Notice
This website is for educational purposes only. Please contact the Office of Research Integrity Assurance for information about applicable policies and regulations regarding research activities involving human beings or animals.
Historically, the term “human subject” largely referred to a person participating in medical, psychological, or other health-related research. Yet the term can apply to a broad range of research activities outside of those realms. Regardless of the type of research, significant ethical issues can emerge if human participants are involved.
A key ethical concept associated with human subjects research is called “informed consent.” Informed consent has three fundamental components:
- subjects being asked to participate in research should be adequately informed about the benefits and risks that may be associated with the research;
- subjects should not be coerced into making decisions about participating in the research, nor should they be forced to remain in the research if they decide to withdraw from it; and
- subjects must be competent to make decisions regarding their participation in research, which is in part determined by their age and mental capacity.
In general, each of the three components must be satisfied before a human being is enrolled in research. At a minimum, researchers should discuss the research protocol with potential subjects. Usually, they should also provide participants with a consent form, a document which is supposed to explain the proposed research in clear and thorough detail.
When conducting human subjects research, it is essential that researchers are familiar with the ethical principles delineated in the Belmont Report. These principles are: respect for persons, beneficence, and justice.
In accordance with federal regulations, each institution that receives federal funds for human subjects research must have at least one institutional review board (IRB). An IRB is responsible for reviewing the scientific, legal, and ethical merits of a research protocol involving human participants before the research starts and, depending on the type of research, while it is ongoing.
Researchers must check with an IRB before proceeding with a protocol involving human participants in order to ensure that those participants are adequately protected.
These fundamental research ethics principles should be considered when preparing your research project.
The research ethics principles detailed below draw upon:
The Belmont Report.
City staff and students conducting research must respect the following principles:
All participants in research must take part voluntarily, free from any coercion or undue influence, and their rights, dignity and autonomy should be respected and appropriately protected.
An autonomous person is capable of deliberation about personal goals and of acting under the direction of such deliberation. To respect autonomy is to give weight to autonomous persons' considered opinions and choices while refraining from obstructing their actions unless they are clearly detrimental to others.
By contrast, when a potential research participant may lack capacity to make autonomous decisions, respect for persons requires that they be protected against harm. The capacity for self-determination matures during an individual's life, and some individuals lose this capacity wholly or in part because of illness, mental disability, or circumstances that severely restrict liberty. Respect for the immature and the incapacitated may require protecting them as they mature or while they are incapacitated. Some persons are in need of extensive protection, even to the point of excluding them from research that has a risk of harm.
Research should be worthwhile and provide value that outweighs any risk or harm. Researchers should aim to maximise the benefit of the research and minimise potential risk of harm to participants and researchers. All potential risk and harm should be mitigated by robust precautions.
The need for a favourable risk/benefit assessment requires an assessment of the probabilities of both the harms and of the benefits that may arise. The term ‘risk’ is generally used for harms but the probability of benefits also needs to be considered. Many kinds of possible harms and benefits need to be taken into account. There are, for example, risks of psychological harm, physical harm, legal harm, social harm and economic harm and the corresponding benefits. While the most likely types of harms to research participants are those of psychological or physical pain or injury, there may be others costs of a social nature to consider.
Discovering what will in fact provide a benefit may require exposing persons to some risk. Conducting research without any risk of causing harm would prevent many improvements in human welfare. Where the participant may benefit directly through the research, such risks are more justifiable. However, where the research project will not benefit the participants directly, the wider benefits to others in terms of the potential to alleviate disease or other harms in the future may justify research with some risk but only after very careful evaluation.
Research should be just as between different members or groups in society. A core principle of justice in relation to research is equal treatment. This a further expression of the principle of respect for persons. An injustice occurs when some benefit to which a person is entitled is denied to them without good reason or when some burden is imposed unduly on them. Researchers need to give careful consideration to the overall societal impact of their research both in the selection of participants and the benefits and burdens arising from it.
