ETHICS-IN-RESEARCH_20240303_181027_0000.pdf

Ethics in research

1. ETHICS IN
RESEARCH
GROUP 3

2. INTRODUCTION
In this presentation, we examine
ethical challenges using the Golden
Rice case. We explore global ethical
principles, legal frameworks, and
implications for research governance.
Through this analysis, we aim to
underscore the importance of ethical
conduct in research involving
vulnerable populations.

3. BACKGROUND
The globalization of clinical research has surged in recent years, with a significant rise in
trials conducted outside the US and Western Europe. Emerging countries, including Eastern
Europe and Russia, have become key locations for industry-sponsored trials.
Factors driving this trend include cost savings, faster testing timelines, and easier
navigation of regulatory barriers. However, concerns arise regarding potential ethical
double standards, with trials rejected in Western Europe being approved in countries like
India and China.
These trends highlight the need for thorough examination of ethical issues in clinical
research, particularly in emerging economies.

4. WORLDWIDE ETHICAL PRINCIPLES
Research with people follows principles of respect, fairness, and dignity, in addition to
doing no harm and promoting good. These principles ensure people can choose to
participate or not, access research fairly, and be treated with dignity.
The Declaration of Helsinki guides medical research ethics worldwide, focusing on the
well-being of participants, especially patients. It emphasizes the importance of health
and safety in research.
CIOMS created guidelines in 1982 for biomedical research ethics. They protect
vulnerable groups and address research in developing countries.
UNESCO's Declaration on Bioethics and Human Rights echoes these principles,
considering cultural differences. It emphasizes human dignity and rights.

5. WORLDWIDE ETHICAL PRINCIPLES
Children are vulnerable in research and need protection. The Declaration acknowledges
their inability to consent. Children's agreement, along with parental consent, is
necessary, and their refusal respected.
CIOMS and the Declaration outline protections for vulnerable subjects, needing special
justification for their involvement in research. Research should benefit them and be
ethically conducted.
Consent procedures are similar in the Declaration and CIOMS Guidelines, requiring legal
consent from a representative if the person can't consent themselves.
Research to improve health should minimize risks, especially for vulnerable
populations. Waiving consent needs approval from an ethical review committee.

6. LAWS IN SPECIFIC REGIONS
This section explores legal frameworks regulating research involving human subjects
across different countries and regions.
A. U.S. Laws and Procedures for Research Conducted Abroad
It explains why U.S. laws apply to research conducted outside the country, citing
funding from U.S. government agencies, involvement of U.S. investigators, and
compliance with U.S. market requirements.
U.S. laws cover research funded by U.S. agencies and involving U.S. investigators,
regardless of location. Many U.S. universities follow federal regulations for research,
irrespective of funding sources. The FDA enforces regulations for drug approval
globally.

7. LAWS IN SPECIFIC REGIONS
B. European Guidelines and Regulations
European countries adhere to the Declaration of Helsinki and CIOMS Guidelines. The
Oviedo Convention underscores human rights in biomedical research. Specific
protocols address research involving individuals unable to consent, including minors.
Directive 2001/20/EC prevents unethical clinical trials. Recent updates extend
standards to trials outside the EU, ensuring ethical compliance for marketing
authorization applications. Regulatory efforts aim to prevent unethical practices,
particularly in developing countries, with initiatives in Sub-Saharan Africa striving for
international standards in clinical trials.

8. GOLDEN
RICE CASE

9. GOLDEN RICE CASE
It was presented as preventive treatment for vitamin a deficiency the study was from the
U. S. National Institute of Health, The study was approved by Zhejiang academy of medical
sciences and Tufts university which was also the sponsor
By 2018 they’ve gone to Hunan, China to conduct the study the Chinese centers for disease
controls and prevention and National Academy of Medical sciences in Zhejiang province
met and signed an agreement with local authorities in Hunan regarding the study
However use of golden rice was not clearly mentioned nor did people at Zhejiang academy
seek ethical approval for the trial in Hunan
FACTUAL BACKGROUND

10. GOLDEN RICE CASE
The Experiment still continued, 68 children participated in the parents met with the
researchers about the study but they were not informed of the use of golden rice, They
were only told that the rice had beta carotene but not that it was genetically modified or
that it was gold rice
In September 2012 the research established the results of the study in an article titled
"American Journal of Clinical nNutrition". Shortly after publication, greenpace china, a
non-profit organization, criticized the study for its experimentation of the effects of
transgenic or genetically modified rice on children
FACTUAL BACKGROUND

