[All instructions (in RED) and text not applicable to the research should be deleted when the form is modified for use on a particular study]
Northwell Health
Campus: ______
Consent for Participation in a Research Study
Title: This is the only section where medical/scientific terminology may be used. The title should conform to the title of any grant application or be consistent with the protocol.
Principal Investigator:______
Sponsor: [If there is no outside funding, the Department name should be listed]
Text for when the participant is a minor or decisionally impaired adult:
(Suggested language)
This consent form is written from the point of view of a research participant. If the parent or legal guardian of a minor or a legally authorized representative will be providing consent, the words "you" and "your" should be read as ("your child" or "the research participant").
Additional text when participant is temporarily decisionally impaired:
(Suggested language)
As the participant's legally authorized representative or next of kin, you are being asked to give consent for the participant to be in a research study. You are being asked to do this because the participant is not able to give consent. When making this decision you should take into account the wishes of the participant. If you agree to allow the participant to take part in this research, the participant will also be asked to give consent if the ability to make healthcare decisions is regained.
Introduction
(Suggested language)
You are being asked to join a research study. The purpose of a research study is to answer specific questions.
This consent form will explain:
· the purpose of the study
· what you will be asked to do
· the potential risks and benefits
It will also explain that you do not have to be in this study to receive medical care. You should ask questions before you decide if you want to participate. You can also ask questions at any time during the study.
Additional Text for Cooperative Group Studies - For cooperative group studies (i.e., CALGB, GOG, RTOG, COG, SWOG, ACTG, NSABP, etc.) the following paragraph is appropriate:
(Suggested language)
This study is sponsored by ____, a group doing clinical research in the field of ____. ____ is a cooperative treatment group working with a network of national medical centers, hospitals and private physicians funded by______. Their research is aimed at improving treatment for _____and finding new ways to detect and prevent ____.
Why is this research study being done?
The objectives and goals of the protocol should be concisely and clearly stated in lay terms. It should be clear that the study involves research, and that there is not only an immediate purpose, but ultimately, a larger purpose for conducting the research. Remember that the purpose of the study is not to improve the health of the specific participant. The purpose should be stated in general terms.
(Suggested language)
The purpose of this research study is to ______. You are being asked to participate in this study because [DESCRIBE REASON PARTICIPANT IS BEING ASKED TO PARTICIPATE].
How many people will take part in this study?
This research study hopes to enroll [STATE NUMBER OF TOTAL PEOPLE]. If multicenter, include: We hope to enroll [INCLUDE NUMBER OF PEOPLE] at this site.
How long will you be in this study?
Include how long participation will last. The subject should be informed of the number of visits required by the study. If there are a large number of visits required for the study, a table or outline with study visit details may be helpful. Many research protocols involve active study procedures as well as follow-up. Express the time period in terms of both so the potential participant knows how much time he/she must commit to the study. For studies involving a one-time procedure, data collection, etc., indicate approximately how long the session/visit will take.
(Suggested language)
If you choose to take part in this study, the study procedures will last for______(days, weeks, months, years), and you will be followed for another ______(days, weeks, months, years). You will be asked to attend ___ visits that will last ___ hours each for a period of ____ (days, weeks, months, years).
What will happen in this research study?
This section should include a detailed explanation of the study and should encompass all procedures involved. The consent form should never state that some procedure will be described in greater detail at another time. However, for some studies where standard procedures are involved, it may be appropriate to say that a separate surgical (or other) consent will be signed.
· Provide a basic chronological description of the procedures involved in this study. Clearly indicate which are experimental/research and which are part of standard care
· If study involves questionnaires, a brief description of the type of questions that will be asked should be provided. In addition, participants should be informed and told that they may review the survey tools prior to agreeing to participate (if appropriate).
· The amount of blood collected should be described using tablespoons or teaspoons (5 cc = 1 teaspoon; 15 cc = 1 tablespoon)
· Include any information about dietary restrictions or medication restrictions
· Include information about follow-up visits and/or phone calls. Who will call, when and why should all be indicated.
· Description of HIV testing, if appropriate, including a reference to the required New York State Dept. of Health consent form for HIV testing
· If participation entails any additional procedures [, EKG, blood draws, etc.] details regarding how these are done should be included.
· If the participant needs to be accompanied home from visits, or will require home assistance include that information.
· Any other requirements should be detailed including, but not limited to: videotaping, keeping a diary, wearing a holter-monitor, etc.
· If certain foods or medications must be avoided, explain which ones and why. This includes alternative remedies, such as over-the-counter herbal supplements, vitamins, etc.(e.g., St. John's Wort, Echinacea, Saw Palmetto, etc.).
· Provide a chart of study visits, if possible.
The following sections provide additional guidance on some of the above elements.
For MRI Studies:
(suggested language)
MRI machines use a strong magnet to make pictures of the inside of your body. During the scanning, you will lie on a long narrow couch for {INDICATE THE AMOUNT OF TIME} while the machine gathers data. You will not feel anything while the data is being collected. You will also hear loud noises that are from the MRI scanner.
Since the MRI scanner is a magnet, metal objects will be attracted to the scanner. It is very important that you tell the researcher about any metal objects, devices or implants that are in or on your body before you enter the scanner room. All metal objects must be removed before entering the magnet room. In some cases, having those devices may mean that you should not have an MRI scan.
