Last Updated 18 Jun 2020

Example of a Consent Form

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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 Protocol Title: Developmental Anatomy Genome Project (DGAP) Principal/Overall Investigator: Cynthia C. Morton, Ph. D. Site-Responsible Investigator(s)/Institution: James 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 Subject Population: Patients with congenital anomalies PURPOSE

We would like permission to enroll you as a participant in a research study. The purpose of this research is to identify and study genes involved in human development. You have been asked to participate in this research study because you (or your child) have (or has) one or more developmental abnormalities and chromosomal abnormalities that have been present since birth. Such chromosomal abnormalities may disrupt the function of genes required for normal growth and development. By identifying these genes in people with specific birth defects, we hope to reach a greater understanding of how the human body grows and develops.

STUDY CONTACTS This study is being organized by Dr. Cynthia C. Morton, who can be reached at 617-732-7980 with any questions you may have during the course of this study. If you enrolled at the MGH, please contact Dr. James Gusella at 617-726-5724. PROCEDURES If you agree to participate, you will donate a blood sample. The amount of blood drawn will vary with age (less than 2 years old: about 1 tablespoon; ages 2-10 years: about 2 tablespoons; ages 11 years and up: about 2-4 tablespoons) and may be reduced for smaller individuals.

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In general, after you have donated blood, cells or tissue samples no additional hospitalization or clinic visits will be required for you to participate in this study. Any of the samples you donate will be used to establish an immortal cell line. This means that an inexhaustible supply of DNA will be available for genetic research. DNA is the genetic material from which genes are made. These samples may be stored/banked for future use and/or shared with other investigators associated with this study. These stored or distributed samples will NOT be labeled with your name.

Do you agree to this (please circle one choice): Page 1 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 Massachusetts General Hospital Version III. a August 1998 Pi_dist9. doc Imprint Patient ID Number YES NO You may be contacted in the future and asked for additional samples to continue research.

If you do not wish to be contacted in the future, you may indicate this below: YES, okay to contact NO, do not contact As mentioned above, samples that are sent to the research laboratory will be assigned a code number. The key to this code will be maintained in locked files by Dr. Cynthia Morton, and your (or your child's) identity will not be revealed to anybody other than your referring physician. Important non-identifying information such as sex, age, and nature of your developmental abnormality will be transmitted to the research laboratory in order to correlate study results with specific developmental problems.

The information obtained 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 only as a means of understanding genes and developmental abnormalities. Results from these genetic studies will NOT be placed in your (or your child's) medical record. We will not communicate these results directly to you; study results will be released to your referring physician. COSTS No charges will be billed to your insurance 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 reimburse 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 needle site. Occasionally a person feels faint when his/her blood is drawn. Rarely an infection develops, but if this occurs the infection can be treated. Disclosure of Study Results Information about your participation in a genetic study may influence insurance and/or employers regarding your health status.

We will use many safeguards to prevent 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 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 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 Women’s Hospital Dana-Farber Cancer Institute Massachusetts General Hospital Version III. a August 1998 Pi_dist9. doc Imprint Patient ID Number

These 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 healthcare (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 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. Only 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. Participation 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 treatment 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 Women’s Hospital Dana-Farber Cancer Institute Massachusetts General Hospital

Version 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 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 investigator’s 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 Women’s Hospital (BWH), Dana-Farber Cancer Institute (DFCI), or Massachusetts General Hospital (MGH), collectively 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 unaffiliated with the Hospitals in a form that could identify you without your written 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 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 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 wish 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 directly involved in the study, or if you feel under any pressure 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 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 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 mind and drop out of the study at any time without affecting 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 third party payers for services you receive for the injury. The Hospitals will not provide you with any additional compensation for such injuries. SIGNATURE I confirm that the purpose of the research, the study procedures and the possible 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 signature below indicates my willingness to participate in this study. Subject/Patient Date Witness/Advocate/Minor/Legal 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 best of my ability.

Study Representative 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 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

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Example of a Consent Form. (2018, Jun 13). Retrieved from https://phdessay.com/example-of-a-consent-form/

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