The Ethical Imperative of Sex and Gender Considerations in Health Research

As Canada's major health research funding agency, CIHR is committed to promoting health research that meets the highest standards of excellence and ethics. Learn more.

Background

The Evidence is Clear

For research to be ethical, it must account for biological (sex) and social (gender) differences between women, men, boys, girls and gender-diverse people. Research has identified huge sex differences in the gravity, frequency, symptoms and age of onset of various diseases.Footnote 1,Footnote 2,Footnote 3,Footnote 4,Footnote 5,Footnote 6,Footnote 7 This growing body of evidence, which go far beyond hormones and reproductive systems, illustrates that results from one sex cannot be presumed to apply to the other. Learn more.

Sex as a Biological Variable

The inclusion of female animals and cells in basic science research is both a question of scientific rigour and of the just and equitable distribution of the benefits of research across a population. When biomedical or preclinical experiments are conducted on cells and animals of both sexes, they quite often discover previously unknown differences. However, many disciplines continue to conduct experiments exclusively on male animals and cells.

Gender Inclusiveness

Sex and gender are distinct yet interrelated concepts. They are no longer considered simple, binary options like male/female or woman/man. Ethics boards are increasingly being faced with questions and concerns regarding how researchers survey participants regarding sex and gender. General consensus is that asking a person’s ‘gender’ and providing only two options is not sufficient; and, in fact, equates to the erasure of a growing segment of the population who do not identify within a gender binary.

Sex and Gender in Research Ethics Review

Ethical reviewers should consult our guidelines for integrating sex and gender into research projects.

The Institute of Gender and Health has developed interactive online competency modules for researchers and reviewers on the integration of sex and gender in health research. Each module is free, takes less than an hour to complete and can be done in 15-minute increments over time. Upon successful completion, participants can download a Sex- and Gender-Based Analysis Core Competency Certificate.

Implications of Sex And Gender in Health Research Ethics

Four generally accepted principles of biomedical ethicsFootnote 8 include:

  1. Respect for autonomy
  2. Doing no harm
  3. Doing good
  4. Justice

  1. Respect for autonomy (or respect for personsFootnote 9): This principle ensures that participants are able to make their own decisions and act intentionally with respect to their self-determination. In the context of research involving humans, this principle includes ‘informed consent’ as a crucial step in the research process.

    Consider: To provide informed consent, participants must be well-informed about the potential risks of participation. We know that the majority of pre-clinical studies are performed on male animals and cells exclusively. However, clinical research on topics relevant to both sexes must include male and female participants.

    If female participants are to provide informed consent, do they need to be informed that no pre-clinical data is available on how the intervention affects female biology?

  2. Doing no harm: This principle requires a fundamental commitment to avoiding or minimizing risk of harm to patients or participants.

    Consider: Diagnosis criteria for depression have been shown to be more applicable to women’s symptoms.Footnote 10 We know that twice as many women are diagnosed with depression while three times more men commit suicide.Footnote 10

    If sex and gender are not scrutinized at various stages of the research process, how can we expect to identify, avoid or minimize potential harms for everyone?

  3. Doing good: This principle is applicable to ‘good’ done for individual patients and society as a whole.

    Consider: Even when both sexes are included in research, the results may not be analyzed by sex. Treatments which may have benefited one sex may not show statistically-significant benefits if results are not disaggregated. Promising treatments, which could benefit many, could be lost.

    If sex- and gender-based analysis is not consistently applied to the analysis of research results, could potential good be overlooked?

  4. Justice: This principle requires the equitable distribution of both the benefits and burdens of research. In a health research context, justice includes “the moral requirements that there be fair procedures and outcomes in the selection of the research subjects.Footnote 11

    Consider: Many researchers believe the inclusion of female animals in preclinical research will make experimentation more time-consuming and expensive and render results more variable. Besides the fact that evidence indicates females do not make results more variable,Footnote 12 the principle of justice demands that convenience and cost-savings not take priority over the principle of equitable distribution of benefits and burdens.

    Without proper considerations of sex and gender, can health-care interventions be equally effective for women, men, boys, girls and gender-diverse people?

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