The format may be modified or expanded, but the consent form is to contain all the elements included below.
Please use language which the average lay person is likely to understand or which is appropriate for the age of
the subjects (specifically on child assent forms).
If the research is being conducted at USM, the heading should reference USM, along with the
specific division and department where the protocol will take place.
Please note sections that may not always be applicable in a consent form have been marked as such.
Please be careful to remove these sections if they do not apply in your protocol so as to avoid confusing your participants.
Statements in italics are instructions for you. They concern information required as part of your consent form. These
instruction statements should not be automatically inserted into your consent form. Instead, you should read the instruction and
then draft a statement that is tailored to your specific protocol.
Reminder: Please check the following items prior to submission:
Readability:
Wherever possible, use a readability analysis to ensure the reading level is no higher than eighth grade;
Justify left margins and make right margins ragged;
Whenever possible, avoid using words with more than three syllables, and
Be careful to balance white space with words in the layout of the consent form.
Grammar:
Make sentences as direct and concise as possible;
Whenever possible, replace technical, i.e. scientific and/or medical term, with terms a lay person will likely understand;
When it is necessary to use a technical term, provide a definition of the term;
Use active voice as opposed to passive voice, and
Use personal pronouns to increase personal identification for participants.
Font size:
Use font that is “easy to read”;
Use at least a 12-point font size, and
Researchers working with elderly or visually impaired persons should use a minimum of a 14-point
font for their informed consent forms.
Informed Consent for Participation as a Subject in a Research Study
YOUR HEADING HERE
Introduction
You are being asked to be in a research
study of [insert a general statement about your study here].
You were selected as a possible participant because [explain how your subjects are identified, and include any
exclusionary criteria].
We ask that you read this form and ask any questions that you may have before agreeing to be in the study.
Purpose of Study
The purpose of this study is
[explain your research question and your purpose in easily understood language].
Participants in this study are from [note what area(s) they are from].
The total number of subjects is expected to be [insert number].
If you and/or members of the investigative team have a consultative or financial interest relating to the study
please precisely state the nature of the relationship to the participants. Examples include:
A paid (or unpaid) consultant to the company sponsoring this study;
Paid membership on the advisory board;
Receiving payment for lectures from the company sponsoring the study;
Have stock in the company that is sponsoring the study;
Hold a patent for the product being investigated in this study.
Description of Study Procedures
If you agree to be in this study, we would ask you to do the following things:
[Explain procedures and tasks; identify any procedures that are experimental].
[State the expected duration of the subject’s participation].
[Explain any alternative procedures or courses of treatment available to the subject. If not
applicable, please inform the participants there are no alternate procedures or courses of treatment
offered to them for this study].
Risks to Being in Study
[OPTIONS: select one]
The study has the following risks: [Please describe any, and/or, reasonably foreseeable risks or
discomforts to the subjects].
[If there are none, please inform the participants that there are no foreseeable risks or discomforts].
[For research involving more than minimal risk, you must include 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].
If you experience an emergency physical or emotional harm as a direct result of your participation in this research,
you will receive care from [insert name or facility, etc.]. [Insert statement as to how care will be paid
for]. Decisions regarding care and compensation for any other research related injury will be made on a case-by-case
basis.
Benefits of Being in Study
The benefits of participation are [explain benefits of participation that will be gained by the participants and/or
others].
[If there are no expected benefits, state that there are no direct benefits to participating in this study.]
Payments
You will receive the following
compensation/reimbursement:
[explain amount of payment or other reimbursement information (e.g., class points, tokens, donations,
etc.), when payment and/or reimbursement will occur, and if any anticipated prorated
payments to the subject will be required].
[If payment is made in money or gifts, include the following statement]: Legally, you can be paid only if
you are a U.S. citizen, a legal resident alien (e.g., possess a “green” card), or have a work eligible
visa sponsored by the paying institution
You will not receive any compensation/reimbursement for your participation in this study.
Costs: [If Applicable]
[OPTIONS: select one]
There is no cost to you to participate in this research study, however, the cost of [insert lab test, procedure,
etc.] will be billed to your insurance company and we will accept as full payment whatever they pay us.
How much you will have to pay depends on whether or not you have medical insurance and what costs your insurance
will cover. You or your insurance carrier will be responsible for the costs of [insert what tests,
treatments, visits, etc.].
The records of this study will be kept private. [Please outline for the participants how this will be kept private.
Explain where the data will be kept secure after it is collected; what, if any, identifying information will be collected;
who will have access to the data and what will happen to the collected individual data once the study is completed].
