Research Ethics

Ethics in research are very important when you’re going to conduct an experiment. Ethics should be applied on all stages of research, such as planning, conducting and evaluating a research project. The first thing to do before designing a study is to consider the potential cost and benefits of the research.

When most people think of ethics (or morals), they think of rules for distinguishing between right and wrong, such as the Golden Rule (“Do unto others as you would have them do unto you”), a code of professional conduct like the Hippocratic Oath (“First of all, do no harm”), a religious creed like the Ten Commandments (“Thou Shalt not kill…”), or a wise aphorisms like the sayings of Confucius. This is the most common way of defining “ethics”: norms for conduct that distinguish between acceptable and unacceptable behavior.

Another way of defining ‘ethics’ focuses on the disciplines that study standards of conduct, such as philosophy, theology, law, psychology, or sociology. For example, a “medical ethicist” is someone who studies ethical standards in medicine. One may also define ethics as a method, procedure, or perspective for deciding how to act and for analyzing complex problems and issues. For instance, in considering a complex issue like global warming, one may take an economic, ecological, political, or ethical perspective on the problem. While an economist might examine the cost and benefits of various policies related to global warming, an environmental ethicist could examine the ethical values and principles at stake.

Designing ethical research studies.

  • The primary concern of the investigator should be the safety of the research participant. Protecting subject safety requires the investigator to use all available information to identify potential risks to the subject, to establish means of minimizing those risks, and to continually monitor the ongoing research for adverse events experienced by subjects. The investigator must be prepared to stop the study if serious unanticipated risks are manifest.
  • The scientific investigator must obtain informed consent from each research participant. This should be obtained in writing (although oral consents are sometimes acceptable) after the participant has had the opportunity to carefully consider the risks and benefits and to ask any pertinent questions. Informed consent should be seen as an ongoing process, not a single event or a mere formality. There are regulations and guidance documents that govern exceptions to the requirement to obtain informed consent, for example in cases of emergency or if the subject is unconscious and thereby unable to give consent.
  • The investigator must protect the subjects’ privacy and confidentiality. Researchers must have mechanisms in place to prevent the disclosure of, or unauthorized access to, data that can be linked to a subject’s individual identity.
  • The investigator must consider how adverse events will be handled. In particular, it must be established a priori who will provide care for a participant injured in a study and who will pay for that care.
  • The investigator must strive for clinical equipoise. A true null hypothesis should exist at the onset regarding the outcome of the trial, that is, if a new intervention is being tested against the currently accepted treatment, the investigator should be genuinely uncertain which approach is superior.

Research Ethics : Codes and Policies

The following is a rough and general summary of some ethical principals that various codes address*:

Honesty

Strive for honesty in all scientific communications. Honestly report data, results, methods and procedures, and publication status. Do not fabricate, falsify, or misrepresent data. Do not deceive colleagues, research sponsors, or the public.

Objectivity

Strive to avoid bias in experimental design, data analysis, data interpretation, peer review, personnel decisions, grant writing, expert testimony, and other aspects of research where objectivity is expected or required. Avoid or minimize bias or self-deception. Disclose personal or financial interests that may affect research.

Integrity

Keep your promises and agreements; act with sincerity; strive for consistency of thought and action.

Carefulness

Avoid careless errors and negligence; carefully and critically examine your own work and the work of your peers. Keep good records of research activities, such as data collection, research design, and correspondence with agencies or journals.

Openness

Share data, results, ideas, tools, resources. Be open to criticism and new ideas.

Respect for Intellectual Property

Honor patents, copyrights, and other forms of intellectual property. Do not use unpublished data, methods, or results without permission. Give proper acknowledgement or credit for all contributions to research. Never plagiarize.

Confidentiality

Protect confidential communications, such as papers or grants submitted for publication, personnel records, trade or military secrets, and patient records.

Responsible Publication

Publish in order to advance research and scholarship, not to advance just your own career. Avoid wasteful and duplicative publication.

Responsible Mentoring

Help to educate, mentor, and advise students. Promote their welfare and allow them to make their own decisions.

Respect for colleagues

Respect your colleagues and treat them fairly.

Social Responsibility

Strive to promote social good and prevent or mitigate social harms through research, public education, and advocacy.

Non-Discrimination

Avoid discrimination against colleagues or students on the basis of sex, race, ethnicity, or other factors not related to scientific competence and integrity.

Competence

Maintain and improve your own professional competence and expertise through lifelong education and learning; take steps to promote competence in science as a whole.

Legality

Know and obey relevant laws and institutional and governmental policies.

Animal Care

Show proper respect and care for animals when using them in research. Do not conduct unnecessary or poorly designed animal experiments.

Human Subjects Protection

When conducting research on human subjects, minimize harms and risks and maximize benefits; respect human dignity, privacy, and autonomy; take special precautions with vulnerable populations; and strive to distribute the benefits and burdens of research fairly.

Components of ethically valid informed consent for research.

