This guidance contains an outline of the signature lines which may need to be included in your consent forms when enrolling children. The IRB makes the determination of whether assent is required and whether one or both parents must provide parental permission for the child’s participation. If the IRB determines two parent signatures are required, a second set of parental signature lines must be included on the consent document.
For more comprehensive information on research involving children please see Children in Research.
Table of Contents:
Assent is not required
Assent is required and will be obtained from the child verbally
Assent is required and will be obtained from the child with written signature
When enrolling child participants who will turn 18 while the study is still collecting data
When assent is not required:
PARENTAL PERMISSION
The above information has been explained to me and all of my current questions have been answered. I understand that I am encouraged to ask questions about any part of this research study at any time. Any future questions will be answered by a qualified person or by an investigator listed on the first page of this consent document at the telephone number(s) given. I understand that I may always request that my questions, concerns or complaints be answered by a listed investigator.
I understand that I may contact the Human Subjects Protection Advocate of the IRB Office, University of Pittsburgh (1-866-212-2668) to discuss problems, concerns, and questions; obtain information; offer input; or discuss situations in the event that the research team is unavailable. A copy of this consent form will be given to me/my child.
__________________________________________
Printed Name of Child-Subject
I understand that as a minor (age less than 18 years), the above-named child is not permitted to participate in this research study without my consent and authorization. Therefore, by signing this form, I give my consent for his/her participation in this research study and provide my authorization for the use of his/her medical records.
Parent’s or Guardian’s Name (Print)______________________________ Relationship to Participant (Child): ___________________________
Parent or Guardian Signature ____________________________ Date:______________
CERTIFICATION of INFORMED CONSENT
I certify that I have explained the nature and purpose of this research study to the above-named individual(s), and I have discussed the potential benefits and possible risks of study participation. Any questions the individual(s) have about this study have been answered, and we will always be available to address future questions as they arise. I further certify that no research component of this protocol was begun until after this consent form was signed.
Name of Person Obtaining Consent (Print)___________________________________ Role in Research Study________________________
Signature of Person Obtaining Consent___________________________________ Date______________
When assent is required and will be obtained from the child verbally:
PARENTAL PERMISSION
The above information has been explained to me and all of my current questions have been answered. I understand that I am encouraged to ask questions about any part of this research study at any time. Any future questions will be answered by a qualified person or by an investigator listed on the first page of this consent document at the telephone number(s) given. I understand that I may always request that my questions, concerns or complaints be answered by a listed investigator.
I understand that I may contact the Human Subjects Protection Advocate of the IRB Office, University of Pittsburgh (1-866-212-2668) to discuss problems, concerns, and questions; obtain information; offer input; or discuss situations in the event that the research team is unavailable. A copy of this consent form will be given to me/my child.
___________________________________________________
Printed Name of Child-Subject
I understand that, as a minor (age less than 18 years), the above-named child is not permitted to participate in this research study without my consent. Therefore, by signing this form, I give my consent for his/her participation in this research study and provide my authorization for the use of his/her medical records
Parent’s or Guardian’s Name (Print) _________________________________ Relationship to Participant (Child)___________________________
Parent or Guardian Signature________________________________ Date______________
CERTIFICATION of INFORMED CONSENT
I certify that I have explained the nature and purpose of this research study to the above-named individual(s), and I have discussed the potential benefits and possible risks of study participation. Any questions the individual(s) have about this study have been answered, and we will always be available to address future questions as they arise. I further certify that no research component of this protocol was begun until after this consent form was signed.
Name of Person Obtaining Consent (Print)___________________________________ Role in Research Study________________________
Signature of Person Obtaining Consent___________________________________ Date____________
VERIFICATION OF EXPLANATION
I certify that I have carefully explained the purpose and nature of this research to the child participant in age appropriate language. S/he has had an opportunity to discuss it with me in detail. I have answered all his/her questions and s/he provided affirmative agreement (i.e., assent) to participate in this research.
