Lesso Ethics in Research

n 3
In the previous lessons, you were oriented with the characteristics
of research and the research process. Aside from them, you also need to know the
importance of ethics because it will guide you in considering the ethical codes and
policies you have to follow in writing and conducting a research.

Let me remind you that ethics is a branch of knowledge that deals

with moral principles on governing a person’s behavior in the conduct of any activity.

WORDS TO REMEMBER

1. Honesty 2. Objectivity 3. Integrity 4. Care 5. Openness 6. Respect 7. Confidentiality

8. Responsibility 9. Competence 10. Legality

READ THIS

Thousands of Indians die in unethical clinical trials (Subramanian, 2018) Thousands

of Indians have died in unethical clinical trials over the past decade, even as a lawsuit
to improve regulation of these trials has dragged unresolved through the Supreme
Court for six years. Between January 2005 and November 2017, 4,967 people died
during the course of drug trials and research, according to government data obtained
by a nonprofit called Swasthya Adhikar Manch (SAM). Another 20,000 odd people
have suffered adverse reactions in such trials. Pharmaceutical companies have offered
compensation to the families of the deceased only in 187 of these cases, said Amulya
Nidhi, who founded SAM. At least 475 drugs have been tested in trials during this
time, according to Sanjay Parikh, the lawyer representing SAM in the lawsuit it filed
against the government in 2012. The trials take advantage of loopholes in rules, loose
oversight, and India’s large population of poor people who are often unaware of their
rights as trial subjects, Mr. Nidhi said. “We need a strong regulatory system, and we
need action on violators.” The number of clinical trials in India rose after 2005, when
India relaxed its testing laws. Drug companies began to recruit clinical research
outsourcing firms to conduct trials in India, where costs are drastically lower. The
annual revenue of these outsourcing firms has grown from $485 million in 2010-11 to
over $1 billion today, according to research from Frost & Sullivan, a market
consultancy. India’s regulators have been unable to keep up with this explosion of
testing. For instance, Mr. Nidhi said, an ethics committee is supposed to oversee every
trial. “At one point, in Chandigarh, there were 257 trials going on, but only one ethics
committee overseeing them,” he said. “How is that even possible?” Trials take place
under the radar as well, Mr. Parikh said, sometimes by simply paying poor subjects
around 500 rupees a day and enlisting them. The details of the trials and the data
harvested remain with the companies. “There’s no way to find this stuff out.” In 2013,
following an interim order from the Supreme Court, the government made it
mandatory for companies to seek written informed consent from each subject before a
trial, and for the process of seeking this consent to be recorded on video. In reality,
however, this rarely happens. What is more commonplace, Mr. Nidhi said, is the kind
of experience Pradeep Gehlot had. His story, as narrated to SAM, forms part of the
non-profit’s case in court. Mr. Gehlot drives an auto rickshaw in the city of Indore,
and when his father Srikrishna, a tailor, fell ill with breathlessness and chest pain, he
admitted him to a government hospital. In the hospital, Mr. Gehlot was given a sheaf
of papers to sign. They were in English, which he couldn’t read very well, but the
doctors told him that his father would be treated, free of charge, with imported drugs,
so Mr. Gehlot went ahead and signed. “Without his consent, Srikrishna was in a
clinical trial for nearly two years,” Mr. Nidhi said. “His health started deteriorating,
and he died in 2012.” When SAM heard about the case and sent a team to talk to Mr.
Gehlot, they confirmed from the documents that a trial had been conducted. After Mr.
Gehlot complained, the doctor’s medical license was suspended for three months. SAM
uncovered other cases of ethical violations in a different Indore hospital and filed
further complaints. The state government, after investigating the hospital, found that
81 “serious adverse events”—including 32 deaths—occurred during clinical trials on
more than 3,000 people. These adverse events had not previously been reported to
regulators. A third Indore hospital enlisted 1,833 children and 233 mentally ill
individuals in trials without their consent, the investigators’ report found. The report
also suggested that doctors and clinicians running these trials had frequently been
sent on trips overseas, or had been paid out of process, by pharmaceutical companies.
Punitive measures are weak, however. After its inquiry, the government imposed fines
of $100 apiece on 12 doctors for not cooperating with its investigations. Two doctors
were barred from conducting further trials for a period of six months. But Chirag
Trivedi, the president of the Indian Society for Clinical Research, a professional body
representing pharmaceutical researchers, argued that the country’s rules are actually
over-stringent, and that they have shrunk the number of ongoing trials. One
regulation, for example, calls for companies to also pay for management of all medical
problems during trials, which is unfair, he said. “There was a cardiovascular drug
trial, which is for a heart ailment, where the company had to pay for tuberculosis
treatment for nine months,” Mr. Trivedi said. “We all know that tuberculosis is caused
by bacteria, not by any drug, and not by a clinical trial for a heart ailment.” In every
case that has warranted compensation, companies have paid out, he said. Mr. Trivedi
admitted that, “as in any industry,” there were companies that indulged in unethical
trials as well. “We cannot condone any irregularities,” he said. “Whatever protects the
rights and safety of individuals, we will support such that. Every life is precious. We
can’t treat Indians as guinea pigs.” He also pointed out that clinical trials are vital to
drug development. “The medicines that help you and me—they wouldn’t be available
without trials.” The next hearing of SAM’s lawsuit in the Supreme Court has been
scheduled for December 4, but all parties to the suit have been asked to file their
suggestions for an amended law next month, Mr. Nidhi said. But the regulations
before 2005 were both sufficient and comprehensive, Mr. Nidhi said. “Bring back the
law that existed before 2005. That is what we are asking

