Protocol
INFORMED CONSENT
PROJECT TITLE
Invitation to Participate:
You are invited to participate in a study of______ (Describe what is to be studied)
____being conducted by ___ (Give names of investigators and their affiliations with
WESTERNU and other institutions involved.) _____.
Basis for Subject Selection:
You have been selected because_____(State reasons why, e.g., subjects with specific
diseases, conditions, characteristics, backgrounds.
When appropriate, give the
approximate number of subjects in the study. When appropriate, describe exclusion
criteria, e.g., pregnancy, age limitations, health restrictions.) ____.
Overall Purpose of Study:
(Give a clear description in simple language of the overall purpose of the research
which should help the subject assess the importance of the study relative to his or her
individual values. When appropriate, this statement must include not only the
immediate purpose of the study, but also any larger, ultimate purpose.)
Explanation of Procedures:
(Describe procedures to be followed. Identify any procedures that are experimental.
Include a statement of where the research will be conducted, when the research will be
conducted, and how much time, per session and in total, will be required of the subject.
If the research involves incomplete disclosure or deception, all subjects must be
debriefed as soon as possible after participation. Include a statement concerning when
and where the debriefing session will be held. If debriefing may be harmful to subjects,
the investigator may request a waiver of the debriefing requirement.)
Potential Risks and Discomforts:
(A risk is a potential harm that a reasonable person, in what the investigator knows or
should know to be the subject's position, would be likely to consider significant in
deciding whether or not to participate in the research. Risks could be physical, social,
psychological, legal, or economic. Give a description of any reasonably foreseeable
risks or discomforts to the subject. When appropriate, 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.
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For any research activity involving the consumption of food or application of chemicals
or other products to the skin [cosmetic research], the following statement must be
included): If you are known to have a sensitivity to any food or food ingredient, or have
had violent allergic reactions to drugs, chemicals, or food ingredients, you should not
participate in this study.
Potential Benefits:
(A benefit is a valued or desired outcome. Benefits associated with participation in
research generally can be classified as those that accrue to the subject directly, e.g.;
improvement of health status, and those that accrue to society, e.g., acquisition of
knowledge. Describe benefits to the participant or others that could reasonably result
from this research. Financial compensation or other forms of remuneration are not
considered a benefit to be derived from research participation and should be
included in a separate section describing compensation.)
Alternatives to Participation:
(Describe appropriate alternative procedures or courses of treatment, if any, that may
be advantageous to the subject. If the prospective subjects are students who would
participate in exchange for receipt of academic credit, the consent form must describe
an alternate way the student can earn the academic credit if he/she chooses not to
participate. The option(s) must be comparable to research participation in terms of
time, effort and educational benefit. This is not the same as "extra credit," which is a
compensation for participation.)
Compensation for Participation:
(If the subject will receive compensation, describe the amount or nature of the
compensation [extra grade credits, money, free medical treatment, etc.]. The nature
and amount of compensation must not constitute undue inducement to participate, i.e.,
the compensation alone should not serve as sufficient inducement for the subject to
volunteer.
If students are given extra academic credit for participation, the
amount/nature of the extra credit with respect to the award of grades must not be
unduly influential.)
Assurance of Confidentiality: (It is required that this statement be in
14-point.
Describe the extent, if any, to which confidentiality of records identifying the
subject will be maintained. In addition, the following statement must be
included): Data and records created by this project are the property of the
University and the investigator. You may have access to information
collected on or about you by making a written request to the principal
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investigator. This right of access extends only to information collected on
or about you and not to information collected on or about others
participating in the project. (This statement does not clearly spell out
whether copies will be provided. In most cases, the investigator and the
University would probably be willing to provide copies to the subject of data
collected on him/her. It leaves open the flexibility, however, in a particular
circumstance to deny copies. An example of such situations might be on a
sponsored research project where information developed could be
considered as proprietary information or required by contract with the
sponsor.)
(If your project involves the investigation of a drug (Phase I-IV), nonapproved use of a drug or substance, or investigation of a medical device
or substance that is subject to FDA regulations, you must add the following
statement): Representatives of the United States Department of Health
and Human Services or the United States Food and Drug Administration
may inspect your _____insert "medical records" or "research records", as
appropriate____ to assess the results of this ____insert "drug treatment",
"medical device therapy", or "research", as appropriate.
Statement of Injury or Special Costs:
(If there is a possibility of special costs to the subject because of participation, describe
them. If there is a possibility of a research-related injury or other reason for medical
treatment, the following paragraph must be included):
In the event that this research activity results in an injury, you should contact
____investigator's name____at the following telephone number(s)____________.
Treatment will be available, including first aid, emergency treatment and follow-up care
as needed. You and your third party payer (such as health insurance, Medicare) must
provide payment for any such treatment. This paragraph does not mean that you are
releasing or waiving any legal right you might otherwise have against the investigator or
WESTERNU as a result of your participation in this research activity. (If a commercial
sponsor has agreed to provide compensation in case of injury to research subjects, the
extent/limitations of the compensation must be stated clearly. WESTERNU standard
compensation statements are not to be used when a commercial sponsor has agreed to
provide compensation for subject injury.)
Withdrawal from the Study:
Your participation is voluntary. Your decision whether or not to participate will not affect
your ____insert "grade" or "treatment" or "present or future relationship with the
university (or other named organization)" as appropriate____. If you decide to
participate, you are free to withdraw your consent and to discontinue participation at any
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time. (When appropriate, include a statement that any significant new findings
developed during the course of the study that may relate to the subject's willingness to
continue participation will be provided to the subject. The investigator must provide
both the subject and the IRB with a written statement concerning any significant
finding(s) that may potentially influence a subject's decision to continue participating in
the study. In this circumstance, the investigator must re-negotiate informed consent.
When appropriate, describe any anticipated circumstances, e.g., adverse reactions,
non-adherence to protocol instructions, under which the subject's participation may be
terminated by the investigator without regard to the subject's consent.)
Offer to Answer Questions:
You should feel free to ask questions now or at any time during the study. If you have
questions about this study, you can contact ____Give your name and telephone number
and the name and telephone number of any co-investigator. If the principal investigator
is a student, the name and telephone number of his/her adviser must also be included.
____If you have questions about the rights of research subjects, contact the
WESTERNU IRB Office, (909) 469-5636.
Consent Statement:
You are voluntarily making a decision whether or not to participate. Your signature
indicates that you have decided to participate, having read the information provided
above. You will be given a copy of this consent form to keep.
I have read this information, which is printed in ____name of language.
language that I read and understand.
This is a
_________________________________________
____________________________
Signature of Subject
Date
_________________________________________
____________________________
Signature of Consenting Investigator
Date
_________________________________________
____________________________
Signature of Primary Investigator
Date
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