VILLANOVA UNIVERSITY INSTITUTIONAL REVIEW BOARD
CONSENT FORM REQUIREMENTS AND TEMPLATE
Last updated: 9/23/2015
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The following elements of informed consent must be included in the consent form for the protocol per VU policy
and federal law.
From 45 CFR 46.116:
Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in
research covered by this policy unless the investigator has obtained the legally effective informed consent of
the subject or the subject's legally authorized representative. An investigator shall seek such consent only
under circumstances that provide the prospective subject or the representative sufficient opportunity to
consider whether or not to participate and that minimize the possibility of coercion or undue influence. The
information that is given to the subject or the representative shall be in language understandable to the
subject or the representative. No informed consent, whether oral or written, may include any exculpatory
language through which the subject or the representative is made to waive or appear to waive any of the
subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its
agents from liability for negligence.
Check that each of the following necessary elements of informed consent that are contained in the proposed
consent form.
A. A statement that the study involves research.
B. An explanation of the purpose of the research.
C. The expected duration of the subject’s participation.
D. A description of the procedure to be followed.
E. Identification of any procedures which are experimental.
F. A description of any reasonably expected risks or discomforts to subject. Risks to confidentiality as well as
psychological, medical, or other unforeseen risks should all be accounted for in both the protocol and the
consent document.
G. A description of benefits to the subject or to others, which may reasonably be expected from the research.
H. Disclosure of appropriate alternative procedures or courses of treatment, if any that might be advantageous
to the subject.
I.
A statement describing the extent, if any, to which confidentiality of records identifying the subject will be
maintained;
J.
For research involving more than minimal risk, an explanation as to whether any compensation and an
explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist
of, or where further information may be obtained.
K. An explanation of whom to contact for answers to pertinent questions about the research and research
subjects' rights, and whom to contact in the event of a research-related injury to the subject. The following
chart specifies the contacts needed on the consent form:
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Telephone number for
questions about your
rights as a research
participant or if you
cannot contact the study
staff.
For questions, concerns
or complaints about the
research, or if you
suspect a research-related
injury
For complaints about the
study
The Villanova Office of Research
Administration
610-519-4220
The Principal Investigator,
Dr. _____________________
or any co-investigator listed at the beginning
of this form
Insert telephone number
Call the Villanova EthicsPoint hotline:
855-236-1443
https://secure.ethicspoint.com/domain/media/
en/gui/35905/index.html
L. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to
which the subject is otherwise entitled, and the subject may discontinue participation at any time without
penalty or loss of benefits to which the subject is otherwise entitled. This could include, but is not limited to,
students’ status in their program, children’s status in their day care center.
M. Additional elements of informed consent. When appropriate, one or more of the following elements of
information shall also be provided to each subject:
a. A statement that the particular treatment or procedure may involve risks to the subject (or to the
embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
b. Anticipated circumstances under which the subject's participation may be terminated by the
investigator without regard to the subject's consent;
c. Any additional costs to the subject that may result from participation in the research;
d. The consequences of a subject's decision to withdraw from the research and procedures for orderly
termination of participation by the subject;
e. A statement that significant new findings developed during the course of the research which may
relate to the subject's willingness to continue participation will be provided to the subject; and
f. The approximate number of subjects involved in the study.
N. The IRB may approve a consent procedure which does not include, or which alters, some or all of the
elements of informed consent set forth above, or waive the requirement to obtain informed consent
provided the IRB finds and documents that:
a. The research or demonstration project is to be conducted by or subject to the approval of state or
local government officials and is designed to study, evaluate, or otherwise examine: (i) public
benefit or service programs; (ii) procedures for obtaining benefits or services under those programs;
(iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in
methods or levels of payment for benefits or services under those programs; and
b. The research could not practicably be carried out without the waiver or alteration.
O. The IRB may approve a consent procedure which does not include, or which alters, some or all of the
elements of informed consent set forth in this section, or waive the requirements to obtain informed
consent provided the IRB finds and documents that:
a. The research involves no more than minimal risk to the subjects;
b. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
c. The research could not practicably be carried out without the waiver or alteration; and
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d. Whenever appropriate, the subjects will be provided with additional pertinent information after
participation.
