SBS NUTRITION CONSENT TEMPLATE – USING OUTLINE FORM
AUB
Title of Research Study: [Insert title of protocol – lay language]
Principal Investigator: [Insert PI name/department/school]
Co-Investigator: [name of co-investigator, especially if this study is thesis or dissertation
research for degree]
Consent Document Template
[All bolded section headings are required elements of informed consent. All
instructions/suggestions in red type describe content that should be included in consent
form by PI. Before submitting this form to the IRB, delete the sections in brackets [..]
and all red type font.]
We are asking you to participate in a research study. Before agreeing to participate in the
research, it is important that you read the information below. This statement describes the
purpose, procedures, benefits, risks, discomforts, and precautions of the study. Also described are
the alternative procedures, if any, available to you, as well as your right to withdraw from the
study at any time. You should feel free to ask any questions that you may have.
A. Purpose of the Research Study: [explain in lay language the purpose of the study. If this is
a comparison study between a known or common aspect of nutrition and nothing at all (a
placebo) or a new product, make this aspect of the study explicitly clear.] The research is
being conducted with the goal of publication in [e.g. academic journal, book,] and
possibly presentation at academic conferences. [If the research study is being conducted
for thesis, dissertation or as a requirement for an advanced degree, state that as one of the
purposes of the research.]
B. Project/Procedures Description
1. In this study, you will [describe tasks/procedures that the subject will be engaging in.
If you will be asking any personal or sensitive questions, state as much here. If there are
multiple tasks, you can show a list of the tasks – for example: complete a health
questionnaire, have a physical exam by the study nurse, body measurements, testing
assessments for dietary needs, etc. - describe any blood samples, bone density
measurements, etc. If there are diet specifics and record keeping by the participant, make
these aspects and tasks very clear.
2. If there are multiple arms of the study, describe the number of participants in total and
then how the participants will be divided into the various arms of the study. Make clear
how the determination of which participant is placed in which arm, e.g. double blind
study, random assignment, etc.]
3. [Include any other additional information about the project and data collection here.
For example, if you will be sharing the information with other researchers or putting data
in public archives.]
C. Duration
The estimated time to complete this study is approximately [add expected time. If there
are multiple visits to compete the study, with time periods in between visits to the
researchers, make the number and spacing of the visits explicitly clear and what will be
done at each visit. Give an estimate of time for each visit].
You may leave the study at any time. If you decide to stop participating, there will be no
penalty to you, and you will not lose any benefits to which you are otherwise entitled.
Your decision will not affect your future relationship with AUB.
D. Risks, Discomforts and Benefits
Your participation in this study does not involve any physical risk or emotional risk to
you beyond the risks of daily life. [If risks are greater than minimal, delete the previous
sentence and fully explain the potential risks here. For example, if there are blood draws,
explain the typical discomfort of having blood drawn; if participant needs to behave in
certain manner – be calm and not move during a blood draw, or during a x-ray. If a
specific diet must be followed describe the requirements for fasting or modifications of
normal diet/eating habits. If extended period of blood draw using needle placed in arm,
explain the specifics, time period, discomfort, risks of infection, etc. Be sure to include
what is being measured in the blood sample, for example – levels of cholesterol, sugar
levels, etc. It is probably also important to tell participants what is not being tested – for
example, if no HIV test is being done, state this. ]
The benefits of this study include [state any potential direct benefits to subjects here.] [If
no direct benefits so state: You receive no direct benefits from participating in this
research; however your participation does help researchers better understand (fill in
benefit to generalizable knowledge in field)]
E. Confidentiality
[State conditions for confidentiality of data here. For example, ‘Your name or other
identifiers will not be attached to your answers so that your confidentiality can be
maintained. Your privacy will be ensured in that all data resulting from this study will be
analyzed, written, and published in aggregate form.’]
[Example:
To secure the confidentiality of your responses, your name and other identifying
information will never be attached to your answers. All codes and data are kept in a
locked drawer in a locker room or in a password protected computer that is kept secure.
Data access is limited to the Principal Investigator and researchers working directly on
this project. All data will be destroyed responsibly after the required retention period
(usually three years.) Your privacy will be maintained in all published and written data
resulting from this study. Your name or other identifying information will not be used in
our reports or published papers.]
There may be circumstances where your confidential information must be released. For
example, personal information regarding your participation may be disclosed if required
by the AUB IRB, the U.S. Office of Human Research Protections or other federal or
international regulatory agencies, or the sponsor of the study, if any, or agency supporting
the study.
F. Compensation/Incentive
[State the facts of payment for serving as a subject. If there are costs that will have to be
paid by the participant, say so. If there are no costs, say so. If participants will receive
any payment or incentive for serving as a subject, explain clearly. If payment is prorated
or dependent on completion of a certain number of tasks, explain this clearly.]
G. Payment for Research-related Injury
[State the facts of any payment for research-related injuries. If there is no monetary
compensation in the event of an injury resulting from the research, say so. If emergency
treatment for research-related injuries is available at AUBMC, state this clearly. If you
are injured as result of participating in this study or for questions about a study-related
injury, you may contact… (Fill in contact information, usually the PI or the IRB office)]
H. Contact Information and Questions
1) If you have any questions or concerns about the research you may contact [list
researcher’s contact information, including name, mailing address, telephone number,
and email address].
2) If you have any questions, concerns or complaints about your rights as a participant in
this research, you can contact the following office at AUB:
Social & Behavioral Sciences Institutional Review Board
[Add address, telephone, and email for administrative contact]
I. Participant Rights
Participation in this study is voluntary. You are free to leave the study at any time
without penalty. Your decision not to participate is no way influences your relationship
with AUB.
Do you have any questions about the above information? Do you wish to participate in this
study?
[If written consent is required, please add a line below for the subject to sign and date. Name and
Signature with date of person obtaining consent is also recommended.]
Example:
Participant Consent:
I have read and understand the above information. I agree to participate in the research
study.
Participant Name: ____________________________ Date: _____________________
Participant Signature: _____________________________
Printed Name of person authorized to consent for subject: _________________________
Relationship to Subject:___________________________________
Signature of Person authorized to consent: _____________________ Date: ___________
Documentation of Consent:
Printed Name of Person obtaining Consent:_____________________________
Signature of Person obtaining Consent:________________________________
Date:__________________________________________