Version Date:
TUFTS MEDICAL CENTER
TUFTS UNIVERSITY
[Department name]
INFORMED CONSENT TO PARTICIPATE IN RESEARCH
TITLE:
PROTOCOL NO.:
SPONSOR:
PRINCIPAL INVESTIGATOR:
PRINCIPAL INVESTIGATOR
PHONE NUMBER AND PAGER NUMBER:
[Add this paragraph when the research involves decisionally impaired persons.] A person who takes part in a research study is called a research subject. In this consent form “you” always refers to the research subject. If you are the legally authorized representative giving permission for the subject to take part in this study, please remember that “you” refers to the research subject.
[Add this paragraph when the research involves minors.] A person who takes part in a research study is called a research subject. This consent form is used to document the permission of a parent(s) or guardian(s) to allow a minor to take part in a research study. In this consent form “you” refers to the minor who will take part in the research study.
SUMMARY
[This section may be modified to follow the protocol]
You are being invited to be in a research study. Taking part in this research study is totally your choice. You can decide to stop taking part in this research study at any time for any reason. If you stop being in this research study, it will not affect how you are treated at Tufts Medical Center/Tufts University.
Please read all of the following information carefully. Ask your study doctor or another member of the study staff, to explain any words, terms, or sections that are unclear to you. Ask any questions that you have about this research study. Do not sign this consent form unless you understand the information in it and have had your questions answered to your satisfaction.
If you decide to take part in this research study, you will be asked to sign this form. You will be given a copy of the signed form. You should keep your copy for your records. It has information, including important names and telephone numbers, to which you may wish to refer in the future.
New things might be learned during this study that you should know about. The study staff will tell you about new information that may affect your willingness to stay in this study.
If you are eligible to participate and agree to be in the study, the Principal Investigator may still choose to stop your participation in this study if [she/he] thinks it is in your best medical interest. The study doctor or the sponsor may also stop your participation in this study at any time without your consent for any of the following reasons:
· You do not later consent to any future changes that may be made in the study plan;
· [Include all reasons for removing subject; if the protocol lists specific reasons, insert them here].
If you leave the study before the planned final visit, you may be asked by the study doctor to have some of the end of study procedures done.
[Add this paragraph when the research involves a drug or device.]
As a participant in this study, your identity, medical records, and data relating to this study will be kept confidential, except as required by law. The U.S. Food and Drug Administration, which regulates investigational drug and device studies, and the study sponsor may also look at records that identify you.
If you have question about your rights as a research study subject, call the Tufts Health Sciences Institutional Review Board (IRB) at (617) 636-7512. The IRB is a group of people who independently review research.
This study is overseen by the Tufts Health Sciences IRB.
Your medical records may become part of the research record. If that happens, your medical records may be looked at and/or copied by the sponsor of this study and government agencies or other groups associated with the study.
Your medical insurance may be billed for any standard medical care you receive during the research study. If your insurance company is billed then it may have access to the research records. Insurance companies may not pay for treatment that is part of a research study. Taking part in a research study could affect your current or future insurance coverage.
· Must include how research differs from regular health care.
PURPOSE OF THE STUDY
[Lead IRB language submitted]
PROCEDURES
[Lead IRB language submitted]
RISKS AND DISCOMFORTS
[Lead IRB language submitted]
NEW FINDINGS
[Lead IRB language submitted]
SAMPLE BANKING [Investigators are to include this section only if sample banking is REQUIRED as part of the study – if banking is optional, use optional banking ICF template.]
[If sample banking is required as part of the study, please detail as applicable to the protocol:
· The purpose of the banking, including what will be done with the sample and who will have access to it.
· How long the sample will be banked and where.
· Whether the banked sample will be sent off site for any reason and why.
· What information will accompany a sample (e.g., de-identified, coded – with what info) and if access to medical record information will be needed (and for what timeframe) and if MR info will accompany the sample.
· How to withdraw samples from banking (now and in the future).
· Any potential benefits.
· The potential risks associated with banking, including confidentiality risks, etc.
· Confidentiality measures.
· How they might be used in the future and for what purpose(s).
· Refer to optional banking ICF for additional information/detail.]
GENETIC TESTING [Investigators are to include this section only if the study involves genetic testing]
[If genetic testing is being performed as part of the research, please detail as applicable to the protocol:
· The clinical significance of the results, if any (based on technology, etc., now vs. at a future point in time when new test may be available, etc.).
· What will ultimately happen to the samples (discarded at the conclusion of the study, banked, etc. If banked – information about where samples will be banked, who is responsible, etc.).
· The potential risks associated with the testing, including risks to employability, insurability, learning upsetting information, etc.
· Any potential benefits (e.g., early diagnosis, no benefit, unknown benefit at this time).
· If the results will be shared with the subject and/or their personal physician.
· How to withdraw samples from analysis (now and in the future).
· Confidentiality measures.
· If applicable, information that the samples might be linked back to the subject if they are used in future research and are coded.
· If samples will be banked, how they might be used in the future and for what purpose(s).]
BENEFITS
[Lead IRB language submitted]
COSTS
[If there are costs to subjects related to being in the study state them in this section. State who will be financially responsible (the subject, his/her insurance carrier, the sponsor, etc.) for the costs. Otherwise, state that there are no costs associated with participation, if true.]
