ࡱ>  ^bjbj 7dgdgVm  8\M^(>(fff> #M%M%M%M%M%M%M$,PRIMIMff4^M4Fff#M#M5D09Gf3̳>$M<MESSH9G9GS+KIMIMMS X j: INSTRUCTIONS FOR MINIMAL RISK CONSENT TEMPLATE: 1. tHIS TEMPLATE SHOULD ONLY BE USED IF YOU ARE CONDUCTING A MINIMAL RISK STUDY THAT IS NOT USING OR ACCESSING PROTECTED HEALTH INFORMATION (phi) OR BIO SPECIMENS. 2. Please delete or modify text in this template that is not applicable to your study. Be sure to delete the instructions found throughout this template document highlighted yellow. 3. Consent documents should be written at an 8th grade reading level or below. 4. please submit consent forms for review as a word document with no footer. once approved the consent form will be stamped/validated with the approval date and protocol number assigned by the irb office and returned. only stamped/validated consent forms should be used. 5. Please include the VCom logo at the top. 6. SUBJECTS MUST BE GIVEN A COMPLETE COPY (OR DUPLICATE ORGINAL) OF THE SIGNED CONSENT FORM. EDWARD VIA College of Osteopathic Medicine (vcom) CONSENT TO TAKE PART IN A RESEARCH STUDY TITLE: (complete title of the study and local protocol reference number) INVESTIGATOR(S): List names, positions, divisions, telephone numbers and email addresses of individuals involved in the project. Information for the Principal Investigator (PI) must be included. A concise summary at the beginning of the consent document is now required for consent forms longer than 4 pages (not including signature pages). The summary should be a focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative (LAR) in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension. SUMMARY This consent form contains important information to help you decide whether to take part in a research study. You should read and discuss all the information in this consent form with the study staff. A brief summary of the study is provided below. Being in this research study is voluntary; it is your choice. If you join this study, you can still stop at any time. Do not join this study unless all of your questions have been answered. Briefly describe why this study is being conducted. Briefly describe why the individual may choose to participate. Provide a general idea of the study procedures Your participation is expected to last XXX over XXX study visits Possible benefits to you are XYZ; The most likely risks to you are XYZ; Your options other than participating are XYZ; Being in the study WILL/WILL NOT cost anything The study staff will explain this study in detail to you. Ask questions about anything that is not clear at any time. You may take home an unsigned copy of this consent form to think about and discuss with family or friends. Please read this consent form carefully. WHAT IS INFORMED CONSENT? Include an explanation that this is a research study. State who is sponsoring/conducting the research and who the principal investigator is. Explain how prospective subjects are chosen. Include a statement that describes what informed consent is. Example: You are being asked to take part in a research study because you XYZ. {Alternative: You are being asked to take part in a research study that will study XYZ.} The research is sponsored by XYZ. The person running this study locally is XYZ. Before you decide whether to take part in the research, you should be told about the risks and benefits with this study. This process is known as informed consent. This consent form will give you information about this study and your rights as a research subject. This consent form may have words or information you do not understand. The research staff will explain anything that you do not clearly understand. Please ask as many questions as you need to make sure that you know what will happen to you in this study and why you are being asked to be in it. WHY IS THIS RESEARCH BEING DONE? Explain the purposes of the research, an approximate number of subjects involves, and the expected duration of the subjects participation. Use lay terms and keep as concise as possible. Use second person throughout. No more than one paragraph of 5-10 lines is recommended. Example: The purpose of this research is to learn about XYZ. There will be XYZ subjects from XYZ locations taking part. Locally there will be XYZ subjects taking part. The length of time you can expect to be in this research is XYZ. WHAT WILL HAPPEN IN THIS RESEARCH STUDY? Using lay terms, give a concise yet complete description of the study procedures that the subjects will be expected to follow as part of this study (i.e. what a survey entails, how it is to be answered, any interviews that may occur, etc.). Describe the overall participant experience that will be encountered. If there are multiple steps, user headers, bullets, tables and/or pictures as appropriate. When appropriate, include the following items: Description of where this research will be done A time-line description of procedures, including screening procedures if applicable. It is acceptable to use tables or charts if they are helpful to explain the schedule. Description of each group or arm. If the research involves random assignment to groups describe this and the probability of assignment to each group. Indicate all telephone or written follow-up visits planned and indicate the length and duration of visits and procedures. Identify all questionnaires, surveys or diaries by