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R# xx-xxxx version 00/00/0000 NYU SoM IRB HRPP Institutional Review Board Veteran’s Administration Hospital Physical Address: 423 East 23rd Street | 10th Floor, West Wing | NY, NY 10010 Mailing Address: 550 1st Avenue | #VET 10th Floor, West Wing | NY, NY 10016 http://irb.med.nyu.edu [P.I. Name] INFORMED CONSENT FORM TO PARTICIPATE AND AUTHORIZATION FOR RESEARCH Instruction to PI: All yellow highlight areas should be deleted when you‟re done. All green text should be replaced with actual values relevant to your study; the green highlighting should be removed. Delete any parts of the standard consent template that are irrelevant for your specific study. Remember: your consent should be written in lay language and should be kept at a 6th-8th grade level. If there is more than one consent for the study, please be sure to label each page of each consent accordingly, e.g. patient consent, or control consent. TITLE OF RESEARCH This is the only section where medical/scientific terminology may be used. The title should conform to the title of any grant application/protocol. A. PURPOSE OF THE STUDY In addition to stating the purpose of the study, the investigator should provide the rationale for performing the study (e.g. results of previous studies, etc.) You are being asked to volunteer in a research study. This consent/authorization form includes information about this study. The purpose of this study is [your study purpose here]. You are being asked to participate in this study because [reason why you’re asking person to participate in study] B. SUBJECT PARTICIPATION Estimate the number of subjects that will be enrolled (a) at the NYU and affiliate site; and (b) at all sites for multi-center trials. This number is the number of enrollees needed to obtain a valid result. We estimate that the following number of subjects will enroll in this study: At this site: [number] Total at all sites: [number] Subject Participation Inpatient Outpatient Other [healthy subjects, etc.] Please specify: [specify] The IRB expects that research will be available, as appropriate, to all persons regardless of race, gender, age, or economic circumstances Subject’s Initials: ___________ Date: _____________ (IRB Official Use Only) This Consent Document is approved for use by the New York University’s Institutional Review Board (IRB). Only the IRB-stamped approved form may be used. Approved: Start: _______________ End: ______________ (do not use this form after the End date) Document1 page 1 of 10 R# xx-xxxx version 00/00/0000 NYU SoM IRB HRPP Your participation will involve [number] number of visits, which will take place over [your study visit schedule described here]. Indicate the approximate total length of the subject‟s proposed participation by the number of days, months or years (from screening to final termination). Each of these visits will take the following amount of time: [time in hours, minutes] Indicate the approximate length of each visit in minutes or hours. (For example, Visits 1, 3 and 5 will each involve approximately 2 hours; visits 2 and 4 will each involve approximately 30 minutes.) C. DESCRIPTION OF THE RESEARCH [describe your research] All research activities should be described in readily understandable lay language: If the research includes procedures that the subject would undergo in the course of standard diagnostic and/or therapeutic treatment as well as procedures that would not be performed in the course of standard diagnostic and/or therapeutic treatment, describe separately the research procedures and standard diagnostic and/or therapeutic procedures. If hospitalization is involved, the length of days should be stated. If blood will be drawn, indicate the amount in teaspoons per single specimen and the number of specimens. For example: 5ml/cc= 1tsp. If urine, CSF, etc. are to be collected, any stated amounts should be in teaspoons. If tests will be repeated, the schedule should be described. If a drug is to be given, indicate the dosage, the route of administration, and the duration of administration. If the study is randomized, double-blind and/or involves a placebo, this must be stated and explained. Randomization should be explained as “You will be assigned to one of the groups by chance. The chance of being in each group is ____________” (whatever that chance is, depending on the randomization scheme). Also explain who will be blinded to whether a participant has been randomized to receive study drug or a placebo. Explain what substance will be used for the placebo (sugar pill). For research involving genetic testing, please use the standard language found in the Specimen Banking Consent Template which can be found here: http://irb.med.nyu.edu/forms- guidance/consent-forms. D. COSTS/REIMBURSEMENTS If the drug or device is being provided free of charge without any payment to NYU or PI include the following: The [Sponsor Name], is providing the [name of drug or device] free of charge to participating research subjects. For research that includes standard of care treatment: You will be receiving medical care as a part of this research study. You or your insurance company will/will not be charged or held responsible for the costs of that care. Some of these tests would have been done as part of regular care. You