INDIAN COUNCIL OF MEDICAL RESEARCH

GUIDANCE ON
ETHICAL REQUIREMENTS FOR
LABORATORY VALIDATION
TESTING

FEBRUARY 2024
 Ethical Requirements for Laboratory Validation Testing

1. Background:
1.1. Laboratory validation tests are used to ensure that laboratory test data and results are
accurate, consistent, and precise. These are processes that are documented and
standardized to establish that the methods or instruments used will provide consistent
results within the prescribed acceptance criteria to be clinically applicable. Validation is
defined as establishing documented evidence that provides a high degree of assurance
that a specific process will consistently produce a product meeting its predetermined
specifications and quality attributes.
1.2. Validation test or processes in laboratory medicine may typically refer to the multi-tiered
process of evaluating the performance of a new instrument or test methodology, that is
currently in use for diagnostics. A validation may be extensive, e.g., to validate a newly
developed in-house method, or it could be narrow in scope, e.g., to validate a commercial
method that is already in use and has had minor modifications. Validation is different
from evaluation which is used to describe the measurement of performance capabilities
of a test method and is a systematic and extensive process.

2. Scope:
2.1. This guidance refers to the Laboratory Validation Tests which may include tests to ensure
reproducibility, sensitivity, specificity, accuracy, reliability, fitness for purpose, quality
control/ assurance purposes, etc. done using residual/ archived/ unlinked/ anonymous
samples.
2.2. It does not include independent evaluation of novel products/ innovations for which
clinical evaluation is required and may involve regulatory pathways.

3. Laboratory Validation Testing vs Biomedical and Health Research Involving Humans:

3.1. Biomedical and health research on humans includes studies that are designed primarily to
increase the scientific knowledge about diseases and conditions (physical or socio-
behavioral), their detection, cause, and evolving strategies for health promotion,
prevention, or amelioration of disease and rehabilitation including clinical research.
Therefore, biomedical research explores scientific questions related to human health and
disease.
3.2. Lab validation testing typically focuses on lab methods undertaken in a controlled
environment to ensure the accuracy and reliability of results and not for exploring
broader scientific questions to understand human health and diseases.
3.3. All laboratory tests must be validated before being introduced for patient testing to
ensure that the values reported will meet clinical expectations with a desired degree of

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 reliability. It involves standard clinical/ laboratory diagnostic practices or the
advancement of standard practices, without any active recruitment of participants.
3.4. The validation testing must not in any way influence patient diagnostics, management, or
treatment and has no bearing on health-related outcomes for a patient.

4. Ethical Considerations:
4.1. Laboratory Validation Testing employs samples or biological materials or biological
specimens such as blood, urine, tissue, cells, saliva, DNA, etc. Often these could be
pooled samples collected from multiple individual samples. The samples must not have
been collected specifically for this purpose but are available as archived samples which
are dis-associated/ delinked/ unidentified/ pooled/ anonymous samples and available
without any patient information and thus pose no risk to patient’s confidentiality.
4.2. If the biological samples are linked to different types of personal identifiers (name,
address, etc.) or with health-related data (chronic illnesses, prior hospital stays), and
other types of potentially sensitive data (travel history, family history) there is a risk for
breach of confidentiality and such samples are not recommended for Lab Validation
Testing without ethics approval from Ethics Committee (EC).
4.3. The laboratory must not tend to collect or extract more samples to be used for future
validation testing (for example, draw more blood volume for use later) than would
typically be needed for the diagnostic procedure. Any extra blood draws would require
appropriate ethics approval and informed consent of the patient.
4.4. At the time of sample collection, if there is a probability of future usage of samples,
appropriate informed consent must be obtained from the patients. The informed consent
must clearly mention the plan for future testing purposes or storage.
4.5. The investigator undertaking Laboratory Validation Testing must keep the ethics
committee informed regarding use of leftover/ archived/ anonymous samples. The
laboratories involved in the validation of tests/ methods, may be exempted from ethical
approval using leftover archived and anonymized samples.
4.6. Regulatory testing carried out at National Control laboratories, involving leftover or
stored samples in biorepositories (hospitals, diagnostic labs, blood banks, IRCS, etc.) may
require administrative approvals from institutional authority and not necessarily ethical
approval provided the samples are anonymized and no extra sample is drawn from
patients.

5. Administrative approval:
5.1 Sites participating in the Lab Validation Testing must ensure that institutional authorities
are kept duly informed before undertaking any Laboratory Validation Testing.

