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IRB Office version 28Feb2011
JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH
INFORMED CONSENT DOCUMENT
Insert an identifier in the footer such as version number and/or date on bottom of this
page.
<<Insert Name of Consent Document>>
If there are multiple consent forms, identify each document by the population who will
sign it, for example, “Adult Controls”, “Parents”, “Teachers”, etc.
Study Title:
Principal Investigator:
IRB No.:
PI Version Date:
Investigators are expected to write consent forms in simple language. The preferred
reading level is 8th grade.
 Please use the Spelling and Grammar feature of Microsoft Word to check the
reading level of the text of the document that you write (instructions for Microsoft
Word are at the end of this document after the signature page).
 Check spacing – make sure headings and text flow together, and remove
unneeded spaces.
What you should know about this study
 You are being asked to join a research study.
 This consent form explains the research study and your part in the study.
 Please read it carefully and take as much time as you need.
 You are a volunteer. You can choose not to take part and if you join, you may
quit at any time. There will be no penalty if you decide to quit the study.
 During the study, we will tell you if we learn any new information that might
affect whether you wish to continue to be in the study.
Purpose of research project
Start with an introductory sentence describing the primary aim of the study as stated in
the research plan. “This research is being done to….”
Explain what the study is designed to discover or establish. If this is a treatment study,
describe how the study intervention is different from standard care. Identify any
procedures or objectives that are experimental.
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<<insert an identifier such as version number and/or date >>
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Why you are being asked to participate
Describe the basic eligibility criteria for the study population and why you are asking the
participant to join the study. You may include the approximate number of people
expected to take part. If the study involves a screening procedure, explain that the
screening will determine whether the participant will be eligible for the study intervention
or interaction.
Procedures
This section should explain to the subjects what will happen if they join the study. For
example, “If you join this study, we will ask you to do the following things:…” Then,
describe the procedures chronologically, using lay language and short sentences, or
bullets and phrases. Keep paragraphs short. Make sure the procedures listed in the
consent form are consistent with those in the research plan.
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Explain concepts like “randomization” using language like “flipping a coin”
Define and explain any medical or scientific terms in ordinary language, for
example, use teaspoons instead of ml. as unit of measurement.
Specify the length of time for participation, frequency of procedures, and the
location of the study intervention.
If placebo is used, clearly define what it is.
If applicable, explain whether study test results will be returned to the subject,
and whether medical results will be provided to the subject’s health care provider.
If your study will include storing of samples for future research, use a separate
consent form for that procedure. In it, explain who will store the specimens, for
how long, how they might be used, and who may have access to the specimens,
and under what conditions. Include any coding or other data security measures
that will be taken to protect the identifiers.
If HIV or Hepatitis testing will be performed, provide language appropriate to the
site. For example, if the testing will take place in Maryland, provide the following:
“As part of the study, you will be tested for HIV virus (the virus that causes AIDS). You
will be given a separate State of Maryland HIV consent form as part of that process. It
means that you will need further testing, and you will receive counseling. The law
requires us to report positive tests to the health department.”
Risks/discomforts
Identify each reasonably foreseeable risk (physical, psychological, social, economic,
legal, emotional) that might result from participation in this study. If the study involves
sensitive personal issues that, if disclosed, could expose the subjects to risk of legal,
economic, emotional, or any other personal risk, acknowledge that risk. If there are
medical interventions, describe the potential risks for each type.
 Include a section on risks related to pregnancy, if applicable.
 If you are drawing blood from a participant, include the risks related to blood
draw: “Taking blood may cause discomfort, bleeding or bruising where the
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needle enters the body. In rare cases, it may cause fainting. There is a small
risk of infection.”
If your study involves exposing research participants to radiation, include the
appropriate consent form language provided in the guidance, “Radiation Risk
Language in JHSPH Consent Forms.” Include a reference to the risk of radiation
for pregnant women, if appropriate.
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Benefits
State the direct personal benefits, or the possibility of direct personal benefits, that are
available through participation in the research. If there are no direct personal benefits,
state: ”There is no direct benefit to you from being in the study”.
NOTE: Financial rewards that will be offered in exchange for participation should go
under the “Compensation” heading. Results of tests that are available to the subject
outside of the study should not be included.
Describe the social, scientific, or community benefits that could accrue from the study.
Payment
For studies that do not offer any financial payment, indicate “There is no payment for
participation.”
For studies that do offer some kind of payment or token of appreciation, clarify the
amount of compensation or what the token will be, when it will be delivered, and
whether there will be a change in payment if a study subject leaves the study early.