You may want to talk with your insurance company about its payment policy for standard medical care given during a research study. Members of the research team are available to help you with this if you want. Please tell the Principal Investigator if you would like help with this. If your insurance company does not pay, you may be billed for those charges.
PAYMENT FOR PARTICIPATION
[If subjects are to be paid for their participation, state the schedule of payment, as well as the total amount to be paid, when, how, and in what format (i.e. ClinCard, check, cash, etc.) the payments will be made. If subjects will not be paid, please state.]
ALTERNATIVES
[Lead IRB language submitted]
CONFIDENTIALITY
[Include details about how subject privacy will be ensured. Provide information about how confidentiality of data will be managed (e.g., coded, restricted access.]
If you decide to take part in this research study, your personal information will not be given to anyone unless we receive your permission in writing. It will only be given if the law requires it. It will also only be given for regular hospital treatment, payment, and hospital management activities.
We will make every effort to keep your information private, but it cannot be totally guaranteed. Certain government agencies may check records that identify you. This might include your medical or research records and the informed consent form you signed. The records of this study might also be reviewed to make sure all rules and guidelines were followed.
Your identifiable information may be given to governmental agencies in other countries where the study [drug or device] may be considered for approval. Medical records which identify you and the consent form signed by you may be looked at and/or copied for research or regulatory purposes by:
· the sponsor;
delete the following if no CRO or SMO
· [CRO name], an agent for the sponsor;
· [SMO name], an agent for the study doctor;
and may be looked at and/or copied for research or regulatory purposes by:
· the US Food and Drug Administration (FDA),
· Department of Health and Human Services (DHHS) agencies such as the Office for Human Research Protections,
· governmental agencies in other countries,
· Tufts Health Sciences IRB.
Total confidentiality cannot be guaranteed because of the need to give information to these parties. The results of this research study may be presented at meetings or in publications. Your identity will not be given out during those presentations.
[If this study will be posted on www.clinicaltrials.gov the following statement must appear in the ICF unaltered, per federal regulation:]
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
PAYMENT FOR RESEARCH-RELATED INJURY
Emergency medical treatment will be given to you if you are hurt or get sick as a direct result of being in this research study. You or your insurance carrier will be required to pay for any such medical care. Any needed medical care is available at the usual cost. All needed facilities, emergency treatment, and professional services are available to you, just as they are to the general public. The institution will not pay for your treatment if you become ill or injured as part of this study.
VOLUNTARY PARTICIPATION AND WITHDRAWAL
[Lead IRB language submitted]
WHOM TO CONTACT
Contact [PI name] at [number(s)] for any of the following reasons:
· if you have any questions about this study or your part in it,
· if you feel you have had a research-related injury or a bad reaction to the study drug or procedure, or
· if you have questions, concerns or complaints about the research.
You can also contact [name, role], at [number] if you cannot reach [PI name].
On nights, weekends, or holidays you can page [PI name] at [number(s)].
If you have questions about your rights as a research subject or if you have questions, concerns or complaints about the research, you may contact:
Tufts Health Sciences IRB
800 Washington Street, Box 817
Boston, MA 02111
Telephone: 617-636-7512
E-mail:
The IRB will not be able to answer some types of questions, such as questions about appointment times. You may contact the IRB if you cannot reach the research team or if you want to talk to someone else.
Your questions will be answered orally, or, if you prefer, with a written statement.
AUTHORIZATION TO USE OR DISCLOSE YOUR IDENTIFIABLE HEALTH INFORMATION
If you sign this document, you give permission to the Principal Investigator(s) named above and research staff at [Tufts Medical Center or Tufts University Health Sciences] as well as other individuals at [Tufts Medical Center or Tufts University Health Sciences] who may need to access your information to do their jobs (such as for treatment, payment (billing) or health care operations) to use or disclose (release) your health information that identifies you for the research study described above.
The parties listed in the preceding paragraph may disclose the health information described below to the following persons and organizations for their use in connection with the research study:
· Individuals or organizations working under the direction of the Principal Investigator(s) for the study,
· Outside individuals or entities that have a need to access this information to perform activities relating to the conduct of this research, such as analysis by outside laboratories on behalf of [Tufts Medical Center or Tufts University Health Sciences]
· Other researchers and institutions that are conducting or participating in this study,
· The study sponsor ______and any companies that they use to oversee, manage, or conduct the research,
· The Office for Human Research Protections in the U.S. Department of Health and Human Services, the United States Food and Drug Administration (FDA) and other federal and state agencies that have the right to use the information as required by law, and
· The members and staff of any Institutional Review Board (IRB) and Data and Safety Monitoring Board that oversee this study.
The health information that we may use or disclose (release) for this research study includes all information in your medical record related to the diagnosis and management of your [condition or diagnosis subject to the research such as “cancer”], including the record of your care, as well as any information collected or created during the course of this study.
[Tufts Medical Center or Tufts University Health Sciences] is required by law to protect your health information. By signing this document, you authorize [Tufts Medical Center or Tufts University Health Sciences] to use and/or disclose (release) your health information for this research. Those persons who receive your health information may not be required by Federal privacy laws (such as the Privacy Rule) to protect it and may share your information with others without your permission, if permitted by laws governing them. You may not be allowed to see or copy the information described on this form as long as the research is in progress, but you have a right to see and copy the information upon completion of the research in accordance with hospital policies.