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Study Title: Behavioral Health Research Laboratory Screening and Registry
VCU Investigator: Caroline Cobb, PhD, Assistant Professor of Psychology, 804-828-8687
Sponsor: National Institutes of Health/Food and Drug Administration
About this Consent Form: You are being invited to participate in a research study. It is important that you carefully think about whether being in this study is right for you and your situation.
This consent form is meant to assist you in thinking about whether or not you want to be in this study. Please ask the investigator or the study staff to explain any information in this consent document that is not clear to you.
Your participation is voluntary. You may decide not to participate in this study. If you do participate, you may withdraw from the study at any time. Your decision not to take part or to withdraw will involve no penalty or loss of benefits to which you are otherwise entitled.
An Overview of the Study
Study Purpose: The purpose of this 10-15 minute screening survey study is to see if you meet criteria for taking part in our current and future research studies that focus on effects of tobacco products and other substances at VCU. We also may use your data to understand the reasons why individuals are eligible or not to participate in our studies and to better characterize the local population.
Description of the Study and Your Involvement: The screening survey will ask you to complete questions about yourself, your health, and your use of tobacco, alcohol, and other drugs. We will use this data to understand substance use correlates and eligibility status for studies currently recruiting at the Behavioral Health Research Lab.
If your answers indicate that you seem eligible to participate, the staff will contact you to schedule an in-person visit.
As a part of this research you will be asked if you would like to join the research registry, which means that we would keep your name and information on file for both current and future studies. If you choose to join the registry, you are giving your permission for our staff to contact you for future studies. Should you be contacted by us you can decide each time if you want to participate in these studies or not. You can also elect to have your name removed from the registry at any time.
Alternatives: Your alternative is to not take part in this survey.
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Risks and Discomforts |
Benefits to You and Others |
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It is possible that some people may feel uncomfortable answering these questions, and there is a risk of loss of confidentiality. |
There is no benefit to you taking part in this survey. Your participation may help researchers learn more about individuals who use tobacco products and benefit others. |
Will I be paid to participate in the study?
You will not get any payment for answering the screening questions or from joining the registry.
Can I stop being in the study?
You do not have to complete the screening questionnaire. If you choose to answer the screening questions, you may stop at any time without penalty. You do not have to join the registry, and you can choose to be removed from the registry without penalty.
How will information about me be protected?
VCU and VCU Health System have established secure research databases and computer system to store information and to help with monitoring and oversight of research. Your information may be kept in these databases but are only accessible to individuals working on this study or authorized individuals who have access for specific research related tasks.
Identifiable information in these databases are not released outside VCU unless stated in this consent or required by law. Although results of this research may be presented at meetings or in publications, identifiable personal information about participants will not be disclosed.
In the future, identifiers might be removed from the information and samples you provide in this study, and after that removal, the information/samples could be used for other research studies by this team or another researcher without asking you for additional consent.
Certificate of Confidentiality
To help us protect your privacy, we have obtained a Certificate of Confidentiality from the National Institutes of Health. The researchers can use this Certificate to legally refuse to disclose information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for example, if there is a court subpoena. The researchers will use the Certificate to resist any demands for information that would identify you, except as explained below.
The certificate cannot be used to resist a demand for information from personnel of the United States Government that is used for auditing or evaluation of federally funded projects or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA).
You should understand that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers may not use the Certificate to withhold that information.
Whom should I contact if I have questions about the study?
The investigator and study staff named below are the best person(s) to contact if you have any questions, complaints, or concerns about your participation in this research:
Dr. Caroline Cobb, 804-828-1867
If you have general questions about your rights as a participant in this or any other research, or if you wish to discuss problems, concerns or questions, to obtain information, or to offer input about research, you may contact:
VCU Office of Research
800 East Leigh Street, Suite 3000
Box 980568
Richmond, VA 23298
804-827-2157
https://research.vcu.edu/human_research/volunteers.htm