Consent Form: Template and Issues
NOTE: This template is designed to help you develop an informed consent document that includes the basics
elements required in the Federal regulations at 45 CFR 46.116. The template is not intended to dictate a special
order but rather to guide you and ensure that you include all the required elements, regardless of order.
NOTE: Items in italics should NOT be included in the final version of your consent form.
UNC Charlotte Consent Form Template
Informed Consent for
(Title of Project)
Project Purpose
Provide a meaningful title of the project for the participant. Explain the purpose(s) of the project. Include a
statement indicating that the study involves research. Paraphrase what new knowledge might be gained from the
study. Technical or complicated language should not be used.
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You are invited to participate in a research study…
Investigator(s)
Provide the name and institutional affiliation of the primary investigator. If the primary investigator is a student,
you should also provide the name of the responsible faculty person.
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The investigator is…
Eligibility
Provide a complete description of who is eligible to participate as well as who is ineligible to participate (use
information from your Protocol Application form’s “Inclusion Criteria” and “Exclusion Criteria” respectively).
An example of Inclusion Criteria might be: “You may participate in this project if you are single, between the ages
of 18 and 25, and currently involved in a dating relationship that has lasted six months or more.”
The Exclusion Criteria for the same study might be: “You may not participate in this project if you are married,
have not yet reached age 18 or are older than age 25, or if you are single, between the ages of 18 and 25, but are
not currently involved in a dating relationship that has lasted six months or more.”
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You are invited to participate in this study if you are…
Overall Description of Participation
Think of the consent form as a tool to explain what the study is about and not as a legal instrument!
Consent forms should be written in language that the participant will be able to understand. Describe the study as
if you are actually speaking to the potential study participant. Explain exactly what the participant will be asked to
do and what will be expected of him/her. Indicate if there are forms, surveys, or questionnaires to be completed and
how long it will take to complete each one. State the total number of individuals that will be involved in the project.
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If you volunteer to participate in this study, you will be asked to…
Length of Participation
State the expected duration of the subject’s participation. Include the number or frequency of any research sessions
and how long each is expected to last (days, hours, or minutes, as appropriate). Tab to the gray block and begin
typing.
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Your participation will take approximately 15 minutes…
Risks and Benefits of Participation
Risks: Explain all reasonably foreseeable risks or discomforts to the subject – physical, psychological, social,
financial, or otherwise. When appropriate, you may also include the statement below about “unforeseen risks”,
otherwise it should also be deleted.
Benefits: Describe potential benefits to the subject if any as well as any larger potential scientific benefits of the
research.
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The project may involve risks that are not currently known.
Compensation/Payment/Incentives
Describe any and all forms of compensation (and amounts.) NOTE: In general, participants are “reimbursed” and
not “paid” for their participation in a research project. Avoid the term “lottery”.
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You will be included in a drawing for three, $5 Food Lion gift cards at the completion of
participation.
Alternatives (If appropriate)
Disclose any appropriate alternative procedures/courses of treatment that might be advantageous to the subject.
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Possible Injury Statement
IF there is a chance for injury to the participants in a project, include the statement below.
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If you are hurt during this study, we will make sure you get the medical treatment you need for
your injuries. However, the university will not pay for the medical treatment or repay you for
those expenses.
Volunteer Statement
The following statement must be included in your Consent Form:
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You are a volunteer. The decision to participate in this study is completely up to you. If you
decide to be in the study, you may stop at any time. You will not be treated any differently if
you decide not to participate in the study or if you stop once you have started.
Confidentiality Statement
Describe the confidentiality and privacy protection procedures that will be used – data security, storage, access, etc.
Discuss how identity will be protected (coding, pseudonym, master list). Discuss audio/video recordings and
transcripts. If data will be shared with co-investigators, how will this occur?
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Any identifiable information collected as part of this study will remain confidential to the extent
possible and will only be disclosed with your permission or as required by law.
Statement of Fair Treatment and Respect
Include the following statement about Fair Treatment in your Consent Form. Also include contact information for
the primary investigator and/or responsible faculty.
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UNC Charlotte wants to make sure that you are treated in a fair and respectful manner. Contact
the university’s Research Compliance Office (704-687-1871) if you have questions about how
you are treated as a study participant. If you have any questions about the actual project or
study, please contact Dr. Jane Doe (704-687-XXXX, jdoe@uncc.edu).
Approval Date
Investigators must add the following statement to the consent form prior to its distribution, immediately following
final IRB approval to use an approved consent form:
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This form was approved for use on Month, Day, Year for use for one year.
Participant Consent vs. Parental Consent
Participant Consent (for participants who are at least 18 years of age or who are emancipated minors
as defined by law. See definition below. The definition may remain in the final informed consent
document IF there is the possibility that some of your participant pool could fit this description.)
