STANFORD SAMPLE CONSENT FORM



<<INSTRUCTIONS PAGE>>Informed consent is required to provide potential participants or their legally authorized representatives with the information necessary for a “reasonable person” to make an informed decision about participating in research. Information in the consent form must be organized to facilitate comprehension. Consent documents should be written in plain language, generally at the 8th grade reading level. Consent text instructions are highlighted in blue and should be deleted.Required language:? Denotes text that must appear verbatim# Denotes required text that must appear - use verbatim or in variationBlue text represents information about the study that you must add.Be sure to use plain language to define all medical terms. See Lay Language Glossary and other resources Consider using large font if you anticipate recruiting participants with visual impairments, e.g., older populations, or for eye studiesUse a file name for each consent document that clearly identifies the type of consent and for which participants it is intended (e.g., adult informed consent, parental informed consent, etc.).For questions about informed consent, please contact irbeducation@stanford.edu. -------------Delete the information above this line before submitting--------------*Are you participating in any other research studies? _____ yes _____no# Concise Summary: Because your study is federally supported, new regulations require the consent form include a concise summary of the key information that a reasonable person would want to have in order to make an informed decision about whether or not to participate in the research. ?Use the bulleted list below to draft your key information as a concise summary, and insert that language into the beginning of the consent, just before the “Purpose of the Research” section:The fact that consent is being sought for research and that participation is voluntary; The purpose(s) of the research, expected duration of the subject's participation, and the procedures to be followed in the research;Reasonably foreseeable risks or discomforts;Benefits to subjects or others that may be reasonably expected from the research; and Appropriate alternative procedures or courses of treatment, if any that might be advantageous to the prospective subject. Other topics to consider:Most important reason why a participant would and would not want to participate.How will they feel during the study?What is the science?What's the difference between being in the study, and being treated for their condition?Will someone profit from the use of their samples or data?? Will they?What happens if they want to stop?Have other people taken this drug/used this device?? What happened to them?PURPOSE OF RESEARCH You are invited to participate in a research study of (state what is being studied). We hope to learn (state what the study is designed to discover or establish). You were selected as a possible subject in this study because (state why the subject was selected).If this study is being conducted jointly by investigators at both the VA Palo Alto and Stanford University, add the following:This study is being done together by researchers at VA Palo Alto and Stanford University. #This research study is looking for state number of people with disease or condition. Clarify if enrollment will occur throughout the United States or internationally. The VA Palo Alto expects to enroll state number of people research study subjects. VOLUNTARY PARTICIPATION *Your participation in this study is entirely voluntary. Your decision not to participate will not have any negative effect on you or your medical care. You can decide to participate now, but withdraw your consent later and stop being in the study without any loss of benefits or medical care you are entitled to. DURATION OF STUDY INVOLVEMENT This research study is expected to take approximately x days, weeks, months, etc. (e.g., this is a 2 year study; 28 days of active participation by each participant; and 180 days collection of information for each participant).If there is a washout period, explain this in lay terms, including the length of time.If there is a follow-up period, state so and the expected length of time.PROCEDURESIf you choose to participate, the investigators will describe all procedures to be followed. Consider inserting a simple chart or calendar; if using a schedule of events from a sponsor protocol, please use lay language within or define all acronyms. Images and diagrams can be very helpful to participants. Chronological descriptions are also helpful. Use lay terminology throughout and define all medical terms. Include the following, as applicable, in this section of the consent:Clearly identify what is experimental in this study.State the purpose(s) of the procedures. Suggestion: refer to your protocol to assist you in identifying all protocol-related procedures.State how often each procedure will be done and how long it is expected to take.Identify invasive procedures, where applicable.If photo/video/audio recording add: You will be asked to (describe video/audio recording, how they will be used for the research, whether they will be disclosed outside VA, and what will become of recordings after use, e.g., shown at scientific meetings; describe the final disposition of the recordings. If disclosed to an outside entity, this must be stated in the HIPAA authorization).If contraception is recommended, describe specifics for all participants For labs and specimen collection: State what specimens will be obtained and the estimated frequency, volume, or size. The total volume should be calculated and presented to the participant in lay terms, e.g., the number of tablespoons of blood drawn.If specimens will be sent out of VA Palo Alto for analysis, include a statement: *Your specimens will be sent [insert where specimens will be sent] for analysis.If specimens could be part of, or lead to the development of a commercially valuable product, include the following: The research we conduct using your [blood] may result in inventions or discoveries that could be used to make new products or diagnostic