Burns, J. K.

Dworkin, Roger B.

Gold, R. L.

Hadro, T

Lebel, R. R.

Mearns, E. A.

English

Indiana University Bloomington Maurer School of Law

Maurer School of Law: Indiana UniversityDigital Repository @ Maurer LawArticles by Maurer Faculty Faculty Scholarship1993Model Consent Forms for DNA Linkage Analysisand StorageRoger B. DworkinIndiana University Maurer School of LawR. L. GoldR. R. LebelE. A. MearnsT HadroSee next page for additional authorsFollow this and additional works at: http://www.repository.law.indiana.edu/facpubPart of the Bioethics and Medical Ethics Commons, Genetics Commons, and the MedicalJurisprudence CommonsThis Article is brought to you for free and open access by the FacultyScholarship at Digital Repository @ Maurer Law. It has been accepted forinclusion in Articles by Maurer Faculty by an authorized administrator ofDigital Repository @ Maurer Law. For more information, please contactwattn@indiana.edu.Recommended CitationDworkin, Roger B.; Gold, R. L.; Lebel, R. R.; Mearns, E. A.; Hadro, T; and Burns, J. K., "Model Consent Forms for DNA LinkageAnalysis and Storage" (1993). Articles by Maurer Faculty. 2472.http://www.repository.law.indiana.edu/facpub/2472AuthorsRoger B. Dworkin, R. L. Gold, R. R. Lebel, E. A. Mearns, T Hadro, and J. K. BurnsThis article is available at Digital Repository @ Maurer Law: http://www.repository.law.indiana.edu/facpub/2472American Journal of Medical Genetics 47:1223-1224 (1993) Model Consent Forms for DNA Linkage Analysis and Storage R.L. Gold, R.R. Lebel, E.A. Mearns, R.B. Dworkin, T. Hadro, and J.K. Burns Sinai Hospital of Detroit, Detroit, Michigan (R.L.G.); Case Western Reserve School of Law, Cleveland, Ohio (E.A.M.); Indiana University School of Law, Bloomington, Indiana (R .B.D.); Genetics Services, Elmhurst (R.R.L.), and Childrens Memorial Hospital, Chicago (T.H.), Illinois; and University of Wisconsin, Madison, Wisconsin (JX.B.1 INTRODUCTION In 1988, the Great Lakes hgional Genetics Group (GLaRGG) created a standing subcommittee to consider the ethical and legal issues pertinent to the genetics professional community. One of our goals was to provide assistance to geneticists in our region in their considera- tion of difficult ethical and legal issues related to DNA testing. At the time, few of the regional genetics groups had such committees, and at this time some still do not have them. At the time of our initial committee discussions, DNA linkage was just beginning to be a part of mainstream genetic testing. There was concern whether a patient was able to understand the nuances of DNA testing, and whether truly informed consent was possible. DNA banking was also a major concern, especially with re- gard to ownership of the DNA. Today we still perceive a need for greater refinement in the treatment of issues having to do with “ownership” and control over the des- tiny of DNA samples deposited in laboratories for anal- ysis analor storage. In 1990, the committee undertook a project to create template or model DNA consent forms. These forms are not intended to be used as is, but to serve as starting points for consent forms. Although we may have missed some of the potential problems, we hope that by publish- ing these models, and by facilitating their formulation, we might encourage the use of explicit and detailed consent forms within the genetics community. The composition of these model consent forms was assisted by our study of forms actually in use in some laboratories of our region, and by our study of the official policies of the American Society of Human Genetics [19901. INTRODUCTION To DNA STORAGE AND LINKAGE ANALYSIS CONSENT FORMS Genes are made up of deoxyribonucleic acid (DNA). DNA found in the cells of the body contains the “blue- print” for inherited traits. DNA comes from our parents in structures called chromosomes. Usually there are 46 chromosomes in each cell, 23 from each parent. Human diseases are often caused by changes (mutations) in DNA. Often these changes can be traced through a par- ticular family. When an inherited condition occurs in a family, relatives often want to know if they might de- velop the condition or if they might be carriers of the mutation which causes it. Carriers of a recessive gene have it and may pass it to their children but ordinarily they do not show signs of the condition it may cause when present in a double dose. A dominant condition usually shows itself in any person who inherits it even in a single dose, but sometimes its effects are delayed until adulthood. Recent advances in DNA technology