Given the appreciation that informed consent is at the crux of human subjects protection, it is not surprising that the regulations reflect extensively upon the necessary elements of the consent document itself as well as on the informed consent process. For an informed consent to be ethically valid, the following components must be present:

  • Disclosure: The informed consent document must make clear that the study is a research study, and not clinical therapy. The potential participant must be informed as fully as possible of the nature and purpose of the research, the procedures to be used, the expected benefits to the participant and/or society, the potential of reasonably foreseeable risks, stresses, and discomforts, and alternatives to participating in the research. There should also be a statement that describes procedures in place to ensure the confidentiality of data and anonymity of the participant. The informed consent document must also disclose what compensation and medical treatment are available in the case of a research-related injury. The document should make it clear whom to contact with questions about the research study, research subjects’ rights, and in case of injury.
  • Understanding: The participant must understand what has been explained and must be given the opportunity to ask questions and have them answered by someone fully conversant in the study particulars. The informed consent document must be written in lay language, avoiding any technical jargon. The potential participant must be able to read and/or understand the language in which the consent form is written. Consent forms for multinational research must be translated into the respective language for each participating country and back-translated to verify accuracy.
  • Voluntariness: The participant’s consent to participate in the research must be voluntary, free of any coercion or inflated promise of benefits from participation. Care should be taken that the consent form is administered by someone who does not hold authority over the participant. Ideally, the potential participant is given the opportunity to discuss their participation in the study with family, trusted friends, or their physician before reaching a decision.
  • Competence: The participant must be competent to give consent. If the participant is not competent due to mental status, disease, or emergency, a designated surrogate may provide consent if it is in the participant’s best interest to participate. In certain emergency cases, consent may be waived due to the lack of competence of the participant and absence of an appropriate surrogate. In the event that there is a question about competence, mental status exams may be administered.
  • Consent: The potential human subject must authorize his/her participation in the research study, preferably in writing. If there is no need to collect personally identifiable information, and a signature on the consent form would be the only thing linking the subject to the study, an oral or implicit consent may be more appropriate. Children who cannot read or write should still signal their willingness to participate by an affirmative act (for example, nodding their head). Consent by minors is referred to as assent.
  • Exculpatory language: No informed consent may contain any exculpatory language by which the participant waives any legal rights or releases the investigator or sponsor from liability for negligence.

Ethical Decision Making in Research

Although codes, policies, and principals are very important and useful, like any set of rules, they do not cover every situation, they often conflict, and they require considerable interpretation. It is therefore important for researchers to learn how to interpret, assess, and apply various research rules and how to make decisions and to act ethically in various situations. The vast majority of decisions involve the straightforward application of ethical rules. For example, consider the following case,

There are many other activities that the government does not define as “misconduct” but which are still regarded by most researchers as unethical. These are sometimes referred to as ” other deviations” from acceptable research practices and include:

  • Publishing the same paper in two different journals without telling the editors
  • Submitting the same paper to different journals without telling the editors
  • Not informing a collaborator of your intent to file a patent in order to make sure that you are the sole inventor
  • Including a colleague as an author on a paper in return for a favor even though the colleague did not make a serious contribution to the paper
  • Discussing with your colleagues confidential data from a paper that you are reviewing for a journal
  • Using data, ideas, or methods you learn about while reviewing a grant or a papers without permission
  • Trimming outliers from a data set without discussing your reasons in paper
  • Using an inappropriate statistical technique in order to enhance the significance of your research
  • Bypassing the peer review process and announcing your results through a press conference without giving peers adequate information to review your work
  • Conducting a review of the literature that fails to acknowledge the contributions of other people in the field or relevant prior work
  • Stretching the truth on a grant application in order to convince reviewers that your project will make a significant contribution to the field
  • Stretching the truth on a job application or curriculum vita
  • Giving the same research project to two graduate students in order to see who can do it the fastest
  • Overworking, neglecting, or exploiting graduate or post-doctoral students
  • Failing to keep good research records
  • Failing to maintain research data for a reasonable period of time
  • Making derogatory comments and personal attacks in your review of author’s submission
  • Promising a student a better grade for sexual favors
  • Using a racist epithet in the laboratory
  • Making significant deviations from the research protocol approved by your institution’s Animal Care and Use Committee or Institutional Review Board for Human Subjects Research without telling the committee or the board
  • Not reporting an adverse event in a human research experiment
  • Wasting animals in research
  • Exposing students and staff to biological risks in violation of your institution’s biosafety rules
  • Sabotaging someone’s work
  • Stealing supplies, books, or data
  • Rigging an experiment so you know how it will turn out
  • Making unauthorized copies of data, papers, or computer programs
  • Owning over $10,000 in stock in a company that sponsors your research and not disclosing this financial interest
  • Deliberately overestimating the clinical significance of a new drug in order to obtain economic benefits

These actions would be regarded as unethical by most scientists and some might even be illegal in some cases. Most of these would also violate different professional ethics codes or institutional policies. However, they do not fall into the narrow category of actions that the government classifies as research misconduct. Indeed, there has been considerable debate about the definition of “research misconduct” and many researchers and policy makers are not satisfied with the government’s narrow definition that focuses on FFP. However, given the huge list of potential offenses that might fall into the category “other serious deviations,” and the practical problems with defining and policing these other deviations, it is understandable why government officials have chosen to limit their focus.

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