Submit Consent Documents in Microsoft Word ONLY
IRB Office Use Only:
Approval Date:
Approved Consent IRB Version No.:
Leave blank for IRB Office Use.
PI Name:
IRB No.
JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH
INFORMED CONSENT DOCUMENT
This is the consent form template for creating your informed consent document. Please review the
companion “Consent Form Instructional Template” for guidance.
Delete this box and all other guidance boxes
Insert an identifier in the footer such as version number and/or date on the first page
If there are more than one consent form, identify each document by the population who will sign it, for
example, “Adult Controls”, “Parents”, “Teachers”, etc.
<<Insert Type of Consent Document here>>
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. Check the instructional template for guidance about assessing reading levels.
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.
Information about each of the following sections may be found in the instructional template.
Purpose of research project
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Submit Consent Documents in Microsoft Word ONLY
IRB Office Use Only:
Approval Date:
Approved Consent IRB Version No.:
Leave blank for IRB Office Use.
PI Name:
IRB No.
Why you are being asked to participate
Procedures
Risks/discomforts
Benefits
Payment
Protecting data confidentiality
Add the following sections, if applicable (see instructional template).
If none are applicable, skip to section titled, “Who do I call if I have questions or problems?”
Protecting subject privacy during data collection
Alternatives to procedures or treatments
Biological specimens
Insert applicable specimen(s) names and use text as written :
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.
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Submit Consent Documents in Microsoft Word ONLY
IRB Office Use Only:
Approval Date:
Approved Consent IRB Version No.:
Leave blank for IRB Office Use.
PI Name:
IRB No.
Cost of participation in the study
What happens if you leave the study early?
Sharing your health information with others
People at [Johns Hopkins/Collaborating Institution] who work on the study or who need to make sure
the study is being done correctly may see the [answers to questions/information].
Conflict of Interest
Payment of treatment costs for injury or illness from study participation
Clinical Trial Registration
You must insert the following language for any “applicable clinical trial”, see information at
http://prsinfo.clinicaltrials.gov/s801-fact-sheet.pdf
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S.
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.
Authorization for Disclosure of Protected Health Information for Research
You must insert the following language if a HIPAA Authorization is required.
We are asking you to authorize the disclosure and use of your private health information for this
research study. By signing this authorization, you agree that the following health care providers may
release your private health information to us for use in this research study:
[List Health Care Providers]
Your private health information that we may use for this research includes:
[Describe PHI]
The people who may receive or use your private health information include the researchers and their
staff.
The Health Care Providers listed above are required by the Federal Privacy Rule to protect your private
health information. By signing this Authorization, you permit them to release your information to the
researchers for use in this research study. The researchers will try to make sure that everyone who
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Submit Consent Documents in Microsoft Word ONLY
IRB Office Use Only:
Approval Date:
Approved Consent IRB Version No.:
Leave blank for IRB Office Use.
PI Name:
IRB No.
needs to see your private information for this research keeps it confidential, but we cannot guarantee
this. Although the researchers may not be covered by the Federal Privacy Rule, they will make an effort
to protect your information using the same standards.
Some other people may see your private health information outside of the research team. They may
include the sponsor of the study, study safety monitors, government regulators, and legal compliance
staff. All these people must also keep your information confidential.
You do not have to sign this Authorization, but otherwise you may not join the study. It is your choice.
Your Authorization does not have an expiration date; it will continue as long as the research continues.
You may change your mind and take back this Authorization at any time. If you take it back, the
researchers may still use the private health information they have collected about you to that point. To
take back the Authorization, you must contact the researcher.
Include in all consent forms
Who do I call if I have questions or problems?
Research conducted in an international setting must provide a local contact name and telephone
number, address, and email, if available. If a local IRB is overseeing the study, replace the information
below with contact information for the local IRB.

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.

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:
Telephone:
Toll Free:
E-mail:
Johns Hopkins Bloomberg School of Public Health
615 N. Wolfe Street, Suite E1100
Baltimore, MD 21205
410-955-3193
1-888-262-3242
JHSPH.irboffice@jhu.edu
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:



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.
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Submit Consent Documents in Microsoft Word ONLY
IRB Office Use Only:
Approval Date:
Approved Consent IRB Version No.:
Leave blank for IRB Office Use.
PI Name:
IRB No.
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
Signature of LAR
Date
Representative (LAR)
___________________________________________________________________
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
Signature of Parent #2
Date
45 CFR 46.406 studies
________________________ _____________________________ __________
Print name of Witness
Signature of Witness
Date
(if needed and approved by IRB)
Always include:
________________________ _____________________________ __________
Print name of Person Obtaining
Signature of Person Obtaining Consent
Consent
Date
Give one copy to the participant and keep one copy in study records
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