Importance of Ethics in Research Resnik (2015), in his article, “What is Ethics in

Research & Why is it important?”, as cited by Cristobal & Cristobal (2017),
enumerates the following reasons why it is important to follow ethical principles in
writing and conducting a research: 1. It promotes the aims of research. Ethics guides
the researchers in obtaining knowledge, truth, and avoidance of error by prohibiting
fabrication, falsification and misrepresentation of research data. 2. It upholds values
that are essential to collaborative work. Many researchers who are working in different
disciplines and institutions cooperate and coordinate to accomplish a particular
research. With ethics in mind, they also maintain trust, accountability, mutual
respect, and fairness. 3. It ensures that researchers can be held accountable to the
public. Ethical norms guarantee the public that researchers are deemed responsible
for committing any form of research misconduct. 4. It builds public support for
research. People express and lend their support by all means if they can trust the
quality and integrity of research. 5. It promotes a variety of moral and social values.
Ethical principles help the researcher avoid practices that can adversely harm the
research subjects and the community. Thus, it encourages social responsibility,
human rights, animal welfare, compliance with the law, and public health and safety.
Ethical Codes and Policies for Research Cristobal & Cristobal (2017), in their book,
“Practical Research 1 for Senior High School”, lists the following ethical codes and
policies that the researcher needs to consider in conducting a study: 1. Honesty The
researcher should strive to truthfully report data in whatever form of communication
all throughout the study. 2. Objectivity The researcher should avoid being biased. The
study should not be influenced by his/her personal motives, beliefs and opinions. 3.
Integrity The researcher should establish credibility through the consistency of
his/her thought and action. He/she should act with sincerity especially on keeping
agreements. 4. Care The researcher should never neglect even the smallest detail of
the study. All information should be critically examined. Records of research activities
should be properly and securely kept. 5. Openness The researcher should be willing to
accept criticisms and new ideas for the betterment of the study. Research results and
findings should be shared to the public. 6. Respect for intellectual property The
researcher should not plagiarize. Credit should be given to who or where it is due. All
authors cited and sources used in the study should be properly acknowledged. -
Plagiarism refers to the act of illegally using another person’s ideas, works, processes,
and results. Thus, it constitutes claiming an intellectual property as one’s own that
can be penalized through Republic Act 8293 known as the Intellectual Property Code
of the Philippines. 7. Confidentiality The researcher should take steps to protect all
confidential communications or documents from being discovered by others. 8.
Responsible publication The researcher should ensure that his/her work is clear,
honest, complete, accurate, and balanced, thus avoiding wasteful and duplicate
publication. It should likewise refrain from selective, misleading, or ambiguous
reporting. 9. Responsible mentoring The researcher should teach responsible conduct
of research and share professional knowledge and skills especially to new or less-
experienced researchers. 10. Respect for colleagues The researcher should show
courtesy to his/her colleagues by treating them equally and fairly. 11. Social
responsibility The researcher should promote social good by working for the best
interests and benefits of the environment and society as a whole. 12. Non-
discrimination The researcher should not discriminate based on sex, race, ethnicity, or
any factor relating to scientific competence and integrity. Thus, research should be
open to all people or entities who will participate in research. 13. Competence The
researcher should possess necessary knowledge and skills in conducting a study.
He/she should be equipped with a sense of professionalism and expertise to ensure
competent results. 14. Legality The researcher should know and abide by relevant
laws, institutional and government policies concerning the legal conduct of research.
15. Human Subject Protection The researcher should protect human lives by
preventing and minimizing harms and risks. He/she should always uphold the human
dignity, privacy, and autonomy of human subjects to be used in the study. Rights of
Research Participants In every aspect of life, rights and responsibilities are inseparably
linked to one another. This means that both the researcher and the participant have
necessary obligations to perform as a prerequisite of their privileges in conducting
research. According to Trochim (2006), Smith (2003) and Polit (2006), the following are
some of the rights of research participants, as cited by Cristobal & Cristobal (2017): 1.
Voluntary participation The research participants must be given the privilege to
exercise their free will whether to participate or not. They have the right to refuse
involvement in the study. Thus, any person should not be forced to take part in any
research undertaking. 2. Informed consent The research participants must be
provided with sufficient information about the procedures and risks involved in the
research. It serves as an initial guide on why and how the study will be conducted.
Hence, the researcher must ensure that they fully understood and agreed upon the
study. 3. Risk of harm The research participants must be protected from any type of
harm whether it may be physical, psychological, social, or economic. The researcher
must avoid, prevent, or minimize threats especially when they are exposed and
engaged in invasive and risky procedures. 4. Confidentiality The research participants
must be assured of their privacy particularly on personal information. The researcher
must secure that all information disclosed by them will not be used without
authorized access. 5. Anonymity The research participants must remain anonymous
or unidentified throughout the study even to the researchers themselves. They have
the right to keep their identities secret as they participate especially in case-sensitive
studies.
Importance of Ethics in Research Resnik (2015), in his article, “What is Ethics in Research &
Why is it important?”, as cited by Cristobal & Cristobal (2017), enumerates the following reasons
why it is important to follow ethical principles in writing and conducting a research:

1. It promotes the aims of research. Ethics guides the researchers in obtaining knowledge,
truth, and avoidance of error by prohibiting fabrication, falsification and misrepresentation of
research data.
2. It upholds values that are essential to collaborative work. Many researchers who are working
in different disciplines and institutions cooperate and coordinate to accomplish a particular
research. With ethics in mind, they also maintain trust, accountability, mutual respect, and
fairness.
3. It ensures that researchers can be held accountable to the public. Ethical norms guarantee
the public that researchers are deemed responsible for committing any form of research
misconduct. 4. It builds public support for research. People express and lend their support by all
means if they can trust the quality and integrity of research.
5. It promotes a variety of moral and social values. Ethical principles help the researcher avoid
practices that can adversely harm the research subjects and the community. Thus, it
encourages social responsibility, human rights, animal welfare, compliance with the law, and
public health and safety.

Ethical Codes and Policies for Research Cristobal & Cristobal (2017), in their book,
“Practical Research 1 for Senior High School”, lists the following ethical codes and policies that
the researcher needs to consider in conducting a study:

1. Honesty The researcher should strive to truthfully report data in whatever form of
communication all throughout the study.

2. Objectivity The researcher should avoid being

biased. The study should not be influenced by his/her personal motives, beliefs and opinions.

3. Integrity The researcher should establish credibility through the consistency of his/her
thought and action. He/she should act with sincerity especially on keeping agreements.

4. Care The researcher should never neglect even the smallest detail of the study. All
information should be critically examined. Records of research activities should be properly and
securely kept.

5. Openness The researcher should be willing to accept criticisms and new ideas for the
betterment of the study. Research results and findings should be shared to the public.
6. Respect for intellectual property The researcher should not plagiarize. Credit should be given
to who or where it is due. All authors cited and sources used in the study should be properly
acknowledged. - Plagiarism refers to the act of illegally using another person’s ideas, works,
processes, and results. Thus, it constitutes claiming an intellectual property as one’s own that
can be penalized through Republic Act 8293 known as the Intellectual Property Code of the
Philippines.

7. Confidentiality The researcher should take steps to protect all confidential communications or
documents from being discovered by others.

8. Responsible publication The researcher should ensure that his/her work is clear, honest,
complete, accurate, and balanced, thus avoiding wasteful and duplicate publication. It should
likewise refrain from selective, misleading, or ambiguous reporting.

9. Responsible mentoring The researcher should teach responsible conduct of research and
share professional knowledge and skills especially to new or less-experienced researchers.

10. Respect for colleagues The researcher should show courtesy to his/her colleagues by
treating them equally and fairly.

11. Social responsibility The researcher should promote social good by working for the best
interests and benefits of the environment and society as a whole.

12. Non-discrimination The researcher should not discriminate based on sex, race, ethnicity, or
any factor relating to scientific competence and integrity. Thus, research should be open to all
people or entities who will participate in research.

13. Competence The researcher should possess necessary knowledge and skills in conducting
a study. He/she should be equipped with a sense of professionalism and expertise to ensure
competent results.

14. Legality The researcher should know and abide by relevant laws, institutional and
government policies concerning the legal conduct of research.

15. Human Subject Protection The researcher should protect human lives by preventing and
minimizing harms and risks. He/she should always uphold the human dignity, privacy, and
autonomy of human subjects to be used in the study. Rights of Research Participants In every
aspect of life, rights and responsibilities are inseparably linked to one another. This means that
both the researcher and the participant have necessary obligations to perform as a prerequisite
of their privileges in conducting research.

According to Trochim (2006), Smith (2003) and Polit (2006), the following are some of the
rights of research participants, as cited by Cristobal & Cristobal (2017):
1. Voluntary participation The research participants must be given the privilege to exercise their
free will whether to participate or not. They have the right to refuse involvement in the study.
Thus, any person should not be forced to take part in any research undertaking.

2. Informed consent The research participants must be provided with sufficient information
about the procedures and risks involved in the research. It serves as an initial guide on why and
how the study will be conducted. Hence, the researcher must ensure that they fully understood
and agreed upon the study.

3. Risk of harm The research participants must be protected from any type of harm whether it
may be physical, psychological, social, or economic. The researcher must avoid, prevent, or
minimize threats especially when they are exposed and engaged in invasive and risky
procedures.

4. Confidentiality The research participants must be assured of their privacy particularly on

personal information. The researcher must secure that all information disclosed by them will not
be used without authorized access.

5. Anonymity The research participants must remain anonymous or unidentified throughout the
study even to the researchers themselves. They have the right to keep their identities secret as
they participate especially in case-sensitive studies.