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DNA projects, by nature of their subject matter, are reviewed for the following information in addition to the standard required review. Genetic information is uniquely personal information and has the potential to influence employment, insurance, finance, education and possibly self-perception. Therefore, genetic information must be carefully maintained in order to protect against stigmatization, discrimination, or significant psychological harm to the subject.
The IRB considers the following issues in its review of the application and the Informed Consent Document:
- Information that can be obtained from DNA samples in general, and the specific questions to be addressed in this study.
- The extent of subject and sample confidentiality if the sample and subsequent information will be part of a registry or database (required for all studies, regardless of being a registry or database).
- The rights and limitations of subjects to require destruction of their sample and/or associated data at a future date. The rights and limitations of subjects to require that their sample and or associated data be stripped of any identifying information.
- Identifying information available to other researchers if their sample and/or associated data are part of a registry or database (required for all studies, regardless of being a registry or database)
- Mechanisms for maintaining confidentiality in long-term studies, registries, or databases.
- Potential for commercial profit by the institution, investigator or sponsor from information gathered in this study.
- The availability or access to genetic counseling in cases where a study may reveal genetically important information (i.e., possessing genetic defects which could be passed on).
- Subjects must have the right to decline receiving genetic information (required for all studies).
- In the absence of a specific authorization to maintain a DNA sample beyond the initial project, DNA samples collected, stored, and/or analyzed in connection with a research project must be destroyed upon completion of the project or withdrawal of the individual from the project. This information must be clearly stated in the Informed Consent Document.
Before involving children in DNA research, the parent(s) or legal guardian(s) must review and sign the Informed Consent Document. The Informed Consent Document must give parents/guardians the option of whether or not they want the results (if available) of the genetic analysis disclosed to them. Whenever appropriate, the child's assent should be solicited. Upon reaching the age of majority, if the subject may request his or her information be disclosed, this should be described in the Consent Document. Investigators must follow the appropriate measures with regard to releasing such information (e.g., counseling, etc.). In some cases it may be possible to determine that some members of the family are not genetic relatives. Issues of genetic relationships (paternity or maternity, as could be hidden by adoption or donor fertilization) and other incidental information should not be revealed. The standard Informed Consent Document template contains suggested language for genetic research and for storing tissue or specimens for future use.