CIP# NMCP.2017.XXXX Enter Title PI:
SIGNATURES FOR THIRD PARTY USE
Investigators must use the following steps in order to orient the potential subject to the purpose of the research and why they might wish to participate:
· Step One: The Investigator must explain the study to the potential subject verbally, providing all pertinent information (purpose, procedures, risks, benefits, alternatives to participation, etc.), and must allow the potential subject ample opportunity to ask questions.
· Step Two: Following this verbal explanation, the potential subject should be provided with a written consent form and afforded sufficient time to consider whether or not to participate in the research. "Sufficient time" can range from hours to days, depending on how long it reasonably takes to evaluate the procedures, risks, potential benefits, and alternative treatments.
· Step Three: After allowing the potential subject time to read the consent form, the Investigator should meet with the potential subject and answer any additional questions he or she may have.
PARENT OR GUARDIAN STATEMENT
You have been asked to provide consent for______, for whom you are either the parent or legal representative, to participate in this research study. By signing below, you are indicating that you were given enough time to read this study consent form, all of your questions about this research project were adequately answered and a copy of this consent form was given to you for future reference.
Parent’s or Guardian’s Signature / Date(DD/MMM/YY) / Typed/Printed Name
INVESTIGATOR STATEMENT
You have explained to the above individual the nature and purpose of the study, the potential benefits and possible risks associated with the study, and the alternatives to participation in this study. You have answered any questions that were raised. You have explained the above to the subject on the date stated on this consent form. Consent was obtained prior to participation in the study.
Investigator performing consent process and obtaining written signature.
Investigator’s Signature / Date(DD/MMM/YY) / Typed/Printed Name
At times there may be inconsistency between the permission of the parent and the assent of the child. A rule of thumb is: a "no" from a child overrides a "yes" from the parent, but a "yes" from a child does not override a "no" from a parent.
ASSENT OF THE CHILD
Child’s Name:We are doing to this study to find out X.
You are being asked to take part in this study because you X.
If you choose to take part in this study X will happen.
We will ask you about X. Your answers will / will not be shared with your parent(s).
There might be risks involved with this study.
· It might hurt when X.
· You might be afraid when X.
The person doing this experiment has explained to you what will happen if you take part in this activity. You know that no one will get mad at you if you say no.
Sign your name if you agree to be in this experiment.
Signature of Child / Date(DD/MMM/YY)
In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. The IRB may determine that assent of the child is not necessary if the capability of some or all of the children is so limited that they cannot reasonably be consulted. [45 CFR 46.408(a)].
In general, assent is waived for lack of capacity in children aged 0-7 years. Assent should be attempted for children aged 8-17, unless waiver is appropriate for maturity or psychological state.
[REMOVE IF N/A]
WAIVER OF ASSENT OF THE CHILD
I have determined that this child does not have the capacity to give assent because of the following:
[ ] Age [ ] Maturity [ ] Psychological state of the child
Investigator performing consent process and obtaining written signature / Date(DD/MMM/YY)
Signature of Parent or Guardian / Date
(DD/MMM/YY)
The IRB may determine that assent of the child is not necessary if the research offers the possibility of a direct benefit that is important to the child’s health or well-being and is available only in the context of research. [45 CFR 46.408(a)]. In such cases a child’s dissent (which should normally be respected) may, at the IRB's discretion, be overruled by the child’s parents.
The IRB is sensitive to parents who, when the child’s health is threatened, may wish to try anything, even when the likelihood of success is marginal and the probability of extreme discomfort for the child is high. When the research involves the provision of experimental therapies for life-threatening diseases such as cancer, difficult decisions must be made when the child does not wish to undertake experimental therapy. In general, if the child is a mature adolescent and death is imminent, the child’s wishes should be respected.
[REMOVE IF N/A]
OVERRIDE OF THE CHILD’S REFUSAL TO ASSENT
Despite the fact that this child does not wish to undergo this procedure, it has been determined by both the parents and the physician that it is in the child's best interest to participate in this study.
Investigator performing consent process and obtaining written signature / Date(DD/MMM/YY)
Signature of Parent or Guardian / Date
(DD/MMM/YY)
CID Version / ICF Date / IRB Administrator
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