Why Research Needs Ethics
Summary
TLDRThe script outlines the historical development of medical ethics, starting with the Nuremberg Trials post-WWII that led to the establishment of the Nuremberg Code in 1947. It highlights subsequent ethical breaches, such as the thalidomide incident and the Tuskegee syphilis study, leading to the formation of the World Medical Association's recommendations and the Belmont Report in 1979. The summary emphasizes the current global ethical principles in research involving humans and animals, including informed consent, minimizing harm, and the role of ethics committees in ensuring the protection of participants' rights and well-being.
Takeaways
- 📝 The Nuremberg Code was established in 1947 following WWII, setting ethical standards for medical experimentation after crimes against humanity were exposed.
- 😷 Despite the Nuremberg Code, unethical studies like the Thalidomide incident, the non-consensual use of Henrietta Lacks' cells, and the Tuskegee syphilis study still occurred.
- 👨⚕️ In 1964, the World Medical Association laid the groundwork for Good Clinical Practice guidelines, emphasizing research based on prior lab and animal studies and the necessity of voluntary, informed consent.
- 📚 The Belmont Report of 1979 outlined key ethical principles for human and animal research, including respect for persons, beneficence, justice, and research integrity.
- ⚠️ Ethical research mandates the dignity, rights, safety, privacy, and well-being of participants, with particular concern for vulnerable groups.
- 👨💻 Institutional Review Boards or Ethics Committees play a crucial role in ensuring research is ethical, comprising medical and non-medical members for a balanced review.
- 📈 Research involving humans categorizes risks as negligible, low, or high, with informed consent documents providing detailed study information to potential participants.
- 🐾 Animal research ethics focus on humane treatment, guided by the 3Rs principle: replacement, reduction, and refinement.
- 🔗 Researchers have ongoing obligations to ethics committees, including reporting protocol variations and any serious issues that arise.
- 👩💻 Ultimately, it is the researcher's responsibility to uphold ethical standards throughout the research process, ensuring society's best interests are served.
Q & A
What was the Nuremberg Code established in response to?
-The Nuremberg Code was established in response to the atrocities committed by German physicians and administrators during World War II, including medical experiments conducted on concentration camp prisoners without their consent, which resulted in serious harm.
What are the key components of the Nuremberg Code?
-The Nuremberg Code emphasizes the necessity of voluntary and informed consent, the importance of conducting research that is based on prior laboratory and animal experimentation, the requirement for research to be carried out by qualified individuals, and the principle that risks should not outweigh benefits.
What historical incidents highlight the importance of ethical research?
-The Thalidomide birth defects incident in 1950, the case of Henrietta Lacks and her unconsented immortal HeLa cells in 1951, and the mistreatment of participants in the Tuskegee Syphilis Study from 1932 to 1972 are historical incidents that underscore the importance of ethical research.
What guidelines were established by the World Medical Association in 1964?
-In 1964, the World Medical Association established recommendations for biomedical research, which formed the basis of the Good Clinical Practice guidelines. These guidelines emphasize the importance of research based on laboratory and animal experiments, independent committee review, informed consent, qualified research conduct, and ensuring that risks do not outweigh benefits.
What is the Belmont Report and when was it established?
-The Belmont Report was established in 1979 and it summarizes the ethical principles and guidelines for the protection of human participants in biomedical and behavioral research. It emphasizes respect for persons, autonomy, and informed consent; beneficence, where the risks must not outweigh the benefits; and justice, which involves fairness, equality, and equity in research.
What role do Institutional Review Boards (IRBs) or Ethics Committees play in research?
-Institutional Review Boards or Ethics Committees are independent panels that review and approve study designs and research protocols to ensure that the proposed research is ethical. They consist of medical professionals, non-medical members, ethicists, and often include members of the public. They are involved in evaluating the utility of research, the rigour of study design, animal welfare, ethical principles, and potential conflicts of interest.
What is the purpose of an Investigator Brochure in research?
-An Investigator Brochure provides detailed information about the experimental drug or treatment being tested, including its chemical structure, pharmacological properties, toxicology, pharmacokinetics, and any previously conducted clinical trial results. It is used to inform the investigators about the drug's safety and potential side effects.
How does the principle of 'replacement, reduction, and refinement' apply to animal research?
