to protect human subjects. This includes de-identified data sets prepared by other investigators with intent to make publicly available to other researchers such as the SEER database: http://seer.cancer.gov/data
  • Many data suppliers may have both publicly available and restricted public use data. Examples: National Center for Health Statistics, National Center for Education Statistics, U.S. Bureau of the Census, CDC.
Download Exempt Forms