Protecting data confidentiality
All studies should include the risk of a breach of confidentiality. Sample language: “All
research projects carry some risk that information about you may become known to
people outside of a study.”
Explain how the risk of a breach of confidentiality will be minimized through protection of
study data and use of good security practices. If relevant, explain how the identifiers
associated with each subject’s data will be protected.
For a Certificate of Confidentiality, insert the following language:
[Insert appropriate agency – it could be “The Federal Government” or “The
Department of Health and Human Services”] has given us a Certificate of
Confidentiality for this study. This Certificate does not mean that the government
approves or disapproves of this study. This Certificate adds special protection for
research information that identifies you. It allows us, in some circumstances, to
refuse to give out study information about you without your consent when it is
sought in a legal action. Still, we may disclose identifying information about you if,
for example, you need medical help.
We may also give out information about you if the government it audits us. The
research team will also give information to local or state authorities:
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if they suspect abuse or neglect of a child or dependent adult;
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if certain communicable diseases are present; and
if the team learns that you plan to harm someone. In this case, the team
also may warn the person who is at risk.
Add the Following Sections, if Applicable. If none are applicable, skip to
section titled, “Who do I call if I have questions or problems?”
Protecting subject privacy during data collection
If data collection involves asking people about personal matters in a public setting or
activities that involve a potential invasion of personal privacy (e.g., a physical
examination, a home visit) explain how you will protect the subject from embarrassment
or unwanted disclosure of personal information.
Alternatives to procedures or treatments
Include a statement that the subject does not have to join the study, and if applicable,
that “your care will not be affected by this decision.”
If other treatments are available to the subject, include this language:
“If you decide not to join this study, other options are available. You do not have to
join this study to get treatment. Other treatments include <describe treatments.>”
Biological specimens
This provision should be included in all consent forms for studies which collect
biological specimens as it establishes ownership of the data/specimens that will be
used in the study. If you plan to store the specimens for future research, submit a
separate biobank consent form. Include below the appropriate name for the biological
material you will collect and use for the study.
The < insert specimen name > and data collected from you during this study are
important to science. You will not own the < insert specimen name > or data after you
give it to the study. You will not receive any financial benefit from any product or idea
created by the investigators using the data or materials collected from you.
Cost of participation in the study
If the study provides medical care, clarify whether the cost of that care will be provided
by the study or is the responsibility of the subject and the subject’s health care insurer.
What happens if you leave the study early?
A subject may leave a study early either because it is his or her choice, or it is the
decision of the PI and/or the sponsor. Make the consequences of any of these possible
decisions clear.
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Sharing your health information with others
Include as a separate section if you intend to share medical information with the
participant’s medical providers or anyone else. Studies in the US (or elsewhere) which
include testing for HIV or other contagious diseases must follow local law and must
include in the consent document any reporting requirements. If your study takes place
in Maryland, please include the following language, if appropriate:
For HIV testing:
If you test positive for HIV, it is required by law that the Maryland Department of Health
and Mental Hygiene be notified. The Health Department will be notified in writing of the
following information: laboratory test date, type of test, result of test, your name, date of
birth, sex, telephone number, and address.
For testing of hepatitis B or C:
If you test positive for hepatitis B or C virus, it is required by law that the Maryland
Department of Health and Mental Hygiene be notified. The Health Department will be
notified in writing of the following information: laboratory test date, type of test, result of
test, your name, date of birth, sex, telephone number, and address.
For other contagious diseases:
Maryland state law requires us to report certain diseases. If reported, this information
may not remain confidential. All of these people are also required to keep your identity
private. Otherwise, the information that identifies you will not be given out to people
who are not working on the study, unless you give us permission.
Conflict of Interest
A conflict of interest occurs when a researcher or the University has a financial or other
interest that might affect the researcher’s judgment when conducting a research study.
In some situations, the results of a study might lead to a financial gain for the
investigator(s) and/or Johns Hopkins. All such conflicts must be disclosed to the COI
Committee.
 Insert language as suggested by the JHSPH Conflict of Interest Committee.
Payment of treatment costs for injury or illness from study participation
For studies involving a physical or medical intervention, include the following:
Johns Hopkins <and the federal government, if applicable> does not have a program to
pay you if you are hurt or have other bad results from being in the study.
Clinical Trials
For studies involving a clinical trial subject to FDA regulation, the following language
explaining about clinical trials registration on clinicaltrials.gov is mandatory.
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A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as
required by U.S. law.
Include in all consent forms
Who do I call if I have questions or problems?
