Sample Consent Form for Clinical Trials
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You may cut and paste the entire content below to create a consent form or incorporate specific
language into an existing consent form. Please make sure that you maintain a consistent font size
and style (e.g., 12 point Times New Roman) throughout the document when inserting text into the
template.
The order of the sections is an important feature of this template; avoid altering the order.
This document includes instructions on how to write a consent form. The instructions are in RED.
Delete or replace all instructions prior to submitting this form for IRB review.
For more information, see The Research Consent Process: A Guide for Researchers.
Study Title:
Insert the full title of the study.
Investigator:
Insert the investigator’s name and his/her hospital/clinic/organization.
Sponsor:
Insert the name of the sponsor and, if applicable, state whether the sponsor is also
the manufacturer of the study drug, biological product, or device.
Conflict of Interest Statement: This study will receive funding from
<Insert the sponsor’s
name.> for costs related to conducting the study. The principal investigator and other study staff
members do not have a financial interest in the company.
If a conflict of interest exists, include a statement that reflects the researcher’s relationship with the
sponsor, such as one of the statements below. Delete them if there is no conflict of interest to disclose.
The principal investigator is a consultant for the sponsor of this study. Please ask any questions you have
about how this relationship might affect the study.
A spouse/partner/relative of the principal investigator is employed by the sponsor.
Research Subject’s Bill of Rights
People who volunteer to participate in an experiment (also called a research study or clinical trial) need
to understand what is expected of them and why the research is being done. As you think about whether
or not to participate, it is important that you know you have rights in place to help protect you. These
rights, listed below, will be further explained as you read this consent form.
If you are asked to participate in a research study, you have the right to the following:
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Be told the purpose and details of the research study.
Have the drugs or devices (implants, instruments, or tools) used in the research study described to
you.
Have the procedures of the research study and what is expected of you explained to you.
Have the risks, dangers, and discomforts of the research study described to you.
Have the benefits and advantages of the research study described to you.
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Be told of other drugs, devices, or procedures (and their risks and benefits) that may be helpful to
you.
Be told of medical treatment available to you if you are injured because of the research study.
Have a chance to ask questions about the research study.
Quit the research study at any time without it affecting your future treatment.
Have enough time to decide whether or not to take part in this research study and to make that
decision without feeling forced or required to participate.
Be given a copy of this signed and dated consent form.
Study Purpose
The purpose of the study is to
. <Explain what you are attempting to prove or discover.>
Subject Selection
You were selected as a possible study subject because
subjects are selected.>
. <Insert an explanation for how and why
Responsibilities of Study Participants
If you decide to participate in this study, we will ask you to do the following:
 Keep your contact information up to date (address, telephone number, etc.).
 Provide truthful information about your medical history and current health.
 Return for follow-up visits and tests as required.
 Tell the study team about any problems you have during the study.
 Tell the study team if you have been in another study during the last 30 days or if you are in another
study now.
Size of the Study
Up to
<Insert number.> subjects will be enrolled in the study.
Study Group Assignments <Include this section if subjects will be randomized.>
To ensure that the study gives a true comparison of
, <Insert the device or drug name or names.>
the study groups must be as much alike as possible. In order to try to make the
<Insert number.>
groups alike, only patients who meet certain conditions are allowed to join the study.
Each person who joins the study is put into a group by chance (randomly), which is like flipping a coin.
You may get either
or
. <Insert the device or drug names.> The chance that you will get
<Insert the study device or drug name.> is
<Insert number.> to 1. In other words,
<Insert number.> out of
<Insert number.> subjects will get
<Insert the study device or
drug name.>, and 1 will get
<Insert placebo or the name of the comparator.>.
Study Procedures and Duration
If you agree to participate in this study, you will be asked to do the following: <Insert information about
what will happen at each visit, which tests and procedures the subject is required to undergo, which
drugs/devices the subject will be expected to take or use, what aspects of the research are experimental,
etc.>
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Risks and Discomforts
The study involves the following risks to subjects:
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List the known risks and/or discomforts the subject may experience. Use lay terms and include the
medical/clinical term in parentheses after it.
Insert the following statement only if the study has no known risks. If it does not apply, delete it.
There are no known risks associated with
, but there may be unforeseeable risks that have not yet
been identified.
Reproductive Risks to Women Insert this section if it is applicable to your study; otherwise, delete it.
The research treatment may involve risks to an embryo or fetus, if you are pregnant now or if you
become pregnant during the study. Some of these risks are currently unknown. Describe any known
risks and the precautions subjects should take to avoid pregnancy.
Benefits of Study Participation
Insert the following statement when there are no direct benefits to the participant:
There are no direct benefits to you for participating in this study. We hope the information learned from
this study may benefit other patients with your condition in the future.
Insert the following statement when information learned in this study may lead to possible benefits to
others in the future:
There may or may not be direct medical benefit to you. We hope the information learned from this study
may benefit other patients with your condition in the future.
Insert the following statement when there are possible benefits to the participant:
Possible benefits you may experience include
. List and describe the possible benefits.
Alternatives to Study Participation
Alternative treatments for patients with
<Insert the condition or symptom.> include the
following: <Insert a list or description of alternative procedures.>
The risks and benefits of these other treatments include
questions you have about these other treatments.
. The study doctor will answer any
OR If there is no alternative treatment, include this statement:
There is no alternative treatment for
. <Insert the condition or symptom.>
AND/OR
Your alternative is not to participate in this study.
