Institutional Review Board Forms and Templates


FORMS

APPLICATION FOR NEW HUMAN SUBJECTS RESEARCH REVIEW This form needs to be completed for FULL and EXPEDITE protocol review. All applications must be submitted online via eProtocol after 02/16/09.
FORM FOR RENEWAL/CONTINUATION Renew your protocol online via eProtocol. Complete and email this form to IRB coordinators only if you cannot access your protocol online.
FORM FOR CLOSURE Close your protocol online via eProtocol. Complete and email this form to IRB coordinators only if you cannot access your protocol online.

Please read the instructions and use this form if your project meets one of the six Exempt criteria.

EXPEDITE REVIEW CRITERIA Use this form to determine if your project meets the criteria for an expedited review.
118 DESIGNATION This designation is only applicable to projects when it is known that subjects will be involved, but definite plans are not available at the time of the human subjects application or grant proposal. This designation is primarily used when funding is needed prior to receiving IRB approval for travel/meetings with collaborators to discuss the methodology/instruments to be developed or to hire someone to develop the instruments, etc.
ADVERSE EVENTS AND DEVIATIONS All adverse events and deviations must be reported to the IRB via eProtocol. Significant adverse events must be reported within 24 hours of the event.

CONSENT templates & waiver of consent descriptions

CONSENT FORM template Use this template when obtaining documentation, signed consent, of the participants.
FDA Consent Form Template Use this template for FDA-regulated research
ELEMENTS OF CONSENT These are the required elements to obtain consent from participants.
COVER LETTER template
COVER LETTER requirements
A cover letter or alteration of consent can be used when the protocol fits the criteria 117(c)(1) or 117(c)(2) listed below.
VERBAL CONSENT template Verbal consent or alteration of consent can be used when the protocol fits the criteria 117(c)(1) or 117(c)(2) listed below. (UNDER CONSTRUCTION)
WAIVER OF DOCUMENTED CONSENT 117(c)(1): That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern;
117(c)(2): That the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context. In cases where the documentation requirement is waived, the IRB may require the investigator to provide participants with a written statement regarding the research, i.e., cover letter, verbal consent.
WAIVER OF CONSENT:
This is primarily used when asking for a waiver of parental permission for participants who are minors.
116(d): An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirements to obtain informed consent provided the IRB finds and documents that:
(1) The research involves no more than minimal risk to the participants
(2) The waiver or alteration will not adversely affect the rights and welfare of the participants;
(3) The research could not practicably be carried out without the waiver or alteration;
and (4) Whenever appropriate, the participants will be provided with additional pertinent information after participation.
ASSENT template for participants who are minors Use one of these formats for participants who are under the age of 18:
1) for children up to 7 years old the researcher shall determine if the child does not want to participate by actions other than verbal, i.e., crying, tantrums, struggle. A brief, simple, verbal script must also be used.
2) for children 7 to 14 years old the assent should be simplified, brief and in age-appropriate language.
3) for young adults 14 to 17 the regular consent form template can be used as it should be in lay language and at a reading level the youngest participant will be able to understand.

Miscellaneous Templates and Guidelines

Letter of Cooperation Guidelines When & how to obtain a letter of Cooperation.
Letter of Cooperation Template Customize this template for your study and provide to the location assisting you with your research.
Email of Cooperation Sample Sample email exchange. You will customize according to your project. Please save your email exchange as a txt file to upload into eProtocol.