Re: IRB question - can children sign consent forms Florevel Fusin-Wischusen 12 Jan 2012 13:53 EST

AZ!!!!zz

"Haven B. Battles" <xxxxxx@HEALTH.STATE.NY.US> wrote:

>
>Children (under the age of 18) are not able to sign informed consent (a
>federal regulation).  They should give their written 'assent' and the
>parent or legal guardian should give their informed consent.  These are
>often separate documents as the language level needs to be brought down
>considerably for the developmental level of the child.
>
>The regs can be found here:
>
>http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.408
>
>part 46.408 deals specifically with children and consent/assent
>
>___________________________________________
>Haven B. Battles, Ph.D.
>Senior Grants Development Manager
>Center for Community Health
>New York State Department of Health
>Corning Tower, Room 515
>518-474-5730 (ph)
>xxxxxx@health.state.ny.us
>
>
>
>From:	Ivona Jukic <xxxxxx@ULM.EDU>
>To:	xxxxxx@lists.healthresearch.org
>Date:	01/12/2012 10:29 AM
>Subject:	[RESADM-L] IRB question - can children sign consent forms
>Sent by:	Research Administration List
>            <xxxxxx@lists.healthresearch.org>
>
>
>
>Dear colleagues,
>
>A question has arisen that addresses ability of children to sign informed
>consent giving first their permission to be interviewed and then the parent
>would sign underneath confirming consent for the child to participate.
>
>Is there anything that you see questionable or objectionable to this
>method? Are children (federal definition) allowed to sign such documents? I
>would greatly appreciate any information. If you would rather call me,
>please do that.
>
>Thank you,
>
>Ivona
>
>Ivona Jukic, CRA
>Grants Manager
>Office of Sponsored Programs & Research
>Walker Hall 1-32
>University of Louisiana at Monroe
>Monroe, LA 71209
>(p) 318.342.1476
>(f) 318.342.1479
>http://ulm.edu/research
>
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