INFORMED CONSENT DOCUMENT
[Insert title of study]
PLEASE DELETE THIS BOX, ALL [ITALICIZED TEXT], and OTHER TEXT THAT
DO NOT APPLY TO YOUR STUDY BEFORE SUBMITTING YOUR FINAL DRAFTS
You are being asked to participate in a research study about [insert general statement about study]. You were
selected as a possible participant because [explain how participant was identified] and [list any specific
inclusion or exclusion criteria]. Please read this form and ask any questions that you may have before
agreeing to be in the research.
Researchers at Case Western Reserve University are conducting this study.
Purpose
The purpose of this research is [to explain research question and purpose in lay language].
Procedures
If you agree to be a participant in this research, we would ask you to do the following things: [Describe the
procedures to be followed (including audio/video recording); indicate expected frequency and duration of
participation; and identify any procedures that are experimental.]
You can choose to stop participating for any reason at any time. However, if you decide to stop participating in
the study, we encourage you to tell the researchers. You may be asked if you are willing to complete some
study termination activities.
Foreseeable Risks and Discomforts
[For minimal risk studies]
There are no known risks, harms or discomforts associated with this study beyond those encountered in normal
daily life. Some of the activities we will ask you to complete might make you feel uncomfortable. You may
refuse to answer any of the questions, take a break, or stop your participation in this study at any time. The
possible risks and/or discomforts associated with the procedures described in this study include: [Categorize the
risks by severity and include the likelihood of the risk/discomfort occurring. Make sure to consider all types
of risks – psychological, social, economic, legal and physical. Examples of risks/discomforts – Keep all
statements that apply to this study and remove/revise as applicable]: Examples: anxiety, embarrassment, and
invasion of privacy.]
[If there are significant physical or psychological risks to participation, the participants should be told under
what conditions the researcher will terminate the study without regard to the participant’s consent.]
[Describe how the study design and procedures will prevent and/or minimize any potential risks or
discomfort. Potential risks and discomforts must be minimized to the greatest extent possible by using
procedures such as appropriate training of personnel, monitoring, withdrawal of the subject upon evidence
of difficulty or adverse event; referral for treatment, counseling or other necessary follow-up.]
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[For greater than minimal risk studies]
Some of the activities we will ask you to complete might make you feel uncomfortable. You may refuse to
answer any of the questions, take a break, or stop your participation in this study at any time. The possible risks
and/or discomforts associated with the procedures described in this study include: [Categorize the risks by
likelihood and severity of the risk occurring. Make sure to consider all types of risks – psychological, social,
economic, legal and physical.]
[If there are significant physical or psychological risks to participation, the participants should be told under
what conditions the researcher will terminate the study without regard to the participant’s consent.]
[Describe how the study design and procedures will prevent and/or minimize any potential risks or
discomfort. Potential risks and discomforts must be minimized to the greatest extent possible by using
procedures such as appropriate training of personnel, monitoring, withdrawal of the subject upon evidence
of difficulty or adverse event; referral for treatment, counseling or other necessary follow-up.]
Anticipated Benefits
[If direct benefit to the subject is anticipated]
The possible benefits you may experience from the procedures described in this study include [Complete this
sentence – the description of subject benefits should be clear and not overstated. Examples: increase reading
comprehension; improved writing skills; learning about ways to improve your memory.]
[If no direct benefit to the subject is anticipated]
You will not directly benefit from participation in this study.
[Insert a statement about possible benefits to science or society here. Examples: greater understanding of
how grassroots organizations contribute to eco-awareness, greater understanding of how stress influences
memory.]
[Explain benefits of participation that will be gained by the participants or others. If there are no benefits,
state such. The description of benefits to the participant should be clear and not overstated. If no direct
benefit is anticipated, then that should be stated. If these benefits may be materially relevant to a
participant’s decision to participate, the benefits should be disclosed in the informed consent document.]
[Compensation is not considered a benefit.]
Compensation
There will be no costs to you for study participation. [If there is a cost, please delete the previous sentence
and explain the cost to subjects.]
[If subjects will not be compensated]
You will not be compensated for your participation in this research study.
[If subjects will be compensated]
You will receive the following payment/reimbursement: [Insert amount of payment information (i.e., class
credits, gift cards), as well as when payment will occur.]
[If subjects will be compensated through the social science lab]
You will receive extra course credit for an eligible course through the CWRU Psychological Sciences human
subjects’ pool. You will receive ____ unit of course credit for each ____ hour of participation in this study.
Total amount of credit you may earn is [Enter total # of credits].
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[If subjects will be compensated with extra course credit: The course instructor offering extra course credit
for participation in research must provide alternatives to earn extra course credit. The alternative
assignment must require equal or less time and effort for the same amount of earned extra credit that you
can earn through participation in research.]
[If subjects will be compensated for one session]
You will receive _____ for your participation in this study. [Example: a $5 gift card to a local merchant, or:
you will be entered into a raffle to win 1 of 10 Amazon gift cards worth $100; chances of winning are
approximately 1 in 100.]
[If subjects will be compensated for multiple sessions]
You will receive _____ for each _____ you complete. [Example: you will receive $5 for each survey you
complete you complete]. There are [Enter # and type of study components.] Total compensation for
participation in this study is [Enter total compensation for completion of the study.] If you decide to withdraw
from the study or are withdrawn by the research team, you will receive compensation for the visits that you
have completed.
[If subjects will be reimbursed for multiple sessions]
[Insert amount of reimbursement information (i.e., parking fees, transportation fees), as well as when
reimbursement will occur.]
[If no reimbursement will be provided]
You will not be reimbursed for any out of pocket expenses, such as parking or transportation fees.