or therapeutic agents. These inventions and discoveries may become financially valuable. You will not receive any money or other benefits from any commercial or other products that are made using your specimens.If leftover specimens will be destroyed at the end of the study add the following: *Any specimens left over after analysis will be destroyed when the study is completed. If specimens will be saved for future research, see Specimen banking for future research text. Use the following subsections below if applicable to your study:MRIPeople of Childbearing PotentialSpecimen banking for future researchGenetic testing (current study or future research)Gene transferIf your protocol uses MRI, insert the following MRI risks paragraph(s): MRI (magnetic Resonance Imaging)MRI machines use a strong magnet and radiofrequency magnetic fields to make images of the body interior. The scanning procedure is very much like an X-ray or CT scan. You will be asked to lie on a long narrow couch for a certain amount of time (state how long) while the machine gathers information. During this time you will not be exposed to x-rays, but rather a strong magnetic field and radiofrequency magnetic fields, which you will not feel. You will, however, hear repetitive tapping noises that arise from the Magnetic Resonance (MR) scanner. We will provide earplugs or headphones that you will be required to wear. The space within the large magnet in which you lie is somewhat confined, although we have taken many steps to relieve the "claustrophobic" feeling.The following language is recommended for studies performed at the Lucas Center. Others might consider similar language if the scan is not a diagnostic study:The scans performed in this study are for specific research purposes and are not optimized to find medical abnormalities. The investigators for this project may not be trained to perform medical diagnosis. The investigators are not responsible for failure to find existing abnormalities with these MRI scans. However, on occasion the investigator may notice a finding on an MRI scan that seems abnormal. If this occurs, a doctor will be asked to look at the images to see if any medical follow-up is needed. If so, the investigator will contact you and recommend you inform your doctor about the findings. Because the images are taken using research settings they will not be made available for clinical purposes.The following language is recommended when people of childbearing potential (non-pregnant) will be enrolled in an investigational study.People of Childbearing PotentialIf you are a person who is able to become pregnant, it is expected that you will use an effective method of birth control to prevent exposing a fetus to a potentially dangerous agent with unknown risk. If you are pregnant or currently breast feeding, you may not participate in this study. You understand that if you are pregnant, if you become pregnant, or if you are breast-feeding during this study, you or your child may be exposed to an unknown risk [or state specific risk].To confirm to the extent medically possible that you are not pregnant, you agree [to have a pregnancy test done before beginning this research study] or [to begin the study after the onset of your next menstrual period] (choose one). You must agree to avoid sexual intercourse or use a birth control method judged to be effective by the investigator and which will not interfere with the proposed investigation. You must accept the risk that pregnancy could still result despite the responsible use of reliable method of birth control. You agree to notify the investigator as soon as possible of any failure of proper use of your birth control method, or if you become pregnant, either of which may result in your being withdrawn from the study.If there are risks associated with causing a pregnancy, add appropriate language. e.g., If you are participating in this study and you could cause your partner to become pregnant, you and your partner must use adequate contraception while you are participating in the study and for at least insert time after last dose of study drug, e.g., 12 weeks after taking your last dose of study medication. Your doctor will discuss with you what methods of birth control are considered adequate. You should inform your study doctor if your partner becomes pregnant.If your study involves pregnancy testing and children, please note that there are California minor consent laws that impact how pregnancy results can be communicated. Please add this language to your consent form:As part of this study, pregnancy testing will be performed. The results of pregnancy tests for those under 18 are confidential according to California Minor Consent Laws. If you are a parent whose child is participating in this study, results will be given to your child by one of the study nurses or doctors in private. Every effort will be made to maintain confidentiality regarding positive pregnancy test results. Although we will not typically tell parent(s) or guardian(s) without your child's permission, under certain circumstances, we might be compelled to reveal this information. For example, if your child's life or someone else's life is at risk or if abuse is suspected, it may be necessary to inform you as parent(s) or guardian(s) of a positive pregnancy test. If we believe it's necessary to tell a parent or guardian of a positive pregnancy test without your child's permission, we will meet with your child first in private to discuss our concerns before divulging any information regarding pregnancy. During research, if your child has a positive pregnancy test, we may withdraw your child from the study. This means that even if we do not reveal the results, you may suspect that your child is pregnant despite our best efforts to maintain confidentiality. If your child becomes pregnant or if there is any chance that your child is pregnant (late menstrual period), please contact the study personnel immediately so that we may provide medical assistance and counseling.Reportable Communicable Diseases (e.g., COVID-19, HIV)You will be tested for communicable diseases list which: COVID, HIV, etc. as