ࡱ> $[ abjbj yjijiWO$PR,~ l~2!!L"""$$ $#l%l%l%l%l%l%l$:oqIl-*x$@$"**Il""xvl...*vR"8"#l.*#l..cl"h"0^M1+e4ll0ler7,xrhh,rh8%rv&.~'R(i%%%IlIl-%%%l****r%%%%%%%%%X :  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 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. 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 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. 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]. Your participation is voluntary. You can decide not to be in this study, or agree to take part now and change your mind later. If you decide to take part in this research or not, or if you decide to take part now but change your mind later. Alternatives to joining this study include [Briefly address alternatives such as standard of care alternatives] 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 or device, you should indicate that the study is to test effectiveness and safety of the drug or device when appropriate in addition to including the sentence: An investigational drug or device 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 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 procedures as well as experimental procedures. Please clearly distinguish which procedures are experimental and which are not standard procedures (if applicable). For standard 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 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. 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. 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. 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 according to  HYPERLINK "http://hsc.utoledo.edu/research/subject_injury_policy.pdf" UTs policy pertaining to subject injury (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, TheUniversity of Toledo 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. TheUniversity of Toledo 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 The University of Toledo is receiving money or other benefits from the sponsor of this research as reimbursement for conducting the 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. CONFIDENTIALITY Describe procedures that will be followed to keep subject information, specimens, and tissues secure and confidential. For example: Participation in research involves collecting and using your personal information to conduct research. The members of the research team will use this information, together with the data or other information collected from you as described above in the Description of Research Procedures section, for the purpose of conducting this research study. Research records will be stored in a locked cabinet 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. We will do our best to make sure that information about you is kept confidential, but we cannot guarantee total privacy. New element of consent: Include one of the three options below: 1. The identifiable data and/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 data and/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. If you do not grant permission for your data and/or biospecimens 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 and/or biospecimens 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 data for future research purposes, please place your initials here: ____ (opt-in); if not ____ (opt-out) [delete if not applicable] If you agree to allow us to use and/or share your de-identified biospecimens for future research purposes, please place your initials here: ____ (opt-in); if not ____ (opt-out) [delete if not applicable] OR (To be used only in cases where the sponsor requires data and/or biospecimens ownership to participate in the research) 3. The identifiable data and/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. If you do not grant permission for your data and/or biospecimens to be de-identified and used for future research purposes, you cannot participate in the research described in this document. Your agreement to this is voluntary and your clinical care will not be affected should you decline to allow your data and/or biospecimens 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 data for future research purposes, please place your initials here: ____ (opt-in); if not ____ (opt-out) [delete if not applicable] If you agree to allow us to use and/or share your de-identified biospecimens for future research purposes, please place your initials here: ____ (opt-in); if not ____ (opt-out) [delete if not applicable] 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. Under some circumstances, the Institutional Review Board, or the Research and Sponsored Programs of the University of Toledo or their designees may review your information for compliance audits. If you receive any payments for taking part in this study, your personal information and limited information about this study will be given to The University of Toledos accounts payable department as necessary to process payment to you. We may also disclose your personal information when required by law, such as in response to judicial orders. You have the right to revoke (cancel) the permission you have given use to use your personal information at any time by giving written notice to the principal investigator. However, the cancelation will not prevent us from using information obtained prior to the cancelation as necessary to maintain the integrity of the research study. [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. Note for sponsored research: Following review and approval by the sponsor and the UT Research and Sponsored Programs Administration, the UT 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 The University of Toledo for medical costs for certain research related injuries. 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. The University of Toledo and The University of Toledo Medical Center do 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. 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 the University of Toledo or The University of Toledo Medical Center. 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 study 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. If any member of the research team has a potential financial conflict of interest in the outcome of the study, subjects must be informed about the nature of the conflict. Example text: [Name of conflicted individual] is a named inventor on patents or patent applications or is the creator of copyrighted material that is licensed or optioned to [company name] that will be used in this research. This means [conflicted individual] could gain financially from this study. 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 University of Toledo Biomedical [or Biomedical Cancer] Institutional Review Board at 419-383-6796. 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.The date you sign this document to enroll in this study, that is, todays date, MUST fall between the dates indicated on the approval stamp affixed to the bottom of each page. These dates indicate that this form is valid when you enroll in the study but do not reflect how long you may participate in the study. Each page of this Consent Form is stamped to indicate the forms validity as approved by the UT Biomedical [or Biomedical Cancer] Institutional Review Board (IRB).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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