About this consent form
Please read this form carefully. It tells you important information about a research study. You have the option to discuss this study with a member of our research team if you wish. 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 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.
If you have questions or concerns about this research study, whom can you call?
You can call us with your questions or concerns. Our telephone numbers are listed below. Ask questions as often as you want.
Craig Surman, MD, is the person in charge of this research study. You can call him at (617) 726-8422, Monday-Friday from 8:30 AM-5 PM.
Additionally, if you have questions about the scheduling of appointments or study visits, please call Dr. Surman.
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
• Any pressure to take part in, or to continue in the research study
Why is this research study being done?
We are doing this research to learn how feasible it is for patients to record the frequency of challenges related to their ADHD by responding to short surveys on their personal mobile devices. We also want to learn whether some of the effects of stimulants for ADHD can be measured in this fashion.
This is a pilot study. Pilot studies are done on a small group of subjects to learn if a larger study would be useful. We plan to enroll up to participants in this study.
Who will take part in this research?
We are asking you to take part in this research study because you are taking stimulant medication for ADHD, are an adult under 80 years old, and are willing to reply to brief questions about some of your experiences on your mobile device. About 200 participants will take part in this study via MGH. Shire Pharmaceuticals is paying for this research to be done.
How long will you take part in this research study?
If you decide to join this research study, it will take you about 10 days to complete the study. This study may be conducted remotely and does not require any in-person visits to Massachusetts General Hospital.
What will happen in this research study?
If you agree to participate in this research, we will ask you to:
1) Give us information about yourself and how to contact you (mobile phone number and an email address we could securely email you at)
2) Fill out two initial surveys regarding ADHD symptoms
3) Choose one item from each survey that you believe you medication impacts
4) Choose which arm of the study you wish to participate in: one where you take a break from your stimulant medication, or one where you continue on stimulant medication in the same pattern as you usually would.
5) Choose a 10 day period during which you will be texted a survey link twice a day at times you specify in the morning and in the evening
6) Click on survey links when they are sent and complete the assigned surveys
7) Complete a survey about your experience in the study upon completion
If you prefer to use a non-electronic method to complete this consent and/or fill out the initial surveys for this study, you can contact us to request paper copies of these materials. However, please note that upon enrollment, all survey links will be sent to you via text messaging and can not be completed in another way.
This study has two arms, one that involves your taking medication as you usually do, and another where you choose to stop your regular medication schedule or dosing. We encourage you to communicate with your prescribing physician if you have any questions about the effects of participating.
How may we use and share your samples and health information for other research?
The samples and information we collect in this study may help advance other research. If you join this study, we may remove all information that identifies you (for example, your name, medical record number, and date of birth) and use these de-identified samples and data in other research. It won't be possible to link the information or samples back to you. Information and/or samples may be shared with investigators at our hospitals, at other academic institutions or at for-profit, commercial entities. You will not be asked to provide additional informed consent for these uses.
Will you get the results of this research study?
No. The research study we are doing is only a stepping stone in understanding the use of mobile surveys for ADHD. Therefore, no information about the results of this research study or the results of your individual participation in the research study will be given to you or your doctor. Tests done for the research using your samples will not be useful in directing your medical treatment. The results of the tests will not be placed in your medical record.
What are the risks and possible discomforts from being in this research study?
If you choose to participate in the study arm involving stopping medication, you may experience return of ADHD or other symptoms that the medication controlled. Again, we encourage you to speak with your prescribing physician if you have any questions about the effects of stopping your medication before deciding to participate in this arm.
Subjective discomfort from answering questions: Some people may feel nervous or uncomfortable when they answer questions regarding their ADHD. Any information gathered will be kept confidential, and only staff members involved in this research study will have access to your information. You do not need to answer any questions you do not want to answer. Texted survey links may be distracting. For your safety, we encourage you to never read or reply to survey messages while driving.
Confidentiality: The survey links will be sent via text message to the phone number you specify upon enrollment. The survey links will say:
"Click here for a survey you have enrolled in"
"Click here to opt out of this and future surveys"
These messages, or the surveys that you take might be viewed by third parties including anyone who views your mobile device. Your answers to the survey items will be stored in a secure database behind the Partners Healthcare firewall, and accessible only by study staff, or individuals who may monitor the conduct of studies at Massachusetts General Hospital.
Risks are adequately minimized by collecting data via technologies that maximize HIPAA compliance, and because our study staff is properly trained about the critical importance of confidentiality and the protection of human research subjects.
What are the possible benefits from being in this research study?
You will not benefit from taking part in this research study. Others with ADHD may benefit in the future from what we learn in this study.
Can you still get medical care within Partners if you don't take part in this research study, or if you 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.
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 you do if you 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 you be paid to take part in this research study?
No. This study is voluntary and unpaid. If you are charged for messages that occur during the study, we can reimburse you. If you are to be reimbursed for charges incurred in participating in the surveys in the study, we will ask for your Social Security Number in order to send a check for your reimbursement.
We may use your samples and information to develop a new product or medical test to be sold. The Sponsor, hospital, and researchers may benefit if this happens. There are no plans to pay you if your samples or information are used for this purpose.
What will you have to pay for if you take part in this research study?
Study funds will pay for certain study-related items and services. We may bill your health insurer for, among other things, routine items and services you would have received even if you did not take part in the research. You will be responsible for payment of any deductibles and co-payments required by your insurer for this routine care or other billed care. If you have any questions about costs to you that may result from taking part in the research, please speak with the study doctors and study staff. If necessary, we will arrange for you to speak with someone in Patient Financial Services about these costs.
What happens if you are 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 beginning of this consent form.
If you take part in this research study, how will we protect your privacy?
Federal law requires Partners to protect the privacy of health information and related information that identifies you. We refer to this information as "identifiable information."
In this study, we may collect identifiable 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 information and why they may need to do so:
• Partners researchers and staff involved in this study
• The sponsor(s) of the study, and people or groups it hires to help perform this research or to audit the research
• Other researchers and medical centers that are part of this study
• The Partners ethics board or an ethics board outside Partners that oversees the research
• A group that oversees the data (study information) and safety of this study
• Non-research staff within Partners who need identifiable information to do their jobs, such as for treatment, payment (billing), or hospital operations (such as assessing the quality of care or research)
• People or groups that we hire to do certain work for us, such as data storage companies, accreditors, insurers, and lawyers
• Federal agencies (such as the U.S. Department of Health and Human Services (DHHS) and agencies within DHHS like the Food and Drug Administration, the National Institutes of Health, and the Office for Human Research Protections), state agencies, and foreign government bodies that oversee, evaluate, and audit research, which may include inspection of your records
• Public health and safety authorities, if we learn information that could mean harm to you or others (such as to make required reports about communicable diseases or about child or elder abuse)
• Other: N/A
Some people or groups who get your identifiable information might not have to follow the same privacy rules that we follow and might use or share your identifiable 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 identifiable 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 identifiable 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 identifiable information for any mailing or marketing list. However, once your identifiable 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 identifiable information. Your permission to use and share your identifiable information does not expire.
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 identifiable 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 identifiable 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 identifiable 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, and such information may continue to be used for certain purposes, such as to comply with the law or maintain the reliability of the study.
You have the right to see and get a copy of your identifiable 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.