Temple The Missing Aspects and Violated Ethical Principles Informed Consent Review

Review the posted informed consent

description of what is wrong (or missing!), which ethical principles are violated, and how the information should be stated correctly.

These are some key things look for * The purpose of the study* All steps of protocol (exactly what they will be asked to do, including how long it will take)* Risks & benefits of participation (including steps to minimize risk)*Compensation* How confidentiality will be protected* Assurance of voluntary participation* Contact information for questions the paper Must be written in language that is clear (no psychological jargon)

Marvel University
Project Universe
Statement of Informed Consent
Researcher’s statement
We are asking you to take part in a research study concerning Alcohol and Cognitive Processing, being
conducted by Dr. Stephen Strange in the Department of Psychology at Marvel University. The purpose of this
consent form is to give you the information you will need to help you decide whether to be in the study or not.
Please read this form carefully. You may ask questions about the purpose of the research, what we would ask
you to do, the possible risks and benefits, your rights as a volunteer, and anything else about the research or this
form that is not clear. When we have answered all your questions, you can decide if you want to be in the study
or not. This process is called “informed consent.” You will receive a copy of this form for your records.
Study Procedures
The purpose of this research will be revealed upon completing the study. You will first be asked to respond to a
basic demographics survey. During today’s research session you may be asked to consume alcohol. If you are in
the alcohol condition, it is essential that you consume the alcohol provided to you by the experimenter. Because
alcohol dosage is determined by weight, you will be weighed by the experimenter. The type of alcohol you may
consume is 100 proof vodka mixed with orange juice. The amount of alcohol you may receive is intended to
raise your breath alcohol content (BAC) to .08 g/kg, which is the equivalent of about 3-4 alcoholic beverages
(e.g., 12-ounce beer, 6-ounce glass of wine, or 1-ounce shot of liquor) in one hour. You will have 9 minutes to
consume the beverage and then will wait until your BAC reaches a pre-determined level before continuing with
the study. While you wait for your BAC to rise, you will be given a breath test every 3-5 minutes. If you do not
receive a beverage containing alcohol, the drink will contain orange juice. You will still have 9 minutes to finish
your drink and will also receive breath tests every 3-5 minutes in order to make your experience as similar as
possible to participants who receive an alcoholic beverage. We will ask all participants to take a pregnancy test
as well as an ovulation test, as phase of menstrual cycle can influence the absorption of alcohol.
Once you have completed the beverage consumption and breath test assessments, you will be asked to engage in
a series of three cognitive tasks to help us understand the influence of alcohol intoxication on different types of
cognitive processes. In general, you will be left alone in the room to complete each of the three separate tasks,
but will be provided with a “call unit” device that will allow you to call the experimenter you have questions or
concerns. The experimenter will return to the room between tasks in order to assess your level of intoxication.
Once you begin the study, you must participate until the experimenter informs you that the study session has
concluded.
After the Study
At the end of the experiment, regardless of your condition (alcohol or sober), you can leave as soon as you are
done completing all the measures and are debriefed by the experimenter. Participation in the experiment will be
about 2 hours.
Risks, Stress, or Discomfort
Some of the potential risks of drinking alcohol include headache, nausea, dizziness, mood alteration, and
flushing. Also, some of the questions may make you feel uncomfortable due to their personal and sexually
explicit content.
Benefits of the Study
You may not experience individual benefits from your participation; however, you may benefit by learning more
about yourself through participation in the study. You may gain increased self-knowledge or a greater
understanding of your behavior. Benefits to society include the opportunity to contribute to the development of
programs intended to educate people about the influence of alcohol on cognitive processing.
PI: Strange (9/13)
Statement of Informed Consent
Page 1 of 2
Project Universe
Other Information
You will not, at any point, be asked to identify any of the materials with your name. All personal information
given today is strictly for scientific use and will be kept completely anonymous. You will be paid $30 an hour
for participating in the study, and you will receive payment at the end of today’s session. We will pay you for all
of the time you spend in the lab, including time needed for your BAC to fall below .03%.
If you become concerned about your drinking or experience distress or discomfort during any part of the study,
you can contact both your experimenter and the head investigator (Dr. Strange) to discuss your concerns. We
will be happy to provide referrals for substance use or mental health counseling services. In addition, we may
contact you if we become concerned about your alcohol use to inform you about the risks of alcohol and
services available in the local community.
Your signature indicates your agreement not to discuss the procedure or content of this study with anyone.
Doing so may influence the responses of anyone who would participate in this study at any point in the future. It
also indicates that you did not drive yourself to the session today and have an alternative way to get home.
Participation does not imply employment with Marvel University, the principal investigator, or any other project
facilitator.
Subject’s Statement
This study has been explained to me. I volunteer to take part in this research. I have had a chance to ask
questions. If I have questions later about the research, I can contact Dr. Strange by e-mail at DrS@marvel.edu. If
I have question about my rights as a research subject, I can contact the Associate Provost for Research at:
Marvel University Institutional Review Board for the Protection of Human Subjects, Office of the Associate
Provost for Research by phone at (123) 456-7890. I will receive a copy of this consent form.
________________________
Signature of Participant
_________________________
Participant’s Printed Name
PI: Strange (9/13)
Statement of Informed Consent
Date
________________________
Signature of Researcher
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Project Universe