name and explain what they involve and how long and how often they will need to be complete. WHAT ARE THE RISKS OF BEING IN THIS RESEARCH STUDY? Include in this section information all foreseeable risks and/or discomforts associated with any research procedure and tests that are done as part of this research study. Include psycho-social and physical risks, including side effects, stress, discomforts, breach of confidentiality or the invasion of privacy that might result from each procedure. Consider: Physical Risks Physiological risks (for example, embarrassment, fear or guilt) Privacy risks (for example, disclosure of private information) Legal Risks (for example, legal prosecution or being reported for child abuse) Social risks (for example, social ostracizing or discrimination) Economic risks (for example, time out of work, losing health insurance, or being unable to obtain a job) Describe safeguards that are to be employed to reduce or minimize the risks must be described. Do not state that there are no risks or that risks should be minimal. Be specific. If appropriate, state how side effects will be handled and whom the subject should contact in the event of a study-related injury, illness or distress. If investigational drugs are used, state that you will provide subjects with any information developed during the study that might affect their willingness to participate. If you will make recordings of subjects, and you will be keeping the recordings indefinitely, share them with other researchers or use them in presentations or publications, explain that subjects will be given an opportunity to review the recordings and delete any portions. If it is possible subjects may suffer a physical injury or illness as a result of taking part in the study, this should be stated: Example: If you think you have an injury or illness related to this study, contact the study staff right away. The study staff will treat you or refer you for treatment. State who will be responsible for the cost of such treatment. Risks related to COVID-19: If you choose to participate in this study, the risk for COVID-19 exposure is about the same as those posed by similar activities while the virus is still spreading in your community. Similar activities could include grocery shopping, having your car repaired, or getting a haircut. In addition, participation might increase risk to your family, the community, and the research team. You should not participate if you have any conditions or risk factors that could make a COVID-19 infection more serious. Risk factors for severe illness include having other medical conditions such as asthma, diabetes, heart problems, or any other illness. Certain populations might also be at increased risk or unknown risk, including people aged 65 and older, people with disabilities, women who are pregnant or breastfeeding, people who are experiencing homelessness, and people who are part of racial and ethnic minority groups. Please share your vaccination status with research personnel if you are comfortable doing so. For those participants who are not fully vaccinated, please wear a face mask covering your nose and mouth. WHAT ARE THE BENEFITS OF BEING IN THIS RESEARCH STUDY? Describe the tangible or intangible benefits, if any, to the subjects who participate. State if subjects will not benefit from being in the study. If applicable, state the larger societal benefits for conducting the research. An analysis of the risks to benefits must clearly be on the benefits side. A statement must be included to the effect that: no promise or guarantee of benefits has been made to encourage you to participate. At the option of the investigator, subjects may be informed that they may contact the researcher at a later time for a summary of the research results. If subjects are children, the parent / guardian must make the request. Example: If it is not known whether the study may benefit the subject use language similar to: Although you may not personally benefit from taking part in this study, the knowledge gained may benefit others. ARE THERE ANY OPTIONS TO BEING IN THIS RESEARCH STUDY? List any options to the procedures and treatment proposed that might be considered. If there are not alternatives to taking part, of the only alternative is to not participate, this should be stated. Example: The only alternative to participation is to choose not to participate. WILL I RECEIVE NEW INFORMATION ABOUT THIS RESEARCH STUDY? The prospective subject should be told how s/he will be informed about any new information related to this study. Example: Sometimes new information comes out that may affect your health, welfare, or willingness to stay in a research study. If this happens, the researchers will tell you about that information. They will also tell you about other options available. You may need to sign another form with your consent to continue in the study. WHAT ABOUT CONFIDENTIALITY? Address how confidentiality of the subjects data/information will be maintained. Avoid legal jargon or language that is unclear. Briefly describe the procedures that will be used to protect the privacy and confidentiality of the subjects data, such as how records will be secured, who will have access to the subjects identifiable data and whether names or ID numbers will be used. If codes or numbers are assigned, explain how the file