Introduction to Research Ethics

Introduction to Research Ethics

• Research entails a systematic, controlled, empirical, and critical investigation of hypothetical propositions concerning relationships among phenomena, as defined by Kerlinger in 1973.
• The research process involves a systematic approach to seeking, organizing, analyzing, discussing, predicting, or providing new insights into the relationships among variables, according to Njoku & Ezenwa in 2012.
• Research can be categorized based on the goal or objective, research design, and data type or method of data analysis.
• Research categorized by goal/objective includes pure and applied research, as well as baseline impact studies.
• Research categorized by research design includes historical, experimental, ex-post facto, and survey research.
• Research categorized by data type/method of data analysis includes qualitative and quantitative research.

What are Ethics?

• Ethics are norms that define acceptable and unacceptable behavior.
• Ethics is defined by moral principles and values which govern the way an individual, group, or institution conducts activities, as specified by Churchill in 1999.
• Actions can be legal but unethical, and vice versa.
• Values are beliefs which motivate people to act certain ways.
• A norm is a rule, standard, or pattern for action (e.g., a social norm).
• Society has legal rules for behavior, but ethical norms are broader and more informal than law.

Research Ethics

• Research ethics involves adhering to procedures that are morally right when conducting research across various disciplines.
• Research ethics can be explored from tridimensional point of views of collecting/analyzing data, societal responsibility, and ethical treatment of participants.

Ethical Principles Underpinning Research

• Strive for honesty in all scientific communications when reporting data, results, procedures, and publication status
• Do not fabricate, falsify or misrepresent data, and avoid deception.
• Maintain integrity by keeping promises and agreements, acting with sincerity, and striving for consistency in thought and action.
• Aim for objectivity to avoid bias in experimental design, data analysis/interpretation, peer review, personnel decisions, grant writing and expert testimony
• Minimize bias or self-deception, and disclose personal/financial interests that may affect the research.
• The "3Rs" (Replacement, Reduction, Refinement) should guide animal care.
• Researchers are expected to show respect and care for animals during research.
• Avoid unnecessary or poorly designed animal experiments.
• Publish to advance research/scholarship, not just personal gains, and avoid wasteful/duplicative publication, which is also known as "publish or perish" mentality.
• Maintain and improve professional competence via lifelong learning, and promote competence in science.
• Human subjects protection involves: autonomy; free and informed consent; respect for vulnerable persons; privacy and confidentiality; justice and inclusiveness; harms and benefits; minimizing harm (non-maleficence); maximizing benefit (beneficence).
• Strive to promote social good and prevent or mitigate harms through research, public education and advocacy.
• Avoid discrimination against colleagues or students based on factors unrelated to competence such as sex, race, or ethnicity.
• Avoid careless errors and negligence; carefully and critically examine works; keep records of research activities like data collection, research design, and correspondence.
• Honor patents, copyrights, and other forms of intellectual property and don't use unpublished data/methods/results without permission; give credit for contributions, never plagiarize.

Research Misconduct

• Research misconduct is the act of fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.
• Research misconduct does not include honest error or differences of opinion; it occurs only when researchers intend to deceive.
• Fabrication involves 'making up' data or results and reporting them.
• Falsification manipulates research materials/equipment/processes or changes/omits data/results such that the research is inaccurately represented.
• Plagiarism appropriates another person's/institution's/organization's ideas, processes, results, or words without giving appropriate credit.
• A case study of research misconduct included the falsification of data by the educational psychologist, Cyril Burt.
• A case study of research misconduct included plagiarism by a graduate student.
• Reasons for committing research misconduct include individual factors like incompetence/lack of knowledge/carelessness.
• Reasons for committing research misconduct include situational factors like workload, time, and pressure to publish.
• Reasons for committing research misconduct include organizational factors like poor organizational ethics, capacity building, mentoring, and ethical review boards.
• Reasons for committing research misconduct include structural factors like systemic issues, poverty, and poor educational systems.
• Reasons for committing research misconduct include cultural factors like tradition/long history of misconduct in the environment.
• Addressing research misconduct involves mechanisms like requirements to report to relevant agencies.
• Sanctions for misconduct include letters of reprimand, termination of grant, demotion, suspension, and disbarment.
• Whistleblowing policies and safeguards for whistleblowers should include guidelines on perspective, rules and procedures, documentation, and dispute resolution.
• There should be safeguards for individuals that are the subjects of allegations.
• Prevention can be done through regular training and re-training.

