RESEARCH ETHICS

Definition

The moral principles and actions guiding and shaping research from its inception to its completion; the dissemination of findings and the archiving, future use, sharing and linking of data.

Research ethics in the social sciences initially drew on the “patient protection” model of medical research. More recently, it has broadened in scope to include consideration of benefits, risks and harms to all persons connected with and affected by the research and the social responsibilities of researchers.

Brief History of Ethics

Throughout history, evidence suggests that ethical issues in human experimentation had been recognized and addressed as early as the late 1800s.

The 1947 Nuremberg Code is commonly cited as the first document to govern the conduct of human research. The main cause of that is the war trials of Nazi physicians accused of conducting “murderous and torturous human experiments” on prisoners in concentration camps in the name of medical science in 1946/1947. This code included 10 ethical principles.

Link: https://media.tghn.org/medialibrary/2011/04/BMJ_No_7070_Volume_313_Th e_Nuremberg_Code.pdf

The World Medical Association published the “Declaration of Helsinki” in 1964. This declaration expands on the ten ethical principles of Nuremberg code, but excludes 2 of the 12 items to address perceived deficiencies in the Nuremberg Code. This declaration continuously undergoes revisions.

Link: https://www.who.int/bulletin/archives/79(4)373.pdf

The 1947 Nuremberg Code is commonly cited as the first document to govern the conduct of human research. The main cause of that is the war trials of Nazi physicians accused of conducting “murderous and torturous human experiments” on prisoners in concentration camps in the name of medical science in 1946/1947. This code included The National Research Act in 1974 was enacted in response to the Tuskegee Study of Untreated Syphilis carried out from 1932 to 1972 that withheld effective therapy for syphilis from hundreds of African American men to observe the progression of syphilis, presumably for the sake of medical research without telling them about the threats of these trails.

This act created the National Commission for the Protection of Clinical Subjects of Biomedical and Behavioral Research to oversee human experimentation in the United States.

Link: https://www.govinfo.gov/content/pkg/STATUTE-88/pdf/STATUTE-88Pg342.pdf

In 1979, the commission drafted the Belmont Report that describes the basic ethical principles underlying the conduct of research: respect for persons beneficence, and justice

Link: https://www.hhs.gov/ohrp/sites/default/files/the-belmont-report508c_FINAL.pdf

The Common Rule , a set of federal regulations necessitating oversight of government-funded research in the United States, was drafted in 1991. Elements of its policy center on the presence and procedures of institutional review boards (IRBs) and general requirements for informed consent

Link: https://www.hhs.gov/ohrp/sites/default/files/ohrp/policy/frcomrul.pdf

The Main Objectives of Research Ethics

There are three objectives in research ethics:

 The first and broadest objective is to protect human participants.

 The second objective is to ensure that research is conducted in a way that serves the interests of individuals, groups and/or society.

 Finally, the third objective is to examine specific research activities and projects for their ethical soundness, looking at issues such as the management of risk, protection of confidentiality and the process of informed consent.

Principles

Basic Principles

 Respect for people’s autonomy through informed consent, and people with diminished autonomy should be protected.

 Beneficence through doing no harm, maximizing benefits for participants, and minimizing risks for them.

 Justice through fairness.

Other Principles

 Honesty and Integrity.

 Objectivity.

 Openness.

 Carefulness.

 Confidentiality.

 Legality.

 Animal Care in animal studies.

Ethical Guidelines for Human Participants

There are seven main principles that guide the conduct of ethical research involving human subjects:

Social and clinical value: The answers to the research question should contribute to scientific understanding of health or improve our ways of preventing, treating, or caring for people with a given disease to justify exposing participants to the risk and burden of research.

Scientific validity: A study should be designed in a way that will get an understandable answer to the important research question. The question asked should be answerable, the research methods must be valid and reliable, and the study has to be designed with accepted principles, clear methods, and reliable practices. Invalid research is unethical because it is a waste of resources and exposes people to risk for no purpose.

