University of Pennsylvania
Informed Consent Form
ALL INSTRUCTIONAL BLUE TEXT SHOULD BE REMOVED OR REPLACED WITH STUDY SPECIFIC INFORMATION – PRIOR TO SUBMISSION TO THE IRB
Title of the Research Study: X
Protocol Number: X
Principal Investigator: (name, address, phone and email)
Co-investigator: (name, address, phone and email)
Emergency Contact: (name, address, phone and email)
You are being asked to take part in a research study. This is not a form of treatment or therapy. It is not supposed to detect a disease or find something wrong. Your participation is voluntary which means you can choose whether on not to participate. If you decide to participate or not to participate there will be no loss of benefits to which you are otherwise entitled. Before you make a decision you will need to know the purpose of the study, the possible risks and benefits of being in the study and what you will have to do if you decide to participate. The research team is going to talk with you about the study and give you this consent document to read. You do not have to make a decision now; you can take the consent document home and share it with friends, family doctor and family. Your doctor may be an investigator in this research study. As an investigator, your doctor is interested both in your clinical welfare and in the conduct of this study. Before entering this study or at any time during the research, you may want to ask for a second opinion about your care from another doctor who is not an investigator in this study. You do not have to participate in any research study offered by your doctor.
If you do not understand what you are reading, do not sign it. Please ask the researcher to explain anything you do not understand, including any language contained in this form. If you decide to participate, you will be asked to sign this form and a copy will be given to you. Keep this form, in it you will find contact information and answers to questions about the study. You may ask to have this form read to you.
What is the purpose of the study?
The purpose of the study is to learn more about
· Fill in the space with a simple, accurate explanation of the purpose and what specific condition or conditions are under study.
· If the study is being conducted for a thesis or dissertation, it should be mentioned in here.
Why was I asked to participate in the study?
You are being asked to join this study because.
· Explain and justify why the subject is appropriate for recruitment. Merely saying that the possible subject is being invited to participate because he or she meets the requirements for participation is not enough. You should state what are those requirements to clearly illustrate why him/her, and not somebody else, is being asked to participate.
How long will I be in the study?
The study will take place over a period of X years. This means for the next X months we will ask you to spend X days a month participating in this study. Each session will last approximately X hours.
· Explain how much time the subject will need to commit in terms of hours, days, weeks, months and years.
Optional: Include the number of subjects that will be enrolled into the study (either at Penn or nationally if appropriate) and if this information is included, add “How many other people will be in the study” to the title of this section.
Where will the study take place?
You will be asked to come to X, located at X on X at X pm or am.
· Explain where the subject will have to go to participate. Be specific about requirements to go to different sites for different aspects of the study such as testing, meetings and alike.
What will I be asked to do?
· Provide a chronology of what the subject will need to do in a simple, non-technical language. If multiple visits are required, explain where the subject will need to go for each visit and what will happen at each visit. Bullets points are acceptable and encouraged. Remember to clearly identify any experimental procedures.
What are the risks?
· The document should clearly state all possible risks regardless of severity. It should also state what measures have been implemented within the study design to minimize the possibility of occurrence of such risks. While writing the protocol, PI should be creative when determining all possible risks. For example, mentioning the risk of a breach in confidentiality may not be enough, unless the document states what such a breach could entail, e.g. public embarrassment, stigmatization, loss of employment, etc.
How will I benefit from the study?
There is no benefit to you. However, your participation could help us understand X, which can benefit you indirectly. In the future, this may help other people to X.
What other choices do I have?
Your alternative to being in the study is to not be in the study.
If you choose not to be in the study the following are other treatment choices that you may want to consider.
· If this applies, provide the pertinent information such as a contact name, phone number and address.
What happens if I do not choose to join the research study?
You may choose to join the study or you may choose not to join the study. Your participation is voluntary.
There is no penalty if you choose not to join the research study. You will lose no benefits or advantages that are now coming to you, or would come to you in the future. Your therapist, social worker, nurse, doctor or X will not be upset with your decision.
If you are currently receiving services and you choose not to volunteer in the research study, your services will continue.
· Simply and directly tell the subject there are no negative consequences should they choose not to participate. The purpose is to mitigate any feelings of obligation or coercion on the part of the subject.
When is the study over? Can I leave the study before it ends?
The study is expected to end after all participants have completed all visits and all the information has been collected. The study may be stopped without your consent for the following reasons:
o The PI feels it is best for your safety and/or health-you will be informed of the reasons why.
o You have not followed the study instructions
o The PI, the sponsor or the Office of Regulatory Affairs at the University of Pennsylvania can stop the study anytime
You have the right to drop out of the research study at any time during your participation. There is no penalty or loss of benefits to which you are otherwise entitled if you decide to do so. Withdrawal will not interfere with your future care.
