Research Ethics

RESEARCH ETHICS
Prabesh Ghimire

Events
of
Historical Importance
Prabesh Ghimire, MPH 2

Nazi Human Experimentation
• Early to mid 1940s, during World War II and the Holocaust.
• Nazi human experimentation: series of medical experiments on
large numbers of prisoners, including children
• By Nazi Germany in its concentration camps
• Nazi physicians and their assistants forced prisoners into
participating in experiments.
• Typically, the experiments resulted in death, trauma,
disfigurement or permanent disability, and as such are
considered examples of medical torture.

• Series of experimentation
• Experiments on twins
• Bone, muscle, and nerve transplantation experiments
• Head injury experiments
• Freezing experiments
• Malaria experiments
• Immunization experiments
• Epidemic jaundice

• Series of experimentation
• Mustard gas experiments
• Sulfonamide experiments
• Sea water experiments
• Sterilization and fertility experiments
• Experiments with poison
• Incendiary bomb experiments
• High altitude experiments
• Blood coagulation experiments

Tuskegee Syphilis Study (1932-1972)
• Tuskegee Study of Untreated Syphilis in the Negro Male
• conducted between 1932 and 1972 by the U.S. Public Health
Service
• The purpose of this study was to observe the natural history of
untreated syphilis
• The African-American men in the study were only told they were
receiving free health care from the United States government.
• Public Health Service worked in collaboration with Tuskegee
University, a historically black college in Alabama.

• Investigators enrolled in the study a total of 600 impoverished,
African-American sharecroppers from Alabama
• Of these men, 399 had latent syphilis and 201 did not have the
disease
• The men were given free medical care, meals, and free burial
insurance for participating in the study.
• The men were told that the study was only going to last six
months, but it actually lasted 40 years

• After funding for treatment was lost, the study was continued
without informing the men that they would never be treated.
• None of the men were told that they had the disease, and none
were treated with penicillin even after the antibiotic was proven
to successfully treat syphilis.
• By 1947, penicillin had become the standard treatment for
syphilis.
• Choices available to the doctors involved in the study might
have included treating all syphilitic subjects and closing the
study, or splitting off a control group for testing with penicillin.

• The Tuskegee scientists continued the study without treating
any participants;
• they withheld penicillin and information about it from the patients.
• scientists prevented participants from accessing syphilis treatment
programs available to other residents in the area
• The victims of the study, all African American, included
• numerous men who died of syphilis, 40 wives who contracted the
disease, and 19 children born with congenital syphilis.
• Led to 1979 Belmont Report
• On May 16, 1997, President Bill Clinton formally apologized on
behalf of the United States to victims of the experiment.

Guatemala Study
• Conducted from 1946-1948
• US Sponsored medical study
• nearly 700 men and women—prisoners, soldiers, mental
patients—were intentionally infected with syphilis
• hundreds more people were exposed to other sexually transmitted
diseases as part of the study) without their knowledge or consent.
• The purpose of the study was to determine whether penicillin
could prevent, not just cure, syphilis infection.
• Some of those who became infected never received medical
treatment.

Guatemala Study
• Study took place with the cooperation of Guatemalan
government officials
• The study results were never published
• The records of the Guatemala experiments were uncovered
after the lead researcher's' death
• Findings was shared with US government officials in 2010
• Secretary of State Hillary Clinton AND Secretary of HHS issued
an apology for the STD study
• President Obama called the Guatemalan president to apologize
for the experiments

Ethics
• Greek word: "Ethos": Custom or character
• Norms of conduct that distinguish between acceptable and
unacceptable behaviour
• Deals with the dynamics of decision making concerning what is
right and wrong
• Ethics in health research deals with the conflicts of interest
across various levels

Ethical Principles on Health Research
• Nuremberg Code, 1947
• Contains 10 principles
• Helsinki Declaration (18th General Assembly of WMA), 1964
• Contains 32 principles
• Belmont Report: Ethical Principles and Guidelines for the
Protection of Human Subjects of Research 1979
• International Ethical Guidelines for Biomedical Research
involving Human Subjects (1982)
• Nepal: Ethical guidelines for Health Research (NHRC)

Four Principles of Biomedical Ethics
Given by Beauchamp and Childress
• Respect of autonomy
• non-maleficence
• beneficence, and
• justice

The Nuremberg Code,1947
• The voluntary consent of the human subject is absolutely
essential
• The experiment should be such as to yield fruitful results
• The experiment should be so designed and based on the
results of animal experimentation and a knowledge of the
natural history of the disease or other problem under study, that
the anticipated results will justify the performance of the
experiment.
• The experiment should be so conducted as to avoid all
unnecessary physical and mental suffering and injury.

