16 CFR 1028.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
(a) The Secretary, HHS, has established, and published as a Notice in the Federal Register, a list of categories of research that may be reviewed by the IRB through an expedited review procedure. The list will be amended, as appropriate after consultation with other departments and agencies, through periodic republication by the Secretary, HHS, in the Federal Register. A copy of the list is available from the Office for Human Research Protections, HHS, or any successor office.
(b) An IRB may use the expedited review procedure to review either or both of the following:
(2) Minor changes in previously approved research during the period (of one year or less) for which approval is authorized.
Title 16 published on 12-May-2017 04:17
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 16 CFR Part 1028 after this date.