Researcher Responsibilities Acknowledgement

Forms and Documents

Document Name	Status
Supporting Statement.doc Supporting Statement A	2009-01-02

IC Document Collections

IC ID	Document Title	Status
187708	Researcher Responsibilities Acknowledgement Other-Acknowledgement	New

ICR Details

OMB Control No: 0720-0042	ICR Reference No: 200901-0720-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: DOD/DODOASHA	Agency Tracking No:
Title: Researcher Responsibilities Acknowledgement
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 03/10/2009
	Date Received in OIRA: 01/02/2009
Terms of Clearance: OMB approves the requested collection for a period of one year after which DoD will submit and extension and OMB shall review the use of the form during its first year of use.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2010	36 Months From Approved
Responses	585	0	0
Time Burden (Hours)	293	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: New DoD guidance now requires principal and co-principal investigators individually and explicitly to acknowledge that they understand and accept responsibility for protecting the rights and welfare of human research subjects. This collection instrument is for use by the Component Designated Official Office (CDOO) within the Office of the Under Secretary of Defense (Personnel and Readiness) to document human research project team leaders’ commitment to the body of regulations designed to protect the well being and privacy of human research subjects whether the research is clinical or behavioral/social.

---

Authorizing Statute(s): None

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:
	73 FR 25685	05/07/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 72454	11/28/2008
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Researcher Responsibilities Acknowledgement

---

ICR Summary of Burden

	Total Approved	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	585	0	0	585	0	0
Annual Time Burden (Hours)	293	0	0	293	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: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: New Collection

---

Annual Cost to Federal Government:

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

---

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: 01/02/2009

---