Written Informed Consent Forms for Social or Behavioral Research
GUIDELINES AND INSTRUCTIONS
This document contains 1) guidelines for writing an informed consent that is IRB
acceptable, 2) the required content and components of informed consent and, 3)
instructions and sample language for each component.
1.) GUIDELINES
What is Informed Consent and why is it required?
Informed consent is the communication process (verbal and written) that allows individuals to make an
informed decision about participation in a given research study, without pressure, coercion or undue
influence. It is an important component to ensure that human research participants are treated
ethically and informed about study goals, risks, benefits and other pertinent information about the
research project. The Informed Consent document serves as the formal authorization by an individual
(or legal representative) of their agreement to participate in the proposed research.
The Institutional Review Board has prepared Informed Consent templates for your convenience. These
Guidelines and Instructions will assist you in completing the Informed Consent template. Documents
must look professional and should be written on your college or department letterhead.
Please be aware that all essential elements of informed consent MUST be present as required by the
federal regulations governing human research, 45 CFR 46, unless a waiver or alteration of informed
consent is requested and granted by the Institutional Review Board. These guidelines and instructions
specify required language versus language that may not be applicable, depending on your proposed
research project.
Basic required consent elements include but are not limited to the following:
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A statement that the study involves research,
An explanation of the purpose of the research,
The expected duration of the subject’s participation,
A description of the procedures to be followed,
Identification of any procedures which are experimental,
A description of any reasonably foreseeable risks or discomforts to the subject,
A description of any benefits to the subject or to others which may reasonably be expected from the
research,
A statement describing the extent, if any, to which confidentiality of records identifying the subject
will be maintained,
An explanation of whom to contact for answers to pertinent questions about the research and
research subject’s rights, and whom to contact in the event of a research-related injury to the
subject,
A statement that research 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.
For questions about Informed Consent, please contact the IRB at 714-628-7392 or irb@chapman.edu.
General Information:
Reading Level
In order to keep informed consent documents easily understandable, you should write the document at
a level appropriate to a the subject population, generally striving for an 8th grade reading level. Your goal
should be to tailor the document to the subject population, avoiding technical jargon or overly complex
terms, using straightforward, plain English so participants can fully understand the implications of
participating in the research.
Writing Tips
Please avoid writing the informed consent document in the first person. It is preferred that the
document be written in the second or third person (“you” or “he/she”), with the required details of the
study explained fully. Only consenting authorization statements for obtaining the subject’s signature
should be referenced by the use of “I”. Also, please take care to avoid information inconsistencies
between the informed consent document and the accompanying Research Protocol application
submitted to the IRB.
Formatting
Informed consent forms should be printed on the PI’s department/college letterhead (1st page).
General formatting for the Informed Consent should include a formal heading, ¾ to 1” side margins and
a 1” to 1 ½” bottom margin and Times New Roman 12 pt font. A 1” to 1 ½” bottom margin is required
to accommodate the IRB certification added to the document at the time approval is issued.
Listing Investigators
The Principal Investigator must be listed on the first page.
If it is a student-directed project, then the Faculty Advisor must be listed, as well as the Student
investigator. If it is not a student-directed project, delete the Student Investigator table from the
template.
You should list Other Investigators only if those investigators will have direct contact with subjects. You
can copy the “Other Investigators“ table to add more investigators to the template form. If there are no
other investigators that will have direct contact with the subjects, delete that section from the template
form.
2.) REQUIRED CONTENT & COMPONENTS
Components of Informed Consent Forms and Submission Procedures:
Informed consent forms must include a statement that the study involves “research” (i.e. you
must use the word “research” when describing the study and the word “research” must be
used in the title of the document). A statement that participation is voluntary, that neither
refusal to participate nor participation discontinuation by the subject at any time will invoke
penalty or loss of benefits to which the subject is otherwise entitled must also be included.
Below is a list of information that should be included in any standard informed consent form.
We have broken this information down by the headings we have provided in the template
document to make it easier to follow. Informed consent MUST include the following:
Required Components and Content:
PURPOSE:
Description of the study: Easy to understand explanation of the purpose of the study,
why it is being done and why it is important.
NUMBER OF PARTICIPANTS & STUDY LOCATION:
Total number of participants.
Where the research will be performed (location).
QUALIFICATION TO PARTICIPATE:
Inclusion Criteria: what qualifies the subject to participate.
