ࡱ> 03-./a bjbj** H=bH=bT tt@@@$dddPT dp pT!L!!!,$B$ N$ppppppp$r~u;pE@'#" $"'';p!!Hp111'!8!p1'p11f(k!:bm(fh4pp0p i.v,.vhk.v@k V$t%1@&&V$V$V$;p;p/\V$V$V$p''''.vV$V$V$V$V$V$V$V$V$tB :  Department Name Department Address City, State, ZIP Phone # Fax # Phone # After following the instructions, please delete all items in red print. If your Consent/Authorization form has an odd number of pages, please remember to include an additional page labeled "NO TEXT THIS PAGE" as page two of the form before copying the entire form double-sided. Please be sure to assign the "NO TEXT THIS PAGE" a page number and include the IRB number. ADULT RESEARCH SUBJECT INFORMATION AND CONSENT FORM and AUTHORIZATION FOR USE AND DISCLOSURE OF PROTECTED HEALTH INFORMATION RESEARCH PROJECT TITLE (Capitalized and bolded, must match the title on the IRB application) Principal Investigator:  FORMTEXT       , [M.D., Ph.D., etc.] Study Coordinator: [Optional]  FORMTEXT       Contact Phone number(s): (419)  FORMTEXT       Study Sponsor: [If applicable]  FORMTEXT       Key Study Information: You may be eligible to take part in a research study. This form contains important information that will help you decide whether to join the study. Take the time to carefully review this information. You should talk to the researchers about the study and ask them any questions you have. You may also wish to talk to others such as your family, friends, or other doctors about joining this study. If you decide to join the study, you will be asked to sign this form before you can start study-related activities. Before you do, be sure you understand what the research study is about. A research study is different from the regular medical care you receive from your doctor. Research studies hope to make discoveries and learn new information about diseases and how to treat them. You should consider the reasons why you might want to join a research study or why it is not the best decision for you at this time. Research studies do not always offer the possibility of treating your disease or condition. Research studies also have different kinds of risks and risk levels, depending on the type of study. You may also need to think about other requirements for being in the study. For example, some studies require you to travel to scheduled visits at the study site in Toledo or elsewhere. This may require you to arrange travel, change work schedules, find child care, or make other plans. In your decision to participate in this study, consider all of these matters carefully. The purpose of this study is [Briefly describe the purpose of the study]. There can be risks associated with joining any research study. The type of risk may impact whether you decide to join the study. For this study, some of these risks may include [Indicate reasonably foreseeable risks. An example is serious health complications.] More detailed information will be provided later in this document. [SELECT ONE OF THE OPTIONS BELOW] [This study may offer some benefit to you now or others in the future by [Briefly summarize]. More information will be provided later in this document. OR [This study may not offer any benefit to you now but may benefit others in the future by [Briefly summarize]. More information will be provided later in this document. We expect the amount of time you will participate in the study will be [Indicate total time commitment]. If you decide not to take part in this research, or if you decide to take part now but change your mind later, your decision will not result in a penalty or a loss of benefits that you would be otherwise be entitled to. Your decision on whether or not to take part in this research will not affect your routine care. Alternatives to joining this study include [Briefly address alternatives such as standard of care alternatives or other clinical trials]. PURPOSE (WHY THIS RESEARCH IS BEING DONE) You are being asked to take part in a research study of state what is being studied. The purpose of the study is to state what the study is designed to discover or test (if the study is for an investigational drug, you should indicate that the study is to test effectiveness and safety of the drug when appropriate in addition to including the sentence: An investigational drug is one which has not been approved by the U.S. Food and Drug Administration (FDA). You were selected as someone who may want to take part in this study because state why the subject was selected and include the approximate (maximum) number of subjects in the study at ProMedica and/or University of Toledo (UT) and elsewhere. DESCRIPTION OF THE RESEARCH PROCEDURES AND DURATION OF YOUR INVOLVEMENT If you decide to take part in this study, you will be asked to describe the procedures to be followed, including the purposes of the procedures, how long they will take, and their frequency. In describing the procedures involved in the study, you should list and describe standard treatment procedures as well as experimental procedures. Please clearly distinguish which procedures are experimental and which are approved standard of care. For approved standard of care procedures, please indicate which of these are being done solely for the purposes of this research. Include the expected duration of the subject's participation. Please list these procedures in an organized manner (e.g. in the order that the participant will be asked to complete them.) A format using bullet points is recommended for research involving multiple procedures and/or visits. If applicable to the study, include a statement about whether clinically relevant research results, including individual research results will be disclosed to subjects, and if so, under what conditions. If applicable to the study, provide a statement about whether the research study will or might include whole genome sequencing. RISKS AND DISCOMFORTS YOU MAY EXPERIENCE IF YOU TAKE PART IN THIS RESEARCH Describe reasonably foreseeable risks, discomforts or inconveniences to persons choosing to take part in this research that are associated with the procedure (experimental or non-experimental) that is being done solely for the purpose of this research. This includes health, legal, economic, psychological, privacy, confidentiality and security risks. When there are multiple risks or discomforts, these should be listed in a bullet point or table format. Be sure to state the likelihood and seriousness of the risks. If this is a treatment study, add this statement: Your condition may not get better or may become worse while you are in this study. State risks related to loss of confidentiality of information, State and explain risks, if any, to pregnant women. If the risk is significant, add the following section (i.e. Risks to Unborn Children). If there is no known additional risk to pregnant women, please state that there are no known additional risk to pregnant women. There may also be risks that we do not know about, or that we cannot reasonably foresee at this time. NOTE: The following section is required if there is a known risk or a potential for risk to unborn children. RISKS TO UNBORN CHILDREN This research represents a significant risk to unborn children. Therefore, if you are a female of childbearing potential, you will be given a pregnancy test prior to the start of this research. If this test is positive, you will not be able to take part in this research. If your pregnancy test is negative at present and you choose to take part in this research, you will be given information on birth control procedures that must be used while you are taking part in this research so that you can avoid getting pregnant. You also will be told about the danger to the fetus (unborn child) should you become pregnant. If applicable, add: Males who are sexually active must take precautions while participating in this research so that that their female partners do not become pregnant. If you are a sexually active male and wish to take part in this research, you will be offered information on birth control procedures that you and your partner must use while taking part in this research so that your female partner does not become pregnant. You also will be advised as to the danger to the fetus should your partner become pregnant. Please be sure to ask the researcher any questions that you may have about acceptable methods of birth control and the risk to you, your partner or your unborn child at any time before or, if you decide to enroll, while you are taking part in this research. RISKS TO PARTICIPATING IN ADDITIONAL STUDIES Being in more than one research study at the same time, or even at different times, may increase the risks to you. It may also affect the results of the studies. You should not take part in more than one study without approval from the researchers involved in each study. POSSIBLE BENEFIT TO YOU IF YOU DECIDE TO TAKE PART IN THIS RESEARCH Describe any non-financial benefits to the subject or to others that may reasonably be expected from the research. Clearly state if the benefit is expected to be primarily for others. If benefits are mentioned, add: We cannot and do not guarantee or promise that you will receive any benefits from this research. ALTERNATIVE(S) TO TAKING PART IN THIS RESEARCH Indicate appropriate alternative procedures or courses of treatment, which may be advantageous to the subject, if any treatment is required. Any standard treatment that is being withheld must be disclosed. Include a statement that one alternative is no further therapy. Palliative care should be included as an alternative if appropriate. IF APPLICABLE, state that a potential participant will receive standard care whether or not he/she participates in the research study. COST TO YOU FOR TAKING PART IN THIS STUDY Specify what costs are the responsibility of the study sponsor and/or Principal Investigator and which are the responsibility of the subject. If there is a possibility of additional costs to the subject because of participation, this must be disclosed. Please note that billing of third-party payors for costs that a subject would not incur if he/she was not taking part in this research is not allowed, unless otherwise allowed by written authorization of the Federal government (as with some special uses of devices/drugs). Billing of third-party payors for routine medical care is allowed only if the cost of the care is not covered by a grant or through a contract with the sponsor. If your research is sponsored, please refer to the approved grant application or executed contract if you have any questions about this. PAYMENT OR OTHER COMPENSATION TO YOU FOR TAKING PART IN THIS RESEARCH If you decide to take part in