LibGuides: Research Ethics: Home

Research Ethics - Robert J. Levine, M.D., Yale University

Dr. Robert Levine of Yale University provides an overview on the events that led to the formation of research ethics.

Yale University (2011). Research ethics [Video]. YouTube. https://youtu.be/jD-YCDE_5yw

What are Research Ethics and Scientific Integrity?

Research ethics is the practice of using discipline-defined norms and standards in conducting research and generating new knowledge. Research ethics can be applied to any discipline, whether it is in the arts and humanities, social sciences, health and medical sciences, engineering, or physical or biological sciences.

Scientific integrity is similar to research ethics and is the result of following professional values and practices when conducting scientific research and applying its results.

Research ethics and scientific integrity ensures the following:

Objectivity
Clarity
Reproducibility
Utility
Transparency
Accountability

They are also important for minimizing or avoiding:

Bias
Fabrication
Falsification
Outside Interference
Inadequate Research Procedures and Security of Data
Other legal (e.g., copyright infringement) or unethical actions (e.g., plagiarism)

Why are these important?

Research and discoveries add to a body of knowledge. They frequently lead to new creations, products, services, treatments, and various innovations. When ethics and integrity are compromised, it has negative effects in many areas:

Erroneous or invalid information: other researchers may base their studies on flawed research which may affect their studies' validity and outcomes.
Wastes of funds, time, or resources.
Identifying misconduct: research misconduct often takes a long time to identify after it happens.
Public trust: the public's trust in research and scholarly activity can diminish, impacting their support or regard for it.

Sources

Scientific Integrity - U.S. Environmental Protection Agency This site provides the background on scientific integrity, why it is important, and its principles.
Glossary of Commonly Used Terms in Research Ethics - NIH National Institute of Environmental Health Sciences

Research Ethics and Scientific Integrity

The following documents describe the development of research ethics and refer to the historical occurrences that initiated them.

The Belmont Report The Belmont Report was written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission, created as a result of the National Research Act of 1974, was charged with identifying the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and developing guidelines to assure that such research is conducted in accordance with those principles.
WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects
The Nuremberg Code (US National Institutes of Health)
Code of Federal Regulations
45 CFR 46 (Title 45, Subchapter A, Part 46 of the Code of Federal Regulations) is also known as the Common Rule. This regulation defines the U.S. HHS policy regarding the protection of human subjects in research, and includes protections for vulnerable populations such as pregnant women, children, and prisoners. The CFR also defines the protection of human subjects for other federal agencies, which can be found through searching this page.
Glossary of Commonly Used Terms in Research Ethics - NIH National Institute of Environmental Health Sciences

The nature of research or scholarly inquiry being done and the involvement of people in the processes determines what is subject to regulations and institutional review. The National Institutes of Health defines human subject research as, "research involving the collection, storage, or use of private data or biological samples from living individuals by means of interactions, interventions, surveys, or other research methods or procedures."

Federal regulations regarding research and human subjects distinguishes research from practice in the following ways:

Research is a systematic activity and involves a plan that tests a hypothesis and structures the approach. This can include qualitative, quantitative, and mixed methods research.
Pilot and preliminary studies that may include research development, testing, and evaluation
The intention of research is to contribute or develop information to a body of knowledge.

Certain types of inquiry such as literary criticism, historical scholarship, and journalistic or intelligence-gathering activities are not defined as being research in the 2018 update of the Common Rule (45 CFR 46.102). However, keep in mind that those methods are subject to following the norms and ethics within their academic or professional disciplines.

Source: CITI Program (2022). IRB reference resource. https://citiprogram.org.

Federal Policy for the Protection of Human Subjects ('Common Rule') - U.S. Department of Health and Human Services
Office for Human Research Protections (OHRP) - U.S. Department of Health and Human Services he Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).
Human Subject Regulations Decision Charts - U.S. Department of Health and Human Services The Office for Human Research Protections (OHRP) provides the following graphic aids as a guide for institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46.
International Compiliation of Human Research Standards - U.S. Department of Health and Human Services The International Compilation of Human Research Standards - PDF is a listing of over 1,000 laws, regulations, and guidelines on human subjects protections in 130 countries and from many international organizations.
Ethical Standards and Procedures for Research with Human Beings (World Health Organization)

Informed Consent

Vulnerable Populations

Code of Federal Regulations (Vulnerable Populations)
See Subparts B, C and D of 45 CFR 46 (Title 45, Subchapter A, Part 46 of the Code of Federal Regulations) for their regulations on research on people and groups vulnerable to coercion or undue influences. Vulnerable populations include pregnant women, children, prisoners, and those with other types of disadvantages (economic, educational, impaired decision-making, etc.).

The CFR also defines the protection of human subjects for other federal agencies, which can be found through searching this page.
Vulnerable and Other Populations Requiring Additional Protections (US NIH) A list of populations that need greater protections from harm through their participation in research. While this is an NIH statement, its definitions can apply to human subjects research in all disciplines.

Some federal-level regulations and policies are used by various entities to guide their conflict of interest policies. See the following for their guidance and recommendations. Some agencies may require disclosing significant financial or other interests when submitting a grant proposal.

FAU Research Integrity Offices and Policies

FAU Division of Research
Research Integrity - FAU Division of Research The Division of Research administers key research-related assurance and compliance programs required by federal and state agencies and programs for the conduct of research at Florida Atlantic University. Research Integrity includes the human subjects research protections program and the animal care and use program. Research Integrity works closely with Comparative Medicine, Sponsored Programs, and Environmental Health and Safety to facilitate regulatory compliance while supporting university research endeavors.
Responsible Conduct of Research (RCR) - FAU Division of Research
Research Misconduct - FAU Division of Research
Institutional Animal Care and Use Committee (IACUC) - FAU Division of Research
The Beacon - Research Integrity News - FAU Division of Research Catch the latest news, tips and advice that supports you and Florida Atlantic University in building a culture of research compliance.

Last updated on Mar 5, 2024 12:17 PM