The Nuremberg Code
• No experiment should be conducted, where there is an a priori
reason to believe that death or disabling injury will occur
• The degree of risk to be taken should never exceed that
determined by the humanitarian importance of the problem
to be solved by the experiment.
• Proper preparations should be made and adequate facilities
provided to protect the experimental subject against even
remote possibilities of injury, disability, or death.

The Nuremberg Code
• The experiment should be conducted only by scientifically
qualified persons.
• During the course of the experiment, the human subject should be
at liberty to bring the experiment to an end, if he has reached the
physical or mental state, where continuation of the experiment
seemed to him to be impossible
• During the course of the experiment, the scientist in charge must
be prepared to terminate the experiment at any stage, if he has
probable cause to believe, in the exercise of the good faith, superior
skill and careful judgement required of him, that a continuation of the
experiment is likely to result in injury, disability, or death to the
experimental subject.

General Ethical Principles in Health
Research
Principle of Essentiality
• Whether the research is considered to be absolutely essential
after a due consideration of the existing scientific knowledge in
the proposed area of research.
• Is research likely to benefit the humanity or environment?

Research
• Volunteerism and informed consent
• Research participants should be fully apprised of the research and the
associated risks and benefits.
• The participants should be informed of the right to abstain from the
research or withdraw consent at any time.
• In case a person is incapable of giving consent, a legally acceptable
guardian should give the informed consent.

Research
• Non-exploitation
• The participants should be fully apprised of all the possible dangers
that may arise during the research so that they can appreciate all the
physical and psychological risks.
• Each research should include an in-built mechanism for compensation
for the human participants either through insurance cover or by any
other appropriate means to cover foreseeable and unforeseeable risks,
and provide remedial action and comprehensive aftercare.

Research
• Privacy and confidentiality
• The identity and records of the participants are as far as possible kept
confidential (except when required for legal reasons).
• This is to avoid any form of hardship, discrimination or stigmatization as
a consequence of having participated in the research.

Research
• Principles of the maximization of the public interest and of
distributive justice
• The research or experiment and its subsequent application should be
conducted and used to benefit all human kind (and not just those who
are socially better off), in particular, the research participants
themselves and or the community from which they are drawn.
• Professional competence
• Research should be conducted by competent and qualified persons
who act with total integrity and impartiality and who have been made
aware of the ethical considerations to be borne in mind in respect of
such research or experiment.

Research
• Principles of accountability and transparency
• The research or experiment should be conducted in a fair, honest, impartial,
and transparent manner
• Full and complete records of the research should be retained for such
reasonable period
• Stakeholders (researchers, ERB members, regulators and sponsors) involved
in the particular research should disclose any existing Conflict of Interest
(CoI)
• Principles of public domain
• The research findings should be brought into the public domain so that its
results are generally made known through scientific and other publications.

For Further Reading
• Avasthi, A., Ghosh, A., Sarkar, S., & Grover, S. (2013). Ethics in medical research:
General principles with special reference to psychiatry research. Indian journal of
psychiatry, 55(1), 86–91. doi:10.4103/0019-5545.105525
• Cash, R., Wikler, D., Saxena, A., Capron, A. M., & World Health Organization.
(2009). Casebook on ethical issues in international health research. World Health
Organization.
• NHRC (2019). National Ethical Guidelines for Health Research in Nepal. Kathmandu
Nepal Health Research Council (NHRC) Ramshah Path, Kathmandu, Nepal.