linking the codes of individual subjects will be secured. In some situations, it may be necessary for an investigator to break confidentiality. If child / elder abuse is known or strongly suspected, investigators are required to notify the appropriate authorities. If a subject is believed to be a threat to herself / himself or others, the investigator should notify the appropriate authorities. The conditions under which the investigator may break confidentiality must be described here. EXAMPLE: All of the information you provide will be confidential. However, if we learn that you intend to harm yourself or others, we must report that to the authorities. For studies that involve video or audio recording or photographs: Describe what will be done with tapes or photographs Include plans for storage during use and what will be done after transcription of tapes, such as how long they will be kept Advise subjects that audio and video recording may be requested to be turned off or that photographs may stop being taken, if that is true for the study If tapes or photographs will be used in publications or at conferences, this fact should be clearly stated on the consent form For studies that involve group interview or focus groups: Advise subjects that they do not need to reveal their name, or that they may us a fictitious name Advise subjects that they must agree not to reveal anything they learn from group discussions or other activities Example: The research records will be kept private on a password-protected computer in a locked office. All research data will be coded with a unique number. Your name and information will be linked to the code number on a master list of those who take part in the study. This master list will be kept separate from the research database and will be stored in a locked filing cabinet. This master list will only be used by the researchers or organizations that govern research quality and safety oversight. Your identity will not be used in any sort of published report without your written permission. Example: Questionnaires will be completed in a private, confidential room. The completed questionnaires will be kept private in a locked office and in a locked filing cabinet. The questionnaires will be coded with a unique number. Your name will be linked to the code number on a master list of those who take part in the study. This master list will be kept separate from the questionnaires and will be stored in a second locked filing cabinet. This master list will only be used by the researchers or organizations that govern research quality and safety oversight. Your identity will not be used in any sort of published report. For all studies in which links between subjects identities and data will be kept, add: Government staff or SWAGƵInstitutional Review Board members sometimes review studies such as this one to make sure they are being done safely and legally. If a review of this study takes place, you records may be examined. The reviewers will protect your identity. The study records will not be used to put you at legal risk of harm. For drug medical device studies regulated by the FDA, add: The U.S. Food and Drug Administration (FDA) reserves the right to review study data that may contain identifying information. For all applicable clinical trials, to include FDA-regulated drugs, biological products, and medical devices that will be registered with ClinicalTrials.gov and will post results in the federal data bank, a statement should be added to disclose this information: A description of this clinical trial will be available on  HYPERLINK "http://www.ClinicalTrials.gov" http://www.ClinicalTrials.gov, as required by the U.S. law. The web site will include a summary of the results. This web site will not include information that can identify you. You can search this web site at any time. For many studies, the following language may be appropriate: Your identity in this study will be treated as confidential. The results of the study, including laboratory or any other data, may be published but will not give your name or include any identifiable references to you. However, any records or data obtained as a result of your participation in this study may be inspected by the persons conducting this study and/or The Edward Via College of Osteopathic Medicines Institutional Review Board, provided that such inspectors are legally obligated to protect any identifiable information from public disclosure, except where disclosure is otherwise required by law or a court of competent jurisdiction. These records will be kept private in so far as permitted by law. WILL IT COST ME MONEY TO TAKE PART IN THE RESEARCH? State whether there will be additional cost to the subject because of taking part in the research, and, if so, what the cost will be (i.e. professional fees, hospital charges, diagnostic and lab studies, drugs, devices, transportation, etc.). State any drug, device, text examination, etc. that may be free of charge. Example: Taking part in this research will not cost you any money. Example: Taking part in this research may lead to added cost to you, such as : XYZ (describe these costs). WILL I BE PAID FOR TAKING PART IN THIS RESEARCH? Inform the subject if there is any direct financial payment that can be expected as compensation for taking part in the study. If payment will be given