Almost all studies require informed consent.  There are very few times when obtaining informed consent is not feasible for a study that is of minimal risk; this usually applies to anonymous surveys, de-identified surveys, and retrospective analysis that also utilizes the de-identification process. The necessary documents can be found on the CMH Institutional Review Board website on the intranet. You will need to complete a Waiver of Authorization or an Alteration of the Authorization if all five of the following criteria are met: The research involves no more than minimal risk to the subjects, AND The research could not practicably be carried out without the waiver or alteration, AND If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format, AND The waiver or alteration will not adversely affect the rights and welfare of the subjects, AND (Whenever appropriate) Subjects will be provided with additional pertinent information after participation. Please note: If your research requires PHI, then you must also complete a Waiver of HIPAA Authorization. If consent for your research will be obtained verbally, you must also complete a Waiver of Documentation (Signature) of Informed Consent. If you are conducting a case report and the patient is deceased, you will seek the consent of the patient’s Legally Authorized Representative.  There are limited times when a Waiver or Alteration of HIPAA Authorization may also be appropriate. To apply, all 3 criteria below must be met: The use or disclosure of protected health information (PHI) involves not more than minimal risk to the privacy of individuals based on: An adequate plan to protect the identifiers from improper use and disclosure;  An adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers, or such retention is otherwise required by law;  Adequate written assurances that the PHI will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research which the use or disclosure of PHI would be permitted by the Privacy Rule. The research could not be practicably conducted without the waiver or alteration, AND The research could not be practicably conducted without access to and use of the protected health information.    Remember, when applying for a waiver of documentation of consent, you must complete a waiver or alteration of HIPAA Authorization.