or your insurance carrier will be charged or held responsible for the costs of that care. Your individual insurance or government health insurance program may not cover certain services, items or procedures. You may want to Subject’s Initials: ___________ Date: _____________ (IRB Official Use Only) This Consent Document is approved for use by the New York University’s Institutional Review Board (IRB). Only the IRB-stamped approved form may be used. Approved: Start: _______________ End: ______________ (do not use this form after the End date) Document1 page 2 of 10 R# xx-xxxx version 00/00/0000 NYU SoM IRB HRPP discuss this with your insurance carrier in advance. You will be responsible for any co-payments and/or deductibles for services rendered. If the research involves treatment or procedures that are only for research purposes and not part of standard care for the treatment of the subject‟s condition, insurers will not pay for the research treatment or procedure. If the research treatment or procedure is not covered by Medicare, Medicaid, third-party insurers or the research sponsor, the subject will be responsible for payment. In such cases, state which treatment or procedures are not likely to be covered by insurers and state the approximate charge for each. If the research treatment or procedure is covered, the subject should be informed that he/she will be responsible for any applicable co-payments. Since the IRB expects that research be accessible to all without regard to the subjects‟ economic circumstances, Investigators should contact the NYUSM General Clinical Research Center (263- 7900) to discuss the availability of CTSI resources located at BH and NYUMC to support the study. The ethical principal of justice demands equitable access to care, particularly for those projects or centers supported by public funds. Additionally, private sponsors often charitably support access to protocols/drugs/devices under investigation as diagnostic or therapeutic interventions. Ensure all previous relevant statements and those listed below are revised if the project fits the above criteria. Where relevant: All study-related costs associated with your being in this study will be paid by the [Sponsor Name]. You or your insurance company will (or will not) be charged or held responsible for the costs of your routine care (the care you would have received if you were not in this study). If your study is sponsored by industry: The sponsor of this study, [Sponsor Name], is paying New York University to perform this research. If your study is funded by a grant or foundation: This study is being sponsored by a grant from the National Institutes of Health. Portions of Dr. [PI name]’s and [his/her] research team’s salaries are being paid by this grant. See previous instructions regarding further information needed if subjects will be charged for research procedures. E. POTENTIAL RISKS AND DISCOMFORTS The following are risks and discomforts that you may experience during your participation in this research study. List potential risks or discomforts of each test/procedure that is research related. Procedures performed as standard care are to be included if the study involves standard surgical procedures. The IRB determines on a case-by-case basis which studies need to include risks related to standard of care. These include not only physical injury, but also possible psychological, social or economic harm, discomfort or inconvenience, or breach of confidentiality. Include the following if relevant to the specific study: Subject’s Initials: ___________ Date: _____________ (IRB Official Use Only) This Consent Document is approved for use by the New York University’s Institutional Review Board (IRB). Only the IRB-stamped approved form may be used. Approved: Start: _______________ End: ______________ (do not use this form after the End date) Document1 page 3 of 10 R# xx-xxxx version 00/00/0000 NYU SoM IRB HRPP It is possible that the particular treatment or procedure may involve risks to you (or to the embryo or fetus, if you are or may become pregnant) that are not currently known or foreseeable. For research involving pregnant women and fetuses, provide data for assessing potential risks to pregnant women and fetuses, such as: The risk assessment can be based on pre-clinical studies, including studies in pregnant animals, and clinical studies involving studies on non-pregnant women. If you are conducting research that involves genetic testing, you are required to include specific language and address certain questions within the consent document. For more information about genetic testing and the consent process, visit the IRB‟s Guidance page at: http://irb.med.nyu.edu/forms-guidance/guidance-submission F. POTENTIAL BENEFITS Describe direct benefits, if any. In addition, include one or more of the following therapeutic objectives, as appropriate (IE: first and third point) This research study includes procedures that may change the treatment you would otherwise receive. We hope knowledge gained will be of benefit to you There is no direct benefit to you expected from your participation in this study. It is hoped the knowledge gained will be of benefit to others in the future This research study is designed to select by chance which treatment you will receive. It is not known if the