Titlesort descending Description Date
Exception Request Form This is the most recent version of the Exception Request Form. Please see the "How to Submit" page for Exception Requests for additional guidance on requesting exceptions to your approved protocol. Nov 13, 2017
Genetic Information Non-Discrimination Act (GINA) language This language should be included in the risk section of your biomedical Informed Consent Form when genetic testing is being conducted AND the results of genetic tests will be entered into the subject’s University of Pennsylvania Health Care System medical record. Please note, there may be other instances where this language might be required or recommended on a case by case basis as determined by the IRB. May 31, 2016
HIPAA Language Template This template should be used to develop protocol specific HIPAA language when creating an informed consent / HIPAA authorization form. This template version includes the new language to align with the roll out of the Clinical Trials Management System. Jan 24, 2017
Human Subjects Research Determination Form To be used in conjunction with the guidance document "Is IRB Review Required" on the "How to Submit; Initial" page to help determine whether whether IRB submission is required. Completed forms should be sent to a Senior Analyst. Feb 13, 2018
Individual Investigator Agreement Form This form should be used when one person is an investigator on the study team, is not affiliated with Penn and is not affiliated with an FWA institution or the institution does not have an IRB through which a standard IRB Authorization Agreement can be executed. Nov 13, 2017
Informed Consent Form Template (Biomedical) Informed Consent Form Template (Biomedical) -This template version includes the new Common Rule elements of informed consent required after 1/21/2019 as well as a template to build in a concise summary Jun 18, 2019
Informed Consent Form Template (Social and Behavioral Sciences Research) Informed Consent Form Template (Social and Behavioral Sciences Research) - This template version includes the new Common Rule elements of consent that are required after 1/21/2019 including concise summary. Jun 18, 2019
IRB Authorization Agreement (IAA) Form If the Penn IRB will serve as a Relying IRB or Reviewing IRB in a research study collaboration with another institution, this form must be completed by the PI and included with the submission. Nov 13, 2017
Modification Form This is the most recent version of the Modification Submission Form. Please see the "How to Submit" page for modifications for additional guidance on making changes to your already approved study. Jun 18, 2019
Participating Site Addition Form This form should be completed when the Penn IRB will be serving as the Central IRB of Record for a multi site study. Please refer to the "How to Submit: Reliance Agreements" page of this website for full information about requirements for adding new sites under Penn IRB review. Nov 13, 2017