Example of a Consent Form

Topics: Medical record, Genetics, Gene Pages: 12 (2278 words) Published: November 13, 2012
Research Consent Form
Brigham and Women’s Hospital
Dana-Farber Cancer Institute
Massachusetts General Hospital
Version III.a August 1998

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.

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.

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:



Sponsor Protocol Number:


Consent Form Approval Date: DECEMBER 9, 1999

Amendment Number Approved:


IRB Expiration Date:

Amendment Approval Date:


NOVEMBER 22, 2000

Research Consent Form
Brigham and Women’s Hospital
Dana-Farber Cancer Institute
Massachusetts General Hospital
Version III.a August 1998

Imprint Patient ID Number



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...
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