treatment you will receive will be of benefit to you. There may be no direct benefit from agreeing to participate in this study G. ALTERNATIVES TO PARTICIPATING IN THE STUDY Describe appropriate alternative procedures/treatments, if any that might be advantageous to the subject. Any standard treatment that is being withheld must be listed as an alternative. The IRB considers the frequently used language „discuss alternatives with your doctor‟ inadequate as a discussion of alternatives. There is always an alternative to participating in a study, such as: You are eligible for this study because you have not responded to all standard therapies. One alternative is no additional intervention that could result in your disease getting worse. You do not have to participate in this study to receive ongoing care for your condition This is not a study related to diagnosis or treatment of a disease or condition in eligible subjects. You are free to choose not to participate in the study. H. CONFIDENTIALITY Private information about you that identifies you may be used or shared for the purposes of this research project. This section of the consent/authorization form describes how your information will be used and shared in this research, and the ways in which NYU School of Medicine will safeguard your privacy and confidentiality. If you agree to be in this research program, Dr. [PI name] and [his/her] study team will ask you to have certain tests [detail according to what project entails]. Some of these tests would have been done as part of your regular care. [He/She] will use these test results both to treat you and to complete this research. The results of these tests will be kept in your medical chart and will be Subject’s Initials: ___________ Date: _____________ (IRB Official Use Only) This Consent Document is approved for use by the New York University’s Institutional Review Board (IRB). Only the IRB-stamped approved form may be used. Approved: Start: _______________ End: ______________ (do not use this form after the End date) Document1 page 4 of 10 R# xx-xxxx version 00/00/0000 NYU SoM IRB HRPP reported to the [research data office at NYU School of Medicine] OR [data coordinating center in …] OR [Sponsor Name]. Results of tests and studies done just for this research study and not as part of your regular care will [also] OR [not] be included in your medical record. Other persons and organizations, including co-investigators, federal and state regulatory agencies, and the IRB(s) overseeing the research may receive your information during the course of this study. Except when required by law, study information shared with persons and organizations outside of New York University School of Medicine (NYUSM) will not identify you by name, social security number, address, telephone number, or any other direct personal identifier. When your study information will be disclosed outside of NYUSM as part of the research, the information that can identify you as listed above will be removed and your records will be assigned a unique code number. NYUSM will not disclose the code key, except as required by law. Confidentiality of Your Medical Records Your medical records will be kept in accordance with state and federal laws concerning the privacy and confidentiality of medical information. If your participation in this research is for treatment or diagnostic purposes, the facility in which you are treated may ask you to sign a separate informed consent document for specific procedures or treatment, and that informed consent form may be included in the medical record of that facility. The confidentiality of your medical record is also protected by federal privacy regulations, as described below. Confidentiality of Your Study Information Your study records include information that identifies you and that is kept in research files. We will try to keep this information confidential, but we cannot guarantee it. If data from this study are to be published or presented, we will first take out the information that identifies you. Retention of Your Study Information The study results will be kept in your research record for at least six years or until after the study is completed, whichever is longer. At that time either the research information not already in your medical record will be destroyed or information identifying you will be removed from such study results at NYU. Any research information in your medical record will be kept indefinitely. Your HIPAA Authorization A new federal regulation, the federal medical Privacy Rule, has taken effect as required by the Health Insurance Portability and Accountability Act (HIPAA). Under the Privacy Rule, in most cases we must seek your written permission to use or disclose identifiable health information about you that we use or create [your “protected health information”] in connection with research involving your treatment or medical records. This permission is called an Authorization. If you sign this form you are giving your Authorization for the uses and sharing of your protected health information described below. You have a right to refuse to sign this form. If you do not sign the form you may not be in the research program, but refusing to sign will not affect your health care (or payment for your health care) outside the study. This Authorization