Costs
If the sponsor will pay all of the study costs, use this statement:
There is no cost to you to participate in this research study.
If the sponsor will pay for research costs and the research subject or insurance will be billed for routine
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care, use this paragraph:
You will be charged for all tests and procedures required for the treatment of your medical condition. If
your health insurance or Medicare requires any co-payment, co-insurance, or deductible, you will be
responsible for the making the payment. The sponsor,
, <insert name> will pay for the tests or
procedures needed for this study that are not considered routine care for your medical condition.
Billing Error Information
If you believe you have received a bill in error during the research study, contact
investigator or study coordinator’s name and number.>
. <Insert the
Payment or Compensation
Insert this statement when there is no compensation:
You will not receive any payment or reimbursements for participating in this study.
OR
Insert when there is compensation:
In return for your time, effort, and travel expenses, you will receive
<insert the amount> for each
visit for a total of
<insert the amount> if you complete the whole study. If you do not complete
this study, you will be paid
<insert the amount> for each visit you complete.
Compensation for Research-Related Injury: If your participation in this research study results in an
injury, treatment will be available, including first aid, emergency treatment, and follow-up care, as
needed. Care for such injuries will be billed in the ordinary manner to you or your insurance company.
AND
Insert the following statement when the sponsor has NO funds to pay for a research-related injury:
No funds have been set aside to pay for care for injuries resulting from your participation in this study. If
you believe you have suffered a research-related injury, notify the researcher immediately at
.
<Insert a telephone number here.>
OR
Insert when the sponsor has SOME funds available:
The sponsor of the study has set aside some funds to pay for the care of injuries directly related to
participating in the study. If you believe you have suffered a research-related injury, immediately notify
the researcher at
. You may be eligible for reimbursement of medical care costs related to the
injury.
Confidentiality
Every effort will be made to be sure that your participation in this study and all records of your
participation will remain confidential. But absolute confidentiality cannot be guaranteed. Due to the
nature of clinical trial oversight, some funding and regulatory agencies may have the right to review the
records of this study. These include the following agencies or groups: the Food and Drug
Administration, the Allina Health Institutional Review Board (The IRB is a committee that reviews
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research to help ensure that the rights and welfare of the participants are protected and that the study is
carried out in an ethical manner.), and the sponsor
. <Insert the sponsor’s name and any other
regulatory agencies that may inspect study records.>
INCLUDE THE FOLLOWING PARAGRAPHS, IF APPLICABLE—DELETE THEM IF THE
STATEMENTS DO NOT APPLY TO YOUR STUDY:
Insert the following statement if you plan to publish or present the study:
No information that could identify you, such as names or addresses, will be used when the results of this
study are published or presented.
Insert the following statement if you are using the Internet to transmit data:
Patient data transmitted over the Internet will be encrypted. (This means that it is very difficult for an
unauthorized person to see this information.) The utmost care will be taken to make sure all patient data
contained in the study is secure.
Insert the following statement if you are using photos:
Every attempt will be made to disguise identifying features in photographs.
Voluntary Participation
Participation in this study is voluntary. Your decision to participate or not participate in this study will
not affect your current or future care with
<insert researcher’s name> or at
. <Insert the
name of the hospital, clinic, or other organization.>
Right to Withdraw
You may withdraw from the study at any time. Your decision not to take part in or to withdraw from this
study will not involve any penalty or lost benefits to which you are entitled. Your withdrawal will not
affect your access to health care at
<insert the hospital or clinic>. If you do decide to withdraw,
we ask that you contact
<insert principal investigator’s name and address> to let <him or her>
know that you are withdrawing from the study.
Please note that if you choose to withdraw, the data we have collected about you before your withdrawal
must remain part of the study database and may not be removed. The study doctor may also ask whether
you wish to allow further data collection from routine medical care after your withdrawal.
Termination of Your Participation in the Study
The study doctor, sponsor, or FDA may stop your participation in the study without your consent if they
feel that it is in your best interest. They may also end your participation if you do not follow the study
procedures or experience a study-related injury or unacceptable side effects. They may also need to end
your participation for administrative reasons.
New Findings
If we find out new information during the course of the study that may change your willingness to
continue (for example, a new, serious side effect), we will contact you.
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Contacts and Questions
The researcher conducting this study is
. <List the principal investigator by name.)> You may ask
any questions you have now. If you have questions later, you can contact <him or her> at
<insert
telephone number>.
This study has been approved by an Allina Health Institutional Review Board in order to protect your
rights as a subject. If you have any questions about your rights as a research subject or complaints about
this research study, please direct them to the Allina Health Institutional Review Board (IRB)
Administrative Office at 612-262-4920.
Registration on ClinicalTrials.gov is required for all interventional studies—including unfunded,
investigator-initiated studies. Federal regulations require that the following paragraph be included; as
such, it cannot be altered in any way.
A description of this clinical trial will be available on www.clinicaltrials.gov, as required by US Law.
This Web site will not include information that can identify you. At most, the Web site will include a
summary of the results. You can search this Web site at any time.
You will be given a signed copy of this form.
Statement of Consent
I have had the opportunity to ask questions and have had my questions answered. I have been given
enough time to consider participating. I agree to participate.
Required signature lines on all consent forms:
__________________________________________
Printed name of subject
__________________________________________
Signature of subject
___________________________
Date
__________________________________________
Printed name of person obtaining consent
___________________________
Role in study (PI, coordinator)
__________________________________________
Signature of person obtaining consent
___________________________
Date
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