[All instructions (in RED) and text not applicable to the ...



[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

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

Principal Investigator:

Sponsor: [REMOVE IF N/A]

About this research

You are being asked to participate in a research study.

This consent form will give you information about the study to help you decide whether you want to participate. Please read this form, and ask any questions you have, before agreeing to be in the study.

Important Information

(This section is required and cannot be deleted; should be no more than 1-2 pages. The purpose is to provide participants with specific key information that is most likely to assist them in understanding the reasons why one might or might not want to participate in the research.)

This information gives you an overview of the research. More information about these topics may be found in the pages that follow.

|Why am I being asked to provide my |This is a research study, which is different than personal medical care. Scientists do research to answer |

|consent? |important questions which might help change or improve the way we do things in the future. |

|Do I have to join this research |No. Taking part in this research study is voluntary. You may choose not to take part in the study or may |

|study? |choose to leave the study at any time. Deciding not to participate, or deciding to leave the study later, |

| |will not result in any penalty or loss of benefits to which you are entitled. |

|Why is this research study being |[Insert a short, 1-2 sentence summary of the purpose of the research]. |

|done? | |

| | |

| | |

|What will happen to me during the | |

|study? | |

| |[Insert a short summary of the key study procedures]. |

|How long will I participate? |[Insert a description of the length or duration of subject participation] |

| |[Insert a description of the most important risks, with the greatest impact in terms of frequency and/or |

|Will taking part expose me to risks?|severity. This section should include specific risks instead of vague statements. It should not include a |

| |“laundry list” of potential risks. Included should be the risks that a subject would use, without more |

| |information, as a criterion to decide whether or not to participate. Language should not simply refer |

| |subjects to the full risk section later in the consent.] |

|Are there any benefits to |[Insert the specific benefits to the subject or to others that may be reasonably expected from the research.|

|participation? |Monetary compensation to the subject should not be listed as a benefit. If there is no potential benefit to|

| |subjects, this should be explicitly stated.] |

|What are my alternatives to |[Insert the specific alternative procedures or courses of treatment that might be advantageous to the |

|participation? |subject. If the study interventions are available to the subject without joining the study, this should be|

| |indicated. If there are no alternatives, this section can be deleted.] |

Please review the rest of this document for details about these topics and additional things you should know before making a decision about whether to participate in this research.

Text for when the participant is a minor or decisionally impaired adult:

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:

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

You are being asked to join a research study. The purpose of a research study is to answer specific questions.

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 ____.

Financial Disclosure: If any study members have a COI management plan that requires disclosure in the consent form. Please paste that appropriate language here

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.

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. . 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.

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. Use lay language at a 6th to 8th grade level.

• 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:

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.

Information Regarding HIV Testing

This section is required only if HIV testing will be part of the study procedures. (DELETE THIS SECTION IF NOT APPLICABLE).

During screening, your blood will be tested for HIV, as well substances and other conditions.

The following is important information about HIV, HIV testing and HIV test results that you need to know before you decide whether to be tested for HIV:

HIV is the virus that causes AIDS.  It can be spread through unprotected sex (vaginal, anal, or oral sex) with someone who has HIV; contact with HIV-infected blood by sharing needles (piercing, tattooing, drug equipment, including needles); by HIV-infected pregnant women to their infants during pregnancy or delivery, or by breast feeding.

There are treatments for HIV/AIDS that can help a person stay healthy.  People with HIV/AIDS can use safe sex practices to protect others from becoming infected.  Safe practices also protect people with HIV/AIDS from being infected with different strains of HIV.

Testing is voluntary and can be done at a public testing center without giving your name (anonymous testing).  By law, HIV test results and other related information are kept confidential.  Discrimination based on a person’s HIV status is illegal.  Your HIV test result must be given to you in person, not over the phone.

By consenting to participate in this research study, you give consent to be tested for HIV.  This consent is limited to this research study.  If you do not wish to be tested for HIV at this time, DO NOT sign the consent to participate in the research study.

If you are tested for HIV and you are found to be infected with HIV, the research doctor will inform you of the result and will assure that you receive appropriate counseling and prompt, appropriate HIV medical care.

If you test positive for HIV, the research doctor is required, by law, to report the result to the New York State Department of Health.  HIV information is protected by the New York State HIV Confidentiality Law, which limits disclosure to those who need to know in order to provide appropriate care or others to whom you give permission for information to be released.  

