[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 representativewill 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.
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.
- Provide a basic chronological description of the procedures involved in this study.
What are the risks of the research study? What could go wrong?
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?
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?
If you do not join this study, you have other choices for treatment. Talk to your doctor about your choices. Your other choices may include:
- Another research treatment
- Standard treatment
- No treatment
- Comfort care
- Treatment provided on this study
Are there any costs or payments for being in this research study?
You will not have any added costs from being in this study, nor will you be paid for your participation.
What are your rights as a research participant?
Your participation in this project is voluntary. The quality of your medical care will be the same, whether you join, refuse to join, or decide to leave the study.
If you do not join the study you will not be penalized or lose benefits to which you are entitled. If you join the study you may withdraw at any time without prejudice to your future care at Northwell Health.
What happens if new information is learned?
You will be told of any new findings that may change your decision to continue to participate. Your consent to continue to take part in this study may be obtained again.
What information will be collected and used for this study?
(Suggested language)
If you agree to be in this study, we will collect health information that identifies you. We will collect information from your medical record. We will only collect information that is needed for the research. This information has been described in this consent form. If you sign this consent form, you are giving us permission to collect, use and share your health information. This permission is called authorization.If you do not want to provide authorization, then you cannot participate in this research study.
Who else will see your information?
Study records that identify you will be kept private. You will not be identified in study records or publications disclosed outside Northwell Health, except as detailed below.
(If applicable)Investigators will share information collected from this research study with:
[List all outside agencies that may require access to PHI, such as:
- study sponsor and/or its agents,
- other researchers,
- accrediting agencies,
- data safety monitoring board,
- clinical staff not involved in the study who may be involved in participant's treatment, billing,
- health insurers or payers]
The following reviewers may access your study and medical records to make sure that this study is being done properly:
- Representatives from Federal and state government oversight agencies, such asthe Department of Health and Human Services [list representatives from government agencies,i.e., the Food and Drug Administration, NIH, NIMH, etc.],
- Representatives from NorthwellHealth’sHuman Research Protection Program (a group of people that oversees research at this institution)
- Representatives from [sponsor] (If applicable, and if the sponsor is providing oversight)
- Add others as appropriate.
We will do our best to protect the privacy of your records but it is possible that once information is shared with people listed on this form, it may be released to others. If this happens, your information may no longer be protected by the federal law.
In the future, we may publish results of this study in scientific journals and may present it at scientific meetings. If we do we will not identify you.
If the researchers learn about potential serious harm to you or someone else or other public health concerns, it will be shared with the appropriate authorities.
Will you be able to access your records?
If your research records are used for decisions related to your clinical care, then you have the right to review this information and request changes. This is limited to information about your treatment, and does not include information related to procedures or tests that are for research purposes only. You may access this information only after the study analysis is complete. You have the right to know who has and who will see your records. To request this information, please call the Human Research Protection Program at 516-465-1910.
How long will your health information be kept?
There is no limit on the length of time we will keep yourinformation for this research because it may be analyzed for many years. We will keep it as long as it isuseful, unless you decide you no longer want to take part orwe close the study. You are allowing access to this information indefinitely.
Can you change your mind?
If you change your mind about being in the study, you may withdraw at any time. If you want us to stop collecting your health information, you need to send a letter to the researcher at the following address:
Dr.______
Address
Your letter needs to say that you have changed your mind and do not want the researcher to collect and share your health information. You may also need to leave the research study if we cannot collect any more health information. We may still use the information we have already collected. We need to know what happens to everyone who starts a research study, not just those people who stay in it
Does the investigator of this study receive money if you take part?
Indicate the funding source for the study, if any. Briefly describe how the funding is used. For example, this funding is used for (division support, costs of the study, etc). If applicable, describe any direct financial incentive to the investigator if the subject agrees to participate in the study.
Funding for this research study is provided by [Indicate funding sources]. The funding is used to support the activities of the Division of [indicate Division of the PI] and to pay back the Division for the costs of the study personnel. Compensation is based/not based [choose one] upon the number of people enrolled in the study. If your doctor is an investigator for this study s/he is interested in both your healthcare and the conduct of this research. You do not have to take part in a research study conducted by your doctor.
Who can answer your questions about this study?
The key contact names and telephone numbers must be included in the consent form as well as a statement that a copy of the signed consent form will be provided. Federal regulations require that a contact name and phone number be given for 1) questions regarding the study, 2) questions regarding side effects or a research-related injury and 3) questions regarding the participant's rights as a research participant. The following is an acceptable paragraph.
(Suggested language)
If you have any questions about the study, you may call (the Investigator) at (XXX) XXX-XXXX. If you have questions about side effects or injury caused by research you should call (the Investigator) at (XXX) XXX-XXXX. If you need emergency care, dial 911 or go to the nearest Emergency Room.If you have questions about your rights as a research participant, concerns about being in the study, or would like to offer input, you may contact the Office of the Institutional Review Board (the committee that oversees research at this institution) at (516) 465-1910.
A signed copy of this consent form will be given to you.
[Signature Page Follows]
Summation/Signature
A summation/signature section should follow which allows the participant to form a conclusion before they make a decision about participating. The words "I understand" should not be used. Since study participants are not in a position to judge whether or not the information is complete, they should not be asked to certify completeness of disclosure (e.g., "This study has been fully explained to me").
You have read the above description of the research study. You have been told of the risks and benefits involved and all your questions have been answered to your satisfaction. A member of the research team will answer any future questions you may have. You voluntarily agree to join this study and know that you can withdraw from the study at any time without penalty. By signing this form, you have not given up any of your legal rights.
______
Printed Name of Participant /Healthcare Agent/Guardian/Next of Kin
If your site is not asking to use surrogate consent Healthcare Agent/Guardian/Next of Kin should be removed here
______
Signature of Participant/Healthcare Agent/Guardian/Next of Kin Date
If your site is not asking to use surrogate consent Healthcare Agent/Guardian/Next of Kin should be removed here
______
Witness’s Printed Name Witness’s Signature Date
(Note: A witness can be a member of the research team, but cannot be the same person signing consent as the investigator)
When additional signatures are required, the consent form must include additional signature lines as appropriate, as well as a description of the signer's authority to act on behalf of the participant.
Dated signatures required when the participant is a child or is decisionally impaired are as follows:
______
Participant’s printed name
______
Participant’sSignatureDate
______
Parent's or Legally Authorized Representative's printed name
______
Parent's or Legally Authorized Representative's signature Date
Description of signer'sauthority to act on behalf of the participant:______
______
Witness’s Printed Name Witness’s Signature Date
When permission from BOTH parents is required (usually a greater than minimal risk study), the following format may be used:
Participant’s Name:______Age: ______
______
Printed Name of Parent/Legal Guardian Signature of Parent/Legal Guardian Date
______
Printed Name of Parent/Legal Guardian Signature of Parent/Legal Guardian Date
______
Witness’s Printed Name Witness’s Signature Date
Investigator’s Statement
In addition to advising the above participant of other forms of treatment and therapy which are appropriate, I haveoffered an opportunity for further explanation of the risks and discomforts which are, or may be associated with this study and to answer any further questions relating to it.
______
Investigator’s signature Date
______
Investigator’s printed name
THE FOOTER SHOULD ONLY HAVE THE AMOUNT OF PAGES (I.E. PAGE 1 OF 22) ,THE VERSION DATE OF THE CONSENT FORM AND THE IRB PROTOCOL NUMBER.
Version Date:
IRB #:Page 1 of 7