Inclusion Across the Lifespan in Health Research

Children, older persons, pregnant and lactating people are often excluded from research, even when findings will be applied to them. Including these groups in health research is essential to strengthening the health and well-being of communities.

Age and life-stage influence many factors that impact health, such as:

That is why excluding children, older persons, pregnant and lactating people from research can lead to less effective or even harmful interventions, medications, programs, and policies for these groups.

How does lifespan inclusion in health research benefit society?

Strengthens science and research impact
Results in better science that leads to interventions, medications, programs, and policies that meet health needs from childhood through older adulthood.

Builds more representative data
Fills data gaps and generates knowledge that is more representative of the population.

Champions ethical responsibility
Ensures groups are not inappropriately excluded from research based on age or life stage unless there is a valid scientific or ethical reason.

Increases health equity
Addresses the health needs of groups underrepresented in research and responds to existing inequities.

What can lifespan inclusion in health research look like?

An inclusion across the lifespan approach to research requires asking critical questions to ensure health solutions benefit everyone. For example:

Turning commitment into action: CIHR signs joint statement

CIHR is a signatory of the Joint Statement on Strengthening Clinical Trials which outlines a clear commitment from research funders to strengthen the clinical trials ecosystem. As part of this commitment, CIHR will improve application and peer-review processes to account for how trials will include all major population groups the intervention is intended to benefit (e.g., children, older persons, pregnant and lactating people). This aligns with Section 2.1.3 of the WHO Guidance for Best Practices for Clinical Trials which emphasizes appropriate trial inclusion.

Where can I learn more about lifespan inclusion in health research?

The following list highlights examples of guidance relevant to lifespan inclusion in health research in human development, child and youth health. Researchers are encouraged to assess the relevance and applicability of these resources to their own research.

Policies

Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada. (December 2022). Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans.

Chapter 4: Fairness and Equity in Research Participation addresses appropriate inclusion and valid reasons for exclusion relevant to age and life stage in research involving humans.

Centre for Policy, Pediatrics and International Collaboration (CPPIC). (September 2025) Canada's approach to drugs for children and youth.

The CPPIC has developed an action plan to ensure that medications for children and youth meet the same high standards as those established for adult medications.

Guidance

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Efficacy Guidelines.

  • ICH harmonised guideline: Inclusion of pregnant and breastfeeding individuals in clinical trials, E21 (DRAFT)
  • ICH harmonised tripartite guideline: Studies in support of special populations: geriatrics, E7
  • ICH harmonised guideline: Addendum to ICH e11: Clinical investigation of medicinal products in the pediatric population, E11

Canadian Institutes of Health Research. (April 2025). Applying CIHR's research excellence framework – Best practices for clinical trials.

This document recommends that clinical trial plans should include a clear and well-documented rationale for the exclusion of any participant populations, including pregnant people, infants and children, and older adults. Such an approach would support broad inclusion of clinical trial participants and ensure that research results are applicable to trial participants and relevant populations.

World Health Organization. (2024). Guidance for best practices for clinical trials. Geneva. Licence: CC BY-NC-SA 3.0 IGO.

Section 2.1.3 on Appropriate trial population provides guidance for including children, older persons, pregnant and lactating people in clinical trials. Guidance for best practices for clinical trials.

Canadian Institutes of Health Research. (July 2021). Equity, diversity and inclusion resources.

These resources provide guidance to incorporate EDI in research design practices and the research environment, respectfully involve Indigenous communities, reduce bias in peer review and additional information on EDI and research excellence.

WHO HIV, Hepatitis and STIs Pregnancy and Breastfeeding Therapeutics Working Group. (n.d.). Antiretrovirals in pregnancy research toolkit.

This toolkit provides guidance and resources to enable the inclusion of pregnant and lactating people in clinical research such as clinical trials and observational studies.

Reporting Recommendations

Baba A, Smith M, Potter B K, Chan A, Moher D, Toulany A et al. SPIRIT-Children and Adolescents (SPIRIT-C) 2026 extension statement: enhancing the reporting and usefulness of paediatric randomised trial protocols BMJ 2026; 392 :e085062 doi:10.1136/bmj-2025-085062

This extension focuses on the reporting trial protocols and adds 17 new items for pediatric RCTs to the SPIRIT 2025 items. Four items are youth-generated and six youth-endorsed.

Baba A, Smith M, Potter B K, Chan A, Moher D, Toulany A et al. CONSORT-Children and Adolescents (CONSORT-C) 2026 extension statement: enhancing the reporting and impact of paediatric randomised trials BMJ 2026; 392 :e085061 doi:10.1136/bmj-2025-085061

This extension focuses on the reporting completed RCTs and adds 13 new items to the CONSORT 2025 items. One item is youth-generated and six youth-endorsed.

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