P. The consent form shall be on university letterhead, appropriate to originating department.
Q. HIPAA statement, where necessary.
R. For online studies, as appropriate: Your confidentiality will be maintained to the degree permitted by the
technology used. Specifically, no guarantees can be made regarding the interception of data sent via the
Internet by any third parties.
S. The Title of the study at the top of the form.
T. The researcher’s/researchers’ name and status (faculty member, student, etc.) in the University under
the title of the study.
Except as provided above, informed consent shall be documented by the use of a written consent form
approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy
shall be given to the person signing the form.
Except as provided above, the consent form may be either of the following:


A written consent document that embodies the elements of informed consent required by §46.116. This
form may be read to the subject or the subject's legally authorized representative, but in any event, the
investigator shall give either the subject or the representative adequate opportunity to read it before it is
signed; or
A short form written consent document stating that the elements of informed consent required by §46.116
have been presented orally to the subject or the subject's legally authorized representative. When this
method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written
summary of what is to be said to the subject or the representative. Only the short form itself is to be signed
by the subject or the representative. However, the witness shall sign both the short form and a copy of the
summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the
summary shall be given to the subject or the representative, in addition to a copy of the short form.
The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it
finds either:


That the only record linking the subject and the research would be the consent document and the principal
risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether
the subject wants documentation linking the subject with the research, and the subject's wishes will govern;
or
That the research presents no more than minimal risk of harm to subjects and involves no procedures for
which written consent is normally required outside of the research context.
In cases in which the documentation requirement is waived, the IRB requires that the investigator to provide
subjects with a written statement regarding the research. Please attach the written statement to your protocol.
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The following consent template is intended to assist the researcher with creating a compliant consent form.
LETTERHEAD HERE
Villanova University
Informed Consent Document for Human Subjects Research
Department:
Principal Investigator:
Telephone:
Co-Investigator(s):
Telephone:
Study Title:
Study HS number:
Lay Study Title: A research study to …
Please delete the above guidance statement, all highlighting and italicized print, and any remaining instructions
before submitting.
What Is Informed Consent?
You being asked to take part in a research study. As required by federal regulations, this research study has
been reviewed and approved by an Institutional Review Board (IRB), a University committee that reviews,
approves and monitors research involving humans. Before a knowledgeable decision about whether to
participate in a research study can be made, the possible risks and benefits related to the study should be
understood. This process of learning and thinking about a study before deciding to participate is known as
informed consent and includes:
 Receiving detailed information about this research study;
 Being asked to read, sign and date this consent form once the nature of the study is understood and a
decision is made to participate. If there is anything about the study you don’t understand or if there are
questions, you should ask for explanations before signing this form;
 Being given a copy of the signed and dated consent form to keep...
What is the purpose of this study?
How many individuals will participate in the study and how long will the study last?
What will happen during the study?
What are the side effects and other risks or discomforts involved? (For minimal risk studies or if only risk
is loss of confidentiality or psychological discomfort, indicate the potential risks)
Things you should know about side effects (Please eliminate this section or modify/delete the bullets to
meet the needs of your study):
 Who will or will not have side effects is not predictable
 The research staff will discuss the risks listed below in greater detail with you
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Tell the researcher or research team as soon as possible if any of the side effects, risks or discomforts listed
below occur or if you think(s) a side effect that is not listed may be happening.
If questions come up about side effects, ask the researcher or staff at any time during or after the study.
DESCRIBE SIDE EFFECTS/RISKS IN LAY LANGUAGE ONLY. DO NOT USE MEDICAL OR
SCIENTIFIC TERMS UNLESS THEY ARE IN GENERAL USE BY THE PUBLIC. EMOTIONAL
DISTRESS CAN BE A SIDE EFFECT.
What are the risks to fetuses, infants and pregnant women?
Are there benefits from being in this study?
Possible benefits from being in the study may include (include list). There may be no benefit from being in
this research, but we hope that what we learn may be helpful to future patients/participants or society in
general.
Are there alternatives to being in the study?
Participation in this study is entirely voluntary (explain).
How will privacy and confidentiality (identity) be protected?
Federal regulations require that certain information about individuals be kept confidential.
