Research with human subjects has been integral to the discovery and advancement of knowledge regarding drugs, biologics, medical devices, and other clinical and behavioral treatments. Ethical considerations in research are critical in protecting the safety of study volunteers and safeguarding the legitimacy of results.
Whether you’re interested in philosophy or plan to pursue a career in science, exploring ethical issues can highlight principles that you may want to apply in your personal or professional life.
This guide provides an overview of standard research ethics and practices, outlines various types of research misconduct, and discusses the importance of ethical oversight and regulation.
What are ethical considerations in research?
Ethical considerations in research are principles that inform research methods and designs. It’s critical that scientists are held to a stringent code of conduct when performing data collection, evaluating potential medical or psychological treatments, and investigating human behavior. Ethical guidelines help enhance the validity of research, protect the human rights and well-being of study participants, and maintain a high standard of academic or scientific integrity.
Principles guiding research methods, design, and implementation
Ethical considerations in research are essential to creating an environment wherein study participation is informed, voluntary, and confidential—and where subjects are safe from unintended harm as a result of misconduct.
Ethical guidelines for conduct may include but are not limited to:
- Exhibiting honesty, objectivity, and integrity in experimental design, data collection, analyses, reporting, and all other aspects of research
- Critically and carefully examining work, keeping good records, and transparently sharing data, results, and resources
- Showing respect for intellectual property including patents, copyrights, and research methods to avoid plagiarism
- Protecting confidential communications, publishing conscientiously to advance research, and striving to promote social responsibility
- Avoiding discrimination, obeying laws and institutional policies, and respecting human and animal dignity and autonomy
Read on to explore additional principles and best practices that guide ethical and effective research design and implementation.
Validity
Scientific validity is used to evaluate whether the purpose of research is justifiable and feasible, as well as whether the clinical trial or study is designed with legitimate principles, clear research methods, and reliable practices.
Validity is particularly important in quantitative research because it refers to how accurately a practice assesses what it is supposed to measure and produces results consistent with real characteristics, variations, and properties in the physical or social world.
If a scientist’s data collection and other research methods are not valid, the conclusions drawn from the study will not be either.
Voluntary participation
Voluntary participation is one of the ethical guidelines that is enshrined by international law and various scientific codes of conduct. It means that all research participants have chosen to partake without being influenced by outside pressure or coercion.
Researchers must ensure that subjects understand they are free to leave the study or clinical trial at any time, without providing an explanation, and that they won’t experience any negative consequences or repercussions.
Obtaining and maintaining voluntary participation is especially critical for vulnerable groups of people who may find it more difficult to withdraw from experiments of their own accord.
Informed consent
In a similar vein, informed consent refers to the fact that research participants receive and understand all the details they require to decide whether they want to be a part of a study.
Relevant information that should be provided to all subjects includes the purpose, methods, funding, risks, and benefits of the research; how long the study will last; the institutional approval number for the trial; and how this information relates to their specific clinical situations or interests.
Once they’ve received these details, interested study subjects are ready to sign a consent form to confirm they are still willing to participate.
Confidentiality and anonymity
Participants in studies and clinical trials have the inherent right to privacy and the protection of their personal data.
As such, researchers must remove all identifying information from their final reports; take steps to safeguard all sensitive data during collection, access, and storage; and commit to following the confidentiality protocols of their respective institutions.
Anonymity means that researchers are not aware of who their study subjects are and can only be achieved by not collecting any personally identifiable information such as names, phone numbers, IP or email addresses, videos, photos, or physical characteristics.
Potential for harm
Scientists must prepare for the potential risks of harm inherent to clinical research, which may be short- or long-term, relatively trivial, or extremely serious.
As part of research design and implementation, it’s crucial that everything possible is done to minimize risks to research participants and maximize the possible benefits so that they are equal to, or greater than, the risks.
The different types of harm can be psychological (triggering shame or anxiety), social (creating embarrassment or stigma), physical (resulting in pain or injury), or legal (leading to breach of privacy).
Once the possible risks of harm are identified and steps are taken to mitigate them, it’s essential to disclose them to all participants. When necessary, researchers should also provide medical resources or counseling services as preventative measures to protect study subjects.
Fair sampling
A sample refers to the specific group in a population that will be used for data collection.
