THOMAS JEFFERSON UNIVERSITY



Jefferson Office of Human ResearchAddendum to Consent Form OHR-8DVersion Date – FOR OHR USE: 5/22/20Department:Principal Investigator:Study Title:Lay Title:To complete this addendum, please modify it as appropriate for your study. Generally, you will modify the yellow highlighted text as appropriate for your study or remove it if it is a note to you, the author. As you work, please remove all highlighting and prompts to the author. _Add entity, such as Abington-Jefferson Health at_ Thomas Jefferson University [Jefferson] and __________________ have entered into an IRB Authorization Agreement (IAA). This agreement enables both institutions to enroll patients into a study for which Jefferson is relying on the approval and regulatory oversight of the __________________ IRB. The __________________ IRB has reviewed and approved the protocol and consent form for this study.This addendum provides additional information for participants being enrolled at Jefferson, and that is not included in the __________________consent form being used for this study. Keep, and modify, the below Payment section if there are changes specific to the site that differ from the main, approved consent. Otherwise, delete the payment section. PaymentDescribe the payment schedule and/or reimbursement that is specific to your site. If this research or the information or specimens you provide result in commercial profit, you will not receive any money from that profit.CostsYou may have costs for participating in this study. This section MUST be consistent with the budget. Delete the sections below that do not apply. Contact your budget administrator with any questions.Option 1: For studies with no billable activity, or the sponsor pays for everything.There will be no study related items or services billed to you or your insurance company. You may be responsible for other costs. There is no plan to pay you for lost wages, lost time from work, personal discomfort, or for injuries or problems related to your underlying medical condition(s). If you receive a bill that you think is wrong, please contact the research personnel. Delete the following if covered in Payment section in the table above if subjects will receive payment for such items. You will be responsible to pay for your travel to and from the study site and other out-of-pocket expenses such as parking. Option 2: For studies with billable activity and the sponsor is not paying for everything.The study drug(s)/device will be provided to you free of charge. There may be items or services performed during your participation in this study that will be paid for by the sponsor.There may be costs to you for taking part in the study. Some of the procedures and services performed in the study are part of the regular treatment for your condition. These would be performed even if you were not enrolled in the study. The costs for these procedures and services will be billed to your insurance. Additional items may also be billed to your insurance while you are taking part in the study. These items may include administration of the study drug, as well as procedures and services to prevent, diagnose or treat potential complications arising from your participation in the study. You will be responsible for any costs your insurance does not cover. You will be responsible for insurance co-pays and deductibles.There is no plan to pay you for lost wages, lost time from work, personal discomfort, or for injuries or problems related to your underlying medical condition(s). If you receive a bill that you think is wrong, please contact the research personnel. Modify the follow as applicable. You will be responsible to pay for your travel to and from the study site and other out-of-pocket expenses such as parking.You should talk to your insurance carrier to find out what costs you will need to pay before taking part in this study. If you are a Medicare beneficiary and have opted for a Medicare Advantage plan to manage your health care needs, your out-of-pocket expenses may increase while you are on this study.?Depending on your insurance carrier, some of the costs not covered by your insurance may be sizeable. Financial assistance may be available under the institution’s Charity Care Policy and Procedure. For Abington-Jefferson Health. If you are taking part in the study at Abington-Jefferson Health, you may contact a financial counselor to assist you by calling Abington-Jefferson Health Patient Service Center at 215-481-5777.For NCI Supported Trials. For more information on clinical trials and insurance coverage, you can visit the National Cancer Institute’s website at and type “paying for clinical trials” into the website’s search bar. Another way to get this information is to call 1-800-4-CANCER (1-800-422-6237) and ask them to send you a free copy.End of Option 2Research-Related InjuryThis section MUST be consistent with the contract. Delete the section below that does not apply. Contact your contract specialist with any questions.Option 1: For all Commercially Sponsored Research.There is a possibility that you could have research-related injury, which is an illness or an injury that is directly caused by the study drug(s)/device or a study procedure. If you have a research-related injury, reasonable and necessary medical care will be available to you. The cost of care for the research-related injury will be paid by the sponsor of the study.Option 2: For all Government, Philanthropic, or Jefferson Sponsored Research.There is a possibility that you could have research-related injury, which is an illness or an injury that is directly caused by the study drug(s)/device or a study procedure. If you have a research-related injury, we will offer you reasonable and necessary care to treat injuries directly resulting from taking part in this research. Neither Jefferson nor the study will pay for costs associated with treatment of research-related injury or illness. These costs may be billed to your insurance. In addition, you will be responsible for any deductibles and co-payments required under your health plan and for any claims ultimately denied by your health plan. There are no plans for Jefferson to pay you or give you other compensation for the injury. If you think you have been injured as a result of taking part in this research study, tell the research personnel as soon as possible. Please see the contact information in this addendum.Disclosure of Financial InterestComplete if applicable Jefferson is being paid by Insert Entity to conduct this study. Add any other financial disclosures for Jefferson or the investigators/study personnel.Privacy and Confidentiality: HIPAA AuthorizationThe following terms and conditions of confidentiality are the same at both institutions. Information will be collected about you for this study. The information will be seen by the people involved with this research. Steps will be taken to protect your identity. But the information collected about you can never be 100% secure. HIPAA (Health Insurance Portability and Accountability Act) – This is the law that protects your personal health information.To do this study, we need to collect, use, and share your personal health information. This form will explain why your information is being collected, what information will be collected, and who will have access to it. By signing, you are giving