11. GOLDEN RICE CASE
And as a result officials asked the academy of medical sciences in zhejiang to investigate
these events which lead to the chinese centers for disease control and prevention
suspended one of these artists for inconsistencies in his story
Ultimately the authorities of hunan offered financial compensation to the participants,
¥80,000 to the 25 children who ate the rice and ¥10,000 per person for the others
FACTUAL BACKGROUND

12. GOLDEN RICE CASE
At least 4 categories of factual disputes arose
Facts about the process for approval of he research
China's Center for disease control and prevention stated that one of the
researchers had faked the documents for approval
Facts about informed consent of the parent's
Parent's did not know that the children were eating genetically modified rice
and were not informed of the risks of genetically modified food
DISPUTES ABOUT ISSUES OF
FACT

13. GOLDEN RICE CASE
Facts about the amount of golden rice eaten by the children
The study was said to have gone on for 3 weeks but investigation Iater
revealed that the children ate golden rice just once during the study
Facts about the role of the Chinese researchers.
2 of the researchers whose names are in the published article denied
involvement in the study
DISPUTES ABOUT ISSUES OF
FACT

14. ANALYSIS OF ETHICAL ISSUES
IN GOLDEN RICE CASE

15. ANALYSIS OF ETHICAL ISSUES
IN GOLDEN RICE CASE
The study recruitment processes and protocol were approved by Tufts Medical
Center and Zhejiang Academy of Med Sci.
We infer from the article that the ethical review process took place in 2003.122
That was five years before the beginning of the study and took place in a
different province of China, which is a serious concern.123 Moreover, there
was no specific information about the members of the ethics committees,
except for the brief sentence noted above. 124 Who were the members of the
ethics committee? Was there a specialist in pediatrics and a representative of
the parents?
PROCESS FOR APPROVAL

16. ANALYSIS OF ETHICAL ISSUES
IN GOLDEN RICE CASE
The parents were scared of the risks of genetically modified organisms and
there was also discourse about the amount of golden rice fed to the children
The inconsistencies in the golden rice allocation were clear, A researcher
explained in a news report "either they are lying about this now or they lied
about this in the paper its a serious offence either way"
In addition, the study's purpose was to determine the vit. A value from foods
like spinach, golden rice, and pure beta carotene oil. This means there were no
direct benefit for the children involved in the research
RISKS AND BENEFITS

17. ANALYSIS OF ETHICAL ISSUES
IN GOLDEN RICE CASE
As discussed, Although the parents have given their consent, they were not
made aware that the children would be eating genetically-modified rice and
were not informed of the dangers of genetically modified food
the duty of autonomy (the right to make informed choices about participating
in research) should not be overshadowed by the potential benefits of the
research. It concludes that conducting research without proper consent is
unethical, not only because it violates individual rights but also because of the
broader consequences it can have beyond just the participants and their
families.
INFORMED CONSENT

18. The "Golden Rice" study offers valuable
lessons for Chinese lawmakers regarding
the type of research that should allow
minors to participate. Currently, Chinese law
does not specifically restrict or prohibit
research on minors, but it requires informed
consent from legal guardians and assent
from minors themselves. However, due to
information imbalances and lack of medical
knowledge, informed consent is not always
sufficient to guarantee minors' rights and
interests.
RECOMMENDATIONS FOR REFORM:
LESSONS FROM GOLDEN RICE STUDY

19. RECOMMENDATIONS FOR REFORM:
LESSONS FROM GOLDEN RICE STUDY
The Additional Protocol to the Oviedo Convention
distinguishes between two categories of research
based on the potential to produce real and direct
benefit to the potential minor participant. The
research must have minimal risk and burden for the
individual concerned. The Chinese law should adopt a
similar mechanism of classification, dividing clinical
trials into therapeutic and non-therapeutic research,
invasive research, and observational research.
Therapeutic research should be allowed with
informed consent from guardians and assent from
minors. Long-term invasive research should have
justification of purpose and minimal risk acceptance.

20. CONCLUSION
In conclusion, tha Golden Rice highlights the critical need for oversight and ethical
considerations in research, particularly in emerging countries. It highlights the
importance of actively implementing mechanisms to prevent potential ethical errors
and ensuring comprehensive supervision, regardless of location. Moreover, the case
demonstrates the limitations of simply relying on Institutional Review Board approvals,
as conflicts of interest or a lack of independent judgment may compromise ethical
review processes. It is important for lawmakers worldwide to learn from the lessons of
cases like Golden Rice. By studying both the success and failures, we can clarify our
approaches to ethical review, protecting research subjects while upholding the
integrity of the research. This collaborative learning and adaptation of frameworks are
essential for promoting global research that prioritizes ethics and integrity

21. THANK YOU
FOR
LISTENING