to the subject, let them know if it will be prorated if he/she withdraws from the study prior to completion. Example: For taking part in this research, you may be paid up to a total of XYZ. Your payment will be broken down as follows: Describe payment schedule in terms of amount Describe when and how payment(s) will be made Describe the amount of payment if the subject drops out Example: You will not be paid for taking part in this research. If extra credit in a course is the compensation, the subject must be informed as to how much credit is to be earned and the impact of that extra credit on their course grade. If extra credit is a form of compensation for participation in research involving human subjects, there must be alternate and equitable ways to earn the equivalent credit in the same course without participating as a subject in research (the subjects must be so informed). The course syllabus must describe the alternate ways to earn extra credit. WHAT IF I WANT TO STOP BEING IN THE STUDY BEFORE IT IS FINISHED? Subjects are free to withdraw from a study at any time without penalty. State that, if they choose to withdraw, they will be compensated for the portion of the time of the study (if financial compensation is involved). State that, if they choose to withdraw, they will not be penalized by reduction in points or grade in a course (if course credit is involved). Indicate that subjects are free not to answer any questions or respond to experimental situations that they choose without penalty. State that there may be circumstances under which the investigator may determine that a subject should not continue in the study and describe these circumstances. State that the subject will be compensated for the portion of the project completed (if financial compensation is involved). Example: You are free to choose whether or not to participate in this study. There will be no penalty if you choose not to participate. You will be provided with any significant new findings developed during the course of this study that may relate or influence your willingness to continue participation. In the event you decide to discontinue your participation in the study, please notify [name, telephone no., etc.] of your decision so that your participation can be terminated in an orderly fashion. ARE RESEARCHERS BEING PAID TO DO THIS STUDY? Include a disclosure statement regarding the conflict of interest of the principal investigator/study team members. If ANY research team member DOES have any financial relationship with the sponsor of the research and the relationship has not been disclosed to or managed by VCOM, please contact the Office of Research Administration office immediately at 540-231-8239. Example: The principal investigator or at least one member of the research staff will receive money or other benefits from the company that makes the investigational drug or device being tested in this study. Example: The principal investigator or at least one member of the research staff will receive money or other benefits from the company that makes the investigational drug or device being tested in this study. In addition, money or other benefits are going to a research fund, foundation, educational institution, or other organization with which one or more of the research staff is associated. Example: This study does not have any sponsors. It does not have any funding. None of the investigators or research staff will receive money or other types of payment from this study. WHAT ARE MY RESPONSIBILITIES IF I CHOOSE TO PARTICIPATE IN THIS RESEARCH STUDY? Briefly describe the participant responsibilities (i.e. list medical conditions to be reported, staying in a place for a specific length of time after drawing a blood sample, consumption of alcohol, etc.). WHO ARE THE CONTACT PERSONS FOR THIS STUDY? If you encounter complications or have any questions about the study you may call: Investigator Name Address Phone # Email Address This research is being overseen by the Edward Via College of Osteopathic Medicine Institutional Review Board (IRB). An IRB is a group of people who perform independent review of research studies. You may talk with the Chairman of the IRB by calling (540) 231-4981 if: You have questions, concerns, or complaints that are not being answered by the research team. If you have questions about your rights as a research subject. If you need to report a research-related injury. CONSENT SIGNATURES PARTICIPANT: The research study described in this consent form, including the risks and benefits, has been explained to me and all of my questions have been answered. I consent to take part in this research study. My consent is given willingly and voluntarily. I understand that I am free to withdraw my consent at any time. I will receive a signed copy of this consent form. If relevant, also include the following: I give my permission to the researchers to use my medical records as described in this consent form. ______________________________________ __________ Printed Name of Participant Signature of participant Date PERSON OBTAINING CONSENT: I certify I was present for the informed consent discussion. The subject or legally authorized representative had an opportunity to ask questions about the study and appeared to understand the information presented. 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