Consent Form (includes HIPAA Authorization)
Title of Research Study: Active Recruitment Log
Investigator Team Contact Information
For questions about the research study, research results, or other concerns, contact the study team at:
Investigator Name: Dr. Lisa Anderson
Investigator Departmental Affiliation:
Department of Psychiatry & Behavioral Sciences
Phone Number: 612-273-8902
Email Address: ande8936@umn.edu | Study Staff Phone Number: 612-273-9304 Email Address: mcedr@umn.edu |
Supported By: This research is supported by the Minnesota Center for Eating Disorders Research (MCEDR). Research investigators at the MCEDR include Dr. Scott Crow (crowx002@umn.edu), Dr. Carol Peterson (peter161@umn.edu), Dr. Ann Haynos (afhaynos@umn.edu), Dr. Emily Pisetsky (episetsk@umn.edu), Dr. Lisa Anderson (ande8936@umn.edu), and Dr. Melissa Simone
(simon996@umn.edu). Please feel free to contact any of these researchers with questions or concerns.
Key Information About This Research Study
Why am I being asked to take part in this research study?
We are asking you to take part in this research study because you have identified interest in participating in research studies with the Minnesota Center for Eating Disorders Research. Participation in this research study will involve being added to an ongoing recruitment database which would allow research staff to contact you about research opportunities with our group that seem like a good fit for you.
What should I know about a research study?
● Whether or not you take part is up to you.
● You can choose not to take part.
● You can agree to take part and later change your mind.
● Your decision will not be held against you.
● You can ask all the questions you want before you decide.
Why is this research being done?
The Minnesota Center for Eating Disorders conducts a wide variety of research studies at any given time
that recruit many different types of people, and new studies start regularly. This database allows researchers to examine whether or not you may be eligible for one or more of these studies prior to contacting you to see if you may be interested in participating.
How long will the research last?
Completing this research study will take about 10 minutes. We expect that you will be in this research study indefinitely, as it is meant as an ongoing contact list for potential participation in current and/or future research studies with the Minnesota Center for Eating Disorders Research at the University of Minnesota. You would only be removed from the research study if you inform study staff that you are
no longer interested in being contacted about research opportunities, or if you are found to be under the age of 18.
What will I need to do to participate?
You may participate in this study if you are 18 years old or older. If you choose to participate, you will
first be asked to provide your name and contact information. You will then complete a brief survey
which will ask you about eating disorder symptoms, demographic information, mental health history,
and other questions that inform researchers about whether or not you might be eligible for other research studies with our group. The survey will likely take about 10 minutes, and you will not be compensated for participating. Taking part in this research study will not lead to any costs to you.
If, based on the information provided in the survey, it seemed like you were eligible for another research opportunity with our group, you would be contacted with more information about the study and asked whether or not you would like to participate. You would never be required to participate in a research study, and you can remove yourself from this recruitment database at any time. Participation in other research studies with our group would provide compensation for your time.
If, based on the information provided in the survey, it did not seem like you were eligible for studies currently running in our group, you would be informed. Your information, unless you specify otherwise, would be kept in the database for consideration for other research studies started by our group in the future.
Is there any way that being in this study could be bad for me?
The questions could cause possible distress, as the survey asks about mental health history and current symptoms. If this happens, you can choose not to answer specific questions. You can also choose to withdraw, or stop filling out the survey, at any time.
There is also a small risk that there would be a breach of confidentiality of the information you provide in the survey. Every precaution will be taken to avoid this. All data, including name, email, and phone number, are stored on secure computer databases that are only accessible by trained study staff and entities that provide research oversight.
Will being in this study help me in any way?
We cannot promise any benefits to you or others from your taking part in this research. However, possible benefits include being contacted for research opportunities that are most applicable to you. Those studies may or may not provide benefit to you.
What happens if I do not want to be in this research or change my mind later?
There are no alternatives, other than deciding not to participate in this research study. Participation in this recruitment database study is voluntary. Your choice not to be in this study will not negatively affect your right to any present or future medical care, your academic standing as a student, or your present or future employment.
If you take part in this research study by providing your information to this recruitment database and want to be removed from the database, please let our study staff know by phone (612-625-1542) or email (mcedr@umn.edu).
What happens to the information collected for the research, including my health information?
We try to limit the use and sharing of your information, including research study records, any medical records and any other information about you, to people who have a need for this information. But we cannot promise complete confidentiality.
Overview
If you participate in this study, your information, including your health information, will be used and shared for purposes of conducting this research. As described later in this Consent Form, your information may also be used and shared for publishing and presenting the research results, future research, and any optional elements of the research you agree to in this Consent Form, which may include creating audio and video recordings of you. If you sign this Consent Form, you are giving us permission to use and share your health information for these purposes, and if we are using your medical records, you are giving permission to any health care providers who are treating you to share your medical records with us.
What health information will be made available?
Health information about you to be used and shared for the research includes those items checked by the research team below:
☐ Your medical records, which may include records from hospital and clinic visits, emergency room visits, immunizations, medical history and physical exams, medications, images and imaging reports, progress notes, psychological tests, EEG/EKG/ECHO reports, lab and pathology reports, dental records and/or financial records. These records may be used and shared for as long as this research continues.