It is your decision whether you provide the additional samples and have these tests performed.  However, if you decide not to provide the additional samples and have the tests done, you may need to leave the study for your own safety (as the cause of your abnormal liver lab results may not be able to be determined without them).

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-Draw

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

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

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:

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.

Incidental Findings (Language for Imaging that is not standard of care)

Although the imaging you will have in this study is being undertaken for research purposes only, it is possible that doctors may notice something that could be important to your health. Although not likely, it is possible that the doctors may notice something that may be very serious and could immediately affect your life. If so, we will contact you to explain what was observed. If you so desire, we will also talk with your private physician. If you do not have a private physician, we will refer you to an appropriate clinic for follow-up. It will be your choice whether to proceed with additional tests and/or treatments to evaluate what we observed, and you or your insurer will be responsible for these costs.

Interviews/Questionnaires

For interviews, surveys, questionnaires, or other assessments that discuss sensitive issues

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.

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.

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:

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.]

Will I receive my results?

[If clinically relevant results will be returned, insert one of the following:] We may learn things about you from the study activities which could be important to your health or to your treatment. If this happens, this information will be provided to you. [Insert a description of the types of research results which may be returned, under what circumstances subjects will be provided research results, and how subjects will be notified.] You may need to meet with professionals with expertise [ If the results are genetic, suggest genetic counseling] to help you learn more about your research results. The study team/study will not cover the costs of any follow-up consultations or actions.

or

We may learn things about you from the study activities which could be important to your health or to your treatment. If this happens, you can decide whether you want this information to be provided to you. [Insert a description of the types of research results which may be returned, under what circumstances subjects will be provided research results, and how subjects will be notified.] If you decide that you want this information, you may need to meet with professionals with expertise [ If the results are genetic, suggest genetic counseling] to help you learn more about your research results. The study team/study will not cover the costs of any follow-up consultations or actions. Please initial one of the following options:

______ Yes, I want to be provided with this information.

______ I do NOT want to be provided with this information.

Or

[If clinically relevant results will not be returned, insert the following:] We may learn things about you from the study activities which could be important to your health or to your treatment; however, we will not share this information with you.

[** Please note that if results of genetic tests defined by NYS Civil Rights Law 79 L done for research purposes will be returned to subjects, then the consent requirements outlined in NYS Civil Rights Law 79 L apply.

Genetic Test: Any laboratory test of human DNA, chromosomes, genes, or gene products to diagnose the presence of a genetic variation linked to a predisposition to a genetic disease or disability in the individual or the individual's offspring; such term shall also include DNA profile analysis; subject is currently asymptomatic and is not aware that he/she carries the composition of genes which is determined to be associated with an increased statistical risk of being expressed as either a physical or mental disease or disability in the individual or having offspring with a genetically influenced disease.

Consent Requirements when returning genetic test results done for research purposes to subjects:

(1) a general description of the test;

(2) a statement of the purpose of the test;

(2-a) a statement indicating that the individual may wish to obtain professional genetic counseling prior to signing the informed consent.

(3) a statement that a positive test result is an indication that the individual may be predisposed to or have the specific disease or condition tested for and may wish to consider further independent testing, consult their physician or pursue genetic counseling;

(4) a general description of each specific disease or condition tested for;

(5) the level of certainty that a positive test result for that disease or condition serves as a predictor of such disease.  If no level of certainty has been established, this subparagraph may be disregarded;

(6) the name of the person or categories of persons or organizations to whom the test results may be disclosed;

(7) a statement that no tests other than those authorized shall be performed on the biological sample and that the sample shall be destroyed at the end of the testing process or not more than sixty days after the sample was taken, unless a longer period of retention is expressly authorized in the consent.

[**If this is not applicable to the research, remove this section from the document**]

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.

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 for being in this research study?

If the participant or his/her insurance carrier will be responsible for the tests, procedures, etc. included in the study or if all study related procedures will be paid by the sponsor of the study, this shall be detailed in this section. It may be appropriate to state that taking part in the study may lead to increased costs to the participant or his insurance company, if applicable. Using the term "at no cost" is preferable to saying "free" as it is considered less coercive.

For studies in which the sponsor is paying for all the costs of doing the study, the participants should be advised.

This research study is funded by [INSERT SPONSOR NAME]. You will not have any added costs from being in this study. All study related visits, procedures and medications will be given to you at no cost. Neither you nor your insurance company will be billed for your participation in this research.

OR

You will not have any added costs from being in this study.

Will you receive any payments for participating in this research study?

