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 recently revised the Adult and Minor Sample Consent Forms to remove the initial lines in the consent forms (version 06/21/2024). These new templates should be used for any new consent form being submitted to the IRB.
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.
This Pregnant Partner Information Form (Spanish) 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. The use of a short form consent document is largely limited to a study that will enroll small numbers of participants (not more than 1-2 people) who do not speak English.
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. The use of a short form consent document is largely limited to a study that will enroll small numbers of participants (not more than 1-2 people) who do not speak English.
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. The use of a short form consent document is largely limited to a study that will enroll small numbers of participants (not more than 1-2 people) who do not speak English.
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. The use of a short form consent document is largely limited to a study that will enroll small numbers of participants (not more than 1-2 people) who do not speak English.
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. The use of a short form consent document is largely limited to a study that will enroll small numbers of participants (not more than 1-2 people) who do not speak English.
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. The use of a short form consent document is largely limited to a study that will enroll small numbers of participants (not more than 1-2 people) who do not speak English.
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. The use of a short form consent document is largely limited to a study that will enroll small numbers of participants (not more than 1-2 people) who do not speak English.
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. The use of a short form consent document is largely limited to a study that will enroll small numbers of participants (not more than 1-2 people) who do not speak English.
The IRS reporting threshold for research participant payments has increased from $600 to $2000 per calendar year effective January 1, 2026. Payments to non-employees of Duke University totaling $2000 or more will be reported via Form 1099 (Miscellaneous Income), and all research payments remain taxable income. New or amended consent forms must include the templated language explaining the new threshold. For ongoing studies with previously approved consent forms, study teams must either provide participants with the information sheet or provide participants verbal notification and update consent forms at the next IRB modification or continuing review.