Fair subject selection: The primary basis for recruiting participants should be the scientific goals of the study. Participants must not be chosen on the basis of vulnerability, privilege, or other unrelated factors. Participants who accept the risks of research should be in a position to enjoy its benefits. Specific groups of participants (ex. women or children) should not be excluded from the research opportunities unless there is a good scientific reason or a particular susceptibility to risk.

Favorable risk-benefit ratio: Everything should be done to minimize the risks and inconvenience to research participants, while also maximizing the potential benefits. Efforts should also be made to determine that the potential benefits are proportionate to, or outweigh, the risks.

Independent review: To minimize potential conflicts of interest and make sure a study is ethically acceptable before it starts, an independent review panel should review the proposal. The independent panel ensures that the study is free of bias, ethically designed, and ensures the protection of research participants.

Informed consent: Potential participants should make their own decision about whether they want to participate or continue participating in research. This is done through a process of informed consent in which individuals:

 Are accurately informed of the purpose, methods, risks, benefits, and alternatives to the research.

 Understand this information and how it relates to their own clinical situation or interests.

 Make a voluntary decision about whether to participate.

Respect for potential and enrolled subjects: Individuals should be treated with respect from the time they are approached for possible participation, throughout their participation and after their participation ends. Even if they refuse enrollment in a study, they should still be respected. This includes monitoring their welfare, respecting their privacy, keeping their information confidential, and informing them of new information that might emerge from the course of the study.

Ethical Guidelines for Animal Participants

Ethical guidelines for animal participants are generally based on the three R’s of animal research: Replace, Reduce, and Refine.

Respect for animals’ dignity: researchers must have respect for animals' worth, regardless of their utility value, and for animals' interests as living, sentient creatures.

Responsibility for considering options: researchers are responsible for studying whether there are alternatives to experiments on animals. Alternative options must be prioritized if the same knowledge can be acquired without using laboratory animals. If no good options are available, researchers should consider whether the research can be postponed until alternative methods have been developed.

Responsibility for considering and balancing suffering and benefit: Researchers must consider the risk that laboratory animals experience pain and other suffering and assess them in relation to the value of the research for animals, people or the environment. Researchers are responsible for considering whether the experiment may result in improvements for animals, people or the environment. Suffering can only be caused to animals if this is counterbalanced by a substantial and probable benefit for animals, people or the environment.

Responsibility for considering reducing the number of animals: Researchers are responsible for considering whether it is possible to reduce the number of animals the experiment plans to use and must only include the number necessary to maintain the scientific quality of the experiments and the relevance of the results.

Responsibility for minimizing the risk of suffering and improving animal welfare: Researchers are responsible for assessing the expected effect on laboratory animals. Researchers must minimize the risk of suffering and provide good animal welfare. Suffering includes pain, hunger, thirst, malnutrition, abnormal cold or heat, fear, stress, injury, illness and restrictions on the ability to behave normally/naturally.

Responsibility for maintaining biological diversity: Researchers are responsible for ensuring that the use of laboratory animals does not endanger biological diversity. The use of endangered and vulnerable species must be reduced to an absolute minimum.

Responsibility when intervening in a habitat: Researchers are responsible for reducing disruption and any impact on the natural behavior of individual animals, including those that are not direct subjects of research, as well as of populations and their surroundings.

Responsibility for openness and sharing of data and material: Researchers are responsible for ensuring that there is transparency about research findings and facilitating the sharing of data and material from experiments on animals. Such transparency and sharing are important in order to avoid unnecessary repetition of experiments.

Requirement of expertise on animals: Researchers and other parties who handle alive animals must have adequately updated and documented expertise on animals. This includes specific knowledge about the biology of the animal species in question, and a willingness and ability to take care of animals properly.

Requirement of due care: There are national laws and rules and international conventions and agreements regarding the use of laboratory animals, and both researchers and research managers must comply with these.

Ethics in Selecting Study Designs and Other Research Design Elements

Validity: The research design must address specific research questions. Hence, the conclusions of the study must correlate to the questions posed and the results. The methods used must relate specifically to the research questions.

