Guidelines for Creating an Informed Consent Form

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University of North Florida
Office of Research and Sponsored Programs
GUIDELINES FOR CREATING INFORMED CONSENT FORM
The Principal Investigator must prepare, in language appropriate to the level of understanding of the subject, a
narrative description of the planned procedure or treatment. This must be submitted as part of the protocol. For
student projects, the Informed Consent form must contain the name and telephone number of the responsible
faculty member. In all cases, the principal investigator’s name and telephone number must appear on the form.
Additional information about the informed consent document can be found in the Federal Regulations, the UNF
Standard Operating Procedures, and the Informed Consent Checklist.
I.
UNF informed consent documents shall include the following elements of information:
1. Clearly identify UNF as the source of the research
2. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of
benefits to which the subject is otherwise entitled, and that the subject may discontinue participation
at any time without penalty or loss of benefits to which the subject is otherwise entitled.
3. A statement describing the extent, if any, to which confidentiality of records identifying the subject
will be maintained.
4. If applicable, for research involving more than minimal risk, an explanation of whether any
compensation and any medical treatments are available if an injury occurs, and, if so, what they
consist of, or where further information may be obtained.
5. An explanation of who to contact for answers to pertinent questions about the research and, if
applicable, who to contact if a subject suffers research-related injury. Include the name and
telephone number of the Chair of the UNF Institutional Review Board, (904) 620-2498, for questions
regarding the rights of research subjects. The following email address can also be used:
irb@unf.edu.
6. A statement that the study involves research, an explanation of the purposes for the research, the
expected duration of the subject’s participation, a description of the procedures to be followed, and
identification of any procedures that are experimental.
7. A description of any reasonably foreseeable risks or discomforts to the subject.
8. If applicable, a description of any benefits to the subject or to others that may reasonably be
expected from the research.
9. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be
advantageous to the subject.
10. A statement of whether monetary or other compensation or inducement will be awarded or not, and
if so, the amount or nature.
11. If the subject pool could contain minors but they will not be included, attestation that participating
subject is 18 years old or older.
12. If applicable, assent of a minor subject in addition to the consent of parents. Assent may need to be
on a separate form designed to communicate with children. If you plan to involve minors, see
additional section in this document about including minors as participants.
Rev. December 2012
13. Include the following signatures block (below is a sample only):
Subject Name
Date
Principal Investigator
Date
Additional elements of informed consent may be required by the IRB on a case-by-case basis. A copy
of the Informed Consent, signed by the subject is to be retained by the experimenter and a duplicate
copy is to be given to the subject.
II. Waivers
1. Waiver of documentation of informed consent (aka. Waiver of signed informed consent): If in the
judgment of the IRB the participants are not at risk, informed consent may be delivered orally and
signatures may not be required. Please note, that the criteria for receiving a waiver of signed
informed consent are the following:
 The only record linking the subjects and the research would be the consent document, and
the principal risk would be potential harm resulting from a breach of confidentiality.
OR

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.
2. Waiver of informed consent: In special cases that are clearly justified, the informed consent
procedure may be waived by the IRB. Additionally, the IRB may approve a justified consent
procedure which does not include, or which alters, some or all of the elements of informed consent.
Please note, that the criteria for receiving a waiver or alteration of informed consent are the
following:
a) Option 1
 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

The research could not practicably be carried out without the waiver or alteration.
b) Option 2
 The research involves no more than minimal risk to the subjects;
 The waiver or alteration will not adversely affect the rights and welfare of the subjects;
 The research could not practicably be carried out without the waiver or alteration;
AND