will not expire unless you withdraw it in writing. You have the right to withdraw your authorization at any time, except to the extent that NYU has already relied upon it or must continue to use your information to complete data analysis or to report data for this study. The procedure for revoking your authorization is described below in Section K. Subject’s Initials: ___________ Date: _____________ (IRB Official Use Only) This Consent Document is approved for use by the New York University’s Institutional Review Board (IRB). Only the IRB-stamped approved form may be used. Approved: Start: _______________ End: ______________ (do not use this form after the End date) Document1 page 5 of 10 R# xx-xxxx version 00/00/0000 NYU SoM IRB HRPP By signing this form you authorize the use and disclosure of the following information for this research: Delete the bullets that do not apply to your study Your medical records [alternatively “the following information from your medical record’] Your research record Results of laboratory tests Clinical and research observations made during your participation in the research HIV-related information, which includes any information indicating that you have had an HIV-related test, or have HIV infection, HIV-related illness or AIDS, or any information which could indicate that you have been potentially exposed to HIV. By signing this form you authorize the following persons and organizations to receive your protected health information for purposes related to this research: Delete the bullets that do not apply to your study Every research site for this study, including this hospital, and including each sites’ research staff and medical staff Every health care provider who provides services to you in connection with this study Any laboratories and other individuals and organizations that analyze your health information in connection with this study in accordance with the study’s protocol The following research sponsors and the people and companies they use to oversee, administer, or conduct the research: [your description here] The United States research regulatory agencies and other foreign regulatory agencies The members and staff of the hospital’s affiliated Institutional Review Board The members and staff of the hospital’s affiliated Privacy Board Principal Investigator: [P.I. name] Study Coordinator Members of the Research Team The Patient Advocate or Research Ombudsman (CTSI) Members of the NYU/NYUMC Clinical Trials Office/Office of Research and Sponsored Programs Contract Research Organization (Name: [name here]) Data Safety Monitoring Board/Clinical Events Committee Others (as described below): [your description here] If any of the companies or institutions listed above merges or is sold during the course of this research, your Authorization will cover uses and disclosures of your protected health information to the new company or institution that assumes responsibility for the research. Please be aware that once your protected health information is disclosed to a person or organization that is not covered by the federal medical Privacy Rule, the information is no longer protected by the Privacy Rule and may be subject to redisclosure by the recipient. Subject’s Initials: ___________ Date: _____________ (IRB Official Use Only) This Consent Document is approved for use by the New York University’s Institutional Review Board (IRB). Only the IRB-stamped approved form may be used. Approved: Start: _______________ End: ______________ (do not use this form after the End date) Document1 page 6 of 10 R# xx-xxxx version 00/00/0000 NYU SoM IRB HRPP Notice Concerning HIV-Related Information If you are authorizing the release of HIV-related information, you should be aware that the recipient(s) is prohibited from re-disclosing any HIV-related information without your authorization unless permitted to do so under federal or state law. You also have a right to request a list of people who may receive or use your HIV- related information without authorization. If you experience discrimination because of the release or disclosure of HIV-related information, you may contact the New York State Division of Human Rights at (212)480-2493 or the New York City Commission of Human Rights at (212)306-7450. These agencies are responsible for protecting your rights. I. COMPENSATION/TREATMENT IN THE EVENT OF INJURY All forms of medical (or mental health) diagnosis and treatment – whether routine or experimental – involve some risk of injury. In addition, there may be risks associated with this study that we do not know about. In spite of all precautions, you might develop medical complications from being in this study. If you sustain any injury during the course of the research or experience any side effect to a study drug or procedure, please contact the Principal Investigator [your name here] at the following telephone number [your phone here]. If such complications arise, the study doctor will assist you in obtaining appropriate medical treatment but this study does not provide financial assistance for medical or other injury-related costs. You do not give up any rights to seek payment for personal injury by signing this form. Some studies do not relate to medical diagnosis or treatment, such as educational and social science research. This section