The Consent Addendum Template can be used as a supplement to the main consent form. The Consent Addendum Template is appropriate to use when informing participants of a minor change, or adding a new risk.
Consent form template for Database/Repository research project.
Required DUHS Sample Consent - containing all required elements of consent and HIPAA authorization.
Please do not write in, or modify, the footer.
The IRB has revised the Adult and Minor Sample Consent Forms (version 9/25/2023). These new templates should be used for any new consent form being submitted to the IRB. You do not need to revise currently approved consent forms to match the revised template. You should notice that these templates include simplified language and easier to read fonts for participants, as well as clearer instructions for study teams.
Here are also examples of the concise summary that must appear at the top of the consent form.
Required DUHS Sample Consent (Spanish) which contains all required elements of consent and HIPAA authorization.
This is a special template that is required for use with iRIS.
This is a special template that is required for use with iRIS.
This form is referred to as the Personal Data Disclosure Form for Research Participants. It is the payment form that the participant signs in order to get paid. For more information on processing payments to research participants, navigate to Processing Payments to Research Participants.
Personal Data Disclosure Form for Research Participants
Personal Data Disclosure Form for Research Participants (Spanish)
Personal Data Disclosure Form Research Participants-Duke Clincard
Personal Data Disclosure Form Research Participants-Duke Clincard-Spanish
This Pregnant Partner Information Form should be used in conjunction with the DUHS HIPAA Authorization form (or the authorization form used by the pregnant partner’s care provider) whenever a sponsor is requesting permission to collect information regarding pregnant partners of male study participants. No information regarding the partner’s pregnancy (accompanied with identifiers) should be recorded by the study team or the sponsor until the partner has given permission and signed this form.
The federal regulations at 45 CFR 46.117(b)(2) and 21 CFR 50.27(b)(2) permit the use of a Short Form Consent document stating that the required elements of informed consent have been presented to the subject or the subject’s legally authorized representative orally, with a witness present. Within DUHS use of a short form consent document is largely limited to two situations:
- when English is not understandable to a potential research subject who is considering whether to participate in a research study, and the investigator does not have an IRB-approved consent document translated into a language understandable to the potential subject, or
- in the very unusual situation when the window of opportunity for a subject to benefit from research participation is brief, and the IRB finds that by use of the short form consent document the subject or the subject’s legally authorized representative will have sufficient opportunity to comprehend the nature of the study and the risks and benefits associated with the study to make an informed decision about study participation.
Please note the use of a “short form” also requires an alteration of HIPAA authorization unless all elements of a valid authorization are included in the “short form”.
The federal regulations at 45 CFR 46.117(b)(2) and 21 CFR 50.27(b)(2) permit the use of a Short Form Consent document stating that the required elements of informed consent have been presented to the subject or the subject’s legally authorized representative orally, with a witness present. Within DUHS use of a short form consent document is largely limited to two situations:
- when English is not understandable to a potential research subject who is considering whether to participate in a research study, and the investigator does not have an IRB-approved consent document translated into a language understandable to the potential subject, or
- in the very unusual situation when the window of opportunity for a subject to benefit from research participation is brief, and the IRB finds that by use of the short form consent document the subject or the subject’s legally authorized representative will have sufficient opportunity to comprehend the nature of the study and the risks and benefits associated with the study to make an informed decision about study participation.
Please note the use of a “short form” also requires an alteration of HIPAA authorization unless all elements of a valid authorization are included in the “short form”.
The federal regulations at 45 CFR 46.117(b)(2) and 21 CFR 50.27(b)(2) permit the use of a Short Form Consent document stating that the required elements of informed consent have been presented to the subject or the subject’s legally authorized representative orally, with a witness present. Within DUHS use of a short form consent document is largely limited to two situations:
- when English is not understandable to a potential research subject who is considering whether to participate in a research study, and the investigator does not have an IRB-approved consent document translated into a language understandable to the potential subject, or
- in the very unusual situation when the window of opportunity for a subject to benefit from research participation is brief, and the IRB finds that by use of the short form consent document the subject or the subject’s legally authorized representative will have sufficient opportunity to comprehend the nature of the study and the risks and benefits associated with the study to make an informed decision about study participation.
Please note the use of a “short form” also requires an alteration of HIPAA authorization unless all elements of a valid authorization are included in the “short form”.
