INFORMED CONSENT DOCUMENT
AGREEMENT TO BE IN A RESEARCH STUDY
PROTOCOL NUMBER AND TITLE OF STUDY: PRISM Mobile Learning System to Reduce Unconscious Bias Among Healthcare Providers: Usability Testing
NAME OF PERSON IN CHARGE OF THE
RESEARCH STUDY (STUDY DOCTOR/
INVESTIGATOR): Anurag Gupta, MPhil, JD
TELEPHONE NUMBER(S), DAYTIME: (347) 330-0311
AFTER HOURS: (347) 330-0311
KEY INFORMATION
The five elements below should be included in your summary which will aid in the decision on whether or not the subject is truly interested in participation.
This is a research study and your participation is voluntary.
This research study is to test the feasibility of teaching unconscious bias curriculum and PRISM skills on a mobile interface. and should take 50 minutes of your time. You will be asked to complete 10 minutes of daily content for 5 days.
The main benefit to you (or others) for taking part in this study is to learn more about unconscious bias and PRISM tools.
Because this study is being done for research only, your only alternative is to choose not to participate.
INTRODUCTION
You are being invited to volunteer for a mobile app research study. You must read and sign this form before you agree to take part in this study. This form will give you more information about this study. Please ask as many questions as you need to before you decide if you want to be in the study. You should not sign this form if you have any questions that have not been answered.
The purpose of this study is to test the feasibility of teaching unconscious bias curriculum and PRISM skills on a mobile interface.
HOW LONG THE STUDY WILL LAST AND HOW MANY PEOPLE WILL BE IN THE STUDY
The study will last 9 days and involve 5 days of participation and 50 minutes of content. About 75 men and women, ages 22 through 75, are expected to be in this study.
Participant Responsibilities:
While participating in this research study, you will need to:
Be willing and able to follow the study directions and procedures
Tell the study staff about any problems you encounter
Ask questions as you think of them
Tell the investigator or the study staff if you change your mind about staying in the study.
WHAT WILL HAPPEN DURING THE STUDY
Screening:
Before the study starts, you will be asked to sign this consent form agreeing to participate in the study.
Study Procedures:
Download the app on a mobile device (Google Play or TestFlight)
Complete 10 minutes of daily activities for 5 days on the app
Participate in a follow-up video or phone interview to provide feedback
At the end of the study, the Investigator will explain in greater detail what we hope to learn from this research.
You will be asked to give permission for the interview to be audio-recorded to ensure that the Investigator can remember accurately all the information you provide. The audio recordings will only be used by the investigator. If you prefer not to be audio-recorded, the Investigator will take notes instead.
Your participation in this study does not involve any physical or emotional risk to you beyond that of everyday life.
The risks to your participation in this online study are those associated with basic computer tasks, including boredom, fatigue, or mild stress. The only benefit to you is the learning experience from participating in a research study. The benefit to society is the contribution to scientific knowledge.
ADDITIONAL RISKS OR DISCOMFORTS
There are no additional risks or discomforts expected with this study.
We may share the data we collect from you for use in future research studies or with other researchers – if we share the data that we collect about you, we will remove any information that could identify you before we share it.
CONFIDENTIALITY
Your records of being in this study will be kept private except when ordered by law. The following people will have access to your study records:
The investigator
Sponsor company or research institution [including monitor(s) and auditor(s)]
IntegReview IRB
Regulatory authorities
The Institutional Review Board (IRB), IntegReview, and accrediting agencies may inspect and copy your records, which may have your name on them. Therefore, total confidentiality cannot be guaranteed. If the study results are presented at meetings or printed in publications, your name will not be used.
The Investigator may quote your remarks in presentations or articles resulting from this work. A pseudonym will be used to protect your identity, unless you specifically request that you be identified by your true name.
After the research, identifiers might be removed and your de-identified information may be used for future research without additional informed consent.
OTHER INFORMATION
The data will be confidential and only the investigator will have access to identifiable data. Data will be used at the aggregate level to demonstrate comprehension of key concepts. Subjects may refuse to participate or may withdraw from the study at any time without penalty or loss of benefits to which they are otherwise entitled.
