Ethical issues in scientific

research
 CONTENTS
- Ethical issues in scientific research

- Ethical issues in research in biotechnology

- Bioethics in Sri Lanka-Organization and

Administration
Ethical issues in scientific
research
Ethics
- Moral principles of right and wrong not absolute
- May vary by person, by time, by place
- and may be in competition with each other

Definition
Diverse set of values, norms and institutional regulations that
help constitute and regulate scientific activity

Research ethics
- Incorporating ethical principles into research practice
- May involve a balance between and within principles
and practices
- All stages, all those involved, from inception of
research through to completion and publication of results
and beyond
Some important issues related to ethical concern
in research

• Plagiarism
• Misuse of privileged information
• Data
• Authorship and other publication issues buy it
• Interference it has its Pays well
• Research with animals disadvantages
• Research with human
• Subjects
https://www.slideshare.net/sarika111/research-ethics-14166606
- Sudden death mosquitoes - Glow in the dark cats
- Spider goat - Singing mouse
- Popeye pigs - Cows producing human milk
- Glowing fish
Objectives of research ethics
To protect right and welfare of human participants

To ensure accuracy of research

To ensure that research is conducted in a way that serves

interests of individuals, groups and/or society as a whole

To examine specific research activities and projects for their

ethical soundness, protection of confidentiality and the
process of informed consent.

To protect intellectual property rights

History
- 1947- Noremberg Code - 1968- Helsinki Declaration
- 1979- Belmont Report - 1993- CIOMS
- 2005- UNESCO
UNESCO: Ethical guidelines

• Principal investigators
• Integrity of the research enterprise is maintained
• Potential benefit/harmful effects to the participants and society
• Consider the effects of his/her work, including the
consequences or misuse
• Competent fashion
• Awareness of, local customs, standards, laws and regulations
• Informed consent
• Potential participants should be informed about potentially
harmful effects
• Full confidentiality
• Participants should be offered access to research results
• Reported widely
• Acknowledged
• Preserved
 PROFESSIONAL
Reporting Credits Plagiarism Ethics in Research

DATA Gathering
Voluntary participation
Informed Consent
No Harm
PAC- Privacy, Anonymity, Confidentiality

Values
General guidelines

1. Research should be designed, reviewed and undertaken to ensure

integrity and quality.
2. Research staff and subjects/participants must be informed fully about
the purpose, methods and intended possible uses of the research, what
their participation in the research entails and what risks if any, are
involved. Exceptionally, some variation may be acceptable.
3. The confidentiality of information supplied by research subjects and the
anonymity of respondents must be respected.
4. Research participants must participate in a voluntary way, free from any
interference.
5. Harm to participants must be avoided, avoidance of harm extends to
family, kin, community groups should not be unreasonably excluded from
research exceptionally, some limited short term and minimal harm may
be acceptable.
6. The independence of the research must be clear; any conflicts of interest
or partiality must be explicit.
 Eg- Molecular diagnosis of dengue
1. Prepare a sound research proposal and form a research group
2. Obtain ethical permission
3. Obtain permission from the Health Authorities
4. Explain about the research to each patient
5. If a patient likes to participate obtain his/her written consent and
information using a questionnaire
6. Obtain clinical samples with the help of a doctor/nurse
7. Maintain confidentially of patients (number samples, maintain a data
base restricted to investigators)
8. Research data publications – Not to take others data, copy others
information without references; add all investigators
Questionnaire form Consent form
Risks in research (ESRC UK)

• In social science research risks are diverse

Not only - potential physical or psychological harm; discomfort
But also disruption or damage to
Eg-
- a subject’s rights and dignity
- a subject’s personal social standing
- individual privacy
- personal values and beliefs
- a subject’s links to family and wider community
- a subject’s occupational status or position
- implications of revealing illegal, sexual or deviant behaviour
as individuals, as whole communities, or categories of people
Ethical principles in Social Sciences

Voluntary participation (Informed consent- Components,

deception – procedures)

No harm to the subjects - Non-maleficence - Do no harm

(commission or omission) minimize harm

PAC: PRIVACY, ANONYMITY AND CONFIDENTIALITY

Beneficence - promotion of well being (maximize benefit)

Autonomy - make own decisions

Integrity
Voluntary participation

• Subjects must agree to reveal information about themselves.

• Subjects must be able to provide informed consent.

• Behavior observed in public settings is assumed to imply

agreement to being observed.

• Subjects contacted after being observed in a public setting

must be informed they were observed in a public setting.
No harm

• Subjects must be free from reasonably anticipated physical or

emotional harm.

• Subjects must be informed of the manifest content of the

information they will be asked to reveal about themselves.