[Explain how such withdrawal will be pro-rated (i.e., half of the money or extra credit if discontinue
participation half-way through).]
Alternative(s) to Participation
You have the option to not participate. [If there is an alternative, then delete the previous sentence and
explain alternative(s).]
[If subjects will be compensated with extra course credit: The course instructor offering extra course credit
for participation in research must provide alternatives to earn extra course credit. The alternative
assignment must require equal or less time and effort for the same amount of earned extra credit that you
can earn through participation in research.]
Voluntary Nature of the Study
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 names)]. There is no penalty or
loss of benefits for not participating or for discontinuing your participation.
You are free to withdraw from this study at any time. If you decide to withdraw from this study you should
notify the research team immediately. The research team may also end your participation in this study if you
do not follow instructions, miss scheduled visits, or if your safety or welfare are at risk.
If you withdraw or are removed from the study, the researcher may ask you to [Complete this sentence].
[Examples: return for a final visit or evaluation; if you are interested in continuing long-term follow-up
procedures; complete an exit telephone interview.]
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[When research is not subject to HIPAA regulations]
If you elect to withdraw or are withdrawn from this research study, the researchers will discuss with you what
they intend to do with your study data. Researchers may choose to analyze the study data already collected or
they may choose to exclude your data from the analysis of study data and destroy it, as per your request.
[When research is subject to the HIPAA Privacy rule]
If you elect to withdraw or are withdrawn from this research study, you may choose to terminate the continued
use or disclosure of your protected health information (PHI) for research purposes. The request to end the use or
disclosure of your PHI must be made in writing to the Responsible Investigator.
Confidentiality
The records of this research will be kept confidential. Any time information is collected, there is a potential risk
for loss of confidentiality. Every effort will be made to keep your information confidential; however, this
cannot be guaranteed.
In any sort of report we might publish, we will not include any information that will make it possible to identify
a participant. Research records will be kept in a locked file and access will be limited to the researchers, the
University review board responsible for protecting human participants, regulatory agencies, and [add, only if
applicable, sponsors and funding agencies].
Subject Identifiable Data – [Keep all statements under this heading that apply and remove others as needed.]
[Explain whether subject identifiers will be linked to the research data.]
[All/some] information that identifies you will be removed from the study data.
[All/some] information that identifies you will be removed and replaced with a code. A list linking the code and
your identifiable information will be kept separate from the research data. [Explain why personal identifiers
will be retained.]
[All/some] information that identifies you will be kept with the research data. [Explain why personal identifiers
will be retained.]
Data Storage – [Keep all statements under this heading that apply and remove others as needed.]
[Describe how the data will be maintained.]
Research data will be maintained in a secure location at CWRU. Only authorized individuals will have access
to it.
Research data will be stored electronically in an encrypted file [and is password protected].
The [audio/video recordings] that can identify you will be:
 Stored in a secure location;
 Transcribed and erased [as soon as possible OR at the end of the study]. [Select one and delete the
other.];
 The recordings will be retained with the other research data for _____ [If identifiable, insert finite
amount of time. If completely de-identified (no codes/master list), then such data can be kept
indefinitely.]
Data Retention – [Retain the longest option that applies and remove/revise as applicable.]
[Explain how long the research data will be maintained.]
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The researchers intend to keep the research data: [Select all that apply and delete those that do not apply.]
 Until analysis of the information is completed;
 Until the research is published and/or presented;
 For approximately ______ years;
 Indefinitely, because the data are de-identified; AND/OR
 In a repository indefinitely. Other researchers may have access to the data for future research. Any data
shared with other researchers, will not include your name or other personal identifying information.
[Include in the consent if this is applicable]
[Significant New Findings]
[If any significant new finding develop that may affect your decision to participate these will be provided
to you.]
[Include in the consent if this is applicable]
[Significant Financial Interest]
[The responsible investigator and/or other members of the research team have a significant financial interest
in the sponsor of this research OR the product being investigated in this study. If you have any questions
about this interest, please discuss it with the responsible investigator.]
Contacts and Questions
The researchers conducting this study are [Responsible Investigator] and [Co-Investigator(s)]. You may ask
any questions you have now. If you have any additional questions, concerns or complaints about the study, you
may contact them at [contact information].
If the researchers cannot be reached, or if you would like to talk to someone other than the researcher(s) about;
(1) questions, concerns or complaints regarding this study, (2) research participant rights, (3) research-related
injuries, or (4) other human subjects issues, please contact Case Western Reserve University's Institutional
Review Board at (216) 368-4514 or write: Case Western Reserve University; Institutional Review Board; 10900
Euclid Ave.; Cleveland, OH 44106-7230.
You will be given a copy of this form for your records.
[Include in the consent if this is applicable]
[Permission to Record]
[If audio or video recording, indicate that recording is an integral part of the study and that if the
participants do not wish, they should not participate in the study.]
[OR]
[Insert yes/no checkboxes, if applicable. In the procedures paragraph of the consent forms, state that you
will take notes if they refuse to be recorded, if that is an option for this study.]

[YES, I CONSENT to being audio/video recorded. I also understand that I can change my
mind.]

[NO, I DO NOT CONSENT to being audio/video recorded.]
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Statement of Consent
Your signature below certifies the following:
 You are at least 18 years of age. [If creating an assent form, please delete “I am at least 18 years of
age.”]
 You have read (or been read) the information provided above.
 You have received answers to all of your questions and have been told who to call if you have any more
questions.
 You have freely decided to participate in this research.
 You understand that you are not giving up any of your legal rights.
Printed Name of Participant
Date:
Signature of Participant:
Printed Name of Legally Authorized Representative:
Date:
Signature of Legally Authorized Representative
Date: ____________
Signature of Person Obtaining Consent:
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