headers provides suggested verbiage to be used as it applies... OMIT Study Title ______________________________________________________________

Information and Consent Form
Directions: Include all bolded Headers in the consent form. The bulleted language under the
headers provides suggested verbiage to be used as it applies to the proposed study. Use only
language that is relevant to the current study. OMIT these directions on the consent form.
Study Title ______________________________________________________________
Introduction: You are being asked to participate in a research study. Your participation is
voluntary. Your decision to participate or not to participate will have no effect on the quality of
medical care, academic standing, job status, etc. (whatever phrase is appropriate). Please ask
questions if there is anything you do not understand. The purpose of this study is to learn
about… explanation in lay terms of the basic purpose of the study. Or: This research is being
done because ______________________________.
What is involved in the study?
 Briefly explain the tasks, procedures, therapies, tests, etc. involved in this study from
the participants point of view.
 When applicable, explain whether or not all participants receive the same therapy
and the process of randomization.
 If you decide to enroll in this research study, you will be assigned by chance to
one of the following groups:
Group A – receives xxxx
Group B – receives xxxx
How many people will take part in the study?
 It is anticipated that x persons will participate in this research.
How long will I be in the study?
 You will be in the study…..
What are the risks of participating in the study?
 Include any reasonably foreseeable risk or discomfort in language the subjects
will understand.
 Include risk of being in a placebo or observation group.
 If applicable: Pregnancy may be a reason to not participate or to stop participation
in this study. If you are or become pregnant, please notify __________________.
What are the benefits of participating in the study?
 First sentence as appropriate to the specific study: Choose one of the following:
 You will not benefit from being in this research study.
 There is almost no chance that you will benefit from being in this research
 There is little chance you will benefit from being in this research study.
 You may not benefit from being in this study.
 Second sentence, if applicable:
 We hope to gather information that may help people in the future.
What other options are there?
 Instead of being in this study, you have these options: (list)
 This type of treatment may be received outside of this program.
What about Confidentiality?
 All reasonable efforts will be made to keep your personal information confidential.
We cannot guarantee absolute confidentiality. Your personal information may be
disclosed if required by law. Raw data will be stored in a locked file and destroyed
when appropriate.
Organizations or individuals that may inspect and/or copy your research records for
quality assurance and data analysis include groups such as (include those that are
 Bradley University faculty advisor
 The National Cancer Institute (NCI)
 The Food and Drug Administration (FDA)
 The Office of Human Research Protections (OHRP)
 Decatur Memorial Hospital
What are the costs?
 Clearly explain costs for participation as they apply to your study; describe any
payment. Examples are:
 There are no costs for participation in this study.
 The _________ will be supplied by __________ free of charge. Any
additional tests done solely for research purposes will be paid for by
 Taking part in this study may lead to added costs for you or your insurance
company. Please ask about any expected added costs or potential insurance
 In the case of injury or illness resulting from this study, emergency medical
treatment is available but will be provided at the usual charge. No funds have
been set aside to compensate you in the event of injury.
 You will receive no payment for taking part in this study.
What are my rights?
 Taking part in this study is voluntary. You may choose not to take part or may
leave the study at any time.
Who should I call with questions or problems study?
 Questions about this study may be directed to the researcher or the research
advisor in charge of this study: Dr.______at (309) 677-______ during normal
business hours.
If you have general questions about being a research participant, you may contact
the CUHSR office at (677-3877) during normal business hours. The Chairperson
of this committee will discuss the matter with you.
Where can I get more information? (Optional)
 You may call NCI Cancer Information Service at 1-800-4-CANCER
Documentation of informed consent
You are voluntarily making a decision to participate in this study. Your signature means
that you have read and understood the information presented and have decided to participate.
Your signature also means that the information on this consent form has been fully explained to
you and all your questions have been answered to your satisfaction. If you think of any
additional questions during the study, you should contact the researcher(s).
I agree to participate in this study
Signature of Participant or legally authorized representative
Printed Name