Consent form examples - Meharry Medical College



A GUIDE TO WRITING A CONSENT FORM2/20/12Format: Include the proper identification and labeling: the title of the study, the name of the PI, and the name of the department from which the study originates. Insert a space at the bottom of each page of the consent form for the subjects initials if the consent form is longer than one page. Number all pages; the total number of pages must be on each page (e.g. Page 1 of 4)Language: Use lay language: any medical or technical terms or professional jargon must also be described in common terms. The consent form must be free of any language which makes the subject waive or appear to waive any legal rights, including any release of the investigator, the sponsor, the institution or its agents from liability for negligence.Basic Elements of Informed Consent: Address all the basic elements listed below: Purpose: A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation.Procedures: A description of the procedures to be followed, and identification of any procedures which are investigational. If blood is to be withdrawn, include: amount of blood to be withdrawn (in teaspoons, tablespoons, or similar lay units); number of times; period of time covered; potential hazards, including “a bruise at the site of vein puncture” and information that “care will be taken to avoid these complications”. The consent form should also clearly state what the blood is to be used for.Benefits: A description of any benefits to the subject or to others.Costs of Treatment: A description of costs (research and standard care) and who is responsible for paying themRisks: A description of any reasonably foreseeable risks or discomforts including social, legal, or psychological risks. Alternative Procedures: A disclosure of any alternative procedures which might be advantageous to the subject.Confidentiality: A statement describing the extent to which confidentiality of research records identifying the subject will be maintained and who will have access to those records. For projects which asks for sensitive information (drug use, sexual behavior, criminal activity) a very detailed confidentiality statement should be included. In the case of research involving FDA regulated products, include a statement that FDA and the study sponsor may inspect records identifying pensation: The appropriate compensation statement for research involving more than minimal risk must be included.Subject Rights: An explanation of whom to contact for answers to questions involving the research and research subject’s rights, and whom to contact in the event of a research-related injury to the subject. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits, and the subject may discontinue participation at any time without penalty or loss of benefits.Insert a space at the bottom of each page of the consent form for the subject?s initials if the consent form is longer than one page. Signatures: The consent form must be signed by the person obtaining consent, witnessed by a third party, and dated at the time signatures are obtained. If children are to be included as subjects, provision must be made for securing the assent of the child and the consent of the parent(s) or guardian. The participant must be given a permanent copy of the consent form and the consent form must state this. It is not necessary to put subject’s initials on this page.IRB APPROVAL CANNOT BE GRANTED UNTIL A COPY OF THE APPROVED CONSENT FORM IS ON FILE IN THE IRB OFFICE.Investigators must keep consent forms on file during the research and for at least three years after the research RMED CONSENT TO PARTICIPATE IN RESEARCH Principal Investigator:Telephone No.: Meharry Medical CollegeDept.:Title of Project:You are being asked to volunteer as a participant in a research study. This form is designed to provide you with information about this study.PURPOSE: Explain the purposes of the research and the expected duration of the subject’s participation. See Consent form examples.PROCEDURES: Describe the procedures to be followed, expected duration, and identify any procedures which are investigational. See Consent form examples.BENEFITS: Describe any benefits to the subject or to others. See Consent form examples.COSTS OF TREATMENT: Describe any costs incurred by the study and who is responsible for payment. See Consent form examples. RISKS: Describe any foreseeable risks or discomforts, including psychological, legal, or social risks. See Consent form examples.ALTERNATIVE PROCEDURES: Describe alternative procedures which might be advantageous to the subject (if applicable). See Consent form examples. COMPENSATION: (This section is required for projects that involve greater than minimal risk).Explain whether any compensation and/or medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained. See Consent form examples.CONFIDENTIALITY: Describe how data will be kept confidential, who will have access to data (include organizations that will have access, i.e. FDA), where data will be stored, and how long data will be stored. See Consent form examples.SUBJECT RIGHTS: Any questions you have involving the research and your rights may be addressed to [insert Principal Investigator’s name] at ________ or the chair of the Meharry Institutional Review Board, at 327-6735. Your participation in this study is voluntary and you are free to withdraw at anytime without penalty or loss of benefits that you are otherwise entitled to. You will be given a copy of this form to keep.