Form 1 Post-test 1B interview

Interactive Informed Consent for Pediatric Clinical Trials

Attachment 1b post test interview

Children Post-test 1B interview

OMB: 0925-0687

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Public reporting burden for this collection of information is estimated to average 12 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.  An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.  Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-xxxx*).  Do not return the completed form to this address.

OMB Number: 0925-XXXX

OMB Expiration Date: TBD


Post Test interview to determine participants understanding of the details of the clinical asthma trial and clinical trial concepts

  1. Did you know what was the purpose of the asthma study?

  2. Did you understand what would happen to you (or your child) if you were really in the study?

  3. What were the things that you (or your child) might not like (risks) by being in the study?

  4. What were the possible good things (direct benefits) that might happen to you (or your child) by being in the study?

  5. What were the possible good things (indirect benefits) that might happen to other children by you (or your child) being in the study?

  6. Would you (or your child) have a choice of being in the study?

  7. Would you (or your child) have the right to withdraw from the study?

  8. What would happen if you (or your child) chose not to be in the study?

  9. Now that you have read about the study, can you tell me the meaning of the words: clinical trial, placebo, blinding, and randomization?

  10. Would all children in the study receive the new drug being tested?


  1. Can you tell me who would make the final decision about being in the study?

  2. Please rate your overall understanding of this study by choosing a number from 0-10:



0 1 2 3 4 5 6 7 8 9 10

Did not understand Understood completely




File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorJill Graygo
File Modified0000-00-00
File Created2021-01-28

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