Ethical Considerations For Health-Related Research

Original Editor - Angeliki Chorti Top Contributors - Angeliki Chorti

Introduction[edit | edit source]

Health-related research refers to "activities designed to develop or contribute to generalizable health knowledge within the more classic realm of research with humans, such as observational research, clinical trials, biobanking and epidemiological studies. Generalizable health knowledge consists of theories, principles or relationships, or the accumulation of information on which they are based related to health, which can be corroborated by accepted scientific methods of observation and inference". [2]

Relevance to physiotherapy[edit | edit source]

As health professionals and in an era of evidence-based practice, physiotherapists are required to be able to use, assess, interpret, implement and conduct research that informs their practice. This research must be based on ethical codes, the application of which may vary depending on the situation and circumstances of the research. Nevertheless, the principles, values and considerations behind all health-related research are the same.

With ethics being identified as 'fundamental to the practice of physiotherapy', professional bodies around the world are searching for guidance and tools to meet the presenting ethical challenges. [3]

International Guidelines[edit | edit source]

International ethical guidelines for health-related research involving humans is provided in detail by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization. [2]

Watch the launch of the new CIOMS international guidelines for health-related research in the following video [4]:

These guidelines are revolving around the following pillars:

Scientific and social value and respect for rights[edit | edit source]

The ethical justification for undertaking health-related research involving humans is its scientific and social value: knowledge generation relies on the results of research for activities and decisions that impact individual and public health. In other words, proposed studies that are scientifically sound and build on an adequate prior knowledge base, are more likely to lead to important information. Nevertheless, these studies must ensure that they are undertaken in ways that those participating are protected, respected and their rights and welfare are safeguarded. [2]

Community engagement[edit | edit source]

Potential participants and communities should be able to be involved in the study in an early, meaningful and sustained manner. Involvement might include the design, development, consent and monitoring processes, implementation and dissemination of study results. [2]

Research conducted in low-resource settings[edit | edit source]

Research conducted in low-resoure settings must ensure that it is responsive to the health priorities and needs of the community it involves. Local research capacity should be in place for the research to be carried out. Research-related knowledge, products or treatments must be made available as soon as possible and stakeholders / communities consulted when making plans for implementation. [2]

Collaborative partnership and capacity-building for research and research review[edit | edit source]

Governmental authorities must ensure the existence of competent and independent ethics committees as well as competent research teams. Capacity-building for research and review are necessary and activities in this direction might be multidimensional. [2]

Equitable distribution of benefits and burdens in the selection of individuals and groups of participants in research[edit | edit source]

Benefits and burdens in the selection of individuals and groups of participants in research must be distributed in an equitable manner. In other words, the selection of potential participants in health-related research must be based on scientific reasons and not easiness of recruitment; the exclusion of groups in need for special protection must be justified; groups that may not benefit from the research must not bear risks or burdens in a disproportionate manner; under-represented participants should be provided with appropriate access to research. [2]

Choice of control in clinical trials[edit | edit source]

Research participants in the control group of a trial of a diagnostic, therapeutic or preventive measure must be given an established effective intervention. Placebo treatments can be used in control groups when there is no established effective intervention or supplementarily with established effective interventions. [2]

Caring for participants’ health needs[edit | edit source]

Provisions for addressing participants' health needs during research and if needed, their transition to appropriate care when the research is completed must be made, especially in the case of clinical trials. Information on health care appropriate to the needs of participants during and after the study should be included in the informed consent process. [2]

Collection, storage and use of data[edit | edit source]

- Biological materials and related data: Biological materials and related data (e.g. records of health or employment) are collected and stored within a governance system that allows for authorization for future use in research. Local health authorities are usually responsible for the collection and storage of these materials and data. [2]

- Data in health-related research: Health-related data are collected and stored within a governance system that allows for authorization for future use in research. When health-related data are collected in routine clinical care, data can be stored and used for research purposes unless a person objects explicitly and when they are used for population-based registries. [2]

Potential individual benefits and risks of research[edit | edit source]

Any potential risks to participants due to the research undertaken must be minimized, considered in relation to the potential benefits and value of the study, and strategies put in place to address them. A two-step process must be followed; the first step involves the evaluation of the intervention (e.g. diagnostic test, treatment, preventive measure) or procedure of the study (surveys, interviews, clinical exams, monitoring etc.); the second step includes the assessment of the risks and benefits of the whole study. [2]

Treatment and compensation for research-related harms[edit | edit source]

Harm (physical, psychological, or social) incurred as a result of the research process must be compensated with free treatment and costs for lost wages as appropriate. Research ethics committees are responsible for determining whether the processes for compensation are in place for research-related harm. [2]