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5.2 The investigator must commit to Good Laboratory Practice Guidance, fill the checklist
(Annexure II) and provide a self-declaration to the ethics committee and to the
department/ or the relevant institutional authorities/ Head of the Institution.
5.3 The commercial implications related to Lab Validation Testing must not compromise the
scientific integrity and all efforts must be taken to avoid biases in the lab validation
testing.
5.4 After completion of Lab validation testing, a summary of the number and type of samples
used in validation testing should be provided to the institutional authorities as well as the
ethics committees.

Recommendations:

• If the Laboratory Validation Testing involves the use of anonymous or

de-identified samples and focuses on parameters such as sensitivity, or
specificity, etc., without the intention of conducting research or
influencing patient treatment/ management and does not involve any
novel/ innovative diagnosis/ technology, the proposal for laboratory
validation testing is exempted from ethics committee review.
• A self-declaration form (Annexure-II) to be submitted by the
investigators to the institutional authorities and ethics committee for
information.

References:
1. Borovecki A, Mlinaric A, Horvat M, SupakSmolcic V. Informed consent and Ethics
Committee approval in Laboratory Medicine. BiochemiaMedica. 2018;28(3). Available
from: https://doi.org/10.11613/bm.2018.030201
2. Das B. Validation Protocol: First Step of a Lean-Total Quality Management Principle in a
New Laboratory Set-up in a Tertiary Care Hospital in India. Indian J Clin Biochem. 2011
Jul;26(3):235-43. Available from: https://doi.org/10.1007/s12291-011-0110-x
3. Groth-Helms D, Rivera Y, Martin FN, Arif M, Sharma P, Castlebury LA. Terminology and
Guidelines for Diagnostic Assay Development and Validation: Best Practices for Molecular
Tests. PhytoFrontiersTM. 2023 Jun;3(1):23–35. Available from:
http://dx.doi.org/10.1094/PHYTOFR-05-22-0059-FI
4. ICMR National Ethical Guidelines for Biomedical and health research involving human
participants; 2017 [Internet]. Available from:

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 https://ethics.ncdirindia.org/asset/pdf/ICMR_National_Ethical_Guidelines.pdf (Accessed
19 Jan 2024).
5. ISO 15189:2012(en), Medical laboratories — Requirements for quality and competence
[Internet]. Available from: https://www.iso.org/obp/ui/#iso:std:iso:15189:ed-3:v2:en
(Accessed 19 Jan 2024).
6. Remes Lenicov F, Fink NE. Ethical issues in the use of leftover samples and associated
personal data obtained from diagnostic laboratories. ClinicaChimica Acta. 2023
Aug;548:117442. Available from: https://doi.org/10.1016%2Fj.cca.2023.117442
7. UK Standards for Microbiology Investigations Evaluations, validations and verifications
of diagnostic tests [Internet]. Public Health England; 2017. Available from:
https://assets.publishing.service.gov.uk/media/5a8210cfed915d74e6235995/Q_1i5.pdf
(Accessed 19 Jan 2024).

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 Annexure I
Potential Scenarios of Laboratory Validation Tests
S Type of study Scenarios Implications Examples Risk Privacy and Informed Ethics
N on patients assessment confidentiality consent approval

1 Analytical Studies that use None Stored residual sputum or blood No harm/ Samples Not Not required
validation residual or stored samples used for testing analytical discomfort anonymized required
samples sensitivity/ specificity of test kit

2 Clinical Sample collected None Sputum sample is collected for No harm/ Samples Not Not required
validation from patient/ routine diagnosis of TB. One part discomfort anonymized Required
healthy donors as of the sample is used for clinical
per routine practice. diagnosis as per routine practice.
No additional One part of the sample is used for
sample is collected performance evaluation of test kit
for the study.

