Guidance on Ethical Requirements for Laboratory Validation Testing (2024)

'The ICMR has issued guidance on ethical requirements for laboratory validation testing, emphasizing the importance of ensuring accurate and consistent results in laboratory medicine. The document highlights that laboratory validation tests are used to establish that methods or instruments will provide consistent results within prescribed acceptance criteria, with a high degree of assurance. Validation is distinguished from evaluation, which measures performance capabilities of a test method.

The guidance covers various aspects, including the scope of laboratory validation testing, which may include tests to ensure reproducibility, sensitivity, specificity, accuracy, reliability, and fitness for purpose using residual or archived samples. It also emphasizes that this does not include independent evaluation of novel products or innovations requiring clinical evaluation and regulatory pathways.

Key considerations in laboratory validation testing involve ensuring the use of anonymized or de-identified samples without the intention of conducting research or influencing patient treatment/management. The document also addresses scenarios where additional samples are collected with minimum discomfort, potentially leading to negative implications for patients.

The guidance recommends that investigators submit a self-declaration form (Annexure II) to institutional authorities and ethics committees, providing information on the laboratory validation testing process. It further suggests that if all criteria are met, this form can be submitted for information attested by department heads and institutional heads, while proposals with any "no" answers should undergo ethics committee review and approval before commencing lab validation tests.'