Medical genetics : a legal frontier / by Lori B. Andrews.

  • Andrews, Lori B., 1952-
Date:
1987
Catalogue details

Licence: Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0)

Credit: Medical genetics : a legal frontier / by Lori B. Andrews. Source: Wellcome Collection.

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    282 C. Selection of patients Estimate the number of patients to be involved in the proposed study of gene therapy. Describe recruitment procedures and patient eligibility requirements, paying particular attention to whether these procedures and requirements are fair and equitable. 1. How many patients do you plan to involve in the proposed study? 2. How many eligible patients do you anticipate being able to identify each year? 3. What recruitment procedures do you plan to use? 4. What selection criteria do you plan to employ? What are the exclusion and inclusion criteria for the study? 5. How will patients be selected if it is not possible to include all who desire to participate? D. Informed consent Indicate how patients will be informed about the proposed study and how their consent will be solicited. The consent procedure should adhere to the requirements of DHHS regulations for the protection of human subjects (45 Code of Federal Regulations, Part 46). If the study involves pediatric or mentally handicapped patients, describe procedures for seek¬ ing the permission of parents or guardians and, where applicable, the assent of each patient Areas of special concern highlighted below include potential adverse effects, financial costs, privacy, and long-term follow- up. 1. How will the major points covered in Sections I-A through I-C of this document be disclosed to potential participants in this study and/or parents or guardians in language that is understandable to them? 2. How will the innovative character and the theoretically-possible adverse effects of gene therapy be discussed with patients and/or parents or guardians? How will the potential adverse effects be com¬ pared with the consequences of the disease? What will be said to con¬ vey that some of the adverse effects, if they occur, could be irreversible? 3. What explanation of the financial costs of gene therapy and any available alternative therapies will be provided to patients and/or parents or guardians? 4. How will patients and/or parents or guardians be informed that the innovative character of gene therapy may lead to great interest by the media in the research and in treated patients? 5. How will patients and/or parents or guardians be informed: a. That some of the procedures performed in the study may be irreversible? b. That following the performance of such procedures it would not be medically advisable for patients to withdraw from the study? c. That a willingness to cooperate in long-term follow-up (for at least three to five years) will be a precondition for participation in the study?