Data Acquisition and Management

• Data is any collection of facts, measurements, or observations used to describe and make inferences about humans and their physical and social environment.
• Data acquisition begins with a well-formulated research question and the selection of data.
• Data management involves a range of activities including data protection, coding, transformation, storage, and analysis.
• Data protection deals with rules about who should access information, and under what conditions, also known as privacy or confidentiality rules.
• Lacking data protection safeguards/practices, can lead to confidential information being compromised.
• Data protection practices are influenced by factors like the nature of data and its intended use.
• Institutions should have and enforce data protection policies.

Ethical Issues when Dealing with Data

• Data collection is the process of gathering and measuring information on key variables in a specified and acceptable manner.
• Data collection methods vary by discipline, data types, and research design, but ensuring data integrity should be prioritized.
• The data types (e.g., nominal, ordinal, interval, ratio scales), sample size determination, sampling techniques, research designs, and techniques for appropriate data collection should be considered during data collection.
• Data integrity refers to the trustworthiness of information, affirming that data has not been inappropriately modified whether intentionally or accidentally.
• Data integrity ensures the origin or source of data is from the person or entity data users believe it to be.
• Use original data sources, disciplined and knowledgeable personnel, involve enumerators with the research process, and use software for data entry/cleaning for data integrity.
• Consequences of improperly collected data or poor data management include inability to answer questions, replication issues, spurious findings, misleading researchers, compromised decision/policies, harm to participants, and generalization issues.
• Data retention refers to how long data will be kept after a project, and depends on the project's nature, long-term costs, sponsor guidelines, and the journal's policy.
• Usually, data is stored for 5 years post-study, but during litigation, it is kept until the litigation ends.
• Retaining data long after project ends increases unauthorized access risks, which needs proper data protection safeguards.
• Data must be stored securely from unauthorized access but available to legitimate users through periodic backups (e.g., Dropbox, Google Drive).
• Confidential data from human subjects, if exposed, can violate privacy and lead to litigation.
• Data disposal involves destroying data when it is no longer needed, requiring technical expertise to ensure complete and irretrievable destruction.
• Data ownership refers to the possession of and responsibility for data, including rights and obligations for collection, storage, and sharing.
• Data ownership is often regulated by regulations and contracts.
• When lecturers perform research for the university ("work for hire"), the university controls the data's copyright.
• Lecturers conducting research on their initiative own the copyright, and data from student-funded research belongs to the institution/principal investigator.
• Data sharing grants data access to persons outside of the study, funder, or general public.
• Professional norms require researchers to publish results and exchange data freely, known by the term "openness".
• Data sharing’s benefits: permits review to verify/refute/refine results, enable learning of new techniques of colleagues , and avoid repetition of work.

Research with Animal Subjects

• Animal research involves studying living processes in health and disease conditions, where certain animals serve as models for human conditions.
• Animal research benefits both humans and animals by improving our understanding of similarities and differences.
• Animal research is one of research types, followed experimental work with cells, chemicals, and computer simulation.
• Animal research often involves vertebrates, such as cats, mice, frogs, pigs, and primates; some benefit human models include dogs- insulin, monkeys- polio vaccine, mice- rabies vaccine, pigs- for skin grafts and cat scans, rabbits and rats for cornea transplant, etc.
• Degrees of suffering caused by procedures are important ethical considerations when thinking about using animals for study.
• Some argue animals should not be exploited, but most agree it is acceptable for society’s well-being if conducted humanely with integrity, which gave rise to antivivisectionism.
• Antivivisectionism: is a movement against vivisection, which means use of surgery conducted on living animals during experimentations.

Benefits of Animal Research

• Used in medical and paramedical sciences and basic biological discipline
• For education and training including development of surgical skills
• For the manufacture of vaccines, toxoids, antiserums ant toxins and anti vennins
• For testing and standardization of drugs, processing, distribution ad palatability, commonly by mice, rat, dogs and monkeys
• For testing new drugs
• For diagnosis of diseases
• For military research, i.e. animals exposed to radiation to estimate damages
• For feeding, in other words, determine nutritive value of supplements -For Cancer, HIV, COVID research etc.