For example, the selection of research participants needs to be scrutinised in order to determine whether some classes (e.g. particular racial minorities, one gender or persons confined to institutions) are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied. Research supported by public funds should provide advantages not just to those who can afford them and such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research.
Informed consent requires that research staff and participants should be given appropriate (a) information about the research (b) in a comprehensible manner (c) without duress or inappropriate inducement.
The information should include: the research procedure, the purposes, risks and anticipated benefits, alternative procedures (where therapy is involved), and a statement offering the participant the opportunity to ask questions and to withdraw at any time from the research. Where a person is not receiving treatment but is a pure volunteer, the standard of disclosure may be expected to be higher. The extent and nature of information should be such that persons, knowing that the procedure is neither necessary for their care nor perhaps fully understood, can decide whether they wish to participate in the furthering of knowledge. Even when some direct benefit to them is anticipated, the participants should understand clearly the range of risk and the voluntary nature of participation.
Comprehension entails that the manner and context in which information is conveyed is as important as the information itself. For example, presenting information too quickly or in a format that is confusing may adversely affect a participant's ability to make an informed choice. Because a participant's ability to understand is a function of intelligence, rationality, maturity and language, it is necessary to adapt the presentation of the information to the participant’s capacities. Investigators are responsible for ascertaining that the participant has comprehended the information.
Special provision may need to be made when comprehension is severely limited – for example, by conditions of immaturity or mental disability (e.g., infants and young children or those with mentally disabilities). Participants must have the opportunity to choose to the extent they are able, whether or not to participate in research. This situation also requires seeking the permission of other parties in order to protect the participants from harm and represent their best interests.
Voluntariness requires that a participant make their decision without duress or other undue influence. Coercion occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance. Undue influence, by contrast, occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance. Also, inducements that would ordinarily be acceptable may become undue influences if the participant is especially vulnerable. Unjustifiable pressures usually occur when persons in positions of authority or commanding influence – especially where possible sanctions are involved – urge a course of action for a participant.
Individual research participant and group preferences regarding anonymity should be respected and participant requirements concerning the confidential nature of information and personal data should be respected.
In designing the research project, researchers will consider whether personal data is to be studied, including interviews with participants. Where it is, then the process of securing informed consent will entail respect for the confidentiality of the participants. There are a range of options for the type of consent participants can give to the use of their data. These include the use of quotes with or without attribution on the one hand, to full anonymity on the other. Data generated by research must be securely stored appropriately in accordance with relevant legislation and institutional policy.
Research should be designed, reviewed and undertaken to ensure recognised standards of integrity are met, and quality and transparency are assured.
Examples of unacceptable practices include: fabrication by the creation of false data or other aspects of research, including documentation and participant consent; falsifications by the inappropriate manipulation and/or selection of data, imagery and/or consents; plagiarism by the misappropriation or use of others’ ideas, intellectual property or work (written or otherwise), without acknowledgement or permission; misrepresentation of data, for example suppression of relevant findings and/or data, or knowingly, recklessly or by gross negligence, presenting a flawed interpretation of data, material interests, involvement or qualifications and improper dealing with allegations of misconduct by failing to address possible infringements including attempts to cover up misconduct or reprisals against whistle-blowers.
The independence of research should be clear, and any conflicts of interest or partiality should be explicit. A conflict of interest arises where a researcher’s obligation to the institution or a funder to conduct research independently is likely to be compromised, or may appear to be compromised. This can be because they may:
- obtain a personal gain, or a gain to a member of their family or another person to whom they have a close personal relationship arising from the research. This gain may be financial or otherwise and/or,
- have commitments and obligations to another person or body that may appear to act as a potential influence over their independent conduct of the research.
There may be an appearance of conflict of interest even when no conflict actually exists. Researchers must disclose anything that may be perceived by others as a potential conflict of interest.
Following the correct principles of ethical research is an important part of any research degree programme undertaken at City, University of London.
Considerations of ethical issues is an important part of any research degree. Browse our courses below.