__________________________________________________________________Signature of ParticipantDate__________________________________________________________________Signature of WitnessDate___________________________________________________________________Signature of person who obtains consentDateRevised 4/28/03 Page 1 of 1 Consent.docConsent form examplesPURPOSE (example from a study of pregnant women)The purpose of this study is to see if stress can affect early delivery of infants and if visiting nurses can relieve the stress and improve the health of newborns and their mothers. Infant death rate in Davidson County is high and we would like to investigate several factors, which may be related to early delivery; such as, your beliefs, relationships, and level of stress. We will also search for any other factors that may be related to the premature delivery of your baby.Five hundred women will be enrolled in this study. The approximate length of your participation in this study will be fifty-two weeks (1 year). PROCEDURES (example from a behavioral study using a nutrition survey)Our staff at Meharry Medical College in Nashville, Tennessee will call you four times over the next four months to complete four telephone surveys. You will be called at your home on different days of the week at times convenient to you. For three of the surveys, you will be asked to provide a description of the foods and beverages you had during the past 24 hours. Each of these calls will take approximately 30 minutes to complete. At the end of the four-month period, you will be asked to complete the fourth survey, a Food Frequency Questionnaire over the telephone. This questionnaire asks you to estimate how often you ate and drank specific foods and beverages during the past three months. This call will take approximately 45 minutes of your time. Upon completion of the study requirements, we will mail to you a $50 money order to compensate you for your time spent participating in the study. BENEFITS (example from a clinical trial)The main benefit this study hopes to provide is knowledge about the treatment of prostate cancer. We hope to find knowledge that will be useful to other men in the future that have the same condition. If the study shows that any of the study groups has had a good result, the people in the study who take the supplement(s) would receive this benefit. But the use of vitamin E and/or selenium supplements has not been shown to reduce or prevent prostate or other forms of cancer, so there is no guarantee that you will receive any benefit from being in this study.COSTS OF TREATMENT (example from a clinical trial)You or your insurance company will be responsible for the payment of all expenses associated with this study. This includes doctor visits, chemotherapy drugs and other medications, physical exams, x-rays, scans, blood/urine tests, etc. that are considered routine medical care for your cancer. Some insurance companies may not cover costs associated with research studies. If your insurance declines payment, you will be responsible for these costs. You will not be paid for being in this study.COSTS OF TREATMENT (example from a clinical trial)Expenses for procedures or treatments done for research purposes only will be covered by the study and will not be billed to you or your insurance company. However, you or your insurance company will be responsible for the payment of any expenses that are considered routine medical care, such as, doctor visits, physical exams, x-rays, scans, and blood/urine tests. If your insurance declines payment of these expenses, you will be responsible for these costs. You will not be paid for being in this study.RISKS (example from a study involving parents and children – inconveniences rather than risks)One inconvenience from participating in this trial is the time required to talk with the interviewer. The interviews could take up to six hours over all three parent interviews and two hours overall for your child. Although this study is not expected to create discomfort to you or your child, it is possible that talking about certain topics could trigger unpleasant memories. If your child shows signs of discomfort such as crying, leaving the room, crawling under furniture, refusing to speak, etc., the interview will be discontinued. If your child’s reaction to the interviewer’s questions is more severe, we will help you find appropriate or necessary assistance. Finally, if your child tells about any new situation of abuse, the interviewer will have to report this information to the proper authorities. RISKS (example from a study on respiratory infections in children)Your child may have some brief discomfort while the nasal and throat swabs are taken. These procedures may also cause your child to gag or sneeze. Rarely, a small nosebleed may occur. If this should happen, we will treat it promptly. There is also a risk that information obtained from you child’s medical record will inadvertently be disclosed. Since information about your child will be identified only by number, this is very unlikely. The section of this form labeled “Confidentiality” tells more about how we will protect this information.ALTERNATIVE PROCEDURES (example from a clinical trial)If you choose not to take part in this study, you could be treated with standard treatment for your illness such as chemotherapy with other drugs known to be effective for treating breast cancer; such as, tamoxifen, arimidex, radiation therapy and some combination of these options in greater detail. Whatever your decision, your doctor will continue to provide your medical PENSATION* (example from a kidney disease study)You should report any injury or illness, which you believe to be related to this research project to Jane Doe, M.D., Principal Investigator at 327-1234, or the chair of the Meharry Institutional Review Board, at 327-6735. Medical treatment for injury of illness resulting from the research procedures is available at Metropolitan Nashville General Hospital. Payment for this medical treatment is your responsibility. Meharry Medical College, the research sponsor, and their agents and employees are not responsible for the payment of