Templates Apr 15, 2024 Standard Informed Consent Template New IRBMED studies should most often use the latest Standard Informed Consent template available on this webpage. Specialty Consent Templates may be appropriate for low-risk studies with simpler study methodologies.
Templates Apr 15, 2024 Specialty Informed Consent Templates Obtaining the consent of a subject is a process that goes far beyond asking for a signature on a document. Potential participants must understand the nature of the study, the risks, discomforts, inconveniences, and potential benefits involved if... Tags: Regulatory Study Coordinator Principal Investigator Participant Management Study Teams
Templates May 11, 2020 Humanitarian Use Device (HUD) Informed Consent Template This template should be used when submitting the Humanitarian Use Device (HUD) informed consent documents. The Food and Drug Administration (FDA) defines a Humanitarian Use Device (HUD) as “a medical device intended to benefit patients in the...
Templates Nov 27, 2018 Biorepository Informed Consent Informational Sheet (editable PDF) This illustrated biorepository informational sheet is designed to accompany the biorepository informed consent template . Below, click the button that corresponds to the type of biorepository you plan to submit to: the university's Central... Tags: Regulatory
Templates Jul 20, 2018 Foreign Language Short Forms Investigators are responsible for understanding and following the IRBMED Guidance for non-English speaking subjects before using the forms below. Please note, the instructions on this page are for filling out the form, NOT the guidance for using a...
Templates May 4, 2018 Data Office Data Request Form To request data, complete a Data Request Form, which includes IRB information (if applicable), study team information and where you will store your data. Note: You may save your work and submit at a later time Tags: Data Use
Templates Apr 17, 2018 One-Time Blood or Tissue Sample (Minimal Risk) Informed Consent Template This template should be used when creating a One-Time Blood or Specimen Sample ( Minimal Risk ) informed consent document. You may not use this template if you plan to conduct genetic analysis on subjects’ samples you plan to submit subjects’...
Templates Apr 17, 2018 Survey Research Informed Consent Template This template should be used when creating a Survey Research informed consent document. This template may be used only for studies that involve a survey and no other procedures pose minimal risk to subjects
Templates Apr 17, 2018 Eligibility Screening Informed Consent Template This template should be used when creating an Eligibility Screening Informed Consent document. This template may be used only for eligibility screening and only if screening procedures pose no more than minimal risk to subjects. You may not use this...
Templates Mar 13, 2018 Data Office Access Request Form Request an account for a self-serve tool through this online form through Jira. If you have issues accessing this page, please contact the Data Office at [email protected] . Tags: Data Use
Templates Mar 13, 2018 Data Office Data Set Specification To request data, complete a Data Set Specification to define your subject population (inclusion/ exclusion criteria) and the data elements needed in your data set. Note: You may save your work and submit at a later time Tags: Data Use
Templates Mar 29, 2017 FDA Expanded Access Informed Consent Template This template should be used when creating an FDA Expanded Access informed consent document. This template is designed for use in all Expanded Access uses, which include both Compassionate Use and Emergency Use. For more information on specific...
Templates Jan 13, 2014 Assent Template (Recommended for ages 10 to 14-years-old as well as 14 to 17-year-olds when the study involves drug or pregnancy testing and/or birth control.) Return to I nformed Consent Templates page.
Templates Apr 17, 2018 Biorepository Informed Consent Template This biorepository informed consent template is designed to be accompanied by the illustrated biorepository informational sheet . Clinical teams engaging with the patients are provided with the Biorepository Consent and Authorization template to...
Templates Jul 9, 2018 CBR Use Proposal Form Central Biorepository staff will use the information you provide in this form to make contact with the investigator(s) who collected the materials that might be useful to your project, begin to identify candidate samples, and assess and advise on... Tags: Access
Templates Jul 8, 2020 Exempt Consent Template The expectation for all human subject research—whether exempt or not—is for researchers to inform the subjects regarding the research and seek/secure the consent of subjects. Use this consent template for Exempt studies requiring Limited IRB review... Tags: Study Teams
Templates Dec 16, 2020 Central Biorepository Memorandum of Understanding Regarding Use of CBR Resources The CBR plans to provide certain materials (biospecimens and/or data associated with or derived from them) (“CBR resources”) from individuals who have participated as research subjects in the CBR (“CBR participants”), for use in the research project... Tags: Access
Templates Jun 1, 2018 Data & Biospecimen Sharing Checklist This checklist is to be used when individual-level patient/participant data or biospecimens are to be transferred to an external for-profit organization. Tags: Data Use Biorepository Use Access
