Principal Investigator:
Study Title:
Version Date:
Vanderbilt University Institutional Review Board
Place a check in the box beside the category that best describes your proposed research. If the research study includes two pediatric populations (i.e. a healthy control/donor group and a patient/recipient group), identify the appropriate category and provide justification for each group individually.
Minimal risk means that the probability and magnitude of the harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life during the performance of routine physical or psychological exams or tests.
CATEGORY 1 (45 CFR 46.404; 21 CFR 50.51) This proposed research poses no greater than minimal risk to children.
Explain why the proposed research falls under this category:
Explain how adequate provisions are made for soliciting the assent of the children
Explain how adequate provisions are made for obtaining permission/consent of their parents or guardians:
Explain any dissenting behaviors, that when observed, may result in the child being withdrawn from the research*.
Examples of research which poses no greater than minimal risk: Retrospective chart review, surveys; interviews; standardized measures; height and weight measurements; buccal or nasal swabs; blood draws in which the amount of blood does not exceed the lesser of 50mls or 3mls per kg in a 8 week period and is not collected more frequently than twice per week.
Note: When research is covered by §46.405
, informed consent should be sought from both parents unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. Under this category, only consent from one parent is required to allow individual to participate.
CATEGORY 2 (45 CFR 46.405; 21 CFR 50.52) This proposed research poses greater than minimal risk to children and includes an intervention or procedure that DOES hold out the prospect of a direct benefit for the individual child or a monitoring procedure that is likely to contribute to the child’s well-being.
Describe how the risk is justified by the anticipated benefit to the child.
Describe how the relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches.
Describe how adequate provisions are made for soliciting the assent of the children and the permission
(parental/guardian informed consent) of both parents or guardians is sought.
Include any dissenting behaviors that when observed may result in the child being withdrawn from the research*.
Example of research which poses greater than minimal risk with the prospect of direct benefit: Trials of investigational or FDA approved drugs for chronic conditions and life-threatening diseases, which have been shown to be effective or equivalent to current available treatment.
Vulnerable Populations: Children (Form#1117)
Revision Date: November 22, 2010
Replaces Form Dated: February 3, 2010
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Principal Investigator:
Study Title:
Version Date:
Note: When research is covered by §46.406
or §46.407
, informed consent must be obtained from both parents unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
CATEGORY 3 (45 CFR 46.406; 21 CFR 50.53) This proposed research poses greater than minimal risk to children and is presented by an intervention or procedure that DOES NOT hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject, BUT is likely to yield generalizable knowledge about the subject’s disorder or condition.
Describe how the increase in the probability and magnitude of harm is only slightly more than minimal risk.
Describe how any potential harms associated with the procedure will be transient and reversible in consideration of the nature of the harm (restricted to time of procedure or short post-experimental period).
Explain why the intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition, which is of vital importance for the understanding or amelioration of the subjects' disorder or condition.
Explain how adequate provisions are made for soliciting the assent of the children and the permission
(parental/guardian informed consent) of their parents or guardians.
Include any dissenting behaviors that when observed may result in the child being withdrawn from the research*.
Examples of research which pose greater than minimal risk with no prospect of direct benefit; and the risk represents a minor increase over minimal risk: Bone marrow obtained for genetic testing or future research related to disease; extending sedation time to obtain additional MRI research data for non-clinical purposes.
CATEGORY 4 (45 CFR 46.407; 21 CFR 50.54) This proposed research does not meet the requirements of Category 1,
2, or 3 listed above. The IRB will submit the study to the Office of Human Research Protections (OHRP) for review and certification.
Explain why the proposed research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children.
Wards of the State (45 CFR 46.409)
When children as wards of the State are involved in research under 45 CFR 46.406 or 407, the IRB must require appointment of an individual to act on behalf of the child as guardian or in loco parentis. This individual may serve as an advocate for more than one child. The advocate shall be an individual who has the background and experience to act in, and agrees to act in, the best interest of the child for the duration of the c hild’s participation in the research and who is not associated in any way with the Investigators, or the guardian organization.
Long-term Studies
If a child reaches the legal age of consent while enrolled in a study, the subject’s participation in the research is no longer regulated by the requirements of 45 CFR 46.408 regarding parental or guardian permission and subject assent.
Therefore, unless the IRB has waived the requirements for obtaining informed consent, the investigator must obtain the legally effective informed consent in accordance with 45 CFR 46.116, from the now-adult subject to continue any interactions or interventions.
Vulnerable Populations: Children (Form#1117)
Revision Date: November 22, 2010
Replaces Form Dated: February 3, 2010
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Principal Investigator:
Study Title:
Version Date:
*Dissenting behaviors may include, but are not limited to excessive crying, hiding behind the parent, refusing to interact, attempting to leave, trying to physically strike out or being destructive. Consider whether or not the dissenting behavior is in balance with the study procedures.
Vulnerable Populations: Children (Form#1117)
Revision Date: November 22, 2010
Replaces Form Dated: February 3, 2010
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