Ochsner Clinic Foundation - Research Informed Consent - eIRB v 2019.05

Sep 2, 2026

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Ochsner Clinic Foundation research informed consent template for use in eIRB. Provides guidance to help study participants understand study purpose, eligibility, procedures, expected time commitment, and key risks and potential benefits. Includes required “Key Information” wording for certain federally funded studies, emphasizes that participation is voluntary and not a substitute for regular medical care, and outlines how questions and withdrawals are handled.

LanguageEnglish

CategoryForms

FormatDOCX

Pages14

Reading Time5 min

AccessFree to download

Key Information

Voluntary participation and decision-making

Duration and number of participants

Detailed Information

Purpose

Length of study and number of participants

Procedure

Risks and benefits

Alternatives and withdrawal

OCHSNER CLINIC FOUNDATION RESEARCH INFORMED CONSENT INSERT THE NAME OF YOUR STUDY HERE – as it appears on the protocol Principal Investigator: PI Name Here Contact Information: Include mailing address and phone # Alternate Study Contact: Name Here and 2nd phone # Sponsor’s Protocol # as entered in eIRB Sponsor name: if internally funded, enter Ochsner You have been invited to participate in a research study. The doctors and staff at Ochsner study the nature of disease and attempt to improve methods of diagnosis and treatment. This is called clinical research. Understanding this study’s risks and benefits will allow you to make an informed judgment about whether to be part of it. This process is called informed consent. This consent form may contain words that you do not understand. Please ask the study doctor or the study staff to explain any words or information that you do not clearly understand. You may take home an unsigned copy of this consent form to think about or discuss with family or friends before making your decision. Participating in a research study is not the same as getting regular medical care. The purpose of regular medical care is to improve your health. The purpose of a research study is to gather information. Being in this study does not replace your regular medical care. [if needed: In this consent form, “you” always refers to the subject. If you are a legally authorized representative, please remember that “you” refers to the study subject. KEY INFORMATION This section is required for federally funded studies. It is optional for non-funded studies or studies regulated by the FDA or the Department of Justice. This section must be brief and in lay-person language. The IRB staff will return for revision if these instructions are not followed. The following is a short summary of this study to help you decide whether you should participate. More detailed information is listed later in this document. Why is this research being done and why am I being invited to take part? You are being invited to take part in a research study because Fill in study specific details. Fill in the circumstance or condition that makes subjects eligible for the research. What should I know about being in a research study? Someone will explain this research study to you. Whether or not you take part is up to you. You can choose not to take part. You can agree to take part and later change your mind. Your decision will not be held against you. You may discuss whether to participate with family, friends and/or your doctor You can ask any questions before making a decision. How long will I take part in this research? Outline the expected time commitment to complete the study including the length of time and approximate number of study visits, e.g., “It will take you about 14 months to complete the study. During this time, you will be asked to make 14 study visits What will I be asked to do in this study? Provide a limited number of bullet points with a high-level summary of the procedures that will be done, e.g., You will be given an investigational drug. You will be asked to come to the study clinic for 3 study visits. You will give a total of 3 blood samples and fill out questionnaires More detailed information about the study procedures can be found under the PROCEDURE section of this form. Is there any way this study could be bad for me? There can be risks associated with joining any research study. The type of risk may impact whether you decide to join the study. For this study some of these risks may include Indicate reasonably foreseeable risks. This cannot be a list of all potential risks. This is not a complete list of all potential risks. More detailed information about risks can be found under the RISKS section of this form. Will being in this study help me in any way? Select one of the options below that describes the potential benefits for participants. Briefly summarize potential benefits This study may offer some

FAQs

What should participants do if they want to leave the study after enrolling?

Participants may leave at any time if they change their mind and are encouraged to review the rest of the document and ask the study team any questions before agreeing.

Sep 2, 2026

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