The federal regulations at 45 CFR 46.117(b)(2) and 21 CFR 50.27(b)(2) permit the use of a Short Form Consent document stating that the required elements of informed consent have been presented to the subject or the subject’s legally authorized representative orally, with a witness present. Within DUHS use of a short form consent document is largely limited to two situations:
- when English is not understandable to a potential research subject who is considering whether to participate in a research study, and the investigator does not have an IRB-approved consent document translated into a language understandable to the potential subject, or
- in the very unusual situation when the window of opportunity for a subject to benefit from research participation is brief, and the IRB finds that by use of the short form consent document the subject or the subject’s legally authorized representative will have sufficient opportunity to comprehend the nature of the study and the risks and benefits associated with the study to make an informed decision about study participation.
Please note the use of a “short form” also requires an alteration of HIPAA authorization unless all elements of a valid authorization are included in the “short form”.
The federal regulations at 45 CFR 46.117(b)(2) and 21 CFR 50.27(b)(2) permit the use of a Short Form Consent document stating that the required elements of informed consent have been presented to the subject or the subject’s legally authorized representative orally, with a witness present. Within DUHS use of a short form consent document is largely limited to two situations:
- when English is not understandable to a potential research subject who is considering whether to participate in a research study, and the investigator does not have an IRB-approved consent document translated into a language understandable to the potential subject, or
- in the very unusual situation when the window of opportunity for a subject to benefit from research participation is brief, and the IRB finds that by use of the short form consent document the subject or the subject’s legally authorized representative will have sufficient opportunity to comprehend the nature of the study and the risks and benefits associated with the study to make an informed decision about study participation.
Please note the use of a “short form” also requires an alteration of HIPAA authorization unless all elements of a valid authorization are included in the “short form”.
The federal regulations at 45 CFR 46.117(b)(2) and 21 CFR 50.27(b)(2) permit the use of a Short Form Consent document stating that the required elements of informed consent have been presented to the subject or the subject’s legally authorized representative orally, with a witness present. Within DUHS use of a short form consent document is largely limited to two situations:
- when English is not understandable to a potential research subject who is considering whether to participate in a research study, and the investigator does not have an IRB-approved consent document translated into a language understandable to the potential subject, or
- in the very unusual situation when the window of opportunity for a subject to benefit from research participation is brief, and the IRB finds that by use of the short form consent document the subject or the subject’s legally authorized representative will have sufficient opportunity to comprehend the nature of the study and the risks and benefits associated with the study to make an informed decision about study participation.
Please note the use of a “short form” also requires an alteration of HIPAA authorization unless all elements of a valid authorization are included in the “short form”.
The federal regulations at 45 CFR 46.117(b)(2) and 21 CFR 50.27(b)(2) permit the use of a Short Form Consent document stating that the required elements of informed consent have been presented to the subject or the subject’s legally authorized representative orally, with a witness present. Within DUHS use of a short form consent document is largely limited to two situations:
- when English is not understandable to a potential research subject who is considering whether to participate in a research study, and the investigator does not have an IRB-approved consent document translated into a language understandable to the potential subject, or
- in the very unusual situation when the window of opportunity for a subject to benefit from research participation is brief, and the IRB finds that by use of the short form consent document the subject or the subject’s legally authorized representative will have sufficient opportunity to comprehend the nature of the study and the risks and benefits associated with the study to make an informed decision about study participation.
Please note the use of a “short form” also requires an alteration of HIPAA authorization unless all elements of a valid authorization are included in the “short form”.
The federal regulations at 45 CFR 46.117(b)(2) and 21 CFR 50.27(b)(2) permit the use of a Short Form Consent document stating that the required elements of informed consent have been presented to the subject or the subject’s legally authorized representative orally, with a witness present. Within DUHS use of a short form consent document is largely limited to two situations:
- when English is not understandable to a potential research subject who is considering whether to participate in a research study, and the investigator does not have an IRB-approved consent document translated into a language understandable to the potential subject, or
- in the very unusual situation when the window of opportunity for a subject to benefit from research participation is brief, and the IRB finds that by use of the short form consent document the subject or the subject’s legally authorized representative will have sufficient opportunity to comprehend the nature of the study and the risks and benefits associated with the study to make an informed decision about study participation.
Please note the use of a “short form” also requires an alteration of HIPAA authorization unless all elements of a valid authorization are included in the “short form”.