-The principle of 'replacement, reduction, and refinement' is foundational to animal ethics. It emphasizes the use of alternative methods to avoid or replace the use of animals in research, reducing the number of animals used when necessary, and refining experimental procedures to minimize harm and improve animal welfare.
What are the responsibilities of researchers towards the ethics committee throughout the duration of a study?
-Researchers have an ongoing obligation to report any changes to protocols, seek permission for each amendment, and report any serious issues or side effects that arise. They must maintain the welfare of participants at all costs and ensure that all research conducted is in the best interests of society.
What is the significance of informed consent in research?
-Informed consent is a fundamental ethical requirement in research. It ensures that participants understand the purpose, procedures, risks, benefits, and their rights, including the right to withdraw at any time. Participants must voluntarily agree to participate in the study after being provided with all relevant information.
How does the concept of 'respect for persons' manifest in research ethics?
-Respect for persons in research ethics involves recognizing the autonomy and dignity of each individual involved in the research. It requires obtaining informed consent and ensuring that the rights, safety, privacy, and well-being of participants are respected, safeguarded, and considered at all times.
Outlines
📜 Evolution of Ethical Standards in Research
This paragraph outlines the historical development of ethical standards in research, beginning with the 1946 American Military Tribunal's investigation into war crimes committed by German physicians during World War II. It highlights the establishment of the Nuremberg Code in 1947 in response to unethical medical experiments. Despite the Nuremberg Code, unethical studies continued, such as the Thalidomide birth defects incident, Henrietta Lacks's unconsented HeLa cells, and the Tuskegee syphilis study. The World Medical Association's establishment of the Good Clinical Practice guidelines in 1964 and the Belmont Report in 1979 are noted as significant milestones in creating a framework for ethical research involving human participants. These documents emphasize the importance of informed consent, risk-benefit analysis, and the ethical treatment of participants, laying the foundation for today's global principles governing research ethics.
🔬 Responsibilities and Ethical Practices in Research
This paragraph focuses on the operationalization of ethical principles in research, emphasizing the roles and responsibilities of researchers, Institutional Review Boards (IRBs), and Ethics Committees. It details the comprehensive process of research proposal evaluation, including study design, participant safety, and consent procedures, to ensure dignity, rights, and well-being are safeguarded. Highlighted is the continuous obligation of researchers to report any changes or adverse events to ethics committees, underscoring the paramount importance of participant welfare and societal benefit. The paragraph also introduces the concept of animal ethics, founded on the Three Rs principle (Replacement, Reduction, and Refinement), which mandates ethical, humane treatment of research animals, showcasing the extensive considerations researchers must undertake to maintain ethical standards throughout their studies.
Mindmap
Keywords
💡Nuremberg Code
💡Good Clinical Practice
💡Belmont Report
💡Informed Consent
💡Institutional Review Board (IRB)
💡Animal Ethics
💡Research Integrity
💡Beneficence
💡Justice
💡Three R's Principle
Highlights
In 1946, an investigation was opened by the American military tribunal for criminal proceedings against German physicians and administrators for war crimes and crimes against humanity.
Evidence of medical experiments conducted on thousands of concentration camp prisoners without their consent, leading to their serious harm.
The Nuremberg Code was established in 1947 as a result of the trial, setting standards for medical ethics.
Despite the Nuremberg Code, questionable studies continued, such as the thalidomide birth defects incident in 1950.
The case of Henrietta Lacks and her unconsented immortal HeLa cells in 1951 raised ethical concerns about informed consent.
The mistreated Tuskegee syphilis participants from 1932 to 1972 highlighted ongoing ethical issues in research.
In 1964, the World Medical Association established recommendations for biomedical research, forming the basis of Good Clinical Practice guidelines.
Research in humans should be based on laboratory and animal experimentation results, as stated in the 1964 guidelines.
Independent committee review of research protocols was recommended to ensure ethical standards.
Voluntary and informed consent, conducted by qualified individuals, and risk-benefit analysis are key ethical research principles.
The Belmont Report in 1979 summarized ethical principles and guidelines for the protection of human participants in research.
Respect for persons, autonomy, and informed consent; beneficence; and justice were outlined in the Belmont Report.
Ethics in research today is governed by globally applicable principles for interactions between researchers and participants.
