Ethics and Consent

Ethics and Consent

Research Ethics

1. Ethics Framework

Health research and the scientific knowledge it produces are social goods. By conducting research, we aim to (a) improve our understanding of how to prevent and treat diseases, illnesses, and injuries, (b) inform practices and policies that protect and promote human health and well-being, and (c) provide insights into the safety, efficacy, and effectiveness of medical interventions. In other words, research is undertaken for its prospective scientific and social value.

Given the aims of research, it is common for people who participate in studies to be exposed to a wide range of physical, psychological, social, or economic burdens and risks. Consequently, the focal question of research ethics is: when is it ethically permissible to expose individuals to the burdens and risks of research for the benefit of society?

The first comprehensive answer to this question appears in the Belmont Report, a statement of basic ethical principles underlying the conduct of research involving human beings. This document answers the question by appeal to three core ethical principles: respect for persons, beneficence, and justice. While other research ethics frameworks have been proposed, the principles outlined in the Belmont Report are the foundation of most contemporary international and national research ethics guidelines and regulations.

According to the Belmont Report, each abstract ethical principle gives rise to concrete obligations that, when fulfilled, justify the conduct of research. In what follows, the ethical principles of respect for persons, beneficence, and justice are defined, the obligations that stem from each are explicated briefly, and resources relevant to the design, implementation, and review of research involving human beings are provided.

2. Respect for persons

 Respect for persons (sometimes referred to as respect for autonomy) means that people should be treated as autonomous agents, capable of making their own decisions. It also means that people with developing, impaired, or diminished autonomy are entitled to protection. While the concept of autonomy has been the focus of considerable debate, an autonomous person is generally understood as someone who is capable of making their own decisions in accordance with their interests and values.

The ethical principle of respect for persons gives rise to two obligations:

First, researchers should obtain informed consent from prospective research participants, unless conditions for an alteration or waiver of consent requirements are met. While national research regulations have specific provisions for what must be disclosed during a consent process and how it should be documented (e.g., written signature on a form), the regulatory or legal understanding of consent differs from its ethical foundation. At its core, consent is about “protecting [people] against the wrong that occurs when they, as moral agent with the right and responsibility to chart their own lives and actions, are not given an opportunity to decide whether or not to accept an intervention involving their person of things intimately associated with their being” (Capron 2018). Click below to read more about consent and alterations or waivers of consent requirements.

• Informed consent

According to international and national ethics guidelines, there is a presumption that informed consent will be obtained from prospective research participants prior to their enrollment in a trial. Informed consent is best understood as a process that starts from initial contact between a researcher and a prospective participant and concludes at the end of a trial. There are three key components of the consent process: it must be voluntary, informed, and revocable.

For consent to be voluntary, it must be provided in the absence of coercion and undue influence. Coercion occurs when there is a treat of harm or punishment, such as threatening to withhold treatment if a patient does not consent to participate in research. Undue influence occurs when people are induced to act in a manner than they otherwise would. Patients can be influenced in a variety of ways to participate in research (e.g., incentives), but whether a particular influence undermines voluntariness may not always be clear (e.g., excessively large incentives can encourage reckless disregard of research risks, whereas reasonable incentives can encourage voluntary participation). Researchers should take steps to mitigate any potential undue influences in the consent process.

For consent to be informed, researchers should provide prospective participants with information that is essential to making a choice about whether participating in research is right for them, and provide them with amply time to review and discuss the information. Key information to disclose includes: (1) a lay summary of the research; (2) the research question; (3) study interventions; (4) benefits, risks, and alternatives to participation; (5) impact of participation on treatments and day-to-day activities; (6) duration of the research; (7) a statement that participation is voluntary and refusal of consent will not negatively impact their care; and (8) who to contact if questions arise. National regulations contain additional disclosure requirements, such as confidentiality statements and information on how personal data will be used and stored. Recommendations for when and how to obtain informed consent for research from patients receiving hemodialysis are outlined in ethics guidelines co-developed by researchers and patient partners for clinical trials in the hemodialysis setting (Goldstein et al. 2024).

