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Guidance
Aug 31, 2022

Emergency Research (Planned and Approved) with Exception from Informed Consent

Overview The Food and Drug Administration (FDA) regulation at 21 CFR 50.24 , and Office for Human Research Protections (OHRP) Secretary's Waiver , allows a narrow exception to the requirement to prospectively obtain and document informed consent...
Tags: Regulatory
Guidance
Aug 26, 2022

Radiation Exposure Guide

Ionizing radiation includes x-rays, beta-rays, gamma-rays, neutrons, and other high-speed particles. When subjects are exposed to ionizing radiation as part of their study activity, the risks incurred from radiation exposure must be assessed by the...
Tags: Regulatory Study Teams
Guidance
Dec 15, 2021

Waivers and Alterations under OHRP, FDA and HIPAA

Common Rule regulations and FDA guidance , and HIPAA regulations each allow for an IRB to approve research that departs from the usual requirements regarding the participant’s free and informed decision to participate in the study, or regarding the...
Guidance
Dec 15, 2021

Informed Consent Procedures Using Electronic Systems and Remote Use of Paper Documents

Electronic and remote informed consent procedures are permitted by IRBMED and must meet the same regulatory and institutional requirements of an in-person paper-based informed consent process. This guidance is intended for research studies that...
Templates
Nov 25, 2021

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
Policies
Oct 15, 2021

Statement of Practice: Document Revision Guidance, Naming Convention, and Version Control

To assure that study teams are utilizing the most recent IRB approved versions of study documents when making modifications at the time of amendment or when addressing requested changes by IRBMED staff or reviewers, IRBMED has standardized practices...
Tags: Study Coordinator Study Teams IRBMED Statement of Practice
Templates
Jun 14, 2021

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.
Guidance
Jun 4, 2021

Information Blocking in a Blinded Study

Single Blind Studies : A research study done in such a way that the participants do not know (are blinded to) what treatment they are receiving to ensure the study results are not biased (the power of suggestion). Blinded studies are sometimes...
Tags: MiChart OnCore Support Participant Management
Guidance
Mar 19, 2021

Research Involving Children Who Are Wards of State or Any Other Agency, Institution, or Entity

Guidance
Mar 18, 2021

Assent of Children in Research

The IRBMED has developed an assent template for researchers to use in developing an assent document appropriate for children ages 10 to 14. It is available here . Below are frequently asked questions about assent. Links to additional information are...
Guidance
Mar 8, 2021

Children in Research

The involvement of children of any age in human subjects research involves additional regulatory and ethical considerations. Resources on the main categories for consideration follow. Children are persons who have not attained the legal age for...
Guidance
Oct 21, 2020

Prisoners in Research

Convened Board review and approval of research designed to study incarcerated persons, or persons likely to become incarcerated , is a multistep process and must be conducted in accordance with the requirements in 45 CFR 46 Subparts A (Common Rule)...
Guidance
Jul 29, 2020

Seeking Reconsent from Research Participants

Informed consent is an ongoing, interactive process throughout a participant’s study involvement, rather than a one-time information session. In addition to encouraging subjects to ask questions and raise concerns, it may become necessary to seek...
Policies
Jun 18, 2020

Use and Distribution of Biospecimens and Data Policy

This policy operates subject to the Medical School Governing UMMS Research Biorepositories Policy ("Research Biorepositories Policy") and applies to all Central Biorepository (CBR) resources. This policy establishes a framework for appropriate...
Tags: Data Use Biorepository Use
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...
Policies
Feb 12, 2020

Statement of Practice: IRBMED Finalization of Study Documents

This document replaces: ‘ Approval Dates on Consent Documents and Recruitment Materials ’ Statement of Practice. Click here for PDF version.
Tags: IRBMED Statement of Practice
Guidance
Jan 16, 2019

Transition to 2018 Regulations - ARCHIVED

04/23/2021: This page has been archived. This transition is largely complete. All new applications are evaluated according to 2018 Revised Common Rule. With questions, contact your IRB staff. On January 21, 2019 most provisions of the Revised Common...
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
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’...

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