Whenever appropriate, the subjects will be provided with additional pertinent information
after participation.
Rev. December 2012
III. Including minors as participants
a) Child Assent:
 Definition of Assent: “Assent” means a child’s affirmative agreement to participate in
research. Mere failure to object should not, absent affirmative agreement, be construed as
assent. (45 CFR 46.402(b)).
 By definition, children are unable to provide informed consent to participate in research,
although they might be able to give their assent. The IRB should determine that unless
parental permission can be waived if adequate provisions are made for soliciting the
permission of the parent(s) or legal guardian(s).
 While children may be legally incapable of giving informed consent, they nevertheless may
possess the ability to assent to or dissent from participation. Out of respect for children as
developing persons, children should be asked whether or not they wish to participate in the
research. Where appropriate, the IRB may choose to review on a case-by-case basis
whether assent should be sought from given individuals.
 The federal regulations do not require that assent be sought from children starting at any
specific age, but their assent should be sought when, in the judgment of the IRB, the
children are capable of providing their assent, taking into account the ages, maturity, and
psychological state of the children involved.
 For research activities involving adolescents whose capacity to understand resembles that
of adults, the assent procedure should likewise include information similar to what would be
provided for informed consent by adults or for parental permission. For children whose age
and maturity level limits their ability to fully comprehend the nature of the research activity
but who are still capable of being consulted about participation in research, it may be
appropriate to focus on conveying an accurate picture of what the actual experience of
participation in research is likely to be.
 If a child is capable of assent and the Institutional Review Board (IRB) requires that assent
be sought, it must be obtained before the child can participate in the research activity. Thus,
if the child dissents from participating in research, even if his or her parents or guardian
have granted permission, the child’s decision prevails.
b) Parent/Guardian Permission
 Regardless of whether assent is obtained, it will be necessary to obtain permission from
each child’s parent/guardian before the child can be approached.
 The regulations define “permission” at 46.402 (c) as the “agreement of parent(s) or guardian
to the participation of their child or ward in research.” The term “parent” means a “child's
biological or adoptive parent.” The term “guardian” means “an individual who is authorized
under applicable State or local law to consent on behalf of a child to general medical care.”
 An Institutional Review Board (IRB) may waive the requirements for obtaining parental or
guardian permission if it makes and documents the findings under either45 CFR 46.116(c)
or (d). In addition to the provisions for waiver contained in 46.116(c) and (d), if the IRB
determines that a research protocol is designed to study conditions in children or a subject
population for which parental or guardian permission is not a reasonable requirement to
protect the subjects (for example, neglected or abused children), it may waive the parental
permission requirements provided that an appropriate mechanism is in place to protect the
children, and provided that the waiver is not inconsistent with federal, state, or local law (45
CFR 46.408(c)). The choice of an appropriate substitute mechanism (for example,
appointing a child advocate or an assent monitor) for protecting children participating in
research would depend on the nature and purpose of the activities described in the protocol,
the risk and anticipated benefit to the research subjects, and the child’s age, maturity,
status, and condition (45 CFR 46.408(c)).
 Permission by parents or guardians shall be documented in accordance with and to the
extent required by 46.117 in the federal regulations. Essentially, parental permission should
be documented in a manner similar to that used to document informed consent.
Rev. December 2012
IV. Obtaining and documenting informed consent of subjects who do not speak English
 Department of Health and Human Services regulations for the protection of human subjects
require that informed consent information be presented "in language understandable to the
subject" and, in most situations, that informed consent be documented in writing
(45 CFR §46.116 and §46.117).
 Where informed consent is documented in accordance with §46.117(b)(1), the written
consent document should embody, in language understandable to the subject, all the
elements necessary for legally effective informed consent. Subjects who do not speak
English should be presented with a consent document written in a language understandable
to them.
 When documentation of informed consent is waived, the information orally presented to
participants should also be understandable to the participant. Additionally, participants
should be able to ask questions and have those questions answered to their satisfaction.
 The IRB must receive, review, and approve all foreign language versions of the short form
document as a condition of approval under the provisions of §46.117(b)(2).
V. Obtaining Electronic Informed Consent
 In some cases, a secure digital signature can be used for electronic informed consent (e.g.,
online informed consent and data collection). However, in many cases it will be a better
option to request a waiver of signed informed consent if your study meets the criteria for
such a waiver. For information about the criteria required for a waiver of signed informed
consent, please see section II above.
 The UNF IRB generally requires that participants be informed about how they can print a
copy of the electronic informed consent document to keep for their records. Suggested
language:
Please note that you have the option to save or print a copy of this informed consent
document for your records. To print this informed consent page from a PC, look for a Print
icon at the top of the web browser. If you do not see a Print icon, right click anywhere on the
informed consent text and select “Print” from the menu that appears. If you are using a Mac
computer you can print the screen by pressing the Command, Shift and 3 buttons
simultaneously. Screenshots are automatically placed on your desktop by default.
VI. Sources

Lin, M. (1995). Obtaining and documenting informed consent of subjects who do not
speak English. Department of Health and Human Services. Retrieved from
http://www.hhs.gov/ohrp/policy/ic-non-e.html.

Protection of Human Subjects, Title 45 C.F.R. Part 46. (2009). Retrieved from
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.

United States Department of Health and Human Services. (2011). Informed consent - FAQs.
Retrieved from http://answers.hhs.gov/ohrp/categories/1570.
Rev. December 2012
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