For consent to be revocable means that consent, once provided, can be withdrawn at any time without repercussion. If withdrawn, the participant can no longer be intervened upon or, if the intervention has already occurred, they can no longer be interacted with for data collection. People can also request the withdrawal of their health data.

• Alteration or waiver of consent requirements

There are rare circumstances in which researchers may need to deviate from the standard written informed consent process to answer their research question. According to international ethics guidelines, a research ethics committee may approve an alteration or waiver of consent requirements if, and only if, “the research would not be feasible or practicable to carry out without the waiver or modification; the research has important social value; and the research poses no more than minimal risks to participants” (CIOMS 2016). The onus falls on researchers to provide research ethics committees with a clear and compelling justification for why these criteria are met.

If a clear and compelling justification can be provided, researchers “should always implement the most feasible, autonomy-promoting consent approach consistent with the scientific ends of the trial” (Goldstein et al. 2024). It is recommended that researchers (1) aim to preserve as much of the standard consent process as possible, (2) describe the precise nature of the proposed alterations, and (3) adopt a consent process that enables participants to actively accept or refuse participation over an opt-out approach. If an altered consent process is not feasible, a research ethics committee may grant a waiver of consent (i.e., consent is not required to administer study interventions or to collect data). Permitting such an approach requires an abundance of caution, and researchers should explain why all other consent approaches and notification strategies are infeasible.

Second, researchers should safeguard the privacy and confidentiality of research participants by developing and implementing plans to protect information (e.g., data, biological materials) entrusted to them by research participants. Steps taken to protect the confidentiality of private health information should be disclosed in the consent process, and research ethics committees have an obligation to review proposed measures for protecting participants’ information.

3. Beneficence

The term beneficence comes from the Latin word benefactum, meaning “good deed” or “meritorious act,” and is understood colloquially to cover acts of kindness or charity. However, in the context of research, beneficence means that people must be protected from the harms imposed by research and efforts must be made to secure people’s well-being.

The ethical principle of beneficence gives rise to two obligations:

First, researchers should demonstrate that study interventions satisfy equipoise. In other words, there must be a genuine uncertainty in the relevant expert community about the comparative merits of the interventions. Researchers can demonstrate that equipoise exists between study interventions by presenting conflicting evidence, variations in practice, or both. This demonstration should clarify that it is not known, prior to the conduct of the study, that one intervention is better than another.

Second, researchers should ensure that the risk of data collection procedures are minimized and reasonable in relation to the knowledge to be gained from the study. Since it is the responsibility of research ethics committees to undertake a benefit-harm analysis and ensure that potential benefits outweigh the foreseeable risks posed to participants, researchers can assist in this process by outlining the potential benefits and foreseeable risks that are attributable to the research and distinguish those related to clinical practice.

4. Justice

Justice is about treating people fairly or equitably. In the context of research, justice is a question of who ought to receive the benefits of research and bear its burdens.

The ethical principle of justice gives rise to two obligations:

First, research should demonstrate that participant selection procedures are fair by being appropriately inclusive in selecting participants and not unduly excluding people from research based on their attributes or characteristics (e.g., age, disability, ethnicity, gender, language, linguistic proficiency, race, religion, sex, sexual orientation). Researchers can demonstrate fair participant selection by providing clear and valid reasons for all inclusion and exclusion criteria.

Second, researchers should identify and outline protections for vulnerable participants included in research. People receiving hemodialysis are often considered vulnerable due to their reliance on life-sustaining treatments and poor prognosis. However, vulnerability is a technical term in research ethics used to identify individuals who require more than the standard protections offered to all research participants. For example, including people who lack or have fluctuating decision-making capacity in research may require plans to assess decisional capacity before and during research conduct, and plans to identify and obtain consent from substitute decision makers.