Example Consent Text for Study-Specific Activities - IRB-Approved Section Templates

Sep 2, 2026

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Example consent text for study-specific activities provides IRB-approved section language for participants in clinical research. The material guides users to replace placeholder red text with study-specific details and includes selectable components such as study phases, investigational device context, placebo use, randomization, blinding, imaging, radiation, MRI, incidental findings, and reporting requirements. It also defines purpose and benefits sections for Phase I through Phase IV drug studies, and introduces parallel consent wording for investigational medical device studies, emphasizing experimental status and participant uncertainty of benefit.

LanguageEnglish

CategoryLetters

FormatDOCX

Pages21

Reading Time7 min

AccessFree to download

Table of Contents

Phase I Drug Studies

Section: Purpose of the Research

Section: Are there benefits to taking part in the study

Phase II Drug Studies

Section: Purpose of the Research

Section: Are there benefits to taking part in the study

Phase III Drug Studies

Section: Purpose of the Research

Section: Are there benefits to taking part in the study

Phase IV Drug Studies

Section: Purpose of the Research

Investigational Medical Device Studies

Section: Purpose of the Research

Example Consent Text for Study-Specific Activities This document provides example text that can be used for specific research tests, procedures, or processes. Replace all red text with appropriate wording related to your study. Guidance has been given regarding most appropriate section of the consent to include the text. Click on the following item(s) below to view text that has been approved by the IRB and may be included in your consent document: HYPERLINK \l "PhaseIDrugStudies" Phase I Drug Studies HYPERLINK \l "PhaseIIDrugStudies" Phase II Drug Studies HYPERLINK \l "PhaseIIIdrugstudies" Phase III Drug Studies HYPERLINK \l "PhaseIVdrugstudies" Phase IV Drug Studies HYPERLINK \l "invdevice" Investigational Medical Device Studies HYPERLINK \l "GINA" GINA Language for Genetic Testing HYPERLINK \l "placebo" Placebo HYPERLINK \l "randomization" Randomization HYPERLINK \l "blind" Blinding HYPERLINK \l "ctscan" CT Scan HYPERLINK \l "radiation" Radiation HYPERLINK \l "MRI" MRI HYPERLINK \l "incidental" Incidental Findings HYPERLINK \l "mandated" Mandated Reporting HYPERLINK \l "audio" Audio/Video/Photographs HYPERLINK \l "coc" Certificates of Confidentiality HYPERLINK \l "pregnancy" Pregnancy Risks HYPERLINK \l "hipaa" HIPAA Authorization HYPERLINK \l "MUinjury" MU Injury Language Phase I Drug Studies Section: Purpose of the Research - In this study, we want to find out more about the side effects (problems or symptoms) of a drug for condition, called _______ (also called the study drug in this form), and what doses are safe for people to take. Everyone in the study will take study drug, which is experimental (being tested) and has not been approved by the U.S. Food and Drug Administration (FDA). We do not know all of the ways study drug can affect people. If applicable: This study will likely not help you or your condition/symptoms. We hope the information we get from the study will help us develop a better treatment for condition in the future. Section: Are there benefits to taking part in the study – This study is not likely to help you, but it will help us to learn more about procedure/drug/device/intervention. We hope this information will help us develop new treatments for condition in the future. Phase II Drug Studies Section: Purpose of the Research - In this study, we want to find out more about a drug, called _______ (also called the study drug in this form), for people with condition. We want to find out if study drug reduces the symptoms/other reason of condition, and if it causes any problems (also called side effects). Study drug is experimental (being tested) and is not yet approved by the U.S. Food and Drug Administration (FDA) / is approved by the U.S. Food and Drug Administration (FDA) for use but not in patients with condition being studied/but not when given by _______. We are testing study drug to see what effect it has on patients with condition. We don’t know if this study will help you. Your condition may get better, but it could stay the same or even get worse. We hope the information we learn from this study will help us to develop a better treatment for condition in the future. Section: Are there benefits to taking part in the study – We don’t know if this study will help you. Your condition may get better, but it could stay the same or even get worse. We hope that this study will help us to learn more about procedure/drug/device/intervention, and to develop new treatments for condition in the future. Phase III Drug Studies Section: Purpose of the Research - In this study, we want to find out if a drug for condition, called _______ (also called the study drug in this form), works better than comparator/placebo, a routine treatment for condition/something that looks like the study drug but contains no active medicine. To do this, we will compare the two drugs/the study drug and the placebo in people with condition and see which on

FAQs

What is the main purpose of this consent text template?

It provides example wording that can be used in consent documents for study-specific research activities. Users are instructed to replace red placeholder text with details relevant to their specific study.

How do the Phase I drug study consent sections describe the study drug?

They explain that the drug is experimental and not approved by the U.S. Food and Drug Administration (FDA), and they state that the study aims to learn about side effects and safe dosing.

What information is included about potential benefits for participants?

Across the phases, the text indicates the study is not likely to help the participant directly. It emphasizes that participants’ condition may improve, remain the same, or worsen, and that the study results are intended to support better treatments in the future.

Sep 2, 2026

9

0

Upload by Kyle