Detail any payments to research participants. If the participant will be compensated for their time, travel, etc. by the sponsor of the study this needs to be explained. Remember that if a participant withdraws from a study, they are entitled to a prorated reimbursement for the portion of the study they have completed. Any compensation should be in amounts that are appropriate and which would not be considered coercive. Vulnerable participants must not be placed into a study in which they would not participate if there were no compensation. (The IRB will make the determination of the appropriateness of the amount of any payments to research participants).

If the participant will receive compensation/reimbursement from the study, the following is appropriate.

You will be paid $_____ for your time and travel expenses for being in this study. If you do not complete the entire study, you will be paid for the number of visits that you have completed. Payment will be made at the end of the study or when you end your participation.

If the compensation provided in one year is $600 or more:

Since the total amount of payment is more than $600 in a year, Northwell Health needs to report this income to the IRS. We will issue you a 1099 form as your payment will be considered taxable income. You will need to provide your social security number for this purpose. You will be responsible for reporting this income when you file your tax return

If the compensation in one year is less than $600:

If the total payment you receive from Northwell Health, during this year, is equal to $600 or more, the payment is required to be reported to the IRS.  Although this study does not pay $600, if you participate in other Northwell Health studies, it is possible your payment could end up totaling $600.  If this occurs, the payment you receive on this study will be reported to the IRS.   In this case, you will be issued a 1099 form and be required to provide your social security number at that time for reporting purposes.  You will also be responsible for reporting this income while filing your tax return.

For research involving children, it may be appropriate to compensate them directly in the form of toys, stickers, etc., in order to ensure that they are indeed receiving the compensation personally, in a form that they appreciate. This should be detailed in the consent form.

Will my biospecimens be used to create a marketable product? And if so, will I receive payment?

Your specimens may be used to create a marketable product. If this research produces a marketable product, there are no plans for you to receive any money.

Or

Your specimens may be used to create a marketable product. If this research produces a marketable product, you will be compensated (describe compensation plan).

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. Follow-up examinations may be needed to assure your well-being.  

Could you be taken off the study before it is over?

It is also possible that your participation in this study may end without your consent.  This decision may be made by a researcher, study sponsor or the Institutional Review Board (IRB- the committee that oversees research at this institution).   

Reasons for withdrawal may include: 

• failure to follow instructions,

• failure to show up for study visits,

• it is not in your best interest to continue on this study, or

• the study is stopped.  

If you withdraw from this study or if you are withdrawn from the study, any data (or samples) already collected will continue to be used.  However, no new data will be collected.  

It may be appropriate to tell a participant that, for safety reasons, if he withdraws from the study, he will be urged to return for final testing and possible selection of an alternative treatment.

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.

HIPAA Section

When a study DOES NOT entail the creation, use, or disclosure of Protected Health Information [(PHI) = health information that contains identifiers], the following language is appropriate.

What will happen with the information we collect as part of this research study?

Any study information about you will be kept private and will only be given out with your permission. If the results of this study are published, your name will not be used. Your research records will be private to the extent allowed by law. In order to make sure the research is done properly, the Human Research Protection Program (the group of people that oversees research at this institution) may need access to information about your participation in this study.

When a study DOES entail the creation, use, or disclosure of Protected Health Information [(PHI) = health information that contains identifiers], the following paragraphs provide sample language for your confidentiality section consistent with federal regulations, including HIPAA.

What information will be collected and used for this study?

If you agree to be in this study, we will collect health information that identifies you. We may collect the results of tests, questionnaires and interviews [(SELECT TEXT AS APPROPRIATE]. We may also 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 as the Department of Health and Human Services [list representatives from government agencies, i.e., the Food and Drug Administration, NIH, NIMH, etc.],

• Representatives from Northwell Health’s Human Research Protection Program (a group of people that oversee 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 your information for this research because it may be analyzed for many years. We will keep it as long as it is useful, unless you decide you no longer want to take part or we 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.______________(must be PI)

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.

Will information about this study be available to the public?

If this research study is a clinical trial of a drug or medical device, then add:

A description of this clinical trial will be available on  , 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 website at any time.

