Protection of Human Subjects: Common Rule (56 FR 28001)

Forms and Documents

Document	Type	Status	Availability
Supporting Statement_0990-0260_June 2021.pdf	Supporting Statement A	Uploaded 2021-06-24	Available
2018 Requirements - 2018 Common Rule_June 2021.pdf	Supplementary Document	Uploaded 2021-06-21	Missing upstream
Pre-2018 Requirements - Pre-2018 Common Rule_ June 2021.pdf	Supplementary Document	Uploaded 2021-06-21	Repair queued
42 U S C Section 289_0990-0260_ June 2021.pdf	Supplementary Document	Uploaded 2021-06-21	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
246949	.117(c)(2) [Pre-2018 and 2018 Requirements] – Written statement about the research when informed consent documentation is waived		New
246948	.117(a) [Pre-2018 and 2018 Requirements] – Documentation of informed consent		New
246947	.46.116(h) – [2018 Requirements] – Posting clinical trial consent form		New
246944	.46.116(a) and (b) (Pre-2018 Requirements)/ .46.116 (b), (c) and (d) [2018 Requirements] – Elements of informed consent and broad consent		New
187692	.109(d) [Pre-2018 and 2018 Requirements] – Written notification of IRB approval or disapproval of research		Modified
187691	.115 [Pre-2018 and 2018 Requirement] – Preparation and documentation of IRB activities		Modified
10389	.103(b)(5), .113 [Pre-2018 Requirements]/.108(a)(4), .113 [2018 Requirements] - Incident Reporting, Suspension or Termination of IRB approval Reporting	Other-cfr	Modified

ICR Details

OMB Control No: 0990-0260	ICR Reference No: 202104-0990-003
Status: Received in OIRA	Previous ICR Reference No: 201803-0990-003
Agency/Subagency: HHS/HHSDM	Agency Tracking No:
Title: Protection of Human Subjects: Common Rule (56 FR 28001)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 06/25/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	06/30/2021
Responses	611,500	328,980
Time Burden (Hours)	1,442,350	1,138,230
Cost Burden (Dollars)	0	0

---

Abstract: The Common Rule (56 FR 27003) establishes Federal policy for the protection of human subjects of Federally conducted or sponsored research. The common rule, published in 1991, revised in 2017, and amended two times in 2018, requires applicant and awardee institutions to establish procedures to report, disclose and maintain required information including informed consent and assurance of the establishment of an Institutional Review Board.

---

Authorizing Statute(s): US Code: 42 USC 289 Name of Law: IRB
   PL: Pub.L. 99 - 158 491(a) Name of Law: Health Research Extension Act
   EO: EO 12333 Name/Subject of EO: Common Rule
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 19627	04/14/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 33320	06/24/2021
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
.103(b)(5), .113 [Pre-2018 Requirements]/.108(a)(4), .113 [2018 Requirements] - Incident Reporting, Suspension or Termination of IRB approval Reporting
.109(d) [Pre-2018 and 2018 Requirements] – Written notification of IRB approval or disapproval of research
.115 [Pre-2018 and 2018 Requirement] – Preparation and documentation of IRB activities
.117(a) [Pre-2018 and 2018 Requirements] – Documentation of informed consent
.117(c)(2) [Pre-2018 and 2018 Requirements] – Written statement about the research when informed consent documentation is waived
.46.116(a) and (b) (Pre-2018 Requirements)/ .46.116 (b), (c) and (d) [2018 Requirements] – Elements of informed consent and broad consent
.46.116(h) – [2018 Requirements] – Posting clinical trial consent form

---

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	611,500	328,980	0	282,520	0	0
Annual Time Burden (Hours)	1,442,350	1,138,230	0	304,120	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The information collection reflects changes, for Pre-2018 Requirements and 2018 Requirements. The burden hours increased by 304,120 hours and $35,611,450.

---

Annual Cost to Federal Government: $1,992,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

---

Common Form ICR:  No

---

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 06/25/2021

---