Add the statement below to the consent form in the area above the signature fields
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I have read the information in this consent form. I have had the chance to ask questions about
this study, and those questions have been answered to my satisfaction. I am at least 18 years of
age, and I agree to participate in this research project. I understand that I will receive a copy of
this form after it has been signed by me and the principal investigator of this research study.
______________________________________
Participant Name (PRINT)
_______________________
DATE
___________________________________________________
Participant Signature
______________________________________
Investigator Signature
_______________________
DATE
USE/ADD THIS TEXT ONLY IF YOU WILL BE OBTAINING CONSENT FROM A MINOR WHO
MEETS THE CRITERIA DETAILED HERE: *Emancipated Minor (as defined by NC General Statute
7B-101.14) is a person who has not yet reached their 18th birthday and meets at least one of the following
criteria: 1) has legally terminated custodial rights of his/her parents and been declared ‘emancipated’ by
the court; 2) is married, or 3) is serving in the armed forces of the United States.
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OR:
Parental Consent (for participants younger than age 18)
Parental Consent is needed for participants younger than age 18. "Children" are persons who have not
attained the legal age for consent to treatments or procedures involved in the research.
You are also required by the Code of Federal Regulation to ensure that adequate provisions are made to solicit
assent of children involved in your study as well as obtain the permission of their parents or guardians, as set forth
in §46.408. Children should be allowed to actively affirm their willingness to participate in research. For more
specific information, see: http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm#46.408
Change the consent language as appropriate – Your child is invited, your child will, your child is a volunteer, etc.
Investigations involving children must indicate on the consent form that assent to participate was obtained. This
means that the child has been informed of what the study involves and what is expected of her/him.
Add the statement below to the consent form in the area just above the signature fields for studies involving
participants who are younger than age 18.
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I have read the information in this consent form. I have had the chance to ask questions about
this study and about my child’s participation in the study. My questions have been answered to
my satisfaction. I am at least 18 years of age, and I agree to allow my child to participate in this
research project. I understand that I will receive a copy of this form after it has been signed by
me and the principal investigator of this research study.
___________________________________________________
Child’s Name (PLEASE PRINT)
___________________________________________________
Parent’s Name (PLEASE PRINT)
_____________
DATE
___________________________________________________
Parent’s Signature
___________________________________________________
Investigator Signature
___________
DATE
OTHER IMPORTANT ISSUES & CONSIDERATIONS
NOTE: The section below is intended to answer questions about
various aspects of the informed consent process. This material is for
reference ONLY. Do not include the information below in the consent
form that you submit to the Compliance Office.
Once you have read the information below and have addressed the areas that
apply to your study, you should delete everything from the top of this text box to
the end of this document.
If you have questions or concerns not addressed in this template, please contact:
Cat Runden, IRB Compliance Specialist at (704) 687-1871 or crunden@uncc.edu
Conflict of Interest
If applicable, include a section to disclose potential conflicts of interest. This may include financial or
other personal considerations that may compromise or have the appearance of compromising an
individual’s judgment in conducting this research.
Educational research
Signed consent forms are always required if students’ academic records are included in the study unless a
waiver of procedure or documentation can be reasonably justified.
Exempt research and the need for consent
Signed consent forms may not be necessary for exempt research, such as some confidential surveys,
provided that the elements of consent are clearly stated on the questionnaires themselves or in a cover
letter/sheet. Participation is voluntary and in confidential surveys, participants give “implicit consent”
when they return a complete survey or questionnaire.
Remember, you still want to make sure that the participant fully understands the risks/benefits of the
study! How can you achieve this? Follow the template and guidelines for the Informed Consent provided
and leave off the signature area for the participant.
Letterhead
Consent forms for human subjects research conducted by students, faculty, or involving facilities of UNC
Charlotte must be prepared with official UNC Charlotte letterhead. All original and signed consent forms
must be co-signed by the investigator.
Language
Consent forms should be written in language that the participants will be able to understand. Describe the
study and what will be expected of the participants as if you are actually speaking to the potential research
participant. Think of the document as a teaching tool and not as a legal instrument.
Inferred Identity Issues
Written consent is required in those studies in which individuals may be identified either directly or
indirectly. Indirect identification could be a situation where the subject identity could be inferred from a
limited number of responses reported for certain subject groups.
Emancipated minors
The traditional notion of informed consent clearly applies to persons who have reached the legal age of
majority, except when the participant has been determined to be incompetent. Certain minors are deemed
“emancipated” and treated as adults for all purposes.
*Emancipated Minor (as defined by NC General Statute 7B-101.14) is a person who has not yet reached
their 18th birthday and meets at least one of the following criteria: 1) has legally terminated custodial
rights of his/her parents and been declared ‘emancipated’ by the court; 2) is married, or 3) is serving in
the armed forces of the United States.
Archives
How long do you need to keep your records?
Investigators are required to keep or “have available” original and signed consent forms from all
participants for a period of not less than three (3) years following the expiration date of any project
approved by UNC Charlotte’s Institutional Review Board.