Thursday, February 21, 2019

Example of a Consent Form

Research accord Form Brigham and Womens hospital Dana-Farber crabmeat name Massachusetts General infirmary Version III. a prideful 1998 Pi_dist9. medical student Imprint Patient ID topic protocol Title developmental Anatomy Genome Project (DGAP) Principal/Overall Investigator Cynthia C. Morton, Ph. D. Site-Responsible Investigator(s)/Institution throng Gusella, Ph. D. /MGH Co-Investigator(s)/Study Staff Drs. B Quade, A Ligon, R Maas, A Michelson, J Gusella, M MacDonald, E Lemyre, J Lewis Description of egress tribe Patients with natural anomalies PURPOSEWe would like permission to enroll you as a participant in a question plain. The purpose of this question is to identify and analyse genes problematic in human development. You assume a bun in the oven back been asked to go in in this enquiry pick up because you (or your child) have (or has) one or more developmental abnormalities and chromosomal abnormalities that have been present since descent. Such chromosoma l abnormalities whitethorn disrupt the function of genes call for for normal growth and development. By identifying these genes in people with special birth defects, we hope to reach a greater pinch of how the human eubstance grows and develops. teaching CONTACTS This study is being organized by Dr. Cynthia C. Morton, who raft be reached at 617-732-7980 with whatsoever(prenominal) questions you may have during the traverse of this study. If you enrolled at the MGH, please conflict Dr. James Gusella at 617-726-5724. PROCEDURES If you agree to participate, you go away donate a tear sample. The meter of blood ramn ordain vary with age (less than 2 years old to the highest degree 1 tablespoon ages 2-10 years almost 2 tablespoons ages 11 years and up just near 2-4 tablespoons) and may be reduced for smaller individuals.In general, after you have donated blood, cells or tissue samples no additional hospitalization or clinic visits go outing be involve for you to part icipate in this study. Any of the samples you donate allow be used to get to an immortal cell line. This means that an inexhaustible supply of DNA provide be available for genetic look for. DNA is the genetic material from which genes ar made. These samples may be stored/banked for future use and/or shared with early(a) investigators associated with this study. These stored or distributed samples will NOT be labeled with your name.Do you agree to this (please order one choice) Page 1 of 5 Subject world Patients with innate(p) anomalies IRB Protocol fare 1999P-003090 98-09233 Sponsor Protocol derive N/A Consent Form adulation attend celestial latitude 9, 1999 Amendment Number sanctioned N/A IRB Expiration view Amendment Approval Date N/A NOVEMBER 22, 2000 Research Consent Form Brigham and Womens Hospital Dana-Farber genus Cancer Institute Massachusetts General Hospital Version III. a horrible 1998 Pi_dist9. doc Imprint Patient ID Number YES NO You may be seizeed in t he future and asked for additional samples to continue search.If you do non need to be contacted in the future, you may indicate this below YES, okay to contact NO, do non contact As mentioned above, samples that are sent to the research laboratory will be assigned a cipher cast. The primeval to this code will be maintained in locked files by Dr. Cynthia Morton, and your (or your childs) indistinguishability will not be revealed to anybody other than your referring physician. Important non-identifying reading much(prenominal) as sex, age, and nature of your developmental abnormality will be familial to the research laboratory in order to correlate study results with specific developmental problems.The information keeped from this study of your donated blood or tissue is not known to be useful clinically or diagnostically at this time. The research is currently useful just now as a means of understanding genes and developmental abnormalities. Results from these genetic stu dies will NOT be placed in your (or your childs) medical checkup exam record. We will not communicate these results engineerly to you study results will be released to your referring physician. COSTS No charges will be billed to your amends company or to you for this study. You should be sure that no charges for the blood draw are to be filed with your insurance company.If the person who draws your blood intends to bill you, you should pay for this yourself and send a copy of the bill to the investigator who will withhold you. RISKS AND DISCOMFORTS There are minor risks and discomforts associated with blood sampling. This includes a brief amount of pain and possibly a small bruise at the spur site. Occasionally a person feels faint when his/her blood is drawn. Rarely an transmittance