The University of Iowa
Human Subjects Office

iii. Consent Template and HawkIRB

Manuals

Printer-friendly versionPrinter-friendly version

The Informed Consent Document template is available via HawkIRB and contains the required text for preparing an Informed Consent Document.  At the end of the template, there is an Appendix containing suggested language for specific situations.  By following the template, the investigator ensures that the basic and additional elements of consent as required by the federal regulations are included.

For all New Project applications, investigators must begin with the consent template that is available at the end of the HawkIRB application.  In HawkIRB, the consent document is populated with template language based on responses to various questions within the application.  Thus, when downloaded, many of the pertinent sections of the consent template are already included.

The IRB expects the PI of the study and a contact person who is a member of the research team be listed at the top of the Informed Consent Document.  The PI may be listed as both the PI and the contact person for the study.  All other members of the research team may be listed at the discretion of the PI, or may be provided in a separate listing to subjects.  If a separate listing of research team members is provided, it does not need to be reviewed by the IRB unless other study information is also included on the document.  All members of the research team must continue to be listed in the HawkIRB application and IRB approved, even if they are not listed on the consent document.  It is the PI’s responsibility to keep the listing of research team members in HawkIRB current (and on the consent as applicable.)  Only members of the research team which are indicated as involved in the informed consent process in the HawkIRB application can review the informed consent document with a potential subject.  This individual will also sign as the person who obtained consent in the appropriate section of the informed consent document.

The Informed Consent Document must include all of the following that are applicable to the particular study in question:

  1. Title of project.
  2. The name of the PI and a study contact person (may be the PI) and their degrees.
  3. A statement that the study involves research.
  4. An explanation of the purpose(s) of the research.
  5. The expected duration of participation.
  6. A description of the procedures/what will happen during the study and identification of any procedures that are experimental.
  7. A description of any reasonably foreseeable risks or discomforts.
  8. A description of any benefits to subjects or others that may reasonably be expected from the research only.
  9. Appropriate alternative procedures or courses of treatment, if any.
  10. Extent to which confidentiality of records identifying subjects will be maintained and a statement that notes those outside the research team who may have access to identified records including regulatory authorities (e.g. DHHS and FDA).
  11. For research involving more than minimal risk, an explanation as to whether any compensation, an explanation as to whether any medical treatment is available if injury occurs, and if so, what they consist of and where further information may be obtained.
  12. Contact information for questions about the research project, and research subjects’ rights, and whom to contact in the event of research-related injury.
  13. A statement that participation is voluntary and that refusal to participate or discontinuing participation at any time will involve no penalty or loss of benefits to which the subject is otherwise entitled.
  14. The signature and signature date for subject and/or legally authorized representative.
  15. Signature and date lines for person providing verbal explanation of study and obtaining consent (where study appropriate).

Based on the study design and in consideration of the subject’s safety and welfare, as well as the relevance of the information in allowing the prospective subject to make an informed decision about participation, the UI IRB may require additional information in the Informed Consent Document including:

A statement that the particular treatment or procedure may involve risks to the subject which are currently unforeseeable.

  1. A statement that the particular treatment or procedure may involve risks to the embryo or fetus, if the subject is or may become pregnant, which are currently unforeseeable.
  2. Anticipated circumstances under which participation may be terminated by the investigator.
  3. Any additional costs to the subject that may result from participation in the research.
  4. Consequences of the subject’s decision to withdraw from the research.
  5. Procedures for orderly termination of participation by the subject.
  6. A statement that significant new findings developed during the course of a study that may relate to the subject’s willingness to continue will be provided to the subject.
  7. The approximate number of subjects involved