• Is my project research?

    Research is defined as a systematic investigation designed to develop or contribute to generalizable knowledge. Consultations can be helpful in interpreting this definition for your project.back to top

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  • What is an FWA?

    A Federalwide Assurance (FWA) is an agreement between Seattle Children’s Hospital and the Office for Human Research Protections (OHRP), which acts on behalf of the Secretary of the U.S. Department of Health and Human Services. The agreement provides written assurance that the hospital will comply with the basic ethical principles and the federal laws and regulations as well as state and local laws regarding the protection of human subjects in research. The hospital’s FWA number is FWA00002443.back to top

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  • What is informed consent and when is it needed?

    In almost all cases, informed consent must be obtained from the research participants or their legally authorized representative (s) before participation in research begins.

    It consists of providing adequate information to the subject about the study, giving the subject the opportunity to consider options, responding to questions the subject may have and ensuring that the subject or the legally authorized representative (s) understands the information.

    In addition, the process includes obtaining the subject’s voluntary agreement to participate in the research, usually indicated by the participant’s or their legally authorized representative (s) on the written consent document.

    The IRB may approve a waiver of consent or documentation of consent in limited circumstances.

    See the Investigator Manual and protocol documents HRP-90 and HRP-91 for more information.

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  • What is assent and when is it needed?

    Federal regulations require that there are adequate provisions made for soliciting the assent of children when they are capable of doing so. Age, maturity and psychological state need to be taken into account when determining whether to ask for assent. Usually children who are age seven and older are asked to sign an assent form, and adolescents age 13 and older sign the consent form. Both forms should be written at an appropriate reading level.

    Because children have not yet attained legal age to provide consent, the parent or legal guardian is also asked to give permission for participation when a child is asked to take part in research.

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