If your study has a Certificate of Confidentiality, the following language should be used:

Certificate of Confidentiality

[If the study is NIH funded, you automatically receive a Certificate of Confidentiality, and must include this section. If the study is not NIH funded but the study has obtained or intends to obtain one, insert the following as appropriate:] To help us protect your privacy, thsi research is covered by a Certificate of Confidentiality from the US Department of Health and Human Services (DHHS). The Certificate of Confidentiality means that researchers cannot be forced to identify you, even under a court subpoena. The Certificate does not mean the Secretary of DHHS approves or disapproves of the project. It adds special protection for the research information about you. You should know, however, that researchers may provide information to appropriate individuals or agencies if harm to you, harm to others or child abuse becomes a concern. A Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. However, if an insurer, employer or other person learns about your participation and gets your consent to receive research information, then the researchers will have to provide your information.

Will my information be used for research in the future?

[If the research involves the collection or use of identifiable private information or biospecimens, insert one of the following:]

Information or specimens [collected from you] for this research may be used for future research studies or shared with other researchers for future research. If this happens, information which could identify you will be removed before any information or specimens are shared. Since identifying information will be removed, there will not be an additional consent for future research. By consenting to participate in this study you are agreeing to allow your de-identified specimens and/or data to be used by future researchers without additional consent. [If re-identification is possible (i.e. more than a theoretical risk), insert a statement to that effect and describe any risks.]

or

Information or specimens collected from you will not be used for future research studies or shared with other researchers for future unspecified research. (CHOOSE THIS OPTION ONLY IF 100% SURE SAMPLES/RESEARCH WILL NEVER BE USED FOR ANOTHER RESEARCH PURPOSE)

[If the research involves the storage and maintenance of identifiable private information or biospecimens for future use, please ensure the following are addressed: proposed use, collection and storage procedures, procedures for oversight of security and maintenance, who will have access, procedures to protect confidentiality, procedures for withdrawal, etc.]

[*** Please note that if you believe that genetic tests will be performed on stored tissue, the following provisions from NYS Civil Rights Law 79-L must be included in the consent form:

(1) a statement that the sample may be used for future genetic tests;

(2) the time period during which the tissue will be stored, or if no time limit is specified, a statement that the tissue will be stored for as long as deemed useful for research purposes;

(3) a description of the policies and procedures to protect patient confidentiality;

(4) a statement of the right to withdraw consent to use of the tissue for future use at any time and the name of the organization that should be contacted to withdraw consent;

(5) a statement allowing individuals to consent to future contact for any or all purposes, including the following:  (i) research purposes;  (ii) provision of general information about research findings;  and (iii) information about the test on their sample that may benefit them or their family members in relation to their choices regarding preventive or clinical care;  and

(6) a statement explaining the benefits and risks of consenting to future contact for the purposes indicated above.  ***Please note: In no event shall information about specific test results on stored human tissue donated for general research purposes be disclosed to an individual without obtaining informed consent for the disclosure ***

*** If you decide to return the results of genetic testing done on stored samples to participants, and the original consent form does not already include the 7 consent items required for doing so (see above), then subjects must be reconsented with a consent form that includes these items prior to the results being released to them***

What will you do with my genetic information?

[If the study involves genetic testing or the tracking of a particular disease or disorder in an individual’s family, insert the following:] This research follows the Genetic Information Nondiscrimination Act (GINA), a federal law that generally makes it illegal for health insurance companies, group health plans, and most employers to request the genetic information we get from this research and to discriminate against you based on your genetic information.

[For research involving biospecimens, insert the following, as appropriate:] We may use the specimens collected as a part of this study for whole genome sequencing, which involves mapping all of your DNA. [Insert a description including what information will be gained, how the information will be used and stored, any risks of whole genome sequencing, and whether the information will be provided back to the subject, and, if so, whether it may be clinically relevant.]

[**If this is not applicable to the research, remove this section from the document**]

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.

If study has no funding:

The investigators on this study do not receive money for your participation in this study.

If study has funding, but investigators do not financially benefit:

The investigators on this study receive money to conduct the study, but do not financially benefit from your participation.  The money they receive is to pay them back for the costs of conducting the research study. Funding for this research study is provided by [Indicate funding sources]. 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.

If study has funding and investigators do financially benefit:

The investigators on this study will receive money that is directly related to your participation in this study.  Funding for this research study is provided by [Indicate funding sources], money they receive is to pay them back for the costs of conducting the research study.  The amount of money they receive is based 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.

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’s Signature Date

________________________________________________

Parent's or Legally Authorized Representative's printed name

________________________________________________ _________

Parent's or Legally Authorized Representative's signature Date

Description of signer's authority 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 have offered 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.

Please note that if you will be assenting children or decisionally impaired adults, those assent forms must be submitted to the IRB for review. These forms may be attached to the current document. Please see the HRPP website for assent templates.

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