What are the risks and possible discomforts from being in this research study?
You may find some of the questions asked during the questionnaires to be embarrassing or upsetting. You can skip any question that you don't want to answer. You can withdraw from the study or decline to participate in the interview at any time.
What are the possible benefits from being in this research study?
There may be no potential benefit for you as a result of taking part in this study. However, there are possible benefits for both you and society from this research. For you, such benefits include the possibility that you will be invited to participate in a clinical interview with a study clinician, and may be invited to participate in a resilience workshop and/or a four-year period of follow-up assessments.
For society, such benefits include increased knowledge about the resilience and mental health of the undergraduate student population. Also, this study hopes to raise awareness about coping skills, stress and mental health and illness in college students.
What other treatments or procedures are available for my condition?
Your participation in this study is voluntary and you can withdraw from it at any time. You can receive psychological assessments and/or treatment without being part of this research study, including contacting your Student Health Center about monitoring your health status, or if you are already connected to a care provider, contacting them about alternate treatment options. A member of the study team can provide you with contact information for your college's health center.
Can I still get medical care within Partners if I don't take part in this research study, or if I stop taking part?
Yes. Your decision won't change the medical care you get within Partners now or in the future. There will be no penalty, and you won't lose any benefits you receive now or have a right to receive.
Taking part in this research study is up to you. You can decide not to take part. If you decide to take part now, you can change your mind and drop out later. We will tell you if we learn new information that could make you change your mind about taking part in this research study.
What should I do if I want to stop taking part in the study?
If you take part in this research study, and want to drop out, you should tell us. We will make sure that you stop the study safely. We will also talk to you about follow-up care, if needed.
Also, it is possible that we will have to ask you to drop out of the study before you finish it. If this happens, we will tell you why. We will also help arrange other care for you, if needed.
Will I be paid to take part in this research study?
Upon completion of the screening questionnaires, you will be given a $20 gift card. For each follow up visit you complete, a $20 in the form of a check or Amazon gift card will be mailed to you.
What will I have to pay for if I take part in this research study?
Participation in this study is at no cost to you. There will be no charge for any of the visits with the study doctors or the study procedures.
What happens if I am injured as a result of taking part in this research study?
We will offer you the care needed to treat any injury that directly results from taking part in this research study. We reserve the right to bill your insurance company or other third parties, if appropriate, for the care you get for the injury. We will try to have these costs paid for, but you may be responsible for some of them. For example, if the care is billed to your insurer, you will be responsible for payment of any deductibles and co-payments required by your insurer.
Injuries sometimes happen in research even when no one is at fault. There are no plans to pay you or give you other compensation for an injury, should one occur. However, you are not giving up any of your legal rights by signing this form.
If you think you have been injured or have experienced a medical problem as a result of taking part in this research study, tell the person in charge of this study as soon as possible. The researcher's name and phone number are listed in the next section of this consent form.
If I have questions or concerns about this research study, whom can I call?
You can call us with your questions or concerns. Our telephone numbers are listed below. Ask questions as often as you want.
Daphne Holt, M.D., Ph.D. is the person in charge of this research study. You can call her at 617-726-7618 Monday - Friday from 9AM-5PM or page her at 617-726-2241. She can be paged 24 hours a day/7 days a week. You can also call the research coordinator Monday - Friday from 9AM-5PM at 617-643-4441 with questions about the scheduling of appointments or study visits.
If you want to speak with someone not directly involved in this research study, please contact the Partners Human Research Committee office. You can call them at 857-282-1900.
You can talk to them about:
Your rights as a research subject
Your concerns about the research
A complaint about the research
Also, if you feel pressured to take part in this research study, or to continue with it, they want to know and can help.
If I take part in this research study, how will you protect my privacy?
During this research, identifiable information about your health will be collected. In the rest of this section, we refer to this information simply as "health information." In general, under federal law, health information is private. However, there are exceptions to this rule, and you should know who may be able to see, use, and share your health information for research and why they may need to do so.
In this study, we may collect health information about you from:
Past, present, and future medical records
Research procedures, including research office visits, tests, interviews, and questionnaires
Who may see, use, and share your identifiable health information and why they may need to do so:
Partners research staff involved in this study
The sponsor(s) of this study, and the people or groups it hires to help perform this research
Other researchers and medical centers that are part of this study and their ethics boards
A group that oversees the data (study information) and safety of this research
Non-research staff within Partners who need this information to do their jobs (such as for treatment, payment (billing), or health care operations)
The Partners ethics board that oversees the research and the Partners research quality improvement programs.
People from organizations that provide independent accreditation and oversight of hospitals and research
People or groups that we hire to do work for us, such as data storage companies, insurers, and lawyers
Federal and state agencies (such as the Food and Drug Administration, the Department of Health and Human Services, the National Institutes of Health, and other US or foreign government bodies that oversee or review research)
Public health and safety authorities (for example, if we learn information that could mean harm to you or others, we may need to report this, as required by law)
Other: the Behavioral Medicine office at BU, ECAPS at Emerson or MIT Mental Health and Counselling, if there are significant safety concerns.
Some people or groups who get your health information might not have to follow the same privacy rules that we follow and might use or share your health information without your permission in ways that are not described in this form. For example, we understand that the sponsor of this study may use your health information to perform additional research on various products or conditions, to obtain regulatory approval of its products, to propose new products, and to oversee and improve its products' performance. We share your health information only when we must, and we ask anyone who receives it from us to take measures to protect your privacy. The sponsor has agreed that it will not contact you without your permission and will not use or share your information for any mailing or marketing list. However, once your information is shared outside Partners, we cannot control all the ways that others use or share it and cannot promise that it will remain private.
Because research is an ongoing process, we cannot give you an exact date when we will either destroy or stop using or sharing your health information.
The results of this research study may be published in a medical book or journal, or used to teach others. However, your name or other identifying information will not be used for these purposes without your specific permission.
Your Privacy Rights
You have the right not to sign this form that allows us to use and share your health information for research; however, if you don't sign it, you can't take part in this research study.
You have the right to withdraw your permission for us to use or share your health information for this research study. If you want to withdraw your permission, you must notify the person in charge of this research study in writing. Once permission is withdrawn, you cannot continue to take part in the study.
If you withdraw your permission, we will not be able to take back information that has already been used or shared with others.
You have the right to see and get a copy of your health information that is used or shared for treatment or for payment. To ask for this information, please contact the person in charge of this research study. You may only get such information after the research is finished.