Consent Form Templates

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.

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.

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 should be used sparingly and is limited to three situations with IRB approval:

1. The study provides potential direct benefit to a participant that is not available outside of the research, or

2. The study is minimal risk where the oral explanation can adequately address potential concerns, or

3. The study will enroll small numbers of participants (not more than 1-2 people) who do not speak English.

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 should be used sparingly and is limited to three situations with IRB approval:

1. The study provides potential direct benefit to a participant that is not available outside of the research, or

2. The study is minimal risk where the oral explanation can adequately address potential concerns, or

3. The study will enroll small numbers of participants (not more than 1-2 people) who do not speak English.

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 should be used sparingly and is limited to three situations with IRB approval:

1. The study provides potential direct benefit to a participant that is not available outside of the research, or

2. The study is minimal risk where the oral explanation can adequately address potential concerns, or

3. The study will enroll small numbers of participants (not more than 1-2 people) who do not speak English.

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 should be used sparingly and is limited to three situations with IRB approval:

1. The study provides potential direct benefit to a participant that is not available outside of the research, or

2. The study is minimal risk where the oral explanation can adequately address potential concerns, or

3. The study will enroll small numbers of participants (not more than 1-2 people) who do not speak English.

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 should be used sparingly and is limited to three situations with IRB approval:

1. The study provides potential direct benefit to a participant that is not available outside of the research, or

2. The study is minimal risk where the oral explanation can adequately address potential concerns, or

3. The study will enroll small numbers of participants (not more than 1-2 people) who do not speak English.

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 should be used sparingly and is limited to three situations with IRB approval:

1. The study provides potential direct benefit to a participant that is not available outside of the research, or

2. The study is minimal risk where the oral explanation can adequately address potential concerns, or

3. The study will enroll small numbers of participants (not more than 1-2 people) who do not speak English.

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 should be used sparingly and is limited to three situations with IRB approval:

1. The study provides potential direct benefit to a participant that is not available outside of the research, or

2. The study is minimal risk where the oral explanation can adequately address potential concerns, or

3. The study will enroll small numbers of participants (not more than 1-2 people) who do not speak English.

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 should be used sparingly and is limited to three situations with IRB approval:

1. The study provides potential direct benefit to a participant that is not available outside of the research, or

2. The study is minimal risk where the oral explanation can adequately address potential concerns, or

3. The study will enroll small numbers of participants (not more than 1-2 people) who do not speak English.

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”.