Ensuring Adoption and Adherence to the Development and Evaluation Process

The committee’s recommendations to ensure adoption of appropriate research and development practices (Recommendations 4-7) are put forth in the spirit of “best practices.” There could be numerous approaches to ensuring adherence, and the optimal approach will need to be determined by each of the stakeholders involved in omics research.

Investigators and institutions that conduct omics-based research with the goal of improving patient care have responsibilities for supporting that research and test development. Both contribute to the scientific research culture in which omics-based research is conducted; investigators control the culture of individual laboratories, while institutions put policies and procedures in place that support scientific integrity and ensure sound and ethical practices for clinical research. To avoid adding new barriers to innovation in this promising field, the committee’s recommendations aim to emphasize and enhance institutional awareness of existing responsibilities to ensure the integrity of the scientific process. The committee recognized that these recommendations might increase the oversight requirements for omics research in some institutions, but agreed that these potential costs were offset by the added safeguards for the integrity of this research. If an institution does not have the infrastructure or capability to follow the recommended Test Development and Evaluation Process defined in this report, then the committee believes that institution should consider not engaging in the translation of omics-based discoveries into validated tests intended for clinical use.

As the Duke case study clearly demonstrates, existing procedures in some institutions may not adequately ensure the scientific integrity of translational omics. For example, although most institutions have clear policies and procedures for financial conflicts of interest for individuals, there is often less clarity when handling institutional conflicts, both financial and non-financial. An institution might appear so conflicted in certain situations that an outside body should be asked to take responsibility for an investigation.

The committee also addressed responsibilities of funders, FDA, and journals in ensuring rigorous development of omics-based tests (Box S-2). Funders play a leadership role in encouraging a culture of integrity and transparency in science, while they seek to accelerate progress through discovery, translation, and clinical applications. The committee highlighted the importance of funders supporting independent confirmation as well as validation in a CLIA-certified clinical laboratory of candidate omics-based tests. Funders have generally not supported such work in the past because they do not consider it to be original, innovative science. Without

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