this research you will receive If the subject will receive any compensation for their participation, describe the amount or nature. Compensation may include money, free treatment, free medications, or free transportation. Money may be offered to reimburse expenses, time, inconvenience and transportation. However, money may not be used as an inducement to assume risks. Pro-rated subject payment based on how much of the study the participant completes must be stated and the method of pro-rating explained. [If applicable, add]: If you receive payment for taking part in this study, ProMedica and/or UT will collect your name, address, social security number, payment amount, and related information. The information collected will be used for processing the payment to you. ProMedica and/or UT is requiredto submit this information to the Internal Revenue Service (IRS) when you receive any individual or collective payments greater than $599. NOTE: The following section must be included for industry-sponsored research in which the institution is being reimbursed for all or some of the costs of the research. PAYMENT OR OTHER COMPENSATION TO THE RESEARCH SITE [To facilitate appropriate disclosure of potential conflicts of interest in the informed consent document, the following suggested language is provided for sponsored studies. Language should be modified to fit the specific facts and circumstances.] This study is paid for by {name of sponsor} which {has no financial interest in its outcome} (or) {owns the drug/device being tested}. The researchers leading this medical research study might benefit financially from this study. Specifically, {name of sponsor} is paying ProMedica and/or UT for some of the salary for the study staff, along with covering the costs of the tests and procedures done during this study. Also, {name of investigator} receives a payment for each patient enrolled in this research study. Then include the following appropriate language if applicable: {Name of investigator} owns equity (stock) of the company that is paying for this research study. The amount of money the investment is worth might be affected by the results of this study. This means that the person running this study could gain or lose money depending on the results of this study. Besides being paid to conduct this study, {name of investigator} also receives money from {name of sponsor} for work that is not part of this study. These activities may include consulting, advisory boards, giving speeches, training other doctors, writing reports, or paying for flights or other travel costs. The researcher conducting this study might receive hundreds or thousands of dollars for this work. {Name of investigator} is an inventor of {name of the drug/compound/device, etc}, for which a patent may be filed by the institution. If the patent is pursued (based on data from this and other research), royalties and other compensation may be received by the institution and the inventor. Thus, ProMedica and/or UT and the study doctor have a potential financial interest in the outcome of this study. Who could profit or financially benefit from the study results? The company whose product is being studied: The researchers conducting the study: ProMedica and/or UT: Research can lead to new discoveries, such as new tests, drugs, or devices. Researchers, their organizations, and other entities, including companies, may potentially benefit from the use of the data or discoveries. You will not have rights to these discoveries or any proceeds from them. CONFIDENTIALITY OF SUBJECT RECORDS AND AUTHORIZATION TO USE AND DISCLOSE YOUR PROTECTED HEALTH INFORMATION The information below describes how the confidentiality of your research records will be protected in this study, and any sub-studies described in this document. Medical information and billing records are protected by the privacy regulations of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA). When this information contains your personal identifiers, it is called protected health information (PHI). By agreeing to take part in this research study, you give to ProMedica and/or UT, the Principal Investigator and all personnel associated with this research study your permission to use or disclose PHI that we obtain in connection with this study. What protected health information (PHI) about me could be seen by the researchers or by other people? Why? Who might see it? We will use this information to describe the use of the information or purpose for disclosing the information, or delete the word "to" and state for the purpose of conducting the research study as described in the research consent and authorization form. There are many reasons why information about you may be used or seen by the researchers or disclosed to others during or after this study. Examples include: The researchers may need the information to make sure you can take part in the study. The researchers may need the information to check your test results or look for side effects. ProMedica and/or UT compliance or legal staff, Food and Drug Administration (FDA) and/or other government officials, auditors, and/or the IRB may need the information to make sure that the study is done in a safe and proper manner. Study sponsors or funders, or safety monitors or committees, may need the information to: Make sure