Exclusion Criteria: what would prohibit the subject from participating (if applicable).
PROCEDURES:
Who will perform the research with the subject.
What tests, procedures, interview sessions, questionnaires, etc. are required.
How long it takes to participate in each test, procedure, interview session, survey, etc.
Identification of any procedures that are experimental (if applicable).
BENEFITS:
A description of any benefits to the subject or to others that may reasonably be expected
from the research. If there is no direct benefit, this should be stated. Payment or
compensation is NOT considered a benefit of the research or research participation.
RISKS:
A description of any reasonably foreseeable risks or discomforts to the subject. These
include not only physical injury, but also possible psychological, social or economic harm,
discomfort or inconvenience.
PRIVACY & CONFIDENTIALITY:
Description of the measures that will be taken to protect the privacy of the subject, such
as where study data will be kept and secured, who will have access to the data, and when
the data will be discarded.
Description of the extent, if any, to which confidentiality of records identifying the subject
will be maintained, and actions to be taken in the event of a breach of confidentiality.
COMPENSATION, REIMBURSEMENT, COSTS:
If applicable, a statement describing the costs or cash/in-kind compensation to the
subject, including but not limited to gift cards, raffles, etc.
ADDITIONAL INFORMATION:
Any additional information relevant to the research that you may feel pertinent to inform
the subject. This may be where you include the statement regarding voluntary
participation and/or the right of the subject to refuse to participate or withdraw from
participation at any time. If no additional information is necessary, you may delete this
section.
CONTACT INFORMATION:
Names and contact information of ALL co-investigators having direct contact with the
subject
FOR QUESTIONS RELATED TO THE STUDY or TO REPORT A CONCERN:
Use the language already included on the Informed Consent Template. Do not alter this
language.
AUDIO RECORDING and/or VIDEO RECORDING:
If applicable, use the language already included on the Informed Consent Template. Do
not alter this language if it is required. If not applicable, you may delete these sections.
SIGNATURES:
Do not alter the language on the signature page.
The participant’s printed name, signature, and date signed must be included on all
consent forms with the exception of informational consent forms used for anonymous
study participation.
The signature of the Investigator should be included
3.) INSTRUCTIONS AND SAMPLE LANGUAGE FOR EACH SECTION OF INFORMED CONSENT FORM
Below are specific instructions for the required content for each section of the Informed Consent form. Example language is given in
blue and should only be used for reference. Your Informed Consent form should be written specifically for and must include
information appropriate for your particular research study.
Pay close attention to text in RED as that text may be required for your Informed Consent form depending on your study.
PURPOSE:
Instructions:
Examples:
Briefly describe the purpose of the study in lay terms and why the research is being done. Include a statement that
explains why the study is “research”.
- The purpose of this research study is to explore attitudes of first-generation Americans regarding education
because…
- The purpose of this research study is to understand how social support influences mental health…
NUMBER OF PARTICIPANTS & STUDY LOCATION:
Instructions:
Give the anticipated number of participants in the study and where the research will take place. If different
procedures will take place at different locations, specify accordingly.
Examples:
- This study will enroll approximately XXX participants. All study procedures will be done at xxxxxxxx University
- …Interview sessions will be held at xxxxxxx, and remaining procedures will be performed at xxxxxx.
QUALIFICATIONS TO PARTICIPATE:
Instructions:
Describe the inclusion/exclusion criteria to participate (if any)
Examples:
- In order to participate in this study, you must first take a screening exam to help the researchers determine if you
meet the study requirements listed below. The screening procedures include: …(bulleted list)
- You can participate in this study if you are at least 18 years of age and have been clinically diagnosed with
depression.
- You cannot participate in this study if you are taking high blood pressure medications
PROCEDURES:
Instructions:
Explain the research procedures in chronological order. Include the expected duration of each interview or
procedure. If the study involves multiple components (i.e. surveys, focus groups, observations, accessing records,
etc), or multiple cohorts who will participate in different study procedures, it is strongly recommended that you use
headings or tables to delineate between the different study components and/or cohorts.
Examples:
BENEFITS:
Instructions:
Examples:
RISKS:
Instructions:
Examples:
- If obtaining AUDIO-recordings - provide complete details of the process and procedures for obtaining audiorecordings in this section. If you are not conducting audio-recordings please delete the Audio recording section
from the consent form template.
