This guidance contains an outline of the signature lines which may need to be included in your consent forms when enrolling participants with decisional impairment. Please review Chapter 14, Considerations for Special Populations, Research involving Decisionally Impaired Individuals for review requirements and additional information
If the participant is able to provide direct consent
Incorporate the following standard statement if the participant is able to provide direct consent:
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.
By signing this form, I agree to participate in this research study [and authorize the use of my medical records].
_______________________________ __________________
Participant Signature Date [add time if copy will be in medical record]
If the participant is unable to provide direct consent and a proxy will be utilized, include the following wording:
For adults determined to be decisionally-impaired and unable to provide direct consent, incorporate the following standard statements and signature lines:
______________________________
Participant Name (Print)
The above-named individual is unable to provide direct consent for study participation because __[STUDY TEAM CAN COMPLETE]__. Therefore, by signing this form, I give my consent for his/her participation in this research study.
______________________________ ___________________________________
Representative’s Name (Print) Representative’s Relationship to Participant
______________________________ ______________________________
Representative’s Signature Date [add time if copy will be in medical record]
______________________________ ______________________________
Witness Signature Date [add time if copy will be in medical record]
If a participant is unable to provide direct consent but can provide assent:
Incorporate the following statements if the potential subject is capable of exercising some judgment concerning the nature of the research study and whether s/he desires to participate.
VERIFICATION OF EXPLANATION
I certify that I have carefully explained the purpose and nature of this research to the above-named participant in 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 [add time if copy will be in medical record]
If a participant regains capacity to provide direct consent
For research studies where the nature of the subject population is such that an individual may not be capable of providing initial direct consent for study participation, but may recover adequate decision-making capability for direct consent at a later time, also incorporate the following standard statements and signature lines:
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 am now 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 Signature
_________________________
Date [add time if copy will be in medical record]
v. 6/1/21