Examples include:
Research records will be kept in a locked file in the office of the Principal Investigator;
The individually collected data will be destroyed after the study is completed;
Access to the records will be limited to the researchers; however, please note that sponsors, funding agencies,
regulatory agencies, and the Institutional Review Board may review the research records. [Please note that
absolute confidentiality should not be promised to participants].
In any sort of report we may publish, we will not include any information that will make it possible to
identify a participant.
[If you know how you will be publishing your results, please disclose this information to the participants.
Examples of publishing include a “Thinking Matters” presentation, a Muskie Capstone project, a journal
article and a report to a third party agency].
[If audio or video tape recordings are made, explain specifically who will have access to them, if they will
be used for educational purposes, and when they will be erased/destroyed].
[If the study will include the use of an on-line survey, or, will transfer collected data over the internet,
explain to the participant what measures will be used to keep the transferred data secure].
Voluntary Participation/Withdrawal
Your participation is voluntary. If you choose not to participate, it will not affect your current or future
relations with the University [or with other cooperating institutions (insert name)].
You are free to withdraw at any time, for whatever reason*.
[When applicable] There is no penalty or loss of benefits for not participating or for discontinuing your
participation. [For studies with students, state that the subject does not jeopardize grades nor risk loss of
present or future faculty/school/University relationships]. [For medical studies, state that the subject
does not risk loss of present or future care they would otherwise receive]. [Explain any consequences (e.g.,
adjusted monetary benefits) due to early withdrawal].
*You will be provided with any significant new findings that develop during the course of the
research that may make you decide that you want to stop participating.
Dismissal From Study: [If Applicable]
[OPTIONS: select one]
If you do not follow the instructions you are given you will be dismissed from the study.
If the study sponsor decides to stop or cancel the study you will be dismissed from the study.
Contacts and Questions
[Note: Student researchers are required to have a faculty mentor listed as Co-PI on their submissions.]
The researchers conducting this study are [insert name(s) of investigators, including the PI]. For questions
or more information concerning this research you may contact her/him/them at [telephone number and email address of
researcher and/or faculty mentor].
If you believe you may have suffered a research related injury, contact [specify name of researcher or your
faculty mentor if PI is a student]
at [telephone number and email address] who will give you further instructions.
If you have any questions about your rights as a research subject, you may contact: Director, Office of Research
Compliance, USM at (207)780-4517, or usmirb@usm.maine.edu, or TTY (207)780-5646.
Copy of Consent Form
You will be given a copy of this consent form and one will be kept in our records file for future reference.
Statement of Consent
Please carefully read through these options before making your decision. Some of these may not apply.
Please select the appropriate statement of consent from the list below:
For Adult or older child (12-17 years) Consent/Assent (Full form): I have read (or have had read to me) the
contents of this consent form and have been encouraged to ask questions. I have received answers to my questions. I give my
consent to participate in this study. I have received (or will receive) a copy of this form.
For Adult or older child (12-17 years) Consent/Assent (Short Form): I have read (or have had read to me) the
contents of this consent form. An explanation of the research has been given to me and I have been encouraged to ask questions.
I have received answers to my questions. I give my consent to participate in this study. I have received (or will receive) a copy
of this form.
For Child Assent: This form was read to the subject and/or the subject has read this form. An explanation of
the research was given and questions from the subject were solicited and answered to the subject's satisfaction. In my judgment,
the subject has demonstrated comprehension of the information.
For Parental Permission/Consent: I have read (or have had read to me) the contents of this consent form and
have been encouraged to ask questions. I have received answers to my questions. I give my consent for my child to participate in
this study. I have received (or will receive) a copy of this form.
Signatures/Dates
Please carefully read through these options before making your decision. Some of these may not apply.
[OPTIONS: select one]
For Adult or Subject's Legal Representative or older child consent (Full Form):
Study Participant (Print Name): _________________
Participant or Legal Representative Signature: ___________________ Date _____
For Adult or Subject's Legal representative or older child consent (Short Form):
Study Participant (Print Name): _________________
Participant or Legal Representative (Signature): ___________________ Date _____
Witness/Auditor (Signature): _________________________________ Date _____
For Child Assent:
Study Participant (Print Name): _______________________________
Witness/Auditor (Signature): _________________________________ Date _____
For Parental Permission/Consent:
Study Participant (Print Name): _______________________________
Parent/Guardian (Signature): _________________________________ Date _____
2008 IRB
Meeting Schedule
September 16th
October 15th
November 18th
December 10th
Important!
Submissions for IRB review must be received 30 days prior to the next Board meeting, be complete, and in no need of major
revisions. If it does not meet these requirements, then it will be reviewed at the next available opportunity.
