2024-18447. Agency Information Collection Request; 30-Day Public Comment Request

Table 1—Estimated Annual IRB Recordkeeping Burden

Common rule provision	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
.115 [Pre-2018 and 2018 Requirement]—Preparation and documentation of IRB activities	6,000	16	96,000	12	1,152,000
Total			96,000		1,152,000

Table 2—Estimated Annual Third-Party Disclosure Burden

	Number of respondents	Number of disclosures per respondent	Total annual disclosures	Average burden per disclosure	Total hours
.109(d) [Pre-2018 and 2018 Requirements]—Written notification of IRB approval or disapproval of research	6,000	25	150,000	0.5	75,000
.116(a) and (b) (Pre-2018 Requirements)/.116 (b), (c) and (d) [2018 Requirements]—Elements of informed consent and broad consent	6,000	25	150,000	0.5	75,000
.116(h)—[2018 Requirements]—Posting clinical trial consent form	425	5	2,125	0.5	1,063
.117(a) [Pre-2018 and 2018 Requirements]—Documentation of informed consent	6,000	20	120,000	0.5	60,000
.117(c)(2) [Pre-2018 and 2018 Requirements]—Written statement about the research when informed consent documentation is waived	6,000	5	30,000	.5	15,000
Total			452,125		226,063