INT JAMES SCHOOL OF MEDICIEN

PHYSIOLOGY

Dr. N.Sunitha PhD

 The Belmont Report:
Ethical Principles and
Guidelines for Research
Introduction to the Belmont Report

The Belmont Report is a key document in

the field of research ethics.

Created in 1979 by the National

Commission for the Protection of Human
Subjects of Biomedical and Behavioral
Research.

It provides foundational ethical principles

and guidelines for conducting research
involving human subjects.
 • Background:
• Created in response to unethical
research practices, such as the
Historical Tuskegee Syphilis Study.
Context • Aimed at addressing concerns
about the treatment of human
research subjects.
• Established as part of a broader
effort to ensure that research
respects human rights and dignity.
 The report was developed in response to public
outrage over the Tuskegee Syphilis Study, a clinical
study conducted between 1932 and 1972 by the U.S.
Public Health Service.
 In this study, 600 African American men were enrolled
without their informed consent to observe the natural
progression of untreated syphilis. Participants were
misled about their diagnosis and were denied effective
treatment, even after penicillin became the standard
care for syphilis in the 1940s.
 The unethical practices of the Tuskegee study
highlighted the need for clear ethical guidelines in
human research, leading to the creation of the Belmont
Report. This report has since become a cornerstone in
 •1. Respect for Persons
• This principle emphasizes the autonomy of individuals
and their right to make decisions about their own
participation in research. It also calls for extra protection
for individuals with diminished autonomy (e.g., children or
people with cognitive impairments).The principle includes
the requirement for informed consent, ensuring that
participants understand the nature of the research, its
Three Core risks, and their right to withdraw at any time.
•2. Beneficence
Ethical • This principle requires researchers to maximize potential
Principles benefits while minimizing potential harms to participants.It
involves conducting a risk-benefit analysis, where
researchers assess the potential risks of the study and
ensure that the benefits to society or knowledge outweigh
those risks.
•3. Justice
•Justice refers to the fair distribution of the benefits and
burdens of research. It ensures that no group of people is
unfairly burdened by research, and that certain groups
(e.g., vulnerable populations) are not exploited or excluded
from the benefits of research.
  Informed Consent:
 Requires clear communication of the nature of
the study, its risks, and its benefits.
 Participants must voluntarily agree to
participate without force or manipulation.
 Risk and Benefit Assessment:
Ethical  Researchers must assess the risks of research
Guidelines and ensure that the potential benefits
outweigh these risks.
for Research  This includes evaluating both physical and
psychological risks.
 Selection of Subjects:Research subjects
should be selected based on scientific
objectives rather than convenience.
 Special attention must be given to vulnerable
groups (e.g., children, prisoners, or those with
Informed Consent

 Informed Consent Process:

 Key Elements: Information, Comprehension,
Voluntariness.
 Researchers must provide adequate information
for participants to make an informed decision.
 Consent must be voluntary, free of pressure or
undue influence.
 Ongoing Consent: Consent should be a
continuous process throughout the study, with
regular updates if the study changes.
Informed consent
 •Assessing Risks:
•Physical, psychological, social, and legal
risks.
•Determining how risks can be minimized
or avoided.
Risk and •Maximizing Benefits:
Benefit •The research should have a potential to
Analysis benefit society and contribute to the
scientific field.
•Researchers must make efforts to ensure
that participants receive fair treatment and
care.
 Justice in Research
 Principle of Justice:
 Ensures that individuals are not
unfairly burdened or excluded from
the potential benefits of research.
 Equal treatment in selection of
participants based on the goals of the
study.
 Examples of Justice
Violations:Historical examples where
marginalized groups were unfairly
Impact of the Belmont Report

 Long-term Influence:
 TheBelmont Report is the cornerstone of
modern human research ethics.
 Itshaped regulations such as the Common
Rule (Federal Policy for the Protection of
Human Subjects).Ensured protections in
institutional review boards (IRBs) that
oversee ethical practices in research.
 Global Influence:The Belmont Report
served as a model for other countries in
establishing their own ethical guidelines
for research involving human subjects.
  What is an IRB?
A group of professionals who review
research proposals to ensure they
align with ethical guidelines set by
The Role of the Belmont Report.
 IRBsevaluate risks, informed
Institutional
consent processes, and fairness in
Review the selection of participants.
Boards (IRBs)  Responsibilities:Protecting
participants’ rights.
 Ensuring that researchers follow
ethical standards and legal
regulations.
  Limitations of the Belmont Report:
 The report doesn't address all potential
issues of modern research (e.g., digital
privacy, genetic research).
Challenges  It may not fully account for cultural
differences in ethical perspectives.
and  Modern Challenges:Emerging ethical
Criticisms concerns related to big data, AI, genetic
testing, and other new technologies.
 Calls for Updates: Scholars suggest
updating the Belmont Report to address
new ethical concerns in modern
research.
 Summary

 TheBelmont Report established critical

ethical principles that continue to guide
research today.
 Respect for persons, beneficence, and
justice are foundational to ethical research
practices.
 The report has shaped modern regulations,
institutions, and international standards.
 FinalThought: Ethical research is essential
for building trust and ensuring that science
benefits society while protecting human
dignity.
 Plagiarism

 Plagiarism is the act of using someone

else's work, ideas, or intellectual property
without proper acknowledgment or
permission and presenting it as your own.
 Itcan occur in many forms, such as copying
text, images, or ideas from sources without
giving credit or improperly citing those
sources.
  Direct Plagiarism:
 Copying someone else's work word-for-word
without quotation marks or citation.
 Mosaic Plagiarism (or
Patchwriting):Paraphrasing or rearranging
There are someone else's ideas or phrases without
proper citation, often blending it with your
different own thoughts.
types of  Self-Plagiarism:Reusing your own previously
plagiarism, published work or ideas without
acknowledging that it was used before.
including:  Accidental Plagiarism:Occurs when someone
inadvertently fails to cite a source properly,
often due to ignorance or carelessness.
 Paraphrasing without Attribution: Rewriting
someone else’s ideas or text in your own
words without giving credit to the original
  Academic Integrity: Plagiarism
undermines the credibility of the
research or academic work.
 IntellectualProperty Rights:
Why is Authors and creators have a right
to their original work, and
plagiarism plagiarism violates that right.
unethical?  Misrepresentation:Leads to
misleading conclusions about the
person’s knowledge andabilities.
 Consequences:Legal, academic, or
professional penalties can result
from plagiarizing.
 Toavoid plagiarism, it’s essential to always
cite sources properly, whether you’re
quoting directly or paraphrasing someone
else's work.
 Mostacademic institutions and publications
have strict policies and tools (like
plagiarism detection software) to identify
and penalize plagiarism.
 Detection Tools: Tools like Turnitin,
Grammarly, or plagiarism checkers help
identify unintentional plagiarism.
 Consequences of Plagiarism

 Academic Consequences: Failing

grades, suspension, or expulsion.
 LegalConsequences: Lawsuits or
copyright infringement claims.
 Damage to Reputation: Loss of trust
from peers, professors, or the public.
  BuildingTrust: Trust in research
and academic work is based on
The honesty and respect for
intellectual property.
Importance
 Encouraging Originality: Students
of Academic
and researchers should develop
Integrity their own ideas and contribute to
the scholarly community.
 Respecting Others' Work:
Acknowledging others'
contributions promotes
collaboration and learning.
THANK YOU