(explain)
PHI?
When it involves your health and identity, this information is called “protected health information” (PHI). PHI
includes information that identifies an individual personally such as name, address and social security number,
or any medical or mental health record, or test result, that may have this sort of information on it. The laws
state that people may see and review their medical records at any time. However, in a research study, people
may not see the study results or other data about the study until after the research is completed unless the study
doctor decides otherwise.
The following individuals or entities may have access to your PHI and by law must protect it. These include
investigators listed on this consent form and other personnel of Villanova University, other parties involved
in this specific study, the University’s Office of Research Administration and the Institutional Review Board
(IRB).
Is there payment for being in this study?
There is/is not(choose one) payment for participating in this study. (If payment is involved, indicate how much
for each visit and the total amount at the end of the study)
Disclosure of Financial Interest
(If this is a sponsored study, complete the sentence below. If not, delete this section)
The sponsor of this study is, _______, is paying Villanova University to conduct this study.
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Are there costs related to being in this study?
Research Procedures (Describe the procedures that are experimental)
What if the research results in new findings?
Anything learned during the study, beneficial or not, that may affect your health or willingness to continue in
the study, will be explained.
Can I be removed from the study or quit the study?
(Please adjust wording in the paragraphs below if not a treatment or device study)
Your decision to participate in this research study is entirely voluntary. You have been told what being in this
study will involve, including the possible risks and benefits.
You may refuse to participate in this investigation or withdraw consent and quit this study without penalty
and without affecting the ability to receive medical care at Villanova University.
Should you decide to withdraw from the study, please be sure to inform the researcher.
CONTACT INFORMATION
If you are having a medical emergency, call 911 or go directly to an emergency room. You should let
emergency personnel or providers know that you are participating in this study.
Telephone number for
questions about your
rights as a research
participant or if you
cannot contact the study
staff.
For questions, concerns
or complaints about the
research, or if you
suspect a research-related
injury
For complaints about the
study
The Villanova Office of Research Administration
610-519-4220
The Principal Investigator,
Dr. _____________________
or any co-investigator listed at the beginning of this form
Insert
telephone
number
Call the Villanova EthicsPoint hotline:
https://secure.ethicspoint.com/domain/media/en/gui/35905/i
ndex.html
855-236-1443
If you want more information about the Villanova Institutional Review Board or Villanova’s Human
Subjects Protection Program, please visit our website at
https://www1.villanova.edu/villanova/vpaa/orgp/research/ora.html
YOU SHOULD NEVER USE E-MAIL TO REPORT A SUSPECTED ADVERSE EVENT OR ANY
OTHER MEDICAL PROBLEM. THESE SHOULD BE REPORTED BY TELEPHONE.
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Non-Waiver of Legal Rights Statement
 By your agreement to participate in this study, and by signing this consent form, you are not
waiving any of your legal rights.
 In order to be in this research study, you must sign this consent form.
 You affirm that you have read all pages of this consent form. You have been told that you will
receive a copy.
SIGNATURES
______________________
Your Name
______________________
Your Signature
______________________
Name of Person Conducting
Consent Interview
______________________
__________
Signature of Person Conducting
Date
Consent Interview
______________________
Name of Investigator
or Co-Investigator
______________________
Signature of Investigator
or Co-Investigator
Last updated: 9/23/2015
__________
Date
__________
Date
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OPTIONAL TEACH-BACK FOR INFORMED CONSENT (GREATER THAN MINIMAL RISK
STUDIES)
Is the drug or device used in this study FDA approved?
YES ______ NO ______
DON’T REMEMBER ______
Do you have to be in this research in order to be able to receive your usual care?
YES ______ NO ______ DON’T REMEMBER ______
Do you understand the risks of being in this study?
YES ______ NO ______
Is there a risk(s) you would like to know more about?
YES ______ NO ______
If yes, what risk(s)
Is there a benefit to you from being in this study?
YES ______ NO ______ DON’T REMEMBER ______
Will you be paid for being in this study?
YES ______ NO ______ DON’T REMEMBER ______
Do you need to tell the study doctor or study staff if you are going to quit the study?
YES ______ NO ______ DON’T REMEMBER ______
Last updated: 9/23/2015
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