should be modified to reflect this, depending on the specific study. If the Sponsor has agreed in writing to provide compensation for medical or other costs arising from an adverse event, state here exactly what the Sponsor has agreed to. J. VOLUNTARY PARTICIPATION AND AUTHORIZATION Your decision as to whether or not to take part in this study is completely voluntary (of your free will). If you decide not to take part in this study, it will not affect the care you receive and will not result in any loss of benefits to which you are otherwise entitled. You will be told of any significant new findings developed during the course of the research that may influence your willingness to continue to participate in the research. Your decision as to whether to give your Authorization for the use and disclosure of your protected health information for this study is also completely voluntary. If you decline to give your Authorization or if you withdraw your Authorization, you may not participate in the study. Subject’s Initials: ___________ Date: _____________ (IRB Official Use Only) This Consent Document is approved for use by the New York University’s Institutional Review Board (IRB). Only the IRB-stamped approved form may be used. Approved: Start: _______________ End: ______________ (do not use this form after the End date) Document1 page 7 of 10 R# xx-xxxx version 00/00/0000 NYU SoM IRB HRPP K. WITHDRAWAL FROM THE STUDY AND/OR WITHDRAWAL OF AUTHORIZATION If you decide to take part in the study, you may withdraw from participation at any time without penalty or loss of benefits to which you would otherwise be entitled. You may also withdraw your Authorization for us to use or disclose your protected health information for the study. If you do decide to withdraw your consent, we ask that you contact Dr. [PI name here] and let [him/her] know that you are withdrawing from the study. [His/her] mailing address is [address]. If you wish to withdraw your Authorization as well you must contact Dr. [PI name here] in writing. [Be sure to include the PI’s name and full mailing address.] Remember that withdrawing your Authorization only affects the uses and sharing of information after your written request has been received, and you may not withdraw your Authorization for uses or disclosures that we have previously made or must continue to make to complete analyses or report data from the research. The Principal Investigator or another member of the study team will discuss with you any considerations involved in discontinuing your participation in the study. You will be told how to withdraw from the study and may be asked to return for a final check-up. Include the necessary considerations, such as in some cases, the need to taper off a drug rather than end it abruptly, and requiring the return of all unused study medications. The study doctor may also decide to withdraw you from the study for certain reasons. Some possible reasons for withdrawing a subject from the study would be worsening health or other conditions that might make it harmful for you. Consider and include, if applicable, the following circumstances for withdrawing a patient from a study: failure to keep appointments, follow directions or take medications as instructed a serious adverse reaction to drug therapy the need for treatment that is not allowed in the study termination or cancellation of the study by [study sponsor] If applicable, include for withdrawal of samples: If you agree to allow your tissue/blood/cells to be kept for research, you are free to change your mind at any time. We ask that you contact Dr. [PI name] in writing and let [him/her] know you are withdrawing your permission for your tissue/blood/cells to be used for research. [His/her] mailing address is [address]. Any unused tissue/blood/cells will [be destroyed] OR [have all identifying information removed that would link the sample to you. The sample may then be used for other research, but no one will be able to relate those research results to you]. L. PERMISSION TO CONTACT YOU ABOUT FUTURE RESEARCH This section is pending translation into Spanish and Chinese. Investigators who have previously obtained full consent and authorization to contact a research subject as a result of a previously approved research project may contact their former research subjects, provided that the subject agreed to be contacted for information on future research conducted by the same principal investigator or co-investigator(s). Subject’s Initials: ___________ Date: _____________ (IRB Official Use Only) This Consent Document is approved for use by the New York University’s Institutional Review Board (IRB). Only the IRB-stamped approved form may be used. Approved: Start: _______________ End: ______________ (do not use this form after the End date) Document1 page 8 of 10 R# xx-xxxx version 00/00/0000 NYU SoM IRB HRPP The following standard language can be used in consent documents to obtain your subjects‟ permission to be contacted by the principal investigator or co-investigator for future research conducted by original principal investigator or co-investigators: I authorize the principal investigator and his or her co-investigators to contact me about future research on [type of research] within the [department, division or center] provided that this future research is