The information provided below is to help you create a process that reflects ethical research conduct. Before you prepare your consent document, please review the information below and carefully review the Consent Requirements, Consent Samples, and other helpful resources located in the shaded box to the right.

The ethical principle of respect for persons requires that subjects be given the opportunity to choose what shall and shall not happen to them. Valid informed consent requires:

The ethical principle of respect for persons requires that subjects be given the opportunity to choose what shall and shall not happen to them. Valid informed consent requires: 

• That consent must be Prospectively Obtained from the subject or the legally authorized representative of the subject; 

• The information must be Conveyed in Understandable Language and Subject Comprehension is attained; 

• Disclosure of relevant information to prospective subjects about the research; 

• Voluntary Agreement , free of coercion and undue influence, obtained from the prospective research participation prior to participation; and,

• Subjects must not be made to give up legal rights or be given the impression that they are being asked to do so.

Informed Consent is a process not just a form.  Ideally, informed decision-making is a process that includes discussion between the prospective participant and the Principal Investigator (PI) or research assistants as appropriate, and obtaining a signature on the written informed consent document. Depending on the nature, type and duration of the research, ongoing discussion and education of subjects about the study may continue long after the informed consent document is signed. and

Please remember to review the Consent Requirements and Consent Samples.  You will need to use the Consent Translation Form if your consent form(s) will be translated into another language other than English.