Below is a listing of all the various forms that will be needed to submit and maintain and IRB proposal.
There are no submission deadlines for IRB review. If the proposal is determined by the IRB to be exempt or expedited, the screening process is ongoing. If the research project is determined to require a full IRB review, then the submission will be reviewed and discussed at a regularly scheduled IRB meeting at least two weeks after proposal submission. It the responsibility of the investigator to submit the IRB forms in a timely manner.
IRB proposal (rev. 2017). - Expedited or Full review protocol application
IRB Exempt Form (rev. 2017) - Exempt review protocol application
Review the Exempt review checklist to determine if your proposal may be exempt. If your proposal does not meet any of the criteria for exemption on this list, your study may not be classified as exempt. Please file the IRB Proposal form above.
Please submit One Electronic Copy to [email protected] and One hard copy with signatures to Heather Riffle, IRB Officer
The University of Findlay requires that all investigators secure consent for participation from either subject or the subject’s guardian. This consent is to be secured under conditions which give the subject sufficient opportunity to make a considered judgment whether to participate or not and which minimize the possibility of coercion or undue influence.
Informed Written Consent form (For use with subjects age 18 and over)
Research Assent Form (For use with subjects age 7-17)
Parent Consent/Permission template (use in conjunction with Research Assent Form)
The signed, written consent form consists of two sections. The first section constitutes the 'informed' part of the form, that is, a brief statement of the nature of the project, its objectives, its potential benefits in general and possibly to the subject individually. In addition, there must be a complete description of the nature of participation by the subject. This means exactly what the subject will do and what (if anything) will be done to the subject. This section need not be longer than one to several paragraphs but should be complete enough to stand alone as having informed the subject about the nature of the project and what participation means.
Implied Consent Cover Letter Template
Many research projects utilize retrospective cases, surveys or questionnaires as their data
source and pose minimal risk to subjects. Federal regulations at 45 CFR 46.116(d) permit an IRB to approve a consent procedure that eliminates or alters the required elements of informed consent, or to waive the requirement to obtain informed consent altogether.
The use of a signed consent form will, in the cases, be the only means of identifying a person as participating in a project, and will thus be the only potential basis for the risk of violating confidentiality and privacy. At the same time, persons have the right to be informed, and the right to refuse participation in a research project. In order to maintain these rights, and avoid the risk of violating these rights, an implied consent template
has been developed and approved by the IRB. This template should be used in place of the informed consent if the researcher feels that their project meets the above description of minimal risk.