part of this research study. If your test results are positive, the results will be reported to health authorities as required by law. If testing for HIV, include this statement:If you test positive for HIV, counseling will be provided.Specimen Sampling for Research Research using specimens is an important way to try to understand human disease. You have been given this information because the investigators want to include your specimens in a research project and because they want to save the specimens for future research. There are several things you should know before allowing your specimens to be studied. Your specimens will be stored (insert how specimens will be stored - and if appropriate how specimens will be linked) e.g., under diagnosis and medical record or code number and unlinked. The results of the study of your specimens will be used for research purposes only and you will not be told the results of the tests. Or You will be told the results of tests that are part of your clinical care, but you will not be told the results of the research tests, including any future research tests. Specimen Banking for Future Research The following information must be included in your consent if you plan to save specimens for future uses:What specimens will be saved (i.e. blood, urine) Where the specimens will be stored (i.e. VA Palo Alto) The types of future research that the specimens will be used for, if knownThe length of time the specimens will be storedThat the specimens will be labeled with a code that doesn’t contain any personal identifiers (i.e., protected health information as defined by HIPAA) and whether the participant’s clinical information will be linked to the specimenWhen and under what conditions research results will be conveyed to the subject, the subject’s family, or the subject’s physician:Note: Laboratories that test human specimens cannot report patient specific results for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of individual patients unless the laboratory is Clinical Laboratory Improvement Amendments of 1988 (CLIA) certified.The steps necessary for the subject to withdraw their consent for any future uses of their specimens, and information on the continued use of information already collected and the disposition of specimens. Any potential commercial benefits, and if the subject will receive money or other benefitsAny intent to perform genetic testsAny potential risks to the subject or the subject’s family Potential risks may include breach of confidentiality, which may lead to discrimination in the areas of employment, insurability, social stigmatization, or psychological stress caused by disclosure of adverse information to the subject or the subject’s family:Example: As part of this research we would like to save [leftover blood specimens] for future research. Your [blood specimens] will be stored at the Palo Alto VA and will be used for future research on [Alzheimer’s disease and related diseases]. Your specimens will be [pick one of the following (1) stored for [enter number of years] and then destroyed or (2) stored and used for research until the specimen is all used up]. Your specimen and information about you will be labeled with a code that does not contain your name, initials, SSN, date of birth, or other ways that identify who you are. The research we conduct with your [blood] is being done for research purposes only and we will not tell you or your doctor about the results of the research. You may withdraw your permission for us to use your blood for future research at any time. Contact the [Investigator] at [phone number] to withdraw your permission. If you take back your permission, the research team can continue to use information about you collected before you decided to take back your permission, but they will not collect any information about you going forward and any remaining specimens will be destroyed. The research we conduct using your [blood] may result in inventions or discoveries that could be used to make new products or diagnostic or therapeutic agents. These inventions and discoveries may become financially valuable. You will not receive any money or other benefits from any commercial or other products that are made using your specimens.__________ Yes, I give permission for my specimens to be saved for future research, as set-forth above.__________ No, I do not give permission for my specimens to be saved for future research.Include the following language if specimens in study will be used for genetic testing or if future research on specimens will include genetic testing.Specimen Sampling for Genetic TestingGenetic tests will be conducted on your specimens.? The tests we plan to do will allow us to study [describe the scope of the anticipated genetic testing, such as, reactions to medications, responses to treatment, gene sequences, genetic landmarks, gene biochemistry, gene characteristics and gene versions that are transmitted by parents to children].? Sometimes patients have been required to furnish information from genetic testing for health insurance, life insurance, and/or a job.? A Federal law, the Genetic Information Nondiscrimination Act of 2008 (GINA), generally makes it illegal for health insurance companies, group health plans, and employers with 15 or more employees to discriminate against you based on your genetic information. A statement on whether or not whole genome sequencing will occur (include for all research involving specimens): * The process of determining all or nearly all of your DNA sequence is called whole genome sequencing. It is different from genetic testing that does not involve whole genome sequencing because it provides a much more detailed snapshot of your genome. This research [will/might/will not] include whole genome sequencing.We will protect the confidentiality of your specimens and information about you. Your specimens will be stored in a locked area and all information about you will be stored in a locked file cabinet or on a password protected secure computer. If the protocol involves genetic information that will be deposited in NIH-supported repositories the following three