- If obtaining VIDEO-recordings - provide complete details of the process and procedures for obtaining videorecordings in the procedures section of the consent form. If you are not conducting audio-recordings please delete
the Video Recording section from the consent form template.
- Participation in the study will include about XX visits and/or interviews and take a total of about XX hours over a
period of XX days/weeks…
Describe the possible benefits, if any, to the subject from participating in the research or benefits to others or
society
(If NO direct benefit) – You will not directly benefit from participation in this study
(If direct benefit is anticipated) – The possible benefits you may experience from the procedures described in this
study include increased reading comprehension; improved writing skills; learning new ways to improve memory
(If benefits to others or society) – The possible benefits to science or society resulting from your participation in this
research may be a greater understanding of how stress influences memory
Describe any reasonably foreseeable risks to the subject resulting from participation in the study. Categorize the
risks by severity and include the likelihood of the risk/discomfort occurring. Include all types of risks – psychological,
social, economic, legal and/or physical
- There are no known harms or discomforts associated with this study beyond those encountered in normal daily life.
- The possible risks and/or discomforts associated with the procedures described in this study include: anxiety,
embarrassment, social stigma (shame or disgrace), and invasion of privacy.
- You may experience side effects while participating in this study. Everyone taking part in the study will be
monitored carefully, however the research do not know all of the potential side effects that may occur. The
researchers may administer…
PRIVACY & CONFIDENTIALITY:
Subject Identifiable Data
Instructions:
Explain whether subject identifiers will be linked to the research data. If applicable, explain why personal identifiers
will be retained.
Examples:
- All identifiable information collected about you will be removed at the end of the data collection
- Some identifiable information collected about you will be removed at the end of the data collection
- All/Some identifiable information collected about 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.
- All/Some identifiable information collected about you will be kept with the research data.
Data Storage:
Instructions:
Describe how the data will be stored and maintained
Examples:
- Research data will be maintained in a secure location at Chapman University. Only authorized individuals will have
access to it
- Research will be stored electronically on a laptop computer in an encrypted file and is password protected.
- The audio/video recordings that can identify you will be stored in a secure location; then transcribed and erased as
soon as possible (or other specified timeframe)
- The audio/video recordings that can identify you will be stored in a secure location; then transcribed and erased at
the end of the study.
- The audio/video recordings will also be stored in a secure location and transcribed. The recordings will be retained
with the other research data.
Data Retention:
Instructions:
Explain how long the research data will be maintained
Examples:
- The researchers intend to keep the research data until analysis of the information is completed.
- The researchers intend to keep the research data until the research is published and/or presented.
- The researchers intend to keep the research data for approximately XX years.
- The researchers intend to keep the research data indefinitely.
- The researchers intend to keep the research data 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.
- The researchers intend to keep the research data for seven years after all children enrolled in the study reach the
age of majority under applicable law in the jurisdiction in which the research is conducted (e.g. age 18 in California).
Access to Data:
Instructions:
If applicable, explain who will have access to the research data.
Examples:
- The research team, authorized Chapman University personnel, the study sponsor (if applicable), and regulatory
entities such as the Office of Human Research Protections (OHRP), may have access to your study records to protect
your safety and welfare. Any information derived from this research project that personally identifies you will not be
voluntarily released or disclosed by these entities without your separate consent, except as specifically required by
law. Study records provided to authorized, non-Chapman University entities will not contain identifiable information
about you; nor will any publications and/or presentations without your separate consent. While research team
members will make every effort to keep your personal information confidential, it is possible that an unauthorized
person might see it. We cannot guarantee total privacy.
COMPENSATION, REIMBURSEMENT, COSTS:
Instructions:
Explain how, if at all, subjects will be compensated (monetarily, extra course credit, etc). Specify if subjects will be
compensated for each session or for completion of multiple sessions and the amount/value for each. If subjects will
be compensated with extra course credit, the course instructor offering the 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.
Explain if reimbursements will be provided, or if the subject will be responsible for any costs.
Examples:
For compensation:
- You will not be compensated for your participation in this research study.
- You will receive extra course credit for an eligible course through the Chapman University Social Sciences human
subjects’ pool. You will receive a ½ unit of course credit for each ½ hour of participation in this study. Total amount
of credit you may earn is X # of units.
- You will receive $XX.xx for your participation in this study.