3 Additional sample Possibility of Extra volume of sputum sample Minimum Samples Required Required
collected with no negative collected for the study harm/ anonymized (Expedited
Clinical discomfort to implications discomfort review by the
validation- patient EC)

4 Non-invasive Additional sample Possibility of Extra volume of induced sputum Minimum Samples Required Required
samples collected with negative or extra nasal swab collected for harm/ anonymized
minimum implications the study discomfort
discomfort

5 Clinical Additional sample Possibility of Extra volume of blood drawn at Minimum Samples Required Required
validation- collected with no negative the same time with no additional harm/ anonymized (Full EC
Invasive discomfort to the implications needle prick discomfort review)
samples patient

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6 Additional sample Negative Extra needle prick or insert Minimum Samples Required Required
collected with implications required for the study harm/ anonymized (Full EC
minimum discomfort review)
discomfort

7 Repeat tests- Additional sample Negative Patient is called for additional visit Minimum Samples Required Required
Non-invasive (sputum or swab) implication to collect repeat sputum or swab harm/ anonymized
samples collected with extra sample (to resolve discrepancies, discomfort
visit indeterminate/ inconclusive
results, contamination etc)

8 Repeat tests- Additional sample Negative Patient is called for additional visit Minimum Samples Required Required
Invasive collected (blood) implication to collect repeat blood sample harm/ anonymized (Full EC
samples with extra visit discomfort review)

9 Additional lab Additional lab None Quantification of cytokines or CD4 No harm/ Samples Required Information
investigations investigations count from the serum or blood discomfort anonymized to EC/
performed for the collected for routine diagnosis Institutional
study from the head/
sample collected for Authorities
routine diagnosis

10 Concordance Concordance testing None Concordance of fully automated No harm/ Samples Not Not required
testing of new version/ version with partially automated discomfort anonymized required
system/ make with version, high throughput version
existing version/ vs modules with lesser samples
system using
residual or stored
samples

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 Annexure II – Self Declaration Form to be filled by the Investigator
and checklist for Laboratory Validation Tests projects/protocols

Title:

S No. Criteria Yes No

1. Lab Validation Tests will be conducted on samples that are dis-
associated/ delinked/ unidentified/ pooled/ anonymous
samples irreversibly without any patient information.
2. Lab Validation Tests utilize samples already collected for
routine laboratory practices and would involve testing related
to accuracy, sensitivity, specificity, reliability, reproducibility,
precision, fitness for purpose and quality control/ assurance.
3. Lab Validation Testing/ management is the sole purpose of this
process and research/ hypothesis testing/ publication is not an
intent.
4. Lab Validation Tests does not require the collection of clinical
information or additional samples from patients.
5. Lab Validation Tests doesn’t directly or indirectly identify or
impact patient health, disease treatment or management or
other similar scenarios in present or at a future date.
6. Lab Validation Testing doesn’t involve using any new
diagnosis/ innovative/ novel methods or technology/
discovery/ drug development.

If the answer to all the above-mentioned criteria is ‘Yes’, you can proceed with the declaration.
☐I am hereby declaring that the above-mentioned information about this Lab Validation Tests
is true to best of my knowledge.

Place: Signature:
Date: Name:

Head of the Department Head of the institution

Note:
1. If the answer to all the above-mentioned criteria is ‘Yes’, this form should be submitted to the ethics committee for
information attested by the head of the department and head of the institution before undertaking Lab Validation
Test.
2. If the answer to any of the above-mentioned criteria is ‘No’, the proposal should be submitted for ethics committee
review and approval before undertaking the Lab Validation Test.
Edited by:
Dr Roli Mathur, Scientist-F & Head, ICMR Bioethics Unit, Indian Council of Medical Research,
Bengaluru

Suggested Citation:
Guidance on Ethical Requirements for Laboratory Validation Testing, Indian Council of Medical
Research (ICMR), February 2024.

Available from:
https://main.icmr.nic.in/sites/default/files/upload_documents/Guidance_on_Ethical_Requirem
ents_for_Laboratory_Validation_Testing.pdf

List of contributors

Arti Kapil, Professor, Dept of Microbiology, All India Institute of Medical Sciences, New Delhi
(Chairperson).

Sujata Mohanty, Professor, Stem Cell Facility, All India Institute of Medical Sciences, New Delhi.

Nithya Gogtay, Professor & Head, Department of Clinical Pharmacology Seth GS Medical
College & KEM Hospital, Mumbai.

Anup Anvikar, Director, ICMR-National Institute of Malaria Research, New Delhi.

Nivedita Gupta, Scientist-G & Head, Epidemiology and Communicable Diseases (ECD) Division,
Indian Council of Medical Research, New Delhi.

Roli Mathur, Scientist-F & Head, ICMR Bioethics Unit, Indian Council of Medical Research,
Bengaluru (Member Secretary).

Madhumathi J, Scientist-C, Epidemiology and Communicable Diseases (ECD) Division, Indian

Council of Medical Research, New Delhi.

ICMR Bioethics Secretariat

Mirunalini Sundaravadivelu, Consultant.