paragraphs must be included:Genetic Information SharingInformation from analyses of your coded specimens and your coded information will be put into one of the National Institutes of Health (NIH) databases along with information from the other research participants and will be used for future research. These databases will be accessible by the Internet. Only anonymous information from the analyses will be put in a completely public database, available to anyone on the Internet. No traditionally-used identifying information about you, such as your name, address, telephone number, or social security number, will be put into the public database. While the public database will not contain information that is traditionally used to identify you, people may develop ways in the future that would allow someone to link your genetic information in our databases back to you. For example, someone could compare information in our databases with information from you (or a blood relative) in another database and be able to identify you (or your blood relative). It also is possible that there could be violations to the security of the computer systems used to store the codes linking your genetic information to you. However, your privacy is very important to us and we will use safety measures to protect it. Despite all of the safety measures that we will use, we cannot guarantee that your identity will never become known.If the protocol involves gene transfer the following must be included:Gene Transfer StudiesA statement with the approximate number of people who have previously received the genetic material under the study. Explain the purpose and duration of long-term follow-up observations, the time intervals, the locations at which you plan to request the subjects to have scheduled study visits or be contacted by other means, and details as to what those contacts will involve.To obtain vital information about the safety and effectiveness of gene transfer, at the time of death, no matter what the cause, permission for an autopsy will be requested of your family. Please advise your family of this request and of its scientific and medical importance. Neither you nor your family will be liable for any costs associated with the autopsy procedure.PARTICIPANT RESPONSIBILITIES As a participant, your responsibilities include: Choose applicable points; refer to your protocol to ensure participants know what is expected of them:*Follow the instructions of the investigators and study staff.Take the study drug as instructed (if device, explain what is required for study compliance).Keep your study appointments. If it is necessary to miss an appointment, please contact the investigators or research study staff to reschedule as soon as you know you will miss the appointment.Tell the investigators or research study staff about any side effects, doctor visits, or hospitalizations that you may have.Tell the investigators or research staff if you believe you or your partner might be pregnant.Keep the study drug in a safe place, away from children and for your use only.Keep your diaries as plete your questionnaires as instructed.Ask questions as you think of them.Tell the investigators or research staff if you change your mind about staying in the study.WITHDRAWAL FROM STUDYIf you first agree to participate and then you change your mind, you are free to withdraw your consent and stop your participation at any time. If you decide to withdraw from the study, you will not lose any benefits to which you would otherwise be entitled [(if applicable) and your decision will not affect your ability to receive medical care for your condition]. If you want to stop being in the study you should tell the investigators or study staff. You can do this by phone by calling [insert investigator or study staff contact] at [insert telephone number]. Clearly outline the study withdrawal procedures (Suggestion: check your protocol).If you withdraw from the study, or the study medication is stopped for any reason, add anticipated consequences, if any, of discontinuing the study drug or device. Clearly state the protocol-specific termination procedures. Instruct subjects that they must return all study-related supplies, including unused study drug.#The investigators may also withdraw you from the study and the study medication may be stopped without your consent for one or more of the following reasons: (Note to investigator: check your protocol; you may use these reasons and/or add some of your own).*Failure to follow the instructions of the investigators and/or study staff.The investigators decide that continuing your participation could be harmful to you.Pregnancy (if applicable).You need treatment not allowed in the study.The study is cancelled. Other administrative reasons.*Unanticipated circumstances.If FDA regulated, add the following:Data collected on you to the point of withdrawal remains part of the study database and may not be removed per the Food and Drug Administration. POSSIBLE RISKS, DISCOMFORTS, AND INCONVENIENCES This study involves the following risks, discomforts, and possible inconveniences: Describe the discomforts and inconveniences reasonably expected; include the inconvenience of travel, If there is a washout period, describe the risks of discontinuing medications.Describe any reasonably foreseeable risks - include for examplePhysical risks – from study medications and procedures (e.g., venipuncture, exposure to radiation)Privacy risks - legal, employment, and social (i.e., that may place the participant at risk of criminal or civil liability, be damaging to employability or reputation, or be socially stigmatizing)If this is a placebo-controlled study, there may exist the risk that the disease/condition may go untreated and the subject’s condition may worsenIf applicable, include a statement that the particular treatment or procedure may involve risks to the subject, which are currently unforeseeable. MRI Risks:Magnetic fields do not cause harmful effects at the levels used in the MRI machine. However, the MR scanner uses a very strong magnet that will attract some metals and affect some electronic devices. If you have