National Ethical Guidelines
of Health Research in Nepal

1.Informed consent
• Informed consent: mandatory for study involving human
participants
• Should be voluntary, without pressure or coercion or undue
inducements
• For participants aged 18 years and above: Written consent
• For children aged >12 to <18 years: Written assent

1. Informed consent
• For children aged 7 to <12 years: written assent not required
• Obtain verbal assent in presence of the parents or legal representative
• Children <7 years: Written proxy consent from parent or legally
accepted representative

1. Informed consent
• Sufficient information to be provided:
• research procedures, their purposes, risks, discomforts, anticipated
benefits
• Statement offering opportunity to ask questions
• Right to withdraw at any time
• Information to be provided in a language that participant can
understand
• If participant not capable to comprehend, proxy consent of a
legally accepted representative should be taken

Consent in special situations
• Consent from gatekeepers
• Community consent
• Consent from vulnerable groups

2. Research among vulnerable
Populations
• Investigating team must ensure that extra efforts are in place to
protect the rights, dignity, safety and well being of vulnerable
populations
• If vulnerable people lack the ability to consent, a legally
acceptable representative must be involved in decision making
procedure.
• Privacy and confidentiality of vulnerable people.

Who are vulnerable population
• Children (<18 years)
• Elderly people (>60 years)
• Pregnant or lactating women
• Differently abled person
• Refugees, immigrants, migrant workers
• Slum dwellers
• Sex workers
• Under trial population

Who are vulnerable population
• Victims of traumatic events (abuse, natural disasters, war)
• Individual with mental illness or cognitive impairment
• Individual with a life-threatening illness or condition
• e.g. HIV, cancer) or terminally ill persons
• Disadvantaged, marginalized, tribal and indigenous communities
• including ethnic and sexual minorities (e.g. orphans, persons below poverty
line, untouchables, LGBTI)
• Individuals who are highly dependent to follow the command under a
hierarchical system
• prisoners, para-public forces such as armies, polies, students, employees

Additional safeguards for vulnerable
population
• Inclusion in the study must be justified
• No coercion, force, undue influence, threat or incentives for
participation during the investigating period
• Information about benefits, risks, and alternatives be provided in
own language
• Investigators to be careful on the potential conflict of interest
between vulnerable participant and legally acceptable
representative.

Research involving children
• Health research which can be done in adults should not be
done in children.
• Should be carried out only after taking informed consent from
their parents or legally accepted representative.

Research involving children
Research can be done in children only if
• Disease/condition is only seen in children
• Information cannot be generated by other alternative means
• Safety of drugs need to be checked among adult before
administration to children
• In case of children without immediate guardians such as street
children: approval from administrative authorities

Research among reproductive age,
pregnant and lactating women
• Not to carry research unless study is related to pregnancy and
lactation
• In some groups of women, informed consent can be challenging
because of socio-cultural reasons.
• Consider women's autonomy and local cultural practices and
requirements
• Reproductive aged women should be informed of the probable
risk to the fetus if they become pregnant during the period of
their recruitment in the clinical trials.
• In case, if women become pregnant, they should not
automatically be removed from the clinical trial study

3. Privacy and Confidentiality
• Protect the confidentiality of research based information
provided by participants
• Not publish any information or photographs disclosing
participant's identity without consent
• Sensitive information- HIV or leprosy status, mental or social
status, sexual orientation- to be protected to avoid
stigmatization
• Considerations to be taken for protection of electronic data

4. Compensation and payment
• Researchers should have made provisions to compensate
participants for harms suffered during research process
• Provisions to be made for compensation of participant's efforts
and time for research process
• Reimbursement for expenses incurred for research participation
• Travel expenses
• Loss of earning (wage compensation)
• Loss of food supplies
• Participants should not be required to pay for any research
related expenses (except routine clinical care)

4. Compensation and payment
• Participants suffering from direct psychological, physical, social,
legal or economic harm from research participation are entitled
to financial or other assistance
• Dependents are entitled to financial compensation in the event
of death

5. Qualification and competence for
research
• Principal investigator should have basic knowledge of research
methodology and research ethics.
• should have a professional competency for research execution
• A researcher should not have any pre-conceived notion
• should maintain objectivity while collecting the data.
• A researcher must have at least basic idea of data analysis
• also must be able to interpret the outputs of the analyzed data sets,
and write the research report.