the study is done safely and properly Learn more about side effects Analyze the results of the study Insurance companies, government benefit programs, or other organizations may need the information in order to pay your medical bills or other costs of your participation in the study. Your insurance company may ask us for a signed copy of this informed consent form in order to pre-certify you for the care that is billed to them. Do not delete the bullet below unless you are certain that the data or specimens will not be used for future IRB-approved research studies or a technology transfer or licensing agreement. Contact Office of Technology Transfer if you are uncertain. The researchers may need to use the information to create a databank of information about your condition or its treatment. Do not delete the first bullet below unless you are certain information will not be included in the medical record. Information about your study participation may be included in your regular ProMedica and/or UT medical record. Federal or State law may require the study team to give information to government agencies. For example, to report payments made to you, to prevent harm to you or others, or for public health reasons. The results of this study could be published in an article, but the publication would not include any information that would let others know who you are. What PHI will the researchers obtain? PHI about you may be obtained from any hospital, doctor, and other health care provider involved in your care, including: Anything not included in information to be reviewed or recorded should be removed from the list below. Hospital/doctor's office records, including test results (X-rays, blood tests, urine tests, etc.) Mental health care records (except psychotherapy notes not kept with your medical records) Alcohol/substance abuse treatment records HIV/AIDS status Sexually transmitted disease and/or other communicable disease status Genetic counseling/genetic testing records Health plan/health insurance records All records relating to your condition, the treatment you have received, and your response to the treatment Billing information Demographic information Personal identifiers List other information, if applicable, in a specific and meaningful fashion (similar to other items on the above bullet list) How will researchers protect my information? Describe procedures that will be followed to keep subject information, specimens, and tissues secure and confidential. For example: Your research information will be stored in a locked cabinet and will not be made a part of your regular medical record. However, if the researcher orders any tests, the order and results may become part of your regular medical record." Or: Research records will be kept in a separate research file that does not include names, registration numbers, or other information that is likely to allow someone other than the researchers to link the information to you. [If applicable, add] We may also use your information to contact you after this study is closed to update your contact information should we decide it is important to continue following your progress, or to open a new study to follow-up on people who take part in this study. If post-study contact is optional, add: To authorize research staff from ProMedica and/or UT to contact you to update your information or invite you to participate in a new follow-up study, place your initials here: (opt-in) _____(opt out). If you receive any payments for taking part in this study, your personal information and limited information about this study will be given to ProMedica and/or UTs accounts payable department as necessary to process payment to you. We may also disclose your protected health information when required by law, such as in response to judicial orders. What else should I know about the use and disclosure of my health information? Participation in research involves using and sharing your health information to conduct the research. We will do our best to make sure that information about you is kept confidential, but we cannot guarantee total privacy. ProMedica and/or UT is required by law to protect the privacy of your health information, and to use or disclose the information we obtain about you in connection with this research study only as authorized by you in this form. However, the information we disclose with your permission may no longer be protected by privacy laws. This means your information could be used and re-disclosed by the persons we give it to without your permission. Your permission for us to use or disclose your protected health information as described in this section is voluntary. However, you will not be allowed to participate in the research study unless you give us your permission to use or disclose your protected health information by signing this document. Optional paragraph when subjects access to their protected health information is suspended during a research study that includes treatment: Your access to your own protected health information [or describe with particularity how much of the record is restricted] may be denied during the term of the research study, but you can access your information once the research study is completed. You have the right to revoke (cancel) the permission you have given to us to use or