a cardiac pacemaker or any other biomedical device in or on your body, it is very important that you tell the operator/investigator immediately. As metallic objects may experience a strong attraction to the magnet, it is also very important that you notify the operator of any metal objects (especially surgical clips), devices, or implants that are in or on your body before entering the magnet room. All such objects must be removed (if possible) before entering the magnet room. In some cases, having those devices means you should not have an MRI scan performed. In addition, watches and credit cards should also be removed as these could be damaged. You will be provided a way to secure these items. If you have any history of head or eye injury involving metal fragments, if you have ever worked in a metal shop, or if you could be pregnant, you should notify the operator/investigator. You should also notify the operator/investigator if you have any tattoos on your body. Tattoos could become warm and irritated during the scan and remain so for several days. If you would prefer not to participate in the MR scan due to the presence of tattoos on your body, please inform a research team member.If the study uses parameters that might exceed FDA guidelines for dB/dt and result in peripheral nerve stimulation - please check with your MR facility - add the following: There is a possibility that you will experience a localized twitching sensation due to the magnetic field changes during the scan. This is expected and should not be painful. If the study will use contrast media, insert the following: If you have had a previous reaction to Gadolinium-based contrast agents or a history of severe allergies, please notify the operator/investigator. If you have kidney problems, please tell the operator.It has been observed that deposits of Gadolinium-based contrast agent (GBCA) remain in the brains of some people who undergo four or more contrast enhanced MRI scans, long after the last administration. It is not yet known whether these Gadolinium deposits are harmful or can lead to adverse health effects.? You should talk to the study doctor if you have any questions about the use of GBCAs with MRIs. If you might use any radio frequency coil, device, or software that has not been approved by the Food and Drug Administration - please check with your Magnetic Resonance facility - add the following:Some of the radio frequency imaging coils, imaging software and devices being used in your scan are not approved by the FDA but are similar to counterparts that have been approved by the FDA. There is a small risk of heating from the cables associated with these devices. Please report any heating sensation immediately. If you are operating at 3.0T or above, include the following statement: Dizziness or nausea may occur if you move your head rapidly within the magnet.*if you feel discomfort at any time, notify the operator and you can discontinue the exam at any time.POTENTIAL BENEFITS*Describe any benefits that may be reasonably expected (key word-“reasonably”). If none can be expected, state so. ALTERNATIVES#Describe (in layman’s terms) the known appropriate alternative treatments/procedures that might be advantageous to the subject, and a statement that the participants discuss the important potential risks and benefits of the alternatives with a physician. List any standard treatment that may be withheld during the study.If there is no alternative treatment state: "The alternative is not to participate in this research study". .You may also indicate that there may be alternate palliative treatments that are not curative (e.g., some cancer research), if applicable.PARTICIPANT’S RIGHTS*You should not feel obligated to agree to participate. Your questions should be answered clearly and to your satisfaction. *You will be told of any important new information that is learned during the course of this research study, which might affect your condition or your willingness to continue participation in this study.Include the following language, if this study has been or will be registered on *A description of this clinical trial will be available on , as required by U.S. Law.? This Web site will not include information that can identify you.? At most, the Web site will include a summary of the results.? You can search this Web site at any time.CONFIDENTIALITY?If this study collects identifiable private information and/or identifiable specimens include one of the two following statements:Identifiers might be removed from identifiable private information and/or identifiable specimens and, after such removal, the information and/or specimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from you. ORYour information and/or specimens will not be used or distributed for future research studies even if all identifying information is removed. *The purpose of the data collected for this project is for scientific research only and there will be no attempt to identify directly or indirectly any subjects in the research data. We will keep your name and all the information about you used in this study as confidential as possible. We may publish the results of this study for others to read about, but you will not be identified in any articles about the study by name, social security number, address, telephone number, or any other direct personal identifier. Also, other federal agencies as required, such as the VA Office of Research Oversight and the VA Office of the Inspector General may have access to your information. Information about you participating in this research study may be added to your VA Medical Records.