Association for Molecular Pathology (AMP) expressed concern that the determination of the proposed rule that biospecimens can’t de-identified will limit validation of clinical trials.
Despite the positive changes in the proposed rule, the AMP was very concerned about the parts that deal with biospecimens and calls on the Department of health and human services (DHHS) to change the rules to be implemented. In medical practice, molecular pathologists and Laboratory Director to develop and validate tests for clinical use. Generally, the laboratory use of samples collected
outside of research studies, for example, the rest of the network after the operation, or share with other laboratory samples to be used as a control. In this case, all the identifiers have been removed from the sample in order to protect the confidentiality of the patient. “These practices played an important role for Molecular Pathology and necessary to ensure high quality, safe testing for patients,” said Dr. Elaine Lyon, Chairman of the Professional Relations Committee AMP’s. Dr. Lyons emphasized that, “the practice of using samples for validation and verification is part of doing quality control and quality assessment activities, and research.”
Thus, AMPS calls on DHHS to include language that identifies this activity to be a part of clinical care and the practice of medicine, and is not considered as research, to clarify the confusion and prevent possible future misinterpretation.
AMP also believes the proposed rule oversimplifies the ability to link biospecimen de-identified return to individuals based on a sample of DNA is extracted. “It is almost impossible with current technology,” explains Dr. Lyon, “in fact, some examples of when this occurs, the researcher must access samples from family members, or information about a very rare clinical presentation is easy to identify which gives samples.” AMP views proposed rule concerns was reaction was disproportionate to the risks and the conclusion that biospecimens cannot de-identified to achieve much. To overcome this, AMP shares the American Society for investigative pathology’s view that the current policy enforcement and use of biospecimens abuse coupled with strict penalties for violations is the best way to ensure the best protection of human subjects involved in the research.