Interactive Informed Consent for Pediatric Clinical Trials

Forms and Documents

Document Name	Status
Form 1 Parents SNS for numeracy Form	New
Form 1 Parents SORT-R3 for literacy Form	New
Form 1 Parents Perceptions of the program Form	New
Form 1 Parents Post-test 1B interview Form	New
Form 1 Parents Post-test 1C interview Form	New
Form 1 Parents Pre-test interview Form	New
Form 1 Parents Script consent Form	New
Form 1 Children SORT-R3 for literacy Form	New
Form 1 Children Perceptions of the program Form	New
Form 1 Children Post-test 1B interview Form	New
Form 1 Children Post-test 1C interview Form	New
Form 1 Children Pre-test interview Form	New
Form 1 Children Script consent Form	New
Interactive Supporting Statement B_OMB_1292013.doc Supporting Statement B	2013-12-09
Attachment 6 IRB Approval.pdf Supplementary Document	2013-09-26
Interactive Supporting Statement A_OMB 1292013.doc Supporting Statement A	2013-12-09

IC Document Collections

IC ID	Document Title	Status
209639	Parents SNS for numeracy Form	New
209638	Parents SORT-R3 for literacy Form	New
209637	Parents Perceptions of the program Form	New
209636	Parents Post-test 1B interview Form	New
209635	Parents Post-test 1C interview Form	New
209634	Parents Pre-test interview Form	New
209633	Parents Script consent Form	New
209632	Children SNS for numeracy Other-ScreenShot	New
209631	Children SORT-R3 for literacy Form	New
209630	Children Perceptions of the program Form	New
209629	Children Post-test 1B interview Form	New
209628	Children Post-test 1C interview Form	New
209627	Children Pre-test interview Form	New
209626	Children Script consent Form	New

ICR Details

OMB Control No: 0925-0687	ICR Reference No: 201310-0925-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No: 20613
Title: Interactive Informed Consent for Pediatric Clinical Trials
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: 12/26/2013
	Date Received in OIRA: 10/25/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2015	12/31/2014
Responses	1,988	0	0
Time Burden (Hours)	173	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Interactive Informed Consent for Pediatric Clinical Trials. This study will compare parents' and children's understanding of information about a hypothetical clinical trial presented using either a standard paper consent document or an interactive computer-based consent program. Parents' and children's understanding, regardless of whether they received the standard consent or the interactive computer-based program, will be by assessed by face-to-face interview. In addition, parents' and children's perceptions of, and satisfaction with, the information presented will be evaluated by completion of a short questionnaire. The primary hypothesis to be tested is that interactive computer-based research consent information is better understood and accepted by parents and children compared with the standard paper consent document. Given that many individuals have difficulty reading and interpreting standard written consent documents, this technology holds promise as a means to optimize the consent and assent process particularly among individuals with low literacy and numeracy skills. Respondents will interviewed to assess their baseline understanding of key elements of a clinical trial e.g., randomization, blinding, etc. They will then be randomized to either the standard paper consent or the interactive computer-based consent. Immediately after they will be tested again for their understanding of the key elements and interviewed to assess their understanding of the clinical trial details.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 27243	05/09/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 59943	09/30/2013
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 14

IC Title	Form No.	Form Name
Children Script consent	1	Script Consent
Children Pre-test interview	1	Pre-Test
Children SNS for numeracy	1	SNS for Numeracy
Parents Script consent	1	Script Consent
Parents Pre-test interview	1	Pre-Test
Parents Post-test 1C interview	1	Post-test 1C Interview
Parents Post-test 1B interview	1	Post-test 1B interview
Parents Perceptions of the program	1	Perceptions
Children Post-test 1C interview	1	Post-test 1C Interview
Children Post-test 1B interview	1	Post-test 1B interview
Children Perceptions of the program	1	Perceptions
Children SORT-R3 for literacy	1	SORT R3
Parents SORT-R3 for literacy	1	SORT R3
Parents SNS for numeracy	1	SNS for Numeracy

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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	1,988	0	0	1,988	0	0
Annual Time Burden (Hours)	173	0	0	173	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: This is a new information collection request.

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Annual Cost to Federal Government: $72,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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]? 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? Uncollected

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Common Form ICR:  No

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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: 10/25/2013

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