develops, but if this occurs the infection can be treated. Disclosure of Study Results education about your mesh in a genetic study may influence insurance and/or employers regarding your heal th status.We will use many an(prenominal) safeguards to pr typesetters case unintentional disclosure I) information about your participation in, and the results of, this research will NOT be placed in your medical records, II) research data (including data collected from medical charts) will be entered altogether into a research database. No names will be entered into this database, only the codes assigned to submitted samples. Other investigators will NOT be given up a key to this code, and III) NO results from this study will be released to anyone other than your referring physician.You can also minimize these risks by not sharing with others the fact that you have participated in genetic studies. Page 2 of 5 Subject Population Patients with congenital anomalies IRB Protocol Number 1999P-003090 98-09233 Sponsor Protocol Number N/A Consent Form Approval Date DECEMBER 9, 1999 Amendment Number Approved N/A IRB Expiration Date Amendment Approval Date N/A NOVEMBER 22, 2000 Research Consent Form Brigham and Womens Hospital Dana-Farber Cancer Institute Massachusetts General Hospital Version III. a rarified 1998 Pi_dist9. doc Imprint Patient ID NumberThese studies are for research purposes only. Therefore, NO study results will be communicated to you at any time. However, in the event that this research study uncovers information that we feel MAY impact your health care (either positively or negatively), we will convey this information to your physician. After the potential drop significance of such results has been explained to you by your physician, you will be offered an opportunity to obtain independent diagnostic confirmation of this research finding in a laboratory which specializes in this type of clinical testing.This diagnostic testing will ONLY take place IF you provide additional consent for it. except the result of the confirmatory test would be entered into your medical record by the diagnostic laboratory or your physician. BENEFITS At this time, we know of no direct benefit to you (or your child) as a result of participation in this research study. alliance is completely voluntary and your alternative is to not participate. Other individuals may benefit in the future if these studies provide useful information about identifying or treating developmental abnormalities.ALTERNATIVES You are free to participate or not to participate in this study. If you choose not to participate, your medical care and discourse will NOT be affected. Page 3 of 5 Subject Population Patients with congenital anomalies IRB Protocol Number 1999P-003090 98-09233 Sponsor Protocol Number N/A Consent Form Approval Date DECEMBER 9, 1999 Amendment Number Approved N/A IRB Expiration Date Amendment Approval Date N/A NOVEMBER 22, 2000 Research Consent Form Brigham and Womens Hospital Dana-Farber Cancer Institute Massachusetts General HospitalVersion III. a August 1998 Pi_dist9. doc Imprint Patient ID Number THE FOLLOWING PARAGRAPHS CONTAIN measuring rod I NFORMATION WHICH GENERALLY APPLIES TO PERSONS INVOLVED IN A RESEARCH STUDY AND ARE REQUIRED ON ALL CONSENT FORMS. CONFIDENTIALITY Medical information produced by this study will become part of your hospital medical record, unless specifically stated otherwise in this consent form. Information that does not become part of your medical record will be stored in the investigators file and identified by a code number only.The code key connecting your name to specific information about you will be kept in a separate, secure location. Your medical record is available to health care professionals at Brigham and Womens Hospital (BWH), Dana-Farber Cancer Institute (DFCI), or Massachusetts General Hospital (MGH), together with called the Hospitals, and may be reviewed by appropriate Hospital staff members in the course of carrying out their duties however, they are required to maintain confidentiality in accordance with applicable laws and the policies of the Hospitals.Information contained in your records may not be given to anyone independent with the Hospitals in a form that could identify you without your pen consent, except as described in this consent form or as required by law. It is possible that your medical and research record, including sensitive information and/or identifying information, may be inspected and/or copied by the study sponsor (and/or its agent), the Food and Drug Administration (FDA), federal or state giving medication agencies, or hospital accrediting agencies, in the course of carrying out their duties.If your record is inspected or copied by the study sponsor (and/or its agents), or by any of these agencies, the Hospitals will use reasonable efforts to protect your privacy and the confidentiality of your medical information. The results of this study may be published in a medical playscript or journal or used for teaching purposes. However, your name or other identifiers will not be used in any publication or teaching materials without your specific permission. In addition, if photographs, audiotapes or videotapes were taken during the study that could identify you, then you must give special written permission for their use.In that case, you will be given the opportunity to view or listen, as applicable, to the photographs, audiotapes or videotapes before you give your permission for their use if you so request. REQUEST FOR MORE INFORMATION You may ask more questions about the study at any time. The investigator(s) will provide their telephone number so that they are available to answer your questions or concerns about the study. You will be informed of any significant new findings discovered during the course of this study that might influence your continued participation.If during the study or later, you beseech to discuss your rights as a research subject, your participation in the study and/or concerns about the study, a research-related injury with someone not direct involved in the study, or if you feel under any drag to enroll in this study or to continue to participate in this study, you are asked to contact a representative of the Human Research Committees at BWH (617) 732-7200, at MGH (617) 726-3493, or at the Protocol Administration Office at DFCI (617) 632-3029. A copy of this consent form will be given to you to keep. Page 4 of 5 Subject Population Patients with congenital anomaliesIRB Protocol Number 1999P-003090 98-09233 Sponsor Protocol Number N/A Consent Form Approval Date DECEMBER 9, 1999 Amendment Number Approved N/A IRB Expiration Date Amendment Approval Date N/A NOVEMBER 22, 2000 Research Consent Form Brigham and Womens Hospital Dana-Farber Cancer Institute Massachusetts General Hospital Version III. a August 1998 Pi_dist9. doc Imprint Patient ID Number REFUSAL OR WITHDRAWAL OF PARTICIPATION Participation in this study is voluntary. You do not have to participate in this study. Your present or future care will not be affected should you choose not to participate.If you decide to participate, you can change your judgement and drop out of the study at any time without affecting your present or future care in the Hospitals. In addition, the furbish up in charge of this study may decide to end your participation in this study at any time after he/she has explained the reasons for doing so and has helped arrange for your continued care by your own doctor, if needed. stain STATEMENT If you are injured during the course of the study and as a direct result of this study, you should contact the investigator at the number provided.You will be offered the necessary care to treat that injury. This care does not suggest any fault or wrong-doing on the part of the Hospitals or the doctor(s) involved. Where applicable, the Hospitals reticence the right to bill third party payers for services you receive for the injury. The Hospitals will not provide you with any additional compensation for such injuries. touch modality I confirm that the purpose of th e research, the study procedures and the possible risks and discomforts as healthful as potential benefits that I may experience have been explained to me.Alternatives to my participation in the study also have been discussed. All my questions have been answered. I have read this consent form. My signature below indicates my willingness to participate in this study. Subject/Patient Date Witness/Advocate/Minor/ levelheaded Guardian (if required) Date Additional Signature (if required)(identify relationship to subject) Date I have explained the purpose of the research, the study procedures, identifying those that are investigational, the possible risks and discomforts as tumefy as potential benefits and have answered any questions regarding the study to the best of my ability.Study model Date Investigator Complete This Information At Enrollment for hematology/ONCOLOGY PROTOCOLS ONLY (A copy of this form should be faxed to the QCC and to the appropriate Medical Records) indigenous Care Physicians Name Date protocol give-and-take begins for this subject Diagnosis Page 5 of 5 Subject Population Patients with congenital anomalies IRB Protocol Number 1999P-003090 98-09233 Sponsor Protocol Number N/A Consent Form Approval Date DECEMBER 9, 1999 Amendment Number Approved N/A IRB Expiration Date Amendment Approval Date N/A NOVEMBER 22, 2000

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