Capability of giving informed consent[edit | edit source]

Informed consent is an essential process in the research study. Participants must have the opportunity to enter a study freely and fully informed, and to be able to decline participation or withdraw at any time without retribution. A signed consent form is usually employed as evidence of informed consent, otherwise exceptions must be justified for approval to the research ethics committee. Any substantial changes to the study (conditions, procedures, new relevant information) must also be communicated back to the ethics committee and consent of participants renewed. [2]

Modifications and waivers of informed consent[edit | edit source]

In some cases, informed consent might be modified in a way that ensures the ability of the participant to understand the study process and decide appropriately. Depending on the research context, ethics committees may grant permission for modifications or waivers of informed consent in cases there are issues of study feasibility, social value and minimal risks to participants. [2]

Research involving vulnerable persons and groups[edit | edit source]

Recruitment of vulnerable people and groups in research requires protecting their rights and welfare. Vulnerable individuals are considered to have an increased likelihood of suffering injustice or additional harm. In the research process, this might involve the consent as well as the participation process. [2]

-Research involving adults incapable of giving informed consent: Before the study, researchers and ethics committes must ensure that (a) a legally authorised representative of the person who is not capable of giving informed consent is appointed and is considering the participant's preferences and values; (b) the assent of the potential participant has been granted taking into account that person's capacity of understanding relevant research related information ; (c) changes to the ability to provide informed consent must be taken into account and a new consent must be ensured to continue participation. [2]

- Research involving children and adolescents: Children and adolescents are a distinctive group of participants in research and therefore must be considered separately. Before the study: (a) permission must be obtained by a parent or legally authorised individual; (b) the assent of the potential participant has been granted taking into account that person's capacity of understanding relevant research-related information; changes to the ability to provide informed consent (i.e. legal age of maturity) must be taken into account and a new consent must be ensured to continue participation. [2]

- Women as research participants: Some societies' lack of respect for women's autonomy must not change the process of aquiring informed consent for a research study. In addition, women of child-bearing potential must be provided well in advance with information of the risks of participating in a study and the processes in case she becomes pregnant. [2]

- Pregnant and breastfeeding women: Although research on the health needs of pregnant and breastfeeding women is very important, the best available evidence must be taken into consideration before the initiation of any relevant project. Any risks and potential harms must be minimised and carefully weighed against potential benefits of the research. Plans for access to a safe, timely and legal abortion must be made well in advance in case research participation leads to an unwanted pregnancy. [2]

Reimbursement and compensation for research participants[edit | edit source]

Research participants' time and inconvenience costs during the research process should be compensated in monetary or non-monetary terms. In order for reimbursement and compensation to not interfere with the participants' better judgement to consent, ethics committee approval must be sought. [2]

Research in disasters and disease outbreaks[edit | edit source]

Events like war, physical disasters (e.g. tsunamis, earthquakes) and disease outbreaks may have severe adverse effects on affected populations. Research projects responding to the needs of these populations may pose some particular challenges such as the need to have readily available relevant knowledge, with trust of people who may have suffered, and implementing research findings on the rapidly evolving and impaired communities. Careful and flexible planning may be needed to ensure that ethical principles for health-related research are preserved and not compromised. [2]

Cluster randomized trials[edit | edit source]

This type of research design requires further specification on the following: (a) research participants and other groups that may be indirectly affected; (b) informed consent of participants (patients, health professionals, community members); (c) invalidation or compromise of research results when requiring or allowing for refusal to consent; (d) ethical acceptability of a no-intervention group as a comparator; (e) gatekeepers' permission. [2]

Resources[edit | edit source]

Council for International Organizations of Medical Sciences (CIOMS)

World Health Organization (2022). Ensuring ethical standards and procedures for research with human beings.

WMA (2022) Declaration of Helsinki - Ethical principles for medical research involving human subjects.

References[edit | edit source]

  1. <a href="">Image by DCStudio</a> on Freepik
  2. 2.00 2.01 2.02 2.03 2.04 2.05 2.06 2.07 2.08 2.09 2.10 2.11 2.12 2.13 2.14 2.15 2.16 2.17 2.18 2.19 2.20 2.21 2.22 CIOMS. International Ethical Guidelines for Health-related Research Involving Humans. 4th edition, Geneva, 2016. Available online: [20/10/2022]
  3. Maric F., Nicholls D. The fundamental violence of physiotherapy: Emmanuel Levinas’s critique of ontology and its implications for physiotherapy theory and practice. OpenPhysio. 2020. Available online: [accessed 13th November 2022]
  4. Club suisse de la presse. Launch of the new CIOMS international ethical guidelines for health-related research involving humans. 2016. Available online: [accessed 13th November 2022]