Exemption Category 5 – Federal Research/Demonstration Projects
| Pre-2018 Requirements12 (prior exemption category at 45 CFR §46.101) | Final Rule13 (new exemption category at 45 CFR §46.104) |
| (5) Research and demonstration projects which are conducted by or subject to the approval of department or agency heads and which are designed to study, evaluate, or otherwise examine (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs. | (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. |
| (i) Each federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible federal website 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. |
Note: Some sections of the 2018 regulation in the Final Rule are abbreviated in this table.