Efficient: makes the best source of the resources used.

Study designs and variables: it’s unethical to test some variables by specific study designs e.g: smoking and interventional study designs.

Sampling: The design must explain why the study can only be conducted on a particular group of participants. Likewise, it should explain why certain people or groups are excluded. In addition, if the study design includes children or special needs individuals, additional requirements, like parental permission, must be addressed.

Voluntary Participation and Consent: The chosen design must not, under any circumstances, coerce or pressure any subject to participate. This includes any type of persuasion or deception in attempting to gain an individual’s trust.

Confidentiality: Information provided by the research subjects must remain confidential, and the anonymity of respondents must be respected. However, if a participant is at risk of harm, their information might have to be released.

Risk of Harm: There should be a keen focus on the risk-to-benefit ratio. If possible risks outweigh the benefits, the study design must be redesigned or even abandoned altogether.

When choosing the right research methods, the investigators must ensure they are taking the most ethical approach that simultaneously yields the most accurate results. To do so, they must ask the following questions:

1. Which methods most effectively fit the aims of your research?

2. What are the strengths and restrictions of a particular method?

3. Are there potential risks when using a particular research method?

Ethical Guidelines for Writing and Publishing Research

Authorship Guidelines

Naming authors on a research paper ensures that the appropriate individual receives credit and is held accountable for their work. Generally, an “author” is considered to be an individual who has made a significant intellectual contribution to the study.

To be credited as the author of their study, the researcher must meet these four criteria:

1. The researcher must have made a significant contribution to the study design and data analysis.

2. The researcher must have drafted or revised the research article.

3. The researcher must give their approval for the final version.

4. The researcher must agree to be held accountable for all aspects of their work, including accuracy and integrity.

That being said, there are forms of authorship widely deemed unacceptable by the research community. They are a major contributor to authorship disputes, because their participation violates ethics of research publication, they are:

1. Ghost authors, or authors who contribute substantially to the research paper but are not acknowledged for their work. They are often paid. Not acknowledging a writer’s contribution is deemed dishonest, and therefore, unethical.

2. Guest authors, or authors who make little to no contribution to the research paper but are listed to increase the probability of the paper being published. Because they make no discernable contribution to the research paper, their inclusion is unethical.

3. Gift authors, or authors whose only contribution is being affiliated with the study. Like guest authors, their inclusion is unethical.

Competing Interests

When an investigator, author, editor, or reviewer has a financial/personal interest or belief that could affect his/her objectivity, or inappropriately influence his/her actions, a potential competing interest exists. The most obvious competing interests are financial relationships, such as employment, grants, and paid expert testimony.

Undeclared financial interests may seriously undermine the credibility of the journal, the authors, and the science itself. However, competing interests can also exist as a result of personal relationships, academic competition, and intellectual passion.

Plagiarism

Plagiarism is defined as deliberately using the work of another person or entity without permission, credit, or acknowledgement. It is one of the most common types of political misconduct, and, unfortunately, the most damaging.

Plagiarism takes on many different forms, some of which include:

As the name suggests, it is the reproduction of a publication word for word.

Literal Copying

An entire publication or part of it may be copied, without the acknowledgment or crediting of the original author or publisher.

Substantial Copying

Paraphrasing

Text Recycling

Substantial copying is the copying of the research materials, processes, tables, or equipment. It differs from literal copying in that the offender here is plagiarizing the idea, or essence, of the research paper. In literal copying, the offender plagiarizes the words and paragraphs of the research paper, or the literary components.

Paraphrasing is reproducing someone else's ideas while not copying word for word; the offender writes them down in their own words or according to their understanding. It is done without permission and acknowledgment of the original source. Paraphrasing is only acceptable if the original source is properly referenced.

Text recycling occurs when a researcher reproduces their own publication word for word, and submits it as an entirely new publication.

It is similar to literal copying, except that the offender is plagiarizing their work instead of another publisher’s work.