approved by the original IRB of record and that the principal investigator and co- investigator are affiliated with the research protocol. If I agree, then someone from Dr. [your name here]’s research staff might contact me in the future and he or she will tell me about a research study. At that time, I can decide whether or not I am interested in participating [am interested in having my child participate] in a particular study. I will then have the opportunity to contact the researcher to schedule an appointment to be fully informed about the research project. I agree to be contacted by the Principal Investigator or Co-Investigators of the research study titled: [Title of Study] I do not want to be contacted by the Principal Investigator or Co-Investigator of the research study titled: [Title of Study] __________________________________________________________________ Signature of participant or legal representative Date Your permission to allow us to contact you about future research would be greatly appreciated, but it is completely voluntary. If you choose not to allow us to contact you, it will not affect [you OR your child’s care] at any of the NYUSM facilities. Please understand that giving your permission to do this is only for the purpose of helping us identify subjects who may qualify for one of our future research studies. It does not mean that [you OR your child] must join in any study. M. CONTACT PERSON(S) For further information about your rights as a research subject, or if you are not satisfied with the manner in which this study is being conducted and would like to discuss your participation with an institutional representative who is not part of this study, please contact the NYU School of Medicine’s Institutional Review Board at 212-263-4110. If you have any questions or sustain any injury during the course of the research or experience any adverse reaction to a study drug or procedure, please contact the Principal Investigator [your name here] at the following telephone number [your phone here]. AGREEMENT TO PARTICIPATE AND AUTHORIZATION FOR THE USE OR DISCLOSURE OF PROTECTED HEALTH INFORMATION Part of the consent process includes your Authorization to use Protected Health Information for the purposes of this study, as described above. If you do not want to authorize the use of this PHI, you should not agree to be in this study. I have read this consent form or it was read to me by: ______________________. Subject’s Initials: ___________ Date: _____________ (IRB Official Use Only) This Consent Document is approved for use by the New York University’s Institutional Review Board (IRB). Only the IRB-stamped approved form may be used. Approved: Start: _______________ End: ______________ (do not use this form after the End date) Document1 page 9 of 10 R# xx-xxxx version 00/00/0000 NYU SoM IRB HRPP Any questions I had have been answered by: _____________________. I am am not participating in another research project at this time. (If yes, you should discuss this with your study doctor.) I voluntarily agree to participate in this research program at: NYUSM [Skirball Institute; Nelson Institute of Environmental Medicine; Post Graduate Medical School] The Langone Medical Center (Tisch Hospital; the Rusk Institute of Rehabilitation Medicine); Bellevue Hospital Center: this form and your study information will be available to Bellevue Hospital administration and their auditors. Hospital for Joint Diseases Orthopedic Institute; NYU College of Dentistry; The New York Campus of the Veteran’s Affairs New York Harbor Healthcare System. Other, please specify: [specify] I understand that I am entitled to and will be given a copy of this signed Consent/Authorization Form. By signing this Consent/Authorization form, I give my Authorization for the uses and disclosures of my protected health information as described above. WHEN THE SUBJECT IS AN ADULT AND WHEN PARENTAL PERMISSION IS REQUIRED ____________________ _____________________/_____ Print Name of Participant Signature of Participant Date or Legal Representative* or Legal Representative* ____________________ _____________________/_____ Print Name of Person Signature of Person Date Obtaining Consent Obtaining Consent * For subjects who may not be capable of providing informed consent, the signature of a legal representative is required. For a valid HIPAA authorization, the “personal representative” must have authority under state law to make health care decisions for the subject. Use the section below only when a witness will be required. ____________________ _____________________/_______ Print Name of Witness** Signature of Witness** Date ** When the elements of informed consent are presented orally to the subject or representative, a witness to the oral presentation is required. [NOTE: it is unclear whether HIPAA authorization may be presented orally – this might require an IRB waiver to permit alteration of the form of authorization] Subject’s Initials: ___________ Date: _____________ (IRB Official Use Only) This Consent Document is approved for use by the New York University’s Institutional Review Board (IRB). Only the IRB-stamped approved form may be used. Approved: Start: _______________ End: ______________ (do not use this form after the End date) Document1 page 10 of 10
"H_ - NYU Langone Medical Center"