About this consent form
Please read this form carefully. It tells you important information about a research study. A member of our research team will also talk to you about taking part in this research study. People who agree to take part in research studies are called "subjects." This term will be used throughout this consent form.
Partners HealthCare System is made up of Partners hospitals, health care providers, and researchers. In the rest of this consent form, we refer to the Partners system simply as "Partners."
If you have any questions about the research or about this form, please ask us. Taking part in this research study is up to you. If you decide to take part in this research study, you must sign this form to show that you want to take part. We will give you a signed copy of this form to keep.
Why is this research study being done?
We are doing this research to learn more about the typical coping mechanisms for dealing with stress and mental health symptoms on the college campus and their long term outcomes. This study has two parts and this consent form is for Part A. A second reason for this study is to offer a leadership workshop focused on building resilience skills to those who qualify for it (Part B). You are being asked to participate in this research study because you are between 18-30 years old and are enrolled in college. We would like your permission to enroll you as a participant in Part A of this research study. If you are interested in participating in and eligible for Part B you will be presented with another consent form. Over the next three years we aim to enroll 1,000 participants in Part A.
How long will I take part in this research study?
It will take you approximately 45 minutes to complete the questionnaire packet for Part A of this study. Once you complete and hand in the questionnaires, you may be offered the opportunity to meet privately or chat on the phone with a study clinician for a short 10 to 20-minute interview. You will also be asked to complete online follow-up surveys every 6 months for up to 4 years. These will each take approximately 20-30 minutes to complete.
What will happen in this research study?
After you agree to participate and sign this consent form, a study team member will give you the questionnaire packet (hard copies or a tablet to complete electronically). If you are participating online, questionnaires will show up automatically after you sign the consent form. The questions may ask about some sensitive health information such as: your quality of life, how you think, feel and behave with respect to yourself and other people, stressful life events and substance use. This visit will take place at your local university/college or online.
We will also ask you to complete a demographic and contact information sheet that will include your email address, telephone number, full name and mailing address. We ask for this information for two reasons: in case a member of the study team needs to contact you to clarify your question response(s) OR if you choose to participate in Part B of the study, we will use this information to contact you and process your payment for the additional study tasks of Part B.
There is also a possibility that the study team may need to re-contact you at some point in the future to obtain brief supplemental or missing information related to this study.
Would it be okay to re-contact you for this type of information?
must provide value Yes No
Once the questionnaires are completed and handed in, a member of the study team will review and score your responses. If you endorse certain items, you will be offered the opportunity to meet privately or chat on the phone with a study clinician for a short interview. You may choose not to participate in the interview. However, if the clinician is concerned about your responses, you will be contacted after the screening.
If you are interviewed by a study clinician and the study clinician determines you are at imminent risk for harming yourself or others, he/she will recommend appropriate clinical steps. This may include providing information about you to clinicians (including those at your university) to ensure your safety.
If your responses indicate that you are eligible for Part B of the study, you may be presented with the opportunity to participate. If you are interested in participating in Part B, you and a member of the study team will review the consent form for Part B either today or at a later time.
If you are eligible and choose not to take part in Part B of the study, then a list of local mental health resources will be provided to you.
By signing this consent form you are only choosing to participate in the questionnaire part of the study (Part A) at this time. Upon completion of Part A you will be given a $20 gift card.
Taking Part in Future Studies
Are you willing to be contacted about taking part in another study at a future date?
must provide value Yes No
If you express interest in other studies, we may contact you in order to gather some additional information to assess your eligibility for these other studies.
An important part of our research is learning about how you manage stress and adversity over time. So that we can assess this, every six months for up to 4 years following the completion of the study (Part A) you will receive a Partner's secure link to complete a series of questionnaires. You will receive text message reminders to complete these longitudinal questionnaires and homework assignments if you participate in Part B. It will take approximately 20 to 30 minutes to complete these questionnaires. You will receive $20 in the form of a check mailed to you for each follow up visit you complete.
Text messages by mobile/cell phones are a common form of communication. In this study, we will be sending you text message reminders that are relevant to the research study.
Text messages are not encrypted, and therefore carry security risks. This means that information you receive by text message could be intercepted or viewed by an unintended recipient, or by your mobile/cell phone provider or carrier. This research study and Partners Healthcare are not responsible for any interception of messages sent through unencrypted text message communications.
You will be responsible for all fees charged by your carrier's service plan for text messaging. This research study and Partners Healthcare are not responsible for any increased charges, data usage against plan limits or changes to data fees from the research texts.
Text messages will not contain any personal information and will only remind you to complete the questionnaires and/or assigned homework.
Text messaging should not be used in case of an emergency. If you experience a medical emergency, call 911 or go to the nearest hospital emergency department.
You may decide to not receive text messages with staff associated with this research study at any time. You can do this in person or by sending the research number a text message that says "Stop Text." You will not be able to respond to the text messages in any other way.
Your agreement applies to this research study only. Agreeing to other texts from Partners Healthcare, for example appointment reminders, is a separate process. Opting out of other texts from Partners Healthcare is a separate process as well.
It is your responsibility to update your mobile/cell phone number with this research study in the event of a change.
I have had the chance to ask questions about texting with staff associated with this research study. I have been informed of the risks and other information covered above and consent to the use of unencrypted text communications associated with this research study.
must provide value Yes No
Safety Management: In order to ensure your safety, within 24 hours following completion of these online questionnaires, a member of the study team will review your responses. In the event that your scores raise any concerns about your safety, you will be contacted by the study team for an assessment that may be conducted over the phone or in person. Note that if there are very significant concerns, it is possible that information about you could be shared with your school (BU Behavioral Medicine/Emerson Counselling and Psychological Services/MIT Mental Health and Counselling) and/or others.
Also, as part of this follow up, we will work with the Behavioral Medicine Department or the Counseling and Psychological Services center and the University/College Registrar (depending on your institution of enrollment) your university/college to routinely collect information such as your GPA, enrollment status and use of behavioral health services on campus on a yearly basis. Throughout the study, this information will be secured and kept confidential and de-identified (your name will be removed from the information); your name and other identifying information will be stored separately from the research data. Note that you may decline to participate in this aspect of the study but still continue to participate in all other aspects of the study.
Are you willing to allow the study team to work with the university to collect this information?
must provide value Yes No
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.
Informed Consent and Authorization
Statement of Person Giving Informed Consent and Authorization
I have read this consent form.
This research study has been explained to me, including risks and possible benefits (if any), other possible treatments or procedures, and other important things about the study.
I have had the opportunity to ask questions.
I understand the information given to me.
Signature of Subject:
I give my consent to take part in this research study and agree to allow my health information to be used and shared as described above.
must provide value