Participants must have a way to contact the PI and the study team. Provide a
telephone number that works, and other contact information, such as an email address,
to make it easy for participants to communicate with you. Be sure to update the contact
information if it changes after initial approval. Research conducted in an international
setting must provide a local contact name and telephone number, address, and email, if
appropriate.
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Call the principal investigator, <<insert name>>, at <<telephone number>> if you
have questions, complaints, or get sick or injured as a result of being in this
study.
Study subjects have the right to contact the IRB if they have questions, concerns, or
complaints about the conduct of the study. For international studies, if a local IRB is
overseeing the conduct of the study, replace the information below with contact
information for the local IRB.
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Call or contact the Johns Hopkins Bloomberg School of Public Health IRB Office
if you have questions about your rights as a study participant. Contact the IRB if
you feel you have not been treated fairly or if you have other concerns. The IRB
contact information is:
Address:
Johns Hopkins Bloomberg School of Public Health
615 N. Wolfe Street, Suite E1100
Baltimore, MD 21205
Telephone: 410-955-3193
Toll Free: 1-888-262-3242
Fax: 410-502-0584
E-mail: JHSPH.irboffice@jhu.edu
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Keep the questions below on the same page as the signature lines.
What does your signature (or thumbprint/mark) on this consent form mean?
Your signature (or thumbprint/mark) on this form means:
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You have been informed about this study’s purpose, procedures, possible benefits
and risks.
You have been given the chance to ask questions before you sign.
You have voluntarily agreed to be in this study.
Add any of the following lines that are required; delete any that do not apply.
________________________ _____________________________ __________
Print name of Adult Participant
Signature of Adult Participant
Date
________________________ _____________________________ __________
Print name of Legally Authorized
Representative (LAR)
Signature of LAR
Date
___________________________________________________________________
Relationship of LAR to Participant
Ask the participant to mark a “left thumb impression” in this box if
the participant (or participant’s parent) is unable to provide a signature
above.
Include this Assent Statement in all studies involving children, unless using a
separate Assent Form. Delete box and statement below if not applicable.
Assent Statement
_________________________________________
Print name of child participant
This research study has been explained to my child in my presence in language my
child can understand. He/she has been encouraged to ask questions about the study
now and at any time in the future.
________________________ _____________________________ __________
Print name of Parent/Legal Guardian
Signature of Parent/Legal Guardian
Date
_______________________ _____________________________ __________
Print name of Parent #2 for
45 CFR 46.406 studies
Signature of Parent #2
Date
________________________ _____________________________ __________
Print name of Witness
(if needed and approved by IRB)
Signature of Witness
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Date
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Always include:
________________________ _____________________________ __________
Print name of Person Obtaining
Consent
Signature of Person Obtaining Consent
Date
Give one copy to the participant and keep one copy in study records
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Assessing Flesch-Kincaid Readability
Using Microsoft Word (97 - 2003)
1. Open the Microsoft Word document for which you would like to assess
readability.
2. From the top tool bar, select “Tools.” Then, from the drop-down menu, select
“Options.” A box opens. Click the Spelling and Grammar tab in this box. Make
sure that the last check box, titled “Show readability statistics” is selected.
3. Highlight/Select the text which you would like to assess. For consent form
purposes, assess the study-related text leaving out any University boilerplate and
HIPAA language.
4. Unless you know that your Microsoft Word is set for English (U.S.), then you
should select “Tools” from the top tool bar. Then, from the menu that drops down,
select “Language”, then select “Set Language.”
5. A dialog box will appear. Use the list provided in this box to assure that the
appropriate language is highlighted. Usually, this is “English (U.S.)”.
Occasionally, studies are targeting a population using another language, or
another type of English, such as U.K., Singapore, etc.
6. Once you have selected a language, make sure that the option within this box
that reads, “Do not check spelling or grammar” is unchecked.
7. Next, click the “OK” button at the bottom of this dialog box.
8. Now, from the top tool bar, select “Tools.” Then, from the menu that drops down,
select “Spelling and Grammar,” or select the “ABC” icon from your toolbar.
9. Microsoft Word will start guiding you through the Spelling and Grammar function.
Use this chance to correct spelling/grammar errors that Word may have
identified. (Use discretion - This function is not fool proof!)
10. Once Spelling and Grammar are complete, a dialog box will appear asking if you
would like to continue checking the remainder of the document. Click “No.”
11. Once you click “No,” a box containing the readability statistics for the selected
text will open.
12. The Flesch-Kincaid Grade Level is the last number listed under the Readability
section in the dialog box.
Click “OK” to exit Readability Statistics and to continue using this Word document.
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