disclose your protected health information at any time by giving written notice to [list the name and address of the research study personnel that should receive the revocation]. However, a cancellation will not apply if we have acted with your permission, for example, information that already has been used or disclosed prior to the cancellation. Also, a cancellation will not prevent us from continuing to use and disclose information that was obtained prior to the cancellation as necessary to maintain the integrity of the research study. Except as noted in the above paragraph, your permission for us to use and disclose your protected health information [state an expiration date or expiration event that relates to the individual or the purpose of the use or disclosure of information. Will stop at the end of the research study or has no expiration date may be appropriate, especially if the study involves the creation or maintenance of a research database or repository.] If you are concerned about a possible violation of your privacy or concerned about a study you may contact the confidential ProMedica Hotline at (419) 824-1815 or (800) 807-2693 or The University of Toledos Privacy Officer at (419) 383-6933. [If applicable, add:] A description of this clinical trial will be available on  HYPERLINK "http://www.ClinicalTrials.gov" http://www.ClinicalTrials.gov, 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 Web site at any time. You can search this Web site at any time and in order to find information on this trial, you can specifically search for NCTXXXXXXXX. What happens to information about me after the study is over or if I cancel my permission to use my PHI? As a rule, the researchers will not continue to use or disclose information about you, but will keep it secure until it is destroyed. Sometimes, it may be necessary for information about you to continue to be used or disclosed, even after you have canceled your permission or the study is over. Examples of reasons for this include: To avoid losing study results that have already included your information To provide limited information for research, education, or other activities. (This information would not include your name, social security number, or anything else that could let others know who you are.) To help ProMedica and/or UT and government officials make sure that the study was conducted properly As long as your information is kept within ProMedica and/or UT, it is protected by the ProMedica and or UTs privacy policies. For more information about these policies, ask for a copy of the ProMedica and/or UT Notice of Privacy Practices. FUTURE USE OF YOUR INFORMATION OR BIOSPECIMENS New element of consent: Include one of the two options below: 1. The identifiable information or biospecimens that are collected from your participation in this research will not be used or distributed for future research. OR 2. With your permission, the identifiable information or biospecimens that are collected from your participation in this research may be used in future research studies without your consent, but only after your identifying information has been removed from the information. If you do not grant permission for your data to be de-identified and used for future research purposes, you can still participate in the research described in this document. Your agreement to this is voluntary and there are no consequences should you decline to allow your data to be used for future research purposes. [Indicate any additional risks the future research may pose and describe efforts to minimize them]. If you agree to allow us to use and/or share your de-identified information or biospecimens for future research purposes, please place your initials here: ____(opt-in) ____ (opt-out) Note for sponsored research: Following review and approval by the sponsor and the ProMedica or UT IRB Offices, the reviewing IRB may request modifications to the indemnification language contained in the In the Event of a Research Related Injury section of the Consent/Authorization form. Grayed language has been approved by Legal Counsel and should not be modified. IN THE EVENT OF A RESEARCH-RELATED INJURY If you suffer a research-related injury, medical treatment is available but you can choose where to go for treatment. The Sponsor has made conditional plans to reimburse ProMedica and/or UT for medical costs for certain research related injuries. You must notify the study doctor right away so that the doctor can notify the Sponsor. The study doctor can provide further information about reimbursement from the Sponsor. The Sponsor does not offer other compensation. Delete this paragraph if payment for injury is not available from the sponsor, such as for investigator-initiated or government-sponsored research. ProMedica and/or UT does not offer reimbursement for medical expenses or other compensation for research-related injuries. In the event that any medical expenses are not reimbursed by the Sponsor, they will be billed to you or your insurance. By signing this form you do not give up any of your legal rights if you are injured. In the event of a research-related injury, contact: You must provide the name and 24-hour phone number the responsible contact person(s) here. Please be sure to separate this statement from the rest of the sentence so that it can