☒ Information collected as part of this research study, including research procedures, research visits, and any optional elements of the research you agree to, all as described in this Consent Form. This information might not be part of your medical record, and may include things like responses to surveys and questionnaires, and information collected during research visits described in this Consent Form.
What about more sensitive health information?
Some health information is so sensitive that it requires your specific permission. If this research study requires any of this sensitive information, the boxes below will be marked and you will be asked to initial to permit this information to be made available to the research team to use and share as described in this Consent Form.
☐ My drug & alcohol abuse, diagnosis & treatment records
☐ My HIV/AIDS testing records
☐ My genetic testing records
☐ My mental health diagnosis/treatment records
☐ My sickle cell anemia records
Who will access and use my health information?
If you agree to participate in this study, your information will be shared with:
● The University of Minnesota research team and any institutions or individuals collaborating on the research with us;
● Others at the University of Minnesota and M Health/Fairview who provide support for the research or who oversee research (such as the Institutional Review Board or IRB which is the committee that provides ethical and regulatory oversight of research at the University), systems administrators and other technical and/or administrative support personnel, compliance and audit professionals (Such as the Quality Assurance Program of the Human Research Protection Program (HRPP)), individuals involved in processing any compensation you may receive for your participation, and others);
● The research sponsor(s), any affiliates, partners or agents of the sponsor(s) involved in the research, organizations funding the research, and any affiliates, partners or agents of the funding organization(s) involved in the research;
● Organizations that process any payments that may be made to you for participating in this study, and any other individuals or organizations specifically identified in this Consent Form.
Additional sharing of your information for mandatory reporting
If we learn about any of the following, we may be required or permitted by law or policy to report this information to authorities:
● Current or ongoing child or vulnerable adult abuse or neglect;
● Communicable, infectious or other diseases required to be reported under Minnesota’s Reportable Disease Rule;
● Certain wounds or conditions required to be reported under other state or federal law; or
● Excessive use of alcohol or use of controlled substances for non-medical reasons during pregnancy.
How will my information be used in publications and presentations?
We may publish the results of this research in scientific, medical, academic or other journals or reports, or present the results at conferences. Information that makes it easy to identify you (such as your name and contact information, SSN and medical records number) will not be part of any publication or presentation. If you have an extremely unique or rare condition that is not shared by many others, it is possible that some people may be able to determine your identity even without these identifiers.
What will be done with my data when this study is over?
We may use and may share data for future research. They may be shared with researchers/institutions outside of University of Minnesota. We will not ask for your consent before using or sharing them. We will remove identifiers from your data, which means that nobody who works with this data for future research will know who you are. Therefore, you will not receive any results or financial benefit from future research done on your specimens or data.
Do I have to sign this Consent Form and give my permission to make my information, including my health information, available for use and sharing?
No, you do not have to sign this Consent Form. But if you do not sign, you will not be able to participate in this research study. Treatment available outside of the study, payment for such treatment, enrollment in health insurance plans and eligibility for benefits will not be impacted by your decision about signing this Consent Form.
Does my permission for making my health information available for use and sharing ever expire?
No, there is no expiration date.
May I cancel my permission for making my health information available for use and sharing?
Yes. You may cancel your permission at any time by writing to the researcher at the address on the first page of this Consent Form. If you cancel your permission, you will no longer be in the research study. You may also want to ask someone on the research team in canceling will affect any research related medical treatment. If you cancel your permission, any health information about you that was already used and shared may continue to be used and shared for the research study and any optional elements of the study to which you agree in this Consent Form.
What happens to my health information after it is shared with others?
When we share your information with others as described in this Consent Form, privacy laws may no longer protect your information and there may be further sharing of your information.
Will I be able to look at my records?
It is possible that the research team may not allow you to see the information collected for this study. However, you may access any information placed in your medical records after the study is complete.
Whom do I contact if I have questions, concerns or feedback about my experience?
This research has been reviewed and approved by an IRB within the Human Research Protections Program (HRPP). To share feedback privately with the HRPP about your research experience, call the Research Participants’ Advocate Line at 612-625-1650 (Toll Free: 1-888-224-8636) or go to z.umn.edu/participants. You are encouraged to contact the HRPP if:
● Your questions, concerns, or complaints are not being answered by the research team.
● You cannot reach the research team.
● You want to talk to someone besides the research team.
● You have questions about your rights as a research participant.
● You want to get information or provide input about this research.
Will I have a chance to provide feedback after the study is over?
The HRPP may ask you to complete a survey that asks about your experience as a research participant. You do not have to complete the survey if you do not want to. If you do choose to complete the survey, your responses will be anonymous.
If you are not asked to complete a survey, but you would like to share feedback, please contact the study team or the HRPP. See the “Investigator Contact Information” of this form for study team contact information and “Whom do I contact if I have questions, concerns or feedback about my experience?” of this form for HRPP contact information.
What happens if I am injured while participating in this research?
In the event that this research activity results in an injury, treatment will be available, including first aid, emergency treatment and follow-up care as needed. Care for such injuries will be billed in the ordinary manner, to you or your insurance company. If you think that you have suffered a research related injury let the study physicians know right away.
Your electronic signature documents your permission to take part in this research recruitment database. You will not be provided a copy of this signed document, however a full copy will be made available to you upon request.