§ 46.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.

§ 46.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.

(a) The Secretary , of 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 amendedSecretary will evaluate the list at least every 8 years and amend it, as appropriate, after consultation with other federal departments and agencies , through periodic republication by the Secretary, HHS, and after publication in the Federal Register for public comment. A copy of the list is available from the Office for Human Research Protections, HHS, or any successor office.

(b)

(1) An IRB may use the expedited review procedure to review

either or both of

the following:

(

1

i) Some or all of the research appearing on the list

and found by the reviewer(s) to involve no

described in paragraph (a) of this section, unless the reviewer determines that the study involves more than minimal risk

,

;

(

2

ii) Minor changes in previously approved research during the period

(of one year or less) for which approval is authorized.

for which approval is authorized; or

(iii) Research for which limited IRB review is a condition of exemption under § 46.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7) and (8).

(2) Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the

non-expedited

nonexpedited procedure set forth in § 46.108(b).

(c) Each IRB which that uses an expedited review procedure shall adopt a method for keeping all members advised of research proposals which that have been approved under the procedure.

(d) The department or agency head may restrict, suspend, terminate, or choose not to authorize an institution's or IRB's use of the expedited review procedure.

[56 FR 28012, 28022, June 18, 1991, as amended at 70 FR 36328, June 23, 2005]