Informed Consent Documents

Download	Description
Informational Letter MS Word - 26.5 K	Informational Letter Investigators are required to obtain agreement from research participants before collecting data.  In many instances, an informational letter can be used for exempt studies.
WaiverOfConsent MS Word - 21K	Justification For Waiver of Documentation of Informed Consent Federal regulations permit the IRB to waive the requirement for the investigator to obtain a signed consent form for some or all of the subjects, if it meets the attached criteria.
Waiver Justification MS Word- 20 K	Informed Consent Justification of Waiver Federal regulations do permit modifications in the consent procedure, and, under certain circumstances, informed consent may be waived entirely if the research meets these conditions.
Informed Consent-Adult MS Word - 24.5 K Tissue/Bodily Fluid Consent MS Word- 46 K Stored Specimen Consent MS Word- 51 K	Informed Consent There are several templates for obtaining informed consent. A generic template for consent of adults in research not involving a tissue specimen can be found under Informed Consent-Adult. There are two separate consents for research involving tissue specimens (including blood, bodily fluids or tissue products). For research involving a tissue specimen that will be used only for the currently approved protocol, any remaining tissue will be destroyed and there is no intention of storage of specimens for future use or testing, the template can be downloaded as Informed Consent-Tissue. For research involving the storage of a tissue specimen for the purpose of future testing, the template can be found at Informed Consent - stored specimen.
Parental Permission MS Word - 25.5 K Student/Minor Assent MS Word- 22 K	Informed Consent for Research Involving Minors Whenever research involves the use of minors, there is a need to either inform or obtain parental consent prior to the child's participation in the research. The template for the parent consent can be found at Parental Permission. The minor may likewise (dependent upon age) be given an opportunity to give their assent for participation in the research. The template for minor assent can be found at Informed Consent - Student Assent.

Note: Forms are updated on a regular basis. Users are encouraged not to save current forms for future use. Protocols submitted using older (or out-of-date) forms will be returned.

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Template Available:
You may utilize our templates for the development of the consent form to ensure that all necessary elements are present.

The consent form will be pre-screened by the Office of Research Compliance, prior to submission to the IRB for approval. There may be additional changes later required, but this pre-screening process will identify any omissions and help streamline the review process.

Any revisions or additions to a previously submitted informed consent statement should be highlighted and reference made to the IRB assigned number, along with the name of the principal investigator and the title of the protocol as it was originally submitted to the IRB. In addition, a clean current consent form is submitted so that the approval and expiration stamp can be affixed to the consent form for use by the principal investigator.

Request for Waiver of Informed Consent:
Federal regulations do permit modifications in the consent procedure, and, under certain circumstances, informed consent may be waived entirely if the research meets these conditions.

The IRB may approve a waiver of all of the consent requirements provided:

• the research involves no more than minimal risk to subjects;
• the waiver will not adversely affect the rights and welfare of the subjects;
• the research could not be carried out practicably without the waiver; and
• as appropriate, the subjects will be provided with additional pertinent information after they have participated in the study.

If you wish to request a waiver, written justification must accompany this packet. Please address the above elements in your justification statement. It may be written on a separate sheet of paper and included with the packet submission.

A sample of a justification is available for your review: Waiver Justification