Dignity, rights, safety, privacy, and well-being of participants must be respected at all times.
Institutional Review Boards or Ethics Committees oversee research ethics, consisting of medical professionals and non-medical members.
Research committees review study design, research protocol, statistical analysis plan, and informed consent documentation.
Ongoing obligation to report protocol variations and serious issues to the ethics committee is required throughout the study duration.
The welfare of participants must be maintained at all costs, and research must serve the best interests of society.
It is the researcher's responsibility to uphold ethical standards at all times during the research process.
Transcripts
in 1946
an investigation was opened by the
american military tribunal
at the end of world war ii for criminal
proceedings
against german physicians and
administrators
citing participation in war crimes
and crimes against humanity among the
charges
was evidence that medical experiments
had been conducted on
thousands of concentration camp
prisoners without their consent
and participants were seriously harmed
as a result of this trial the nuremberg
code was established in 1947
numerous questionable studies still took
place in the years following
well-known examples in history include
the thalidomide
birth defects incident in 1950
henrietta lacks his unconsented immortal
hela cells in 1951 and the mistreated
tuskegee syphilis participants from
1932 to 1972.
in 1964 the world medical association
established recommendations for
biomedical research
and this formed the basis of the good
clinical practice guidelines
we now use universally it states that
research in humans
should be based on the results of
laboratory and
animal experimentation first that
research protocols
should be reviewed by an independent
committee prior to commencement
that voluntary and informed consent is
necessary
that research should be conducted by
qualified individuals
and that the risks should not outweigh
the benefits
then the belmont report was established
in 1979
summarizing the ethical principles and
guidelines
of the commission for protection of
human participants of biomedical and
behavioral research
these were respect for persons autonomy
and informed consent beneficence
the risks must not outweigh the benefits
justice
fairness equality and equity
and research integrity so today
ethics in research refers to a set of
globally applicable principles
that govern the way any research
involving interactions
between researchers and participants is
designed managed and conducted
this includes living animals or humans
as well as their associated tissue and
data
ethical research requires the dignity
rights
safety privacy and well-being of the
participants
be respected safeguarded and considered
at
all times particularly those from
vulnerable groups
these aspects are governed by
institutional review boards or ethics
committees
which are an independent panel
consisting of medical professionals
and non-medical members that determine
if the proposed
research is ethical a research committee
is usually comprised of researchers
best positioned to evaluate utility of
research
and the rigour of the study design
veterinarians
able to comment on animal welfare
ethicists who have an understanding
of ethical principles and identifying
ethical conflicts
and members of public best position to
identify and advocate
social risks and benefits they are
involved in reviewing
and approving the study design research
protocol
which states what how and why of what
you are going to do
the statistical analysis plan
investigator brochure if
drug safety is involved testing and side
effects for new treatments
the suitability of the investigators
facilities
and the methods and materials to be used
in obtaining and documenting
informed consent they also review the
feasibility of animal numbers and
welfare
in the case of animal research human
ethics
states that you must minimize harm to
participants
all research involving people will have
a certain amount of risk
attached to it this may be negligible
low or high levels of risk
each of these categories may be assessed
differently
for example a new cancer treatment that
may have side effects
that cause a bit of harm but the
potential benefits of having a new
therapeutic
may outweigh the risk potential
participants will be given a clear
information consent form it includes
information like what their study is
about
and what is required of them recruitment
inclusion and exclusion criteria
the contact details of the researchers
for queries
privacy and confidentiality protection
information
the right to withdrawal sources of
funding
any remuneration for their time
how data will be managed and used how
findings will be fed back to the
participant
if any publications will eventuate and
the foreseeable benefits of the work
animal ethics warrants ethical humane
and responsible care and use of animals
in research
and is founded on the three hours
principle of replacement
reduction and refinement
which emphasizes considerations around
least harm
and greatest utility of research animals
throughout the duration of your study
you have an ongoing obligation to the
ethics committee
to report any variations to protocols
being used
and to seek permission for each change
every time
with an amended submission you are also
required to report any serious
issues or side effects that arise the
welfare of the participants must be
maintained at all costs
and all research conducted must be in
the best interests of society
ultimately it is the researcher's
responsibility to ensure
that ethical standards are upheld at all
times
during the research
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