*If this is an FDA regulated study (i.e. involves an investigational drug or device), include the following: Because this study involves an investigational [drug or device], the Food and Drug Administration may also have access to information about you collected in this study. *Include the following language if this study is NIH funded:CERTIFICATE OF CONFIDENTIALITYThis research is covered by a Certificate of Confidentiality from the National Institutes of Health. The researchers with this Certificate may not disclose or use information, documents, or specimens that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a court subpoena, unless you have consented for this use. Information, documents, or specimens protected by this Certificate cannot be disclosed to anyone else who is not connected with the research except, if there is a federal, state, or local law that requires disclosure (such as to report child abuse or communicable diseases but not for federal, state, or local civil, criminal, administrative, legislative, or other proceedings, see below); if you have consented to the disclosure, including for your medical treatment; or if it is used for other scientific research, as allowed by federal regulations protecting research subjectsUse the following language as applicable: The Certificate cannot be used to refuse a request for information from personnel of the United States federal or state government agency sponsoring the project that is needed for auditing or program evaluation by [THE AGENCY] which is funding this project or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA). ?You should understand that a Certificate of Confidentiality does not prevent you from voluntarily releasing information about yourself or your involvement in this research. If you want your research information released to an insurer, medical care provider, or any other person not connected with the research, you must provide consent to allow the researchers to release it.Language such as the following should be included if researcher intends to disclose information covered by a Certificate, such as potential child abuse, or intent to hurt self or others in response to specific federal, state, or local laws. The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, state, or local law of [list what will be reported, such as child abuse and neglect, or harm to self or others].Language such as the following should be included if researcher intends to disclose information covered by a Certificate, with the consent of research participants. The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you have consented to in this informed consent document [restate what will be disclosed, such as including research information in the medical record].Health Information Portability and Accountability Act (HIPAA)The written VA HIPAA Authorization may not be combined with the informed consent form when the project involves:Use of data or specimens for banking or further analysis (future use projects).The study subject population is expected to include subjects with legally authorized representatives/legal guardians and/or personal representatives.There are rules to protect your private health information. Federal and state laws and the federal medical law, known as the HIPAA Privacy Rule, also protect your privacy. By signing this form, you provide your permission called your ‘authorization,’ for the use and disclosure of information protected by the HIPAA Privacy Rule.How will my health information be used in the study?Describe how the health information will be used in the study. What Personal Health Information Will Be Used or Shared?The following health information, [linked to you by (insert the identifiers that will be used: e.g., your name, SSN, date of birth)], will be used for this research:Individually list the medical information you will use or disclose in this study. Information included should be limited to the least amount of information needed to accomplish the purpose of the research. Potential categories of information include:Medical history and physical examination informationProgress notesLaboratory Test Results on blood, tissue, urine, salivaHIV (testing or infection) recordsSickle cell anemia informationOperative reportsX-ray and MR scansDischarge summarySurvey/Questionnaire responsesMental health (not psychotherapy) notesPsychological test resultsDrug abuse InformationAlcoholism or alcohol use informationPhotographs, videotapes, other imagesBilling recordsOther (describe information)Who May Use or Share Your Health Information?By signing this document, you allow the following individuals and entities to obtain, use and share your health information for this research study: The Principal Investigator (Insert Name of VA Principal Investigator) and members of the VA research team. Departments within the VA Health Care System responsible for the oversight, administration, or conduct of research. The Stanford University Administrative Panel on Human Subjects in Medical Research and other Stanford University Officials responsible for the oversight, administration, or conduct of research.Who May Receive and Use Your Health InformationThe investigators may share your health information with the following individuals as part of this research study. List all other collaborating investigators who will receive VA identifiable data. Note: If this study is being done by investigators at both VA Palo Alto and Stanford University and VA identifiable data will be shared with your Stanford colleagues, include the following:Stanford University collaborating investigators and research staff. If the study is sponsored, list the study sponsor (i.e., industry sponsor or NIH), including any CRO, outside lab or data monitoring board that will receive participant information. If study funding is administered by PAVIR, include:The Palo Alto Veterans Institute for Research (PAVIR), who administers the funding for this project, and any agents or outside entities hired by PAVIR to assist them in carrying out their responsibilitiesThe following two entities must be included: The Office for Human Research Protections in the U.S. Department of Health and Human ServicesOther outside individuals or entities hired by the VA Palo Alto Health Care System to do certain work in support of the VA Health Care SystemIf the study involves a drug or device, include:The Food and Drug AdministrationWe will protect your health information as required by all laws, however health information shared with others may no longer be protected by Federal laws or regulations and might be shared by the parties above. Do I have to sign this form?No. Signing this