When recruiting research participants, scientists must look to the goals of the study, select people who accept the risks and could enjoy the benefits, and ensure that specific groups (such as women or children) are not excluded without a specific susceptibility to risk or relevant scientific reason for doing so.
Using probability research methods—such as random or stratified sampling—is commonplace because it can reduce the risk of sampling bias, help ensure that the sample is representative of the population and enhance internal and external validity.
Independent reviews
Independent reviews can enhance transparency, help ensure that studies are ethically designed, identify conflicts of interest or bias, and increase the safety of research participants.
Independent review by peers or people with clinical methodological or technical expertise provides an opportunity for scientists to obtain important feedback before and during clinical trials that can bolster quality assurance and validity.
International bodies such as the World Health Organization (WHO) and the National Institute of Care Excellence (NICE) include independent review as a routine part of the guidelines for their development processes.
Equitable compensation
Compensation for research participants may be monetary or non-monetary, including cash, vouchers, course credits, or gift cards. Payment plans should be practical and fair but also not so great that they compromise informed consent.
It’s pertinent to note that routine costs associated with participating in clinical trials can create barriers to enrollment for economically disadvantaged individuals, so reimbursement for these expenses is also important.
Researchers should also consider how race, ethnicity, and gender are linked to differences in socioeconomic status, which can negatively impact the inclusion of historically underrepresented groups in clinical research, such as women and people of color.
Research misconduct
Research misconduct is a fraudulent and unethical act that results in the waste of funding and resources while undermining academic and institutional credibility. Whether it involves intentionally making up data, manipulating analyses, or misrepresenting reporting, the consequences can be grave.
For example, when Andrew Wakefield published a report with fabricated and manipulated data that linked the measles, mumps, and rubella (MMR) vaccine to autism in children, it contributed to falling vaccination rates in some Western countries, compromised herd immunity, and caused damage to the autism community.
Although the paper was retracted and Wakefield’s conflicts of interest were eventually disclosed and his medical license revoked, 25 years later people continue to share his debunked research to fuel the anti-vax movement.
Plagiarism, fabrication, and falsification
Plagiarism occurs when a researcher submits someone else’s ideas, processes, words, or results, unintentionally or not, without providing proper citation. It’s also considered ethical misconduct for a scientist to resubmit their own work, or parts of it, and present it as new when it’s been published previously.
When a researcher makes up data or results it is referred to as fabrication. Falsification occurs when a scientist manipulates research material, processes, or equipment, or alters or omits information to skew results.
Any research professional who commits one or more of these misconducts not only puts their career at risk, but they also denigrate the overall reputation of the institution of science.
Ethical oversight and regulation
Prior to the current system of US federal regulations and requirements, there were many historical examples of unethical research that occurred without patient consent, with poor experimental design, and which resulted in harm to research participants and scientific integrity.
One of the most well-known examples of this is the US Public Health Service Tuskegee Syphilis Study of 1932-72. Initiated to observe the harmful health effects of untreated syphilis over time in approximately 600 Black men, the study did not obtain informed consent from its subjects. Additionally, penicillin was withheld from the study subjects when it became available as a treatment for syphilis in 1947. As a result, many of the men developed advanced syphilis, some died from the disease, and others unknowingly passed it to their partners and children.
The study became widespread public knowledge when journalist Jean Heller published an article in The New York Times in 1972 that highlighted its many ethical issues. By 1974, the National Research Act was passed by the federal government. It created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was tasked with establishing a code of research ethics.
Institutional review boards (IRBs) and regulatory agencies
An Institutional Review Board (IRB) is a committee designated to review and monitor research that involves human subjects. In accordance with current FDA regulations, IRBs have the authority to approve, require modifications, or reject plans for biomedical research. As mentioned above, this advanced and periodic review of research protocols and related materials helps to protect the rights and welfare of study participants.
Given the significance of ethical considerations in research, there are also many government agencies, professional associations, and universities that uphold codes, rules, and ethical guidelines.
Examples of American regulatory agencies that oversee research include:
- Food and Drug Administration (FDA)
- Environmental Protection Agency (EPA)
- United States Department of Agriculture (USDA)
- National Institutes of Health (NIH)
- National Science Foundation (NSF)
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