be easily identified. By signing this form you do not give up any of your legal rights if you are injured. The researchers have taken steps to minimize the risks of this study. Even so, you may still have problems or side effects, even when the researchers are careful to avoid them. Please tell the researchers about any injuries, side effects, or other problems that you have during this study. You should also tell your regular doctors. VOLUNTARY PARTICIPATION Taking part in this study is voluntary. You may refuse to participate or discontinue participation at any time without penalty or a loss of benefits to which you are otherwise entitled. If you decide not to participate or to discontinue participation, your decision will not affect your future relations with ProMedica and/or UT, its personnel, and associated facilities. NEW FINDINGS You will be notified of new information that might change your decision to be in this study if any becomes available. Study specific option. POST-STUDY COMPLETION PERMISSION TO CONTACT Participation in this study includes permission to contact you after the study ends (specify frequency) to update your contact information so we know how to reach you should we decide that it is important to continue following your progress or open a new study to follow-up on people who take part in this study. We may also ask questions about (specify). [If applicable] OTHER IMPORTANT INFORMATION If the research involves a study drug or placebo that is being taken home, include: It is important that you are the only one that takes the investigational drug or placebo that you are given as part of this research. (NOTE: Delete placebo if not applicable) It is very important that you keep it (these) out of the reach of children and persons who may not be able to read or understand the label. ADDITIONAL ELEMENTS Include this section when there is information that needs to be included in this document, but does not apply to the other sections. If applicable to the study, include a statement of the consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject. If applicable to the study, include anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent/authorization and procedures for orderly termination of participation by the subject. If applicable to the study, include a statement that biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit. Example: Although the results of research, including your donated materials, may be patentable or have commercial value, you will have no legal or financial interest in any commercial development resulting from the research. Note: All of the following information (from "Offer to Answer Questions" to the end of the document) is an integral part of the consent form and cannot be divided between two pages. Please remember to insert an additional page in this document (as the 2nd single sided page) with "NO TEXT THIS PAGE" typed on it when appropriate (see instructions on top of first page) if this document has an odd number of single-sided pages. If there is a large gap in text between "Offer to Answer Section" and the section prior to it, please type "CONTINUED NEXT PAGE" in the gap. OFFER TO ANSWER QUESTIONS Before you sign this form, please ask any questions on any aspect of this study that is unclear to you. You may take as much time as necessary to think it over. If you have questions regarding the research at any time before, during or after the study, you may contact[insert name of one or more researchers and their telephonenumber(s)]. If you have questions beyond those answered by the research team or your rights as a research subject or research-related injuries, please feel free to contact the Chairperson of the ProMedica Institutional Review Board at 419-291-5362 or The University of Toledo Institutional Review Board at 419-383-6796, during office hours Monday through Friday, 8 a.m. to 4:30 p.m. SIGNATURE SECTION (Please read carefully) YOU ARE MAKING A DECISION WHETHER OR NOT TO PARTICIPATE IN THIS RESEARCH STUDY. YOUR SIGNATURE INDICATES THAT YOU HAVE READ THE INFORMATION PROVIDED ABOVE, YOU HAVE HAD ALL YOUR QUESTIONS ANSWERED, AND YOU HAVE DECIDED TO TAKE PART IN THIS RESEARCH.BY SIGNING THIS DOCUMENT YOU AUTHORIZE US TO USE OR DISCLOSE YOUR PROTECTED HEALTH INFORMATION AS DESCRIBED IN THIS FORM.The date you sign this document to enroll in this study, that is, todays date, MUST fall after the approval date OR between the approval and expiration dates indicated on the IRB approval stamp located on this document. The date(s) indicate that this form is valid when you enroll in the study but does not reflect how long you may participate in the study. It is the responsibility of the study team to ensure that you are signing the currently approved version of the informed consent form.Name of Subject (please print)Signature of Subject or Person Authorized to ConsentDatea.m.Relationship to the Subject (Healthcare Power of Attorney authority or Legal Guardian)Timep.m. Name of Person Obtaining Consent (please print)Signature of Person Obtaining ConsentDate Name of Witness to Consent Process (when required by ICH Guidelines) (please print)Signature of Witness to Consent Process (when required by ICH Guidelines)Date YOU WILL BE GIVEN A SIGNED COPY OF THIS FORM TO KEEP.   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