LEGAL RIGHTS
You will not lose any of your legal rights by signing this consent form.
If you have questions, concerns, or complaints about this study or to report a study related injury, contact:
Anurag Gupta
(347) 330-0311
If you are unable to reach anyone at the number(s) listed above and you require immediate (life threatening) medical attention, please go to the nearest emergency room.
If you do not want to talk to the investigator or study staff, if you have concerns or complaints about the research, or to ask questions about your rights as a study subject you may contact IntegReview. IntegReview is a group of people that has reviewed this research study. The main goal of this review is to protect the rights and well-being of the human subjects participating in research studies. IntegReview’s policy indicates that all concerns/complaints are to be submitted in writing for review at a convened IRB meeting to:
Mailing Address: OR Email Address: | |
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Chairperson IntegReview IRB 3815 S. Capital of Texas Highway Suite 320 Austin, Texas 78704 |
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If you are unable to provide your concerns/complaints in writing or if this is an emergency situation regarding subject safety, contact our office at:
512-326-3001 or
toll free at 1-877-562-1589
between 8 a.m. and 5 p.m. Central Time
IntegReview has approved the information in this consent form and has given approval for the investigator to do the study. This does not mean IntegReview has approved your being in the study. You must consider the information in this consent form for yourself and decide if you want to be in this study.
PAYMENT FOR BEING IN THE STUDY
You will not be paid for being in this study.
It is your choice if you want to be in the study. No one can force you to be in the study. You may not want to be in this study or you may leave the study at any time without penalty or loss of benefits to which you are otherwise entitled.
REQUIRED BY INTEGREVIEW: Include appropriate wording below for either vulnerable populations that are allowed to participate in the study:
Employees of the investigator/sponsor: Keep highlighted for master IC’s
Employees of the investigator or sponsor are allowed to participate in this study. If you are an employee:
The decision to participate or not will not affect your performance evaluation.
The decision to participate or not will not affect possible promotions.
The decision to participate or not will not affect your pay.
Students:
Students of this institution are allowed to participate in this study. If you are a student:
The decision to participate or not will not affect your grade, recommendations, employment or the like.
For mandatory participation or for extra credit, you will be given other options for fulfilling the research requirement, such as writing short papers or book reports, special projects, and brief quizzes on additional reading.
Failure to participate will not have a negative affect on your relationship with the investigator or the faculty.
The investigator or IntegReview IRB may take you out of the study without your permission, at any time, for the following reasons:
If you do not follow the investigator’s instructions
If we find out you should not be in the study
If the study is stopped
If it becomes harmful to your health
If you leave the study or if you are taken out of the study, you may be asked to return for a final visit to have some end of study evaluations or tests. If information generated from this study is published or presented, your identity will not be revealed. If you leave the study, no more information about you will be collected for this study. However, all of the information you gave us before you left the study will still be used.
If there is new information or any significant new findings that could relate to your willingness to continue participation we will tell you. You can then decide if you still want to be in the study.
AGREEMENT TO BE IN THE STUDY
This consent form contains important information to help you decide if you want to be in the study. If you have any questions that are not answered in this consent form, ask one of the study staff.
Please answer YES or NO to the following questions:
Is this document in a language you understand?
Do you understand the information in this consent form?
Have you been given enough time to ask questions and talk about the study?
Have all of your questions been answered to your satisfaction?
Do you think you received enough information about the study?
Do you volunteer to be in this study of your own free will and without being
pressured by the investigator or study staff?
Do you know that you can leave the study at any time without giving
a reason and without affecting your health care?
Do you know that your health records from this study may be reviewed
by the sponsor company and by government authorities?
IF YOU ANSWERED “NO” TO ANY OF THE ABOVE QUESTIONS,
OR YOU ARE UNABLE TO ANSWER ANY OF THE ABOVE QUESTIONS,
YOU SHOULD NOT SIGN THIS CONSENT FORM.
My verbal agreement to participate in this survey implies my consent to participate in this research and I have been given a second copy of this form to keep for my records.