6.Data collection, storage, security and
transfer
• Primary and data collection sources should be well defined
• Research should explain how data will be stored (paper or
electronic)
• Need to mention- how many years such data will be kept of use
in future
• Details of measures to be taken for securing research data to
be mentioned
• Physical security of equipment
• Digital security mechanisms
• File cabinet security process like lock and key
• Data storage and back up plan

6. Data collection, storage, security and
transfer
• For sensitive data such as
• Medical records of PLHIV, TB/leprosy/cancer etc
• Police records of people involved in accidents, alcoholism, prostitution,
criminal proceedings, drug abuse
Regulatory permission from responsible authority of relevant section is
needed
• If data is being transferred to abroad, the reason should be
clearly mentioned in the proposal

7. Biological specimen collection,
storage, security and bio-banking
• Researcher should quantify the number of biological samples
and its volume to be collected from the targeted research
participants
• Explanations required on:
• How such specimens will be stored?
• At which temperature (short and long term)?
• Researchers must apply appropriate security system like lock
and key, digital door with password, surveillance camera
• Appropriate facilities, equipment, policies and procedures for
storage should be ensured

8. Transfer of biological specimen
• Justification to be provided for the study involving transfer of
biological samples to other countries
• If researcher (Nepali student) has an opportunity to test the bio-
samples at free of cost in abroad, he/she may ask permission to
ERB for transferring such bio-samples.

Concept of IRB

Institutional Review Board (IRB)
• The Institutional Review Board (IRB): an administrative body of
an institution (particularly university/ academia/ international
organizations)
• Also called Independent ethics committee (IEC), Research
Ethics Board (REB), Institutional Review Committee (IRC)
• Established to protect the rights and welfare of human research
participants recruited to participate in research activities
conducted under the auspices of the institution with which it is
affiliated.
• In Nepal, currently there are 51 IRCs approved by NHRC

Structure of IRB/IRC
• Structure: Usually have 5-6 members (but might vary)
• Members from varying backgrounds in order to provide
complete and adequate review of human research and its
institutional, legal, scientific and social implications.
• In Nepal every IRC team is multidisciplinary, having at least one
female member and one external member not affiliated with the
institution.

Roles of IRB/IRC
• Responsibility for reviewing, prior to its initiation, all research
(whether funded or not) involving human participants.
• Ethical clearance to research proposals:
• The IRB has the authority to approve, disapprove, and require
modifications in research proposals from researchers within the
institution

Roles of IRB/IRC
IRCs in Nepal are not authorized to provide approval to the
following research proposals:
• Research proposed intended for studies at the national or
international level
• Externally sponsored/funded research (the term “externally”
indicates not only outside of the country but also outside of the
particular health care facility or institution)
• Clinical trials involving human and/or animal participants

Functions of ERB of NHRC

Ethical Review Board (ERB)
• ERB: Independent board to review scientific quality and ethical
standard of the research proposals involving human
participants.
• Formed by Nepal Health Research Council
• Includes: 7-15 members from different fields
• ERB members are non-affiliated to NHRC executive board
(except member secretary of ERB)

Roles and Functions of ERB
• Review and ensure the rights, dignity, safety and well-being of
human research participants and comply with national and
international guidelines
• provide constructive feedback with a view to approve, or disapprove
the submitted research proposal
• Monitor the research activities for ensuring that the research is
conducted according to the proposal approved by the ERB
• investigate if there is any breach/violation/deviation in approved
proposal.

• Accountable of any sort of research misconduct of the approved
proposals.
• Provide assistance and facilitate the researchers for conducting
research adhering to the ethical guidelines.
• Provide approval for accreditation of IRCs, guide them
periodically and oversee their functions and duties.
• Conduct meeting/workshop/training programs for members of
IRCs and proposal reviewers on the ethical review process.

• Oversee the health researches involving human participants
and analyze complaint(s) (if any) related to unethical conduct of
research in the country and take appropriate decisions for
actions, and
• Facilitate and provide protection to the researchers if necessary.

Research Ethics

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