us permission to use your information as described in this form.We are committed to respecting your privacy and to keeping your personal health information confidential. Your personal health information includes the information in your health care records and information that can identify you. For example, personal information may include your name, address, phone number, social security number, and medical information. The personal health information that may be collected, used, and shared for this research includes:Information from your medical recordsDemographic information such as name, gender, birth date, ethnicity, medical history, and health care providersPhysical examinations, procedures, tests, labs, your medical conditions, and medications you useInformation collected about any research related injuryInformation about mental health, sexually transmitted diseases, HIV, AIDS, drug and alcohol use, genetic test results, and other sensitive informationList any additional information that will be collected that is not included above. Examples: demographics including race and ethnicity (required if the research is federally funded), labs, imaging results (e.g., x-rays), questionnaires, photos, video, audio and any other information/results collected for this study.Your personal information will be used by and shared with the following:Modify the list below as necessary.Personnel at Thomas Jefferson University and its affiliates for the purpose of this researchResearch personnel at RothmanInstitutional Review Boards (ethics committees that review research) including insert reviewing IRB(s)Health insurance providersInsert Sponsor (sponsor), which is providing money to the researcher to carry out this researchResearch monitors hired by the sponsor to oversee the study and review health care records to ensure study-related information is correctGovernment Agencies like the Food and Drug Administration (FDA)An organization such as a contract research organization (CRO) that has been hired to coordinate the study (Specify if known)Public health authorities who monitor such things as sexually transmitted diseases, HIV, AIDS, child abuse, as required by lawGroups monitoring the safety of the study such as a data and safety monitoring committeeOthers as required by lawAdd others as necessaryWhen your personal information is provided to some of the people listed, it may no longer be protected under the HIPAA privacy law. You can see your health care records at any time. However, generally you will not be able to see your study records or the study results until the study is completed. A copy of this signed form, information about this study, and the results of any study test or procedure may be included in your health records which may be seen by your insurance company and your health care providers. This authorization does not have an expiration date. Please inform the investigator in writing if you want to end your permission to collect information/samples. Please note that anything already collected will still be used and you may not be able to continue in this study.The information from this study may be published in scientific journals or presented at scientific meetings, but you will not be personally identified.A description of this study will be available on , as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.One of the following statements must be included if the research involves the collection of identifiable private information or identifiable biospecimens.Your private information and specimens, with the identifiers removed, could be used for future research studies or distributed to other researchers for future research studies without your additional permission. ORYour private information and specimens will not be used or distributed for future research studies, even if the identifiers are removed.ContactsIf you are having a medical emergency, call 911 or go directly to an emergency room. You should let emergency personnel or providers know that you are taking part in this study.Add contact information/phone numbers as needed.For Questions About:Person or OfficeContact InformationThe Study or Research Related InjuryMain Investigator: NameInvestigator: NamePhone NumberPhone NumberIf you need to contact someone other than the study personnel about a concern or your rights as a research subjectJefferson Center CityInstitutional Review Board (Ethics Committee)215-503-0203215-503-8966215-955-4239Please delete if the study is not being done at Abington.If you need to contact someone other than the study personnel about a concern or your rights as a research subjectAbington-Jefferson HealthThe Director of Risk Management at Abington-Jefferson HealthInstitutional Review Board (Ethics Committee) at Abington-Jefferson Health215-481-2209215-481-7467SignaturesMake sure the finished signature page fits on one page.Patient/Subject: By signing this form, you are agreeing that:You were given the opportunity to read this form.All of the information in this form was discussed with you by an investigator or other research personnel to your satisfaction.All your questions have been answered to your satisfaction.You were not pressured and you voluntarily agree to take part in this research.______________________ ______________________ __________Your NameYour Signature Date______________________ ______________________ __________Name of Person Obtaining/Signature of Person Obtaining/ DateAssisting with ConsentAssisting with Consent Choose one of the following 3 options for the investigator’s signature. This applies to all Jefferson studies regardless of location.Include for studies involving any MCARE procedures (See OHR policy IC 701).The physician investigator’s signature certifies that s/he personally provided the study participant with a description of the study, study procedures, risks, benefits and alternatives to participation.Include for studies that receive FULL IRB review (initially or at any time) but do not include any MCARE procedures (See OHR policy IC 701).The investigator’s signature certifies that s/he personally provided the study participant with a description of the study, study procedures, risks, benefits and alternatives to participation.Include for all other studies.The investigator’s signature certifies that the study participant has been provided with a description of the study, study procedures, risks, benefits and alternatives to participation. ______________________ ______________________ __________Name of InvestigatorSignature of Investigator Date______________________ ______________________ __________Name of WitnessSignature of Witness Date(Witness required if the only language the subject speaks and understands is English, but the subject cannot read English, or if the subject is blind or cannot physically sign the consent form.)If you will be consistently using a different method (e.g., EPIC, consent checklist) of documenting that a copy of the signed and dated consent form was given to the Subject/Parent/LAR, the following checkbox may be deleted. FORMCHECKBOX Copy of Signed and Dated Consent Form Given to the Subject/Parent/LAR______________________ ______________________ __________Name of MinorSignature of Minor Date(If subject is a minor and this addendum is being used both as consent and assent form.) ................
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