Consent to be a Research Subject Protocol #: 14-251

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Protocol Number: 14-251
Version and Date Received: ROC(1) V1, 7/8/15
Consent to be a Research Subject
Protocol #:
14-251
Title: The UCCS Research Registry
Principal Investigator: Michele Okun, PhD
Funding Source: N/A
Introduction
UCCS and The Lane Center for Academic Health Sciences are actively seeking adults to participate in research studies.
To that end, we are collecting names to form a Participant Registry database. This form is designed to tell you everything
you need to think about before you decide to consent (agree) to be a part of this Registry. A member of the research
team will describe the process to you and answer any questions. It is entirely your choice. If you decide to take part,
you can change your mind later on and withdraw from the research registry. You can skip any questions that you do
not wish to answer.
This Database contains names of individuals who have expressed an interest in participating in research studies at UCCS.
If you decide to participate, we will record your name, and other demographic information such as gender, year of birth,
race, ethnicity, veteran/military status, phone number, email, and mailing address. Even if you decide not to provide all
of this information, you can still be added to the database.
Before making your decision:
 Please carefully read this form or have it read to you.
 Please ask questions about anything that is not clear.
Feel free to take your time thinking about whether you would like to participate. By signing this form you will not give up
any legal rights. If you are completing this consent form online, you may want to print a copy of the consent form for
your records.
Overview: We are asking your permission to put contact and minimal demographic information about you in a UCCS
Research Registry database. This research registry will allow UCCS investigators to find individuals, such as you, who
may want to take part in research. The information we are collecting includes basic information and other demographic
information such as gender, year of birth, race, ethnicity, veteran/military status, phone number, email, and mailing
address. We are asking all residents of the Pikes Peak region who are 18 years of age or older to participate.
Procedures: If you agree to participate in this research registry, your contact information will be provided to the
researchers who place a written request with the designated data manager. Only if you meet minimum eligibility
requirements, such as age or gender, will your contact information be provided to the researcher. You may then be
contacted by a researcher (via mail, phone or email) who will talk to you about a specific study. If you sign up for the
research registry, you can still refuse to take part in any (future) research study. If you decide to take part in any
research study, you must sign a separate consent form for that study.
Other people in this study: We are asking all residents of the Pikes Peak region (~300000) 18+ years if he/she would be
willing to be added to the Research Registry in order to be contacted for future research purposes.
Risks and Discomforts: We anticipate minimal risk or discomfort with this data collection. You may have concerns about
the information being collected and whether it can be connected back to you. In order to address this potential
discomfort/risk, we are not collecting any personal identifying medical information from you. You will have full access to
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Version Date: 05/22/2014
Protocol Number: 14-251
Version and Date Received: ROC(1) V1, 7/8/15
clinical services at any UCCS related clinic even if you do not wish to have your data used for research purposes.
Services are not contingent on agreeing to have information used for future research purposes.
Benefits: There are no anticipated benefits from being in this registry. However, if you do choose to participate in
specific research study from which your information was provided, you may realize direct benefit from that.
Compensation: Compensation is not provided for signing up for the registry.
Confidentiality: None of your contact information will be publicly available. All information will be maintained in a
password, encrypted database. Requesting investigators are likewise obligated to maintain your confidential
information. You will not be specifically identified in any publication of research results. Only the individual consenting
you and the Database Manager will be aware of your identity. Your information will be entered into a password
protected and firewalled database that is only accessible by the Data Manager.
Certain offices and people other than the researchers may have access to registry records.
Government agencies and UCCS employees overseeing proper study conduct may look at your registry records. These
offices include the:
UCCS Institutional Review Board
UCCS Office of Sponsored Programs
UCCS will keep any research records confidential to the extent allowed by law. A study number rather than your name
will be used on registry records wherever possible.
Registry records may be subject to disclosure pursuant to a court order, subpoena, law or regulation.
Voluntary Participation and Withdrawal from the Study
Taking part in this study is voluntary. You have the right to leave a study at any time without penalty. You may refuse to
do any procedures you do not feel comfortable with, or answer any questions that you do not wish to answer. If you
withdraw from the study, you may request that your research information not be used by contacting the Principal
Investigator listed above and below.
Contact Information
Contact (PI’s info): Michele Okun, PhD; 412-302-8030; mokun@uccs.edu
 if you have any questions about this registry or your part in it
Contact the Research Compliance Specialist at 719-255-3903 or via email at irb@uccs.edu:
 if you have questions about your rights as a research participant, or
 if you have questions, concerns or complaints about the research.
Consent
A copy of this consent form will be provided to you.
I understand the above information and voluntarily consent to participate in the research. I choose to be in this registry.
By signing this consent, I am confirming that I am 18 years of age or older.
Signature of Participant
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Date
Version Date: 05/22/2014
Protocol Number: 14-251
Version and Date Received: ROC(1) V1, 7/8/15
Please complete any or all of the following items:
Name: ____________________________________
Gender:
Your Year of Birth: ___________________
Phone #: ___________________________
Address: _____________________________________
Email:______________________________
_____________________________________________
Preferred method of contact: Email
Please circle your ethnicity:
1. Hispanic
Please circle your race:
1. White
2. Black or African American
3. Native Hawaiian or Other Pacific Islander
4. American Indian or Alaska Native
5. Asian
6. More than one race
7. Other or unknown
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male
female
Phone
2. Non-Hispanic
Please indicate your veteran or military status:
1. Veteran
2. Active Military/Reserve
3. Civilian
4. Other/NA (indicate):______________________
Version Date: 05/22/2014
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