have produced tests which can find mutations, so that people can know if they have the changed gene or can pass it on to their children. Each test looks at  a specific change in DNA. Often several relatives must be studied in order to find these changes. Not all genetic conditions have been studied, but scientists are working to develop more DNA tests. Some people may want to store samples of their DNA, so that it may be used to aid other relatives, should tests become available in the future. DNA is obtained most commonly from the cells in a sample of blood. Storage of DNA is called “DNA bank- ing.” A person who is considering submitting a sample of DNA for analysis should also consider what is to be done with leftover material when the test is completed (stor- age or disposal). Received for publication June 4,1993; revision received July 12, 1993. Address correspondence to Dr. R.R. Lebel, Chairperson of the GLaRGG Subcommittee on Ethical and Legal Issues, Genetics Services, SC, 360 West Butterfield Road, Suite 245, Elmhurst, IL 60126. 0 1993 Wiley-Liss, Inc. 1224 Gold et al. (DNA bank letterhead) (DNA bank letterhead) CONSENT FOR DNA STORAGE 1. I, ~ , wish to submit a Sam- ple of my blood for the purpose of storing DNA (genetic material) from the cells in the blood. The reason for this is that members of my family have or might have genetic changes associated with the clinical condition The following conditions apply to the DNA: (circle an:y and all that you wish) A. To be used for any future testing as requested in writing by me. B. To be used by members of my immediate family (spouse, descendants, parents, grandparents, sibs and their descendants). C. To be used as above only until the time of my death, when the remaining DNA in storage is to be de- stroyed. D. To be used for research purposes without my or my family members’ knowledge, a t  the discretion of CONSENT FOR DNA ANALYSIS I, request that an attempt be made to assess the probability that I or my unborn child might have inherited the gene for I understand that the DNA for analysis is to be ob- tained from: a) blood cells, b) skin sample, c) other: . The methods, discomfort, and risks of obtaining the specimen have been explained to me. I also understand that: 1. The test procedure is specific to the genetic condi- tion mentioned above and cannot determine the com- plete genetic makeup of an individual. 2, Lack of cooperation by key relatives in providing blood samples may decrease the accuracy of the test result and/or the ability to perform the test. 3. An error in diagnosis may occur if there is any- thing incorrect in what I say about the biological rela- tionships of relatives involved. 4. Sometimes the genetic pattern in a family renders the test results “uninformative” (not clarifying the point in question). 5.  Even under the best conditions, current technology of this type is imperfect, and may lead to incorrect re- sults. 6. The test results, when reported to me, may be distressing. 7. I may withdraw my consent at any time without penalty. When the test has been completed, if there is any remaining unused DNA material (circle one letter): a. I wish for it to be stored (“banked”) and have submitted the appropriate DNA banking con- sent form, or b. I do not wish to bank the leftover DNA, and prefer that it be destroyed. All of the above has been discussed with me, and my questions answered by patient signature witness E. To be used without any restrictions. F. Other 2. I understand that the DNA sample will be stored under the following conditions and limitations (these depend on the specific lab): A. Services provided by the bank: (e.g. shipping to B. Risks associated with banking: (e.g. loss or mis- C. Method of maintaining contact between depositor 3. I understand that I may change my mind and with- draw my consent for DNA banking at  any time. I also understand that there may be some discomfort and/or bruising associated with drawing blood from a vein in my arm. All of the above has been discussed with me, and my questions answered by other laboratories withtwithout charges). placement of samples, catastrophic events). and bank: depositor signature witness date date date date REFERENCES Ad HOC Committee on DNA Technology (1988): DNA banking and DNA analysis Points to consider. Am J Hum Genet 42:781-783. 

Model Consent Forms for DNA Linkage Analysis and Storage

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Model Consent Forms for DNA Linkage Analysis and Storage

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