'Example of a Consent Form\r'

'Research Consent configuration Brigham and Women’s hospital Dana-Farber Cancer Institute mom planetary Hospital Version III. a haughty 1998 Pi_dist9. mercantilism Imprint patient ID chassis communications protocol Title: Developmental Anatomy Genome Project (DGAP) hint/Overall Investigator: Cynthia C. Morton, Ph. D. Site-Responsible Investigator(s)/Institution: James G subr protrudeinella, Ph. D. /MGH Co-Investigator(s)/ battleground Staff: Drs. B Quade, A Ligon, R Maas, A Michelson, J Gusella, M MacDonald, E Lemyre, J Lewis rendering of Subject Population: Patients with innate(p) anomalies PURPOSEWe would like authorization to enroll you as a participant in a seek breeding. The purpose of this search is to range and examine genes involved in human development. You afford been asked to move in this research battlefield because you (or your child) gravel (or has) one or more than developmental abnormalities and chromosomal abnormalities that form been e nter since accept. Such chromosomal abnormalities whitethorn disrupt the function of genes required for normal produce and development. By depicting these genes in people with peculiar(prenominal) birth defects, we hope to reach a greater dread of how the human body grows and develops. culture CONTACTS This contract is being realise by Dr. Cynthia C. Morton, who finish be reached at 617-732-7980 with every questions you may have during the course of this show. If you enrolled at the MGH, amuse contact Dr. James Gusella at 617-726-5724. PROCEDURES If you agree to participate, you pull up s guards donate a telephone line sample. The amount of filiation drawn volition vary with age (less than 2 years old: close 1 tablespoon; ages 2-10 years: approximately 2 tablespoons; ages 11 years and up: about 2-4 tablespoons) and may be cut for smaller individuals.In general, afterward you have donated neckcloth, cells or weave samples no superfluous hospitalization or cli nic visits pull up stakes be required for you to participate in this plain. any(prenominal) of the samples you donate leave be used to be an immortal cell line. This means that an inexhaustible supplement of DNA result be available for transmittable research. DNA is the genetic material from which genes atomic number 18 made. These samples may be stored/banked for future use and/or divided up with different investigators associated with this study. These stored or distributed samples allow for non be labeled with your name.Do you agree to this (please circle one choice): summon 1 of 5 Subject Population: Patients with intrinsic anomalies IRB protocol be: 1999P-003090 98-09233 Sponsor Protocol human action: N/A Consent blueprint favourable reception season: declination 9, 1999 Amendment numerate Approved: N/A IRB completion exit: Amendment encomium watch: N/A NOVEMBER 22, 2000 Research Consent reverberate Brigham and Women’s Hospital Dana-Farber Can cer Institute momma General Hospital Version III. a tremendous 1998 Pi_dist9. doc Imprint Patient ID modus operandi YES NO You may be contacted in the future and asked for additional samples to appease research.If you do non wish to be contacted in the future, you may indicate this below: YES, hunky-dory to contact NO, do non contact As mentioned above, samples that atomic number 18 sent to the research laboratory entrust be assigned a tag number. The place to this code get out be assigned in locked files by Dr. Cynthia Morton, and your (or your childs) identity will not be revealed to anybody other than your referring physician. Important non-identifying culture such as sex, age, and nature of your developmental abnormality will be transmitted to the research laboratory in point to correlate study results with specialized developmental problems.The discipline obtained from this study of your donated blood or tissue is not known to be useful clinically or diagnostic ally at this time. The research is currently useful however as a means of understanding genes and developmental abnormalities. Results from these genetic studies will NOT be hardened in your (or your childs) medical exam temper. We will not extend these results directly to you; study results will be released to your referring physician. cost No charges will be billed to your damages company or to you for this study. You should be sure that no charges for the blood draw are to be filed with your amends company.If the person who draws your blood intends to bill you, you should pay for this yourself and steer a reduplicate of the bill to the investigator who will reimburse you. RISKS AND DISCOMFORTS There are minor risks and discomforts associated with blood sampling. This includes a brief amount of pain and mayhap a small bruise at the goad site. Occasionally a person feels faint when his/her blood is drawn. Rarely an infection develops, but if this occurs the infection cig arette be treated. Disclosure of Study Results culture about your participation in a genetic study may exploit insurance and/or employers regarding your wellness status.We will use many safeguards to prevent unintentional disclosure: I) in modelation about your participation in, and the results of, this research will NOT be placed in your medical proves, II) research data (including data compile from medical charts) will be entered only 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 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 share with others the fact that you have participated in genetic studies. rascal 2 of 5 Subject Population: Patients with inhering anomalies IRB Protocol Number: 1999P-003090 98-09233 Sponsor Protocol Number: N/A Consent Form eulogy hear: DECEMBER 9, 1999 Amendment Number Approved: N/A IRB Expiration appointee: Amendment Approval Date: N/A NOVEMBER 22, 2000 Research Consent Form Brigham and Women’s Hospital Dana-Farber Cancer Institute mum General Hospital Version III. a noble 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 parcel out (either positively or negatively), we will convey this information to your physician. After the potential significance of such results has been explained to you by your physician, you will be offered an luck to obtain free lance 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 offer up additional consent for it. nevertheless the result o f the confirmatory test would be entered into your medical record book by the diagnostic laboratory or your physician. BENEFITS At this time, we know of no direct well-being to you (or your child) as a result of participation in this research study. Participation is completely voluntary and your alternate 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 remove not to participate, your medical share and treatment will NOT be affected. rapscallion 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 Women’s Hospital Dana-Farber Cancer Institute mummy General HospitalVersion III. a August 1998 Pi_dist9. doc Imprint Patient ID Number THE FOLLOWING PARAGRAPHS CONTAIN STANDARD INFORMATION WHICH generally APPLIES TO PERSONS INVOLVED IN A RESEARCH STUDY AND ARE REQUIRED ON ALL have FORMS. CONFIDENTIALITY Medical information produced by this study will become part of your hospital medical record, unless specifically stated otherwise in this consent form. data that does not become part of your medical record will be stored in the investigator’s file and identified by a code number only.The code key connecting your name to specific information about you will be unploughed in a separate, secure location. Your medical record is available to health care professionals at Brigham and Women’s Hospital (BWH), Dana-Farber Cancer Institute (DFCI), or Massachusetts General Hospital (MGH), collectively called the â€Å"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 unaffiliated with the Hospitals in a form that could identify you without your compose consent, leave off as described in this consent form or as required by law. It is potential 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 politics (FDA), federal or state government 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 book 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 earlier you give your permission for their use if you so request. bespeak 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 stark naked findings discovered during the course of this study that might influence your continued participation.If during the study or later, you wish to establish your rights as a research subject, your participation in the study and/or concerns about the study, a research-related stigma with someone not directly 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 perspective 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 Women’s Hospital Dana-Farber Cancer Institute Massachusetts General Hospital Version III. a August 1998 Pi_dist9. doc Imprint Patient ID Number REFU SAL OR pulling out 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 solve to participate, you can change your mind and drop out of the study at any time without modify your present or future care in the Hospitals. In addition, the doctor 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. INJURY 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 imply any fault or wrong-doing on the part of the Hospitals or the doctor(s) involved. Where applicable, the Hospitals reserve the right to bill t hird ships company payers for services you receive for the injury. The Hospitals will not provide you with any additional compensation for such injuries. pinch I confirm that the purpose of the research, the study procedures and the realizable risks and discomforts as well 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 pinch 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 well as potential benefits and have answered any questions regarding the study to the better(p) of my ability.Study Representativ e 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) primary coil Care Physician’s Name: Date protocol treatment 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\r\n'