Signature of Person Obtaining Assent________________________________ Date______________
When assent is required and will be obtained from the child with written signature:
PARENTAL PERMISSION
The above information has been explained to me and all of my current questions have been answered. I understand that I am encouraged to ask questions about any part of this research study at any time. Any future questions will be answered by a qualified person or by an investigator listed on the first page of this consent document at the telephone number(s) given. I understand that I may always request that my questions, concerns or complaints be answered by a listed investigator.
I understand that I may contact the Human Subjects Protection Advocate of the IRB Office, University of Pittsburgh (1-866-212-2668) to discuss problems, concerns, and questions; obtain information; offer input; or discuss situations in the event that the research team is unavailable. A copy of this consent form will be given to me/my child.
Printed Name of Child-Subject______________________________
I understand that, as a minor (age less than 18 years), the above-named child is not permitted to participate in this research study without my consent. Therefore, by signing this form, I give my consent for his/her participation in this research study and provide my authorization for the use of his/her medical records.
Parent’s or Guardian’s Name (Print)_______________________________ Relationship to Participant (Child)___________________________
Parent or Guardian Signature_______________________________ Date______________
CERTIFICATION of INFORMED CONSENT
I certify that I have explained the nature and purpose of this research study to the above-named individual(s), and I have discussed the potential benefits and possible risks of study participation. Any questions the individual(s) have about this study have been answered, and we will always be available to address future questions as they arise. I further certify that no research component of this protocol was begun until after this consent form was signed.
Name of Person Obtaining Consent (Print)___________________________________ Role in Research Study________________________
Signature of Person Obtaining Consent___________________________________ Date____________
CHILD ASSENT
This research has been explained to me, and I agree to participate.
Signature of Child-Subject__________________________________ Date______________
VERIFICATION OF EXPLANATION
I certify that I have carefully explained the purpose and nature of this research to (name of child) in age appropriate language. He/she has had an opportunity to discuss it with me in detail. I have answered all his/her questions and he/she provided affirmative agreement (i.e., assent) to participate in this research.
Signature of Person Obtaining Assent_________________________________ Date______________
When enrolling child participants who will turn age 18 while the study is still collecting data:
Minor participants initially enrolled via parental permission who turn 18 while the study is still collecting data muster-consent to participation as autonomous adults. This can be done in two ways:
- Have the subject sign a new adult version of the consent form. This is typically done when subjects are still undergoing research visits
- Incorporate a “Consent for Continued Research Participation” section into the original child consent form and have the subject sign upon turning 18. This is typically done when most of the study visits have been completed but additional follow up or data collection is still occurring.
The following section should be included at the end of the consent document and be completed at the time the participant has turned 18 when using the Consent for Continued Research Participation method.
CONSENT FOR CONTINUED RESEARCH PARTICIPATION
I understand that I am currently participating in a research study. I further understand that consent for my participation in this research study was initially obtained from my authorized representative since I was unable to provide direct consent at the time that this initial consent was requested. I have now turned age 18 and I am able to provide direct consent for continued participation in this research study.
The above information has been explained to me and all of my current questions have been answered. I understand that I am encouraged to ask questions, voice concerns or complaints about any part of this research study during the course of this study. Future questions, concerns or complaints will be answered by a qualified person or by an investigator listed on the first page of this consent document at the telephone number(s) given.
I understand that I may always request that my questions, concerns or complaints be addressed by a listed investigator. I understand that I may contact the Human Subjects Protection Advocate of the IRB Office, University of Pittsburgh (1-866-212-2668) to discuss problems, concerns, and questions; obtain information; offer input; or discuss situations in the event that the research team is unavailable. I agree to participate in this research study and provide my authorization for the use of my medical records.
By signing below, I agree to continue my participation in this research study. A copy of this consent form will be given to me.
Participant’s Signature________________________________ Date____________
CERTIFICATION of INFORMED CONSENT
I certify that I have explained the nature and purpose of this research study to the above-named individual(s), and I have discussed the potential benefits and possible risks of study participation. Any questions the individual(s) have about this study have been answered, and we will always be available to address future questions as they arise. I further certify that no research component of this protocol was begun until after this consent form was signed.
Name of Person Obtaining Consent (Print) ___________________________________ Role in Research Study________________________
Signature of Person Obtaining Consent___________________________________ Date____________