What are the risks of the research study? What could go wrong?
Include all risks/discomforts that are reasonably foreseeable, listing the most significant risks first. Only include risks that are related to the study - not standard care. Keep in mind that not all risks are physical or immediate. Likewise, not all risks are to the individual. Some risks may be delayed or may impact a class of people or specific group. Each item mentioned in the procedure section should be addressed, e.g., questionnaires, blood draws etc., even for something that seems innocuous (such as the use of a topical anesthetic, or the potential contraindication of herbal therapies or alternative therapies).
Blood-Drawing (Suggested language)
There are no major risks of having blood drawn. It can be uncomfortable and can sometimes cause a bruise. In rare cases, it can cause fainting. Only trained staff will draw your blood.
Genetic testing
Involving proband only with unknown disease, disorder or condition – no risk of uncovering non-paternity but a potential risk of uncovering a genetic variation of condition that would be news to the participant, family or insurer
(Suggested language)
You should be aware that there might be social and economic burden associated with collecting genetic information. Our testing might find an inherited gene, which puts you or a relative at risk for a genetic disorder in the future. This does not mean you will get the disorder. We will do our best to keep all information confidential. Only with your permission would we make this information available to others.
Genetic testing
Involving proband and family members –non-paternity could be discovered and a potential risk of uncovering a genetic variation of condition that would be news to the participant, family or insurer
(Suggested language)
Some people involved in genetic studies feel anxious about the possibility of carrying a gene that places them at risk for a disease or condition that may be passed on to their children. If you have these feelings at any time during the study, you may contact us and we will set up time for you to speak with a genetic counselor.
Because we are testing family members we may detect instances of nonpaternity or adoption. If you wish, you may let us know in confidence if this is a possibility. In all cases, this information will be kept in the strictest confidence and will not be told to anyone.
You should also be aware that there might be social and economic burden with collecting genetic information. Our testing might find an inherited defective gene, which puts you or a relative at risk for a genetic disorder in the future. We will do our best to keep all information confidential. Only with your permission would we make this information available to others.
Magnetic Resonance Imaging (MRI) Studies
Some or all of the following paragraphs may be appropriate for your study:
(Suggested language)
The magnetic resonance imaging (MRI) machine is a powerful magnet. This magnet may cause any metal in your body to move. If you know of any metal in your body, you will need to tell the researcher right away. Otherwise, there are no known risks of MRI. Some people with claustrophobia (fear of closed spaces) may find the MRI scanner too confining. In that case, you can ask to be removed from the scanner and this will be done immediately. The MRI scanner makes a loud sound. We may ask you to wear protective earplugs during scanning.
If the scan reveals a condition that could affect your health, you will be referred for the proper follow-up care to your primary care physician or another specialist.
Interviews/Questionnaires
For interviews, surveys, questionnaires, or other assessments that discuss sensitive issues
(Suggested language)
Some of the questions we will ask you are personal. You may feel embarrassed or stressed. You may ask to see the questions before deciding whether or not to take part in this study.
For interviews, surveys, questionnaires, or other assessments that discuss sensitive issues that may cause emotional upset, such as grieving:
(Suggested language)
Some of these questions may seem very personal or embarrassing. They may upset you. You may skip any question that you do not want to answer. If the questions make you very upset, we will help you to find a counselor. NOTE: This statement is not necessary if you are discussing routine matters that do not cause emotional upset.
Standard of Care/No Additional Expected Research Risk
Sometimes a study may involve the collection of data from participants who are receiving standard treatment for a particular condition. If there are no additional risks imposed by the research and ALL of the testing done is part of the standard of care, the following statement is appropriate:
Your part in this research study is allowing the researcher to use data from your medical record. The tests and treatments you will receive are part of the standard of care for your condition. This study does not require you to have any extra procedures or treatments. Therefore, being in this study does not involve any risks that you would not face during your routine treatment.
What are the benefits of this research study?
List and explain the potential benefits the research participant, or society in general, might derive from their participation. Keep in mind that not all benefits are physical or immediate.
(Suggested language)
The possible benefits you may experience from the procedures described in this study include [Complete this sentence – the description of participant benefits should be clear and not overstated]. Also include a statement of the benefits to science and/or society.
If no personal benefit is to be derived, but the participant's participation might result in increased medical knowledge, the following statement is appropriate:
(Suggested language)
This research will not benefit you directly. However, information we learn about this disease or condition may help patients in the future. [Detail any potential direct benefit, but do not promise results that the study is trying to assess.]
If you do not want to take part in this research study, what are your other choices?
List specifically any medication or treatment options that the participant might choose as an alternative to participation, including other investigational treatments, alternative treatments, and non-pharmaceutical treatments. Both the generic and trade names of any alternative drugs should be given. If the research treatment is available without participating in the study, this should specifically be stated.
The consent form should clearly state that the participant does not have to participate in the study to receive the treatments that are already available. If, for example, the protocol involves a comparison between two drugs that are commercially available, an alternative would be to receive either one without participating in the study. A statement such as "your doctor will discuss alternative treatments with you" is not sufficient. If no other treatments are available to treat the condition under study, the consent form should make that clear.
If the study does not involve any treatment or intervention and the alternative is to not participate, this section does not need to be included in the consent form.