- You will receive a gift card in the amount of $XX.xx/ You will be entered into a raffle to win 1 of 10 gift cards of
$XX.xx.
- You will receive XXX amount of compensation for each study component you complete. There are XX components.
Total compensation for participation in this study is xxxx. 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.
For reimbursement:
- You will be refunded for the following expenses that you incur: i.e. parking fees, transportation fees, etc.
- You will not be reimbursed for any out of pocket expenses, such as parking or transportation fees.
For costs:
- You will be responsible for the following costs: (list any/all costs for which subject is responsible)
ADDITIONAL INFORMATION:
In case of Injury:
Instructions:
The following statement is required for all studies that have a potential for subject risk of injury or harm. This
statement cannot be altered except to fill in the study sponsor name. If not applicable, please do not include in the
Informed Consent form.
REQUIRED
It is important that you promptly tell the researchers if you believe that you have been injured because of taking part
TEXT (if
in this study. You can tell the researcher in person or call him/her at the number listed at the top of this form. If you
applicable):
cannot reach the researcher, contact the Institutional Review Board at 714-628-7392 or (714) 628-7392 or by email
at irb@chapman.edu.
- In the event of any physical injury as a result of being in this study, Chapman University will facilitate to the best of
our ability necessary medical services. Chapman University cannot directly provide medical services and does not
provide compensation for injury beyond that stated above. Services rendered for the acute care of a study-related
injury may be covered by the study sponsor (for industry sponsored studies only), or billed to you or your insurer by
your healthcare provider.” The University does not normally provide any other form of compensation for injury.
Information regarding research-related injury may be directed to the Institutional Review Board, Office of Research
and Sponsored Programs Administration at (714) 628-7392 or (714) 628-2805 or by email at irb@chapman.edu.
Subject Withdrawal
Instructions:
Required IF subject participation may be terminated by researcher and/or if there are adverse consequences
(physical, social, psychological, economic, or legal) of the subject’s withdrawal from the study
Example:
- 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 your safety and welfare are at risk.
If you withdraw or are removed from this study, the researcher may ask you to:
- Example: return for a final visit or evaluation
- Example: continue long-term follow-up procedures if you are interested
- Example: complete an exit telephone interview, etc.
- When research is not subject to HIPAA (PHI) 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.
CONTACT INFORMATION:
Instructions:
List the Names and Contact information (Phone and email address) for the PI and ALL Co-Investigators having direct
contact with the subject(s). Only include Co-Investigators prepared and willing to respond to participants’ questions
and or comments.
Example:
Dr. John Johnson, Principal Investigator
555-555-1234
jjohnson@email.com
Dr. Joanna Johannson, Co-Investigator
555-555-4321
johannsonj@email.com
QUESTIONS RELATED TO STUDY
Instructions:
Use the language already included on the Informed Consent Template (also included below). Do not alter this
language
REQUIRED
If you have any comments or questions regarding the conduct of this research, your participation in the study, or
TEXT:
about the consent form, contact a member from the research team listed above.
TO REPORT A CONCERN:
Instructions:
Use the language already included on the Informed Consent Template (also included below). Do not alter this
language
REQUIRED
If you would like to report a concern about the study or the informed consent process, you may contact Chapman
TEXT:
University’s Institutional Review Board, Office of Research and Sponsored Programs Administration by phone (714)628-7392 or (714) 628-2805, by email at irb@chapman.edu, or by mail at Chapman University, ORSPA, One
University Dr. Orange, CA 92866.
AUDIO RECORDING or VIDEO RECORDING:
Instructions:
If applicable, use the langue already included on the Informed Consent Template for either or both Audio recording
or Video recording consent. If research includes participants that cannot sign for themselves include “(or
Parent/Legal Guardian)” next to “Signature of Participant”.
If your research does not involve either Audio or Video recording, then you may delete these sections from the
Informed Consent form.
REQUIRED IF
APPLICABLE
SIGNATURES:
Instructions:
REQUIRED:
See Informed Consent Template
Use the language and signature lines already included on the Informed Consent Template. If research includes
participants that cannot provide consent on their own behalf, include “(or Parent/Legal Guardian)” next to
“Signature of Participant”.
Printed name of participant
Signature of Participant
Signature of Principal Investigator
If you have any questions regarding any of the Informed Consent Form Content, please
contact us at 714-628-7392 or at irb@chapman.edu.