medical care or for compensation of any expenses associated with research-related illness or injury. The above “Compensation” statement does not limit your legal rights. You do not waive any legal rights by signing this form.If the sponsor will not pay for research-related, illnesses, or injuries, the compensation section must have the same language as the example given.CONFIDENTIALITY (example from FDA for clinical trial studies effective March 2011)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 (example from a behavioral study using focus groups)The focus group will be recorded by a tape recorder; no video will be taken. During the focus group you will not be referred to by name. No record of your name or any other information that could identify you will be made during the focus group. A typist will transcribe the tape of the meeting, but no information that can identify you as an individual will be recorded in the transcription. After the transcription is complete, the initial record of participants’ names will also be destroyed.CONFIDENTIALITY (example from a sickle cell study) If you enroll in this study, the principal investigator will assign you a code number and prepare a key that links your name with the code number. All the information we record about you will be kept in paper and computer files that are labeled only with your code number. Only the Principal Investigator and his staff (co-investigator and study coordinator) will have access to the key that links your name with your files. Your data will be stored in a locked filing cabinet in the Principal’s Investigator’s office for a period of 5 years after the study has been completed. The electronic files will be kept on a computer network at Meharry called a server. Your computer record will only have your code number on it, and will be accessible only to persons who have been given a pass by the Principal Investigator. Should the results of this project be published, you will be referred to only by number.CONFIDENTIALITY (example from a clinical trial)If you enroll in this study, the principal investigator will assign you a code number and prepare a key that links your name with the code number. All the information we record about you will be kept in paper and computer files that are labeled only with your code number. Only the Principal Investigator and his staff (co-investigators, study coordinator, and clinical trials administration) will have access to the key that links your name with your files. All data obtained on you during the course of this study will be accessible only to the principal investigator, study coordinator, funding company, and any suitable government agency on this project. All or part of your medical records may be reviewed and analyzed by the Meharry Institutional Review Board, government agencies, including the NCI, the Office for Human Research Protections (OHRP), and the Canadian Health Protection Branch (HPB), representatives of the CTSU, NSABP, or representatives of Aventis, the manufacturer of Docetaxel. Research records, just like any other hospital record, may be inspected by federal regulatory authorities, and legally authorized parties. Should results of this project be published, you will be referred to only by number. All data will be kept in locked cabinets in the Principal Investigator’s office for 3 years. When notified by the NSABP that data no longer need to be kept, the records will be destroyed following standards for disposal of confidential medical records. CONFIDENTIALITY (example from a clinical trial-biological specimen banking)If you enroll in this study, the principal investigator will assign you a code number and prepare a key that links your name with the code number. All the information we record about you will be kept in paper files that are labeled only with your code number. Only the Principal Investigator and his staff (co-investigators, research nurse, and study coordinator) will have access to the key that links your name with your files. All data will be kept in locked cabinets in the Principal Investigator’s office for 3 years. At the end of three years, the records will be destroyed following standards for disposal of confidential medical records. Your blood, toenail clippings, tissue samples, and health information will be sent to and stored by the Southwest Oncology Group and may be used for future genetic studies. However, the samples will not be labeled with your name or any other information that would divulge, or be linked to, your identity. The only key that could possibly link this information to you will be in the sole custody of Meharry Medical College. The Southwest Oncology Group will be the only cooperative group analyzing your samples and health information and it will not be shared with other investigators. No one who works with these samples will have access to your name. The Southwest Oncology Group will keep your samples indefinitely. In addition, your name and any identifiable information will not be used in any reports. Individual results about research done with your blood, toenail clippings, or tissue will not be given to you or your doctor. These reports will not be put in your health record. The research will not have an effect on your care. If we publish any information we learn from this study, you will be referred to only by number. FOR CLINICAL TRIALS (New language is required going forward – 2/20/12) – TO BE INSERT INTO CONSENT FORMSA 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 rmation for investigators:This language is required in consent forms for “applicable clinical trials”, as was stated in the FDA’s final rule.? The FDA has published a guidance document that explains more about what an applicable clinical trial is, that can be found at: ................
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