If you no longer wish to be in the research study, please contact X, at X and take the following steps:
· Describe how subjects can withdraw from the study and explain the consequences, if any, for doing so (for example, medical or emotional related consequences, if any).
How will confidentiality be maintained and my privacy be protected?
[If your study involves testing for infectious diseases, please include the language in paragraphs two/three below]
We will do our best to make sure that the personal information obtained during the course of this research study will be kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.
If you test positive for <reportable infectious disease>, by law we have to report the infection to the City of Philadelphia Health Department/PA Department of Health. We would report your name, gender, racial/ethnic background, and the month and year you were born.
[Include this additional information if you are reporting a positive HIV result]:
This is to keep track of how many people in the U.S. have HIV infection. It is also to make sure that states get enough money from the federal government to support the medical care of people living with HIV. The Health Department does not share the names of HIV infected people with anyone else. It removes all personal identifiers, such as your name, before giving information on the number of HIV infections to the federal government.
· Explain how confidentiality will be maintained. Be specific about how records will be secured to protect the identity of the subject. State the IRB at the University of Pennsylvania will have access to the records. Explain how subjects will be de-identified; will code numbers be used? Please note; the content of this section will vary according to the research design. There may be cause for more or less protections depending on the nature of the research. The language suggested above should be altered when necessary.
· Note: For studies utilizing private health information, follow HIPAA guidelines. If the research is sensitive in nature, a Certificate of Confidentiality may be warranted. An example may include interviews with prison inmates or juvenile offenders attending a community re-entry program where information obtained from the subject may necessitate extra protection. The need for the Certificate should be determined on a case basis.
Electronic Medical Records and Research Results
[This language is required for most studies. If you believe your study involves research procedures that will not likely be included in the electronic medical record, (EMR), please contact the IRB for guidance]
What is an Electronic Medical Record and/or a Clinical Trial Management System?
An Electronic Medical Record (EMR) is an electronic version of the record of your care within a health system. An EMR is simply a computerized version of a paper medical record.
A clinical trial management system (CTMS) is used to register your information as a participant in a study and to allow for your research data to be entered/stored for the purposes of data analysis and any other required activity for the purpose of the conduct of the research.
If you are receiving care or have received care within the University of Pennsylvania Health System (UPHS) (outpatient or inpatient) and are participating in a University of Pennsylvania research study, information related to your participation in the research (i.e. laboratory tests, imaging studies and clinical procedures) may be placed in your existing EMR maintained by UPHS. Information related to your participation in clinical research will also be contained in the CTMS.
If you have never received care within UPHS and are participating in a University of Pennsylvania research study that uses UPHS services, an EMR will be created for you for the purpose of maintaining any information produced from your participation in this research study. The creation of this EMR is required for your participation in this study. In order to create your EMR, the study team will need to obtain basic information about you that would be similar to the information you would provide the first time you visit a hospital or medical facility (i.e. your name, the name of your primary doctor, the type of insurance you have). Information related to your participation in the study (i.e. laboratory tests, imaging studies and clinical procedures) may be placed in this EMR.
Once placed in your EMR or in the CTMS, your information may be accessible to appropriate UPHS workforce members that are not part of the research team. Information within your EMR may also be shared with others who are determined by UPHS to be appropriate to have access to your EMR (e.g. health insurance company, disability provider, etc.).
What happens if I am injured from being in the study?
(for research that poses greater than minimal risks to participants.)
¨ Provide contact information for research-related injury (i.e. can refer to the contact information noted in Consent header, if appropriate).
¨ Describe what treatment will be provided for research related injuries.
¨ Explain how treatment for research related injuries would be paid.
¨ Subject’s responsibilities relating to research related injuries.
We will offer you the care needed to treat injuries directly resulting from taking part in this research. We may bill your insurance company or other third parties, if appropriate, for the costs of the care you get for the injury, but you may also be responsible for some of them.
There are no plans for the University of Pennsylvania to pay you or give you other compensation for the injury. You do not give up your legal rights by signing this form.
If you think you have been injured as a result of taking part in this research study, tell the person in charge of the research study as soon as possible. The researcher’s name and phone number are listed in the consent form.
--- OR ---
[If there is sponsor-specific injury language, add it here. However, for industry-sponsored research, the sponsor must pay for research related injury unless otherwise negotiated with the institution.]
Will I have to pay for anything?
· Explain the how much it will cost to participate in the study (how much, to whom and why) or state that there are no costs associated with participating in the study.