form is voluntary. The VA may not condition treatment, payment, enrollment or eligibility for benefits based on signing this form. If you decide not to sign the form, you will not be able to take part in this study [or receive any research-related treatment (add if a treatment study)]. If I sign now, can I decide later not to continue in the study?Yes. You are free to take back your permission and stop being in the study. The investigators will not collect any more information about you after you take back your permission, but they can continue to use your information that was collected before you took back your permission. Your request to take back your permission must be done in writing. Either give your written request to the investigator or send it by mail to: [insert VA Principal Investigator and address]Does My Permission for the use my Personal Health Information Expire?Yes. Your information cannot be used forever. Your permission related to the use and sharing of your health information expires when this research study is completed or on ______ [insert date]. HIPAA regulations require you to give separate written permission (signature) for the use of your protected health information.__________________________________________?__________Signature of ParticipantDateNote: If the participant lacks the capacity to give consent, the HIPAA authorization must be obtained from the participants “Personal Representative” (defined as a person with durable power of attorney for health care for the participant or that is the participant’s legal guardian or court appointed conservator)_____________________________________________Signature of Personal RepresentativeDate________________________________________________Description of Representative's Authority to Act for ParticipantFINANCIAL CONSIDERATIONSPayment/Reimbursement#Describe payment if any, including if the payment will be prorated based on study visits or procedures. *If paying participants, add the following: You may need to provide your social security number to receive payment. #If there is no payment, state such: You will not be paid for taking part in this study. CostsNote: Veterans who participant in VA research cannot be required to pay for care received during the study. Some veterans may be required to pay co-payments for routine medical care. If this is a study that involves routine medical care, include the following: *There will be no costs to you for any of the treatment or testing done as part of this research study. However, medical care and services provided by the VA that are not part of this study (e.g., normal hospital and prescription expenses which are not part of the research study) may require co-payments if your VA-eligibility category requires co-payment for VA services.*If the study does not involve routine medical care, include the following: You will not have to pay anything to be in this study. SponsorDisclose what institution(s) -- e.g., NIH - or companies are involved in the study through funding, cooperative research, or by providing study drugs or equipment. The following generic disclosure is acceptable:#(Name of institution/company) is providing financial support and/or material for this study. #Consultative or Financial RelationshipsIf consultative or financial relationships exist for the Protocol Director and/or any investigators in a study, disclose in a separate paragraph in the consent form the name and precise nature of the relationship: Examples: Dr. Jane Doe is a paid consultant to <insert company name>, the company sponsoring this study.Dr. Jane Doe receives honoraria from <insert company name>, the company sponsoring this study.Dr. Jane Doe is paid speaking fees by <insert company name>, the company sponsoring this study.Dr. Jane Doe receives payment for lectures from <insert company name>, the company sponsoring this study.Dr. Jane Doe is a paid advisor to <insert company name>, the company sponsoring this study.Dr. Jane Doe is an unpaid advisor to <insert company name>, the company sponsoring this study.Dr. Jane Doe receives royalties from <insert company name>, the company sponsoring this study.Dr. Jane Doe has an unpaid consulting relationship with <insert company name>, the company sponsoring this study.Dr. Jane Doe is a member of the scientific advisory board for <insert company name>, the company sponsoring this PENSATION for Research Related Injury*If the project is unfunded or federally funded, include the following verbatim:If you are injured as a direct result of being in this study, medical treatment will be available.? If you are eligible for veteran’s benefits, the cost of such treatment will be covered by the VA.? If not, the cost of such treatments may still be covered by the VA depending on a number of factors.? In most circumstances, the treatment must be provided in a VA medical facility.? No other form of compensation for injuries is available.? However, by signing this form you have not released the VA from liability for negligence. ? For industry sponsored projects and where the terms of the contract require the sponsor to pay the costs of medical care for research related injuries, include such a statement – Only after confirming the contract language with PAVIR. Example: If you are injured as a direct result of being in this study, medical treatment will be available.?? If you are eligible for veteran’s benefits, the cost of such treatment will be covered by the VA.? If not, the cost of such treatments may still be covered by the VA depending on a number of factors.? In most circumstances, the treatment must be provided in a VA medical facility.? In addition, if you are injured directly from a properly performed study procedure, the sponsor of this study will pay for the costs of medical care.? No other form of compensation for injuries is available. However, by signing this form you have not released the VA or the sponsor from liability for negligence.? If this study uses a drug, device or vaccine designed to treat, diagnose, cure or mitigate COVID-19, the language regarding the PREP Act below must be included in the consent form: * A new public health law under the