Kennedy Krieger/Johns Hopkins – Sleep, Cognition, Challenging Behaviors and Sensory Processing Difficulties Study

Contact Dr. Smith-Hicks at 443.923.2778 or hicksc@kennedykrieger.org for more information

Date of approval: November 29, 2018
Date of Expiration: November 28, 2019
The JHM IRB approved the above-referenced Application.

Some parents may provide consent electronically. A link to the electronic consent form maintained in Qualtrics (identical to the written consent document) will be provided to the participant/parent. The Board determined that it is appropriate to grant a waiver of documentation of written consent pursuant to 45 CFR 46.117 and 21 CFR 56.109.

45CFR46.404 and/or 21 CFR 50.51: This study has been approved for the inclusion of children as ‘research not involving greater than minimal risk’. The permission of one parent is required.

  • Assent is waived for some children.
  • Assent has been waived for children 0-6 or children with cognitive impairment lacking the maturity to provide assent. Assent will be documented using the assent statement in the consent form.
  • Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).
  • Collection of data from voice, video, digital, or image recordings made for research purposes.
  • Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

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