Interactive Informed Consent for Pediatric Clinical Trials

ICR 201310-0925-002

OMB: 0925-0687

Federal Form Document

ICR Details
0925-0687 201310-0925-002
Historical Active
HHS/NIH 20613
Interactive Informed Consent for Pediatric Clinical Trials
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 12/26/2013
Retrieve Notice of Action (NOA) 10/25/2013
  Inventory as of this Action Requested Previously Approved
12/31/2015 12/31/2014
1,988 0 0
173 0 0
0 0 0

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.

None
None

Not associated with rulemaking

  78 FR 27243 05/09/2013
78 FR 59943 09/30/2013
No

  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
Yes
Miscellaneous Actions
No
This is a new information collection request.

$72,000
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Mikia Currie 3014350941

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
10/25/2013


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