The 3 Rs (Replacement, Reduction, Refinement)

• Replacement means gradually substituting non-animal models , also replacing with animals of lower ethical concern.
• Reduction means reducing the number of animals needed for research with pilot study to find problems before using larger animals, appropriate stats analysis, and consulting with colleagues to avoid repeat study .
• Refinement means finding ways to modify experiment methods and design to ensure minimum pains and distress with analgesics, correct drugs and proper handling etc.
• Procedures are painful or distressful when the same procedure would make a human feel pain or distress.

Research with Plant Subjects

• Research with plants uses a living plant as the primary subject of a research.

Ethical Issues in Plant Research

• Given the limitations of traditional breeding to attain desired traits, modern biotechnology like genetic engineering/recombinant DNA technology has introduced development of transgenic plants.
• Transgenic crops contain one species' gene artificially inserted to the second genome set.
• Genetically modified organisms (GMOs) are organisms which a second organism gene inserted, whose DNA is altered through genetic engineering, to attain features unachievable by conventional breeding.
• There are concerns about possible effects of GMOs impacts both human health and environment (positive/negative).
• When researching genetic transformation of plant, the effect of these plant, the environment, human health, and species must be observed.

Human Subjects Research

• Human subject are are living beings which experimenters get data through:
• Data through intervention or interaction
• Identifiable private information

Regulations Governing Human Subjects Research

• Nuremberg Code: states participants in voluntary research must consent prior, created after world war ll for the atrocities committed by Nazi researchers, it is the first international document that advocates informed concent
• Declaration of Helsinki in 1964: stipulates must be combined with clinical care
• U.S National Research ACT of 1974: created to the syphilis study of Public Health Service from 1932 to 1972, the protection of human subject of biomedical andbehavioral research
• Belmont report in 1978: Protection of subject emphasized three basic principles, respect for persons, beneficence and justice
• Persons are given obligation to the autonomy, right of persons to make decisions for themselves
• Justice states that population be given stem benefits from research, or burden should not be unduly imposed on subjects
• Beneficence is the obligation of maintaining well being of others, which states to do no harm to others Beneficence forces researchers to follow procedures that has least risk possible and cease work with any harm occurring to subject.
• Subject must be well notified during implementing research protocol of process and subjects must be voluntary decision for subjects to enroll and voice decision for participation, children must have their parents/legal authorizes approves if subject is incompetent

Collaborative Research Activities

• Collaboration is the joint effort in conducting research by researchers and institutions.
• Collaboration involves joint effort between researchers with communities around.
• Collaborative research can consist of formulating research questions, research designs, etc. . Funding sources
• Complementary skills
• Technology growth
• Challenges requiring collaborations with researchers, industry, communities
• Evident that such collaboration improves quality

Potential Problems with Collaborative Research

• Differences in investigators research style based on backgrpund
• Differences of academic with industrial research with to data and result sharing
• Ethical considerations.

Mitigating Potential Problems with Collaboration

• Having clear communications early
• Sharing of roles
• Discussions of authorship
• Discussion within data mangement and following steps

Bias and Conflict of Interest in Research

• A situation in which financial or personal consideration will effect judgements
• Having conflict only implies potential for bias and desciion can be made automatically
• Bias and conflict is not always research misconduct

Managing Conflict of Interest

• In research it must be identified, managed, reduces or eliminated by researchers Steps to follow
• Disclosure of investigators financial interests
• Reporting financial relations within sposors
• Modifiying plans
• Monitoring research by independent reviewers
• Divorce significant financial
• Severnce of relationships

Categorization of Conflict of Interest

Tangible - Relationship with finances Intangible- Relations with studies

Publication Practices and Authorship

• An Author writes in publications, contributions of work and creator of ideas
• Substantial contribution with concept, design,execution, interpretation (guideine for professional conduct)
• Substantial is defined by formulating the problem hypotheses and design and data analysis Deceptive authorship practices :
• Author ship by authority
• Gifts
• Politcal
• Ghost

Conditions for Authorship

• "Take credit and take responsibility
• sub cons and desg, data
• drafts
• final approval Seuquence is first to contributors, then least at the end

Publication Problems

• Duplicate or redundant facts
• Piecemeal- division of finding