Public Readiness and Emergency Preparedness Act (PREP Act) was issued by the Department of Health and Human Services on March 10, 2020. This law limits your ability to sue if you are in a COVID-19 research study. If this study uses a drug, device or vaccine designed to treat, diagnose, cure or prevent COVID-19, you cannot sue the manufacturers, the study sponsor, healthcare providers or other professionals involved in the study for injury or harm (i.e., getting hurt) unless the injury or harm was on purpose. You may be compensated for injury or harm through a Department of Health and Human Services program called the Countermeasures Injury Compensation Program (CICP). For more information about this program, please contact the Health Resources and Services Administration’s CICP by phone at 855-266-2427 or online at . VA will provide necessary medical treatment should you be injured by being in this study. You will be treated for the injury at no cost to you. This care may be provided by the local VAMC or arrangements may be made for contracted care at another facility. In case of research related injury resulting from this study, you should contact your study team. If you have questions about medical treatment for any study related injuries, you can call the operator at this VA Medical Center and ask for medical administration. You still have the right to hold VA responsible for negligence that is not related to a COVID-19 research study.CONTACT INFORMATION Contact information should include the following as appropriate. *Questions, Concerns, or Complaints: If you have any questions, concerns or complaints about this research study, its procedures, risks and benefits, or alternative courses of treatment, you should ask the principal investigator (name of Investigator) at (phone number). *Injury Notification: If you feel you have been hurt by being a part of this study, please contact the principal investigator, (name of investigator) at (phone number). *Independent Contact: If you are not satisfied with how this study is being conducted, or if you have any concerns, complaints, or general questions about the research or your rights as a participant, please contact the Stanford Institutional Review Board (IRB) to speak to someone independent of the research team at (650)-723-5244 or toll free at 1-866-680-2906.? You can also write to the Stanford IRB, Stanford University, 1705 El Camino Real, Palo Alto, CA 94306.If applicable:Appointment Contact: If you need to change your appointment, please contact (name) at (phone number).If applicable:Alternate Contact: If you cannot reach the principal investigator, please contact (name) at (phone number and/or pager number).If the contact person for both the first two paragraphs will be the principal investigator, you may combine the two as follows:Questions, Concerns, or Complaints: If you have any questions, concerns or complaints about this research study, its procedures, risks and benefits, or alternative courses of treatment, you should ask the principal investigator, (name and phone number of the investigator). You should also contact them at any time if you feel you have been hurt by being a part of this study. EXPERIMENTAL SUBJECT’S BILL OF RIGHTSAdd the following Bill of Rights to your consent:*As a research participant you have the following rights. These rights include but are not limited to the participant's right to:be informed of the nature and purpose of the experiment; be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be utilized; be given a description of any attendant discomforts and risks reasonably to be expected; be given an explanation of any benefits to the subject reasonably to be expected, if applicable; be given a disclosure of any appropriate alternatives, drugs or devices that might be advantageous to the subject, their relative risks and benefits;be informed of the avenues of medical treatment, if any available to the subject after the experiment if complications should arise; be given an opportunity to ask questions concerning the experiment or the procedures involved; be instructed that consent to participate in the medical experiment may be withdrawn at any time and the subject may discontinue participation without prejudice; be given a copy of the signed and dated consent form; and be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion or undue influence on the subject's decision.*Signing your name means you agree to be in this study and that you will receive a copy of this signed and dated consent form.__________________________________________________Signature of Participant Date____________________________________Print Name of ParticipantNote: If the participant lacks the capacity to consent, consent must be obtained from a legally authorized representative (LAR) of the participant, with a description of the LARs authority to act for the participant. The LAR must be (1) a health care agent appointed by the participant in a dual power of attorney for health care or similar document; (2) a court-appointed guardian of the person, or (3) next-of-kin in the following order of priority: spouse, adult child (18 years or older), parent, adult sibling (18 years of age or older), grandparent, adult grandchild (18 years of age or older), or close friend.Include next two signature lines if consent will obtain consent from a LAR.___________________________________________________Signature of Legally Authorized Representative Date____________________________________Representative's Authority to Act for Subject________________________________Signature of Person Obtaining Consent ________________Date________________________________Print Name of Person Obtaining Consent Include the following if PHI is being collected from the participant under this consent form:HIPAA regulations require the participant to give separate written permission (signature) for the use of their protected health information.Person Obtaining Consent HIPAA Authorization confirmation:-34290019367500???? Confirm the participant signed the VA HIPAA Authorization section of this consent form. ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download