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Informed Consent Templates

These templates help the investigator develop readable consent documents that include the elements required by Federal regulations.

• For more information, please refer to the USF Guidelines for Developing Informed Consent Document.
• For a summary of the required elements, please refer to the information guide: Required Elements of Informed Consent.

Instructions specific to items on the templates appear in red text in brackets: [This is an example]. Sections that may or may not be applicable to your research appear in red text and are shaded [This is an example]. Remove all instructions and non-applicable sections before printing and submitting the informed consent form for IRB review.

Please use the template that fits the population to be enrolled in your study. If you are not sure which type of template fits your population, or if you have questions, contact the Division of Research Integrity & Compliance at (813) 974-9343.

The informed consent form must be written in lay language (6th - 8th grade reading level), avoiding scientific / technical terms. All abbreviations and acronyms should be defined. Readability can be checked via Flesch-Kincaid Grade Level during spell check.

Informed consent forms should be submitted electronically to help streamline the IRB review process. When submitting a revised informed consent form, the IRB requires a clean copy and a copy with the revisions highlighted.

Consent Templates Combined with HIPAA Research Authorization

If your study involves Protected Health Information (PHI) under the HIPAA Privacy Rule, the Informed Consent templates provide the option of incorporating the required Research Authorization form into the Informed Consent document. For more information about the required text, please refer to the USF Guidelines for Developing Informed Consent Document. To determine whether a study involves PHI, please check the HIPAA Decision Tree. For social and behavioral research, please see: Does HIPAA Apply to Social/Behavioral Research?

If a study does NOT involve PHI, please do not include the Research Authorization section in the consent form.

If revisions are required for your already approved HIPAA and Informed Consent document, please be sure to submit the revisions using the integrated Informed Consent/Research Authorization template along with your Modification Request or Application for Continuing Review.

For more information about PHI and when a combined document should be used, please visit our HIPAA Compliance Program Website or contact Vinita Witanachchi, J.D., Research Privacy Officer and Assistant Director, HIPAA Compliance Program, at (813) 974-5478 or by e-mail.

Submit IRB Materials to: USF Division of Research Integrity and Compliance

On-Campus Mail:

MDC35

Regular Mail:

12901 Bruce B. Downs Blvd., MDC35
Tampa, FL 33612

Hand Delivery:

3702 Spectrum Blvd., Suite 155     MAP
USF Research Park, Tampa, FL

Telephone:
Fax:

(813) 974-9343
(813) 974-5618

Medical IRB 01

      Adult Informed Consent/Research Authorization (2007-04-30)
Use for studies with participants who might have difficulty reading and/or understanding an informed consent document or who are from vulnerable populations (e.g., people under considerable stress). If PHI is being used, please insert the section on "Research Authorization & Confidentiality" as explained in the USF Guidelines for Developing Informed Consent Document.

      Adult Informed Consent for Minimal Risk Studies (2007-07-01)
Use for low risk studies with adult participants who will not have difficulty reading and/or understanding an informed consent document and who are not from vulnerable populations. If PHI is being used, please insert the section on "Research Authorization & Confidentiality" as explained in the USF Guidelines for Developing Informed Consent Document.

      Parental Consent/Research Authorization (2007-05-01)
Use for studies involving a parent who might have difficulty reading and/or understanding an informed consent document or who is from a vulnerable population. If PHI is being used, please insert the section on "Research Authorization & Confidentiality" as explained in the USF Guidelines for Developing Informed Consent Document.

      Assent (2007-05-01)
For research involving children. This template can also be used when developing a document for adults determined not to be capable of giving legally authorized informed consent (where proxy or L.A.R. is obtained for the person's participation) but who can understand that they are being asked to volunteer for research.
      Ages 7 to 11: obtain verbal assent and note the child's agreement in the research record. A verbal script for obtaining assent must be submitted as part of the protocol.
      Ages 12 or older: written documentation of assent is required.

      Proxy Informed Consent/Research Authorization (2007-05-01)
If PHI is being used, please insert the section on "Research Authorization & Confidentiality" as explained in the USF Guidelines for Developing Informed Consent Document.

      Consent for Genetic Research (2007-07-01)
Use this template when the study involves genetic research. If PHI is being used, please insert the section on "Research Authorization & Confidentiality" as explained in the USF Guidelines for Developing Informed Consent Document.

      Genetic Addendum for Consent (2007-12-01)
Attach this addendum when blood and/or tissue samples will be collected for genetic testing during a study that does not involve genetic research.

Veterans Administration Forms

      Veterans Administration (VA) Applications and Templates

Social & Behavioral IRB 02

      Adult Informed Consent/Research Authorization (2006-11-13)
Combined Informed Consent with HIPAA Research Authorization. Use for studies with participants who might have difficulty reading and/or understanding an informed consent document or who are from vulnerable populations (e.g., people under considerable stress).

      Adult Informed Consent (2006-11-13)
For studies that do not involve PHI and therefore do not require a HIPAA Research Authorization. Use for studies with participants who might have difficulty reading and/or understanding an informed consent document or who are from vulnerable populations (e.g., people under considerable stress).

      Adult Informed Consent - Minimal Risk Studies (2007-07-01)
For studies that do not involve PHI and therefore do not require a HIPAA Research Authorization. Use for low risk studies with adult participants who will not have difficulty reading and/or understanding an informed consent document and who are not from vulnerable populations.

      Parental Consent/Research Authorization (2007-3-12)
Combined Informed Consent with HIPAA Research Authorization. Use for studies involving a parent who might have difficulty reading and/or understanding an informed consent document or who is from a vulnerable population.

      Parental Consent (2007-3-12)
For studies that do not involve PHI and therefore do not require a HIPAA Research Authorization. Use for studies involving a parent who might have difficulty reading and/or understanding an informed consent document or who is from a vulnerable population.

      Assent (2007-05-01)
For research involving children. This template can also be used when developing a document for adults determined not to be capable of giving legally authorized informed consent (where proxy or L.A.R. is obtained for the person's participation) but who can understand that they are being asked to volunteer for research.
      Ages 7 to 11: obtain verbal assent and note the child's agreement in the research record. A verbal script for obtaining assent must be submitted as part of the protocol.
      Ages 12 or older: written documentation of assent is required.

      Proxy Informed Consent/Research Authorization (2007-3-12)
Combined Proxy Informed Consent with HIPAA Research Authorization.

Division of Research Integrity & Compliance
Mail: 12901 Bruce B. Downs Blvd, MDC35, Tampa, FL 33612-4799   Phone: (813) 974-5638  Fax: (813) 974-5618

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Direct questions or comments about this Web site to jarnaldi@research.usf.edu  Last updated: May 29, 2008