Research and Demonstration Projects Conducted or Supported by a Federal Department or Agency ​

Exempt Criteria 45 CFR 46.104(d)(5)


Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs.

Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.

(i) Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.

Additional Requirements and Considerations

Privacy and 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:

  • PIs are required to contact askirb@pitt.edu to consult about this category.
  • Study must be published on a publicly accessible federal web-site or in such other manner as the department/agency head determines prior to commencing the research
  • Depending on the research activity one of the following forms will most likely need to be completed to provide additional information about the research activities being performed:
    • Exempt Category – Tests, Surveys, Interviews, or Observations of Public Behavior
    • Exempt Category – Secondary Research with Data and/or Specimens

Exempt Form: Research and Demonstration Projects Conducted or Supported by a Federal Department or Agency [Word]