• It is permissible to deceive subjects, as long as the deception

cannot be anticipated to create physical or emotional harm.
Informed consent means

• Purpose of study.
• How respondent was selected.
• Results will be used for research and [other].
• Voluntary participation in the study or any part of it.
• Respondent can keep any incentives if they withdraw
• Confidentiality of responses.
• Contact information of the researcher.
Legitimizing the risks when

• Research which is deliberately opposed to the interests of

the research subjects – E.g.
- studies of power or inequality
- aim to reveal and critique economic, political, or cultural
disadvantage
- may have negative impact on some subjects

• Research which balances short-term risks to subjects

against longer terms gains to beneficiaries
Covert research
must not be undertaken lightly or routinely – only as a last
resort but may be justified

• where it provides unique forms of evidence

• where overt observation might alter the phenomenon being

studied

• if important or significant issues are being addressed, and

matters of social significance are being discovered which
cannot be uncovered in other ways

• where there might be risks for participant or researcher

• would always require full review by R.E.C.

 Areas of academic misconduct (y are moving away from
real ethics)
1. Plagiarism –
You are using other ideas/results/process/data/things without
crediting them)
your ideas in other places in your research (self plagiarism,
Rephrasing -paraphrasing,
Obtaining lot of information and working Mosaic plagiarism),
2. Fabrication (making data) and falsification (manipulating data
and give false data to prove your objectives-change data,
remove data)
3. Non-publication of data
4. Faulty data-gathering procedures
5. Poor data storage and retention
6. Misleading authorship
7. Sneaky publication practices
Non-Publication of data

• Sometimes called “cooking data”

• Data not included in results because they don’t support the
desired outcome
• Some data are “bad” data
• Bad data should be recognized while it is being collected or
analyzed
• Outlier – unrepresentative score; a score that lies outside
of the normal scores
• How should outliers be handled?
Data gathering

• Collecting data from participants who are not complying with

requirements of the study
• Using faulty equipment
• Treating participants inappropriately
• Recording data incorrectly
• Most important and most aggravating.
• Always drop non-compliers.
• Fix broken equipment.
• Treat subjects with respect and dignity.
• Record data accurately.
• Store data in a safe and private place for 3 years.
Authorship

Misleading authorship—who should be an author?

– Technicians do not necessarily become joint authors.
– Authorship should involve only those who contribute directly.
– Discuss authorship before the project!

• Publication of the thesis or dissertation

– Should be regarded as the student’s work
– Committee chair and members may be listed as secondary
authors

• Dual publication
– A manuscript should only be published in a single journal
– What about studies which include a huge amount of data?
Research implications

• Protocol
• Undertaking study
• Interpretation
• Making recommendations
• Presenting your findings
 Ethical issues in
research in biotechnology
 INTRODUCTION
A wide variety of ethical issues are associated with
recombinant gene technology-research, product
development and commercialization.
- Man "playing the role of God"
- Manipulating nature

Ethical issues can be seen in

- Use of animals
- Biopatent and biopiracy
- Food and agriculture
- Gene therapy
- Use of stem cells
- Medical privacy & genetic discrimination
- Human cloning
24
1. USE OF ANIMALS IN RESEARCH/GMO
RELETED ACTIVITIES
Why
Animals are used to evaluate the safety and efficacy
of potential medicines, vaccines and food products
before they are given to humans and animals.

The appropriate and responsible use of animals is

therefore an indispensable part of biomedical and
agricultural research.

25
A. Human treatment of animals
To respect the animals that support our
research and for treating those animals
humanely.
 Use of animals in research
B. Judicious use of animals
Alternative methods
To reduce the number of animals used for research

To replace animal experiments with non-animal methods

when possible (eg-Biotechnology offers great promise for
further reducing use of animals in research)

To refine the use of animals in research (such as using

cell and tissue cultures and computer modeling in early
screening of the toxic potential of a substance)

27
 Use of animals in research
C. High standards of care

To maintain high standards of care for animals used in

biotechnology research.

Guidelines

Institute for Laboratory Animal Research, Commission on

Life Sciences

National Research Council (The Guide for the Care and Use
of Laboratory Animals, 7th ed.,1996)

Federation of Animal Science Societies (The Guide for the

Care and Use of Agricultural Animals in Agricultural Research
and Teaching, 1999). 28
 Use of animals in research
To house animals properly

To feed and keep in surroundings appropriate to

their species

To minimize discomfort, distress, and pain consistent

with sound scientific practices

To allow qualified persons to conduct procedures on

animals and in the husbandry and handling of the
species being studied.

29
 Use of animals in research

D. Regulatory oversight

To subject animal biotechnology research

(including products from transgenic animals) to
science-based regulatory oversight (Eg US).

To encourage increased public awareness and

understanding by raising awareness of how
biotechnology research involving animals is being
applied in
- human health
- animal health
- agriculture
- industries
- environmental areas
30
 Use of animals in research
E. Open discussion of ethical considerations

To study the ethical considerations involved in the

use of animals in biotechnology,

To openly discuss these issues with

- ethicists
- consumers
- medical professionals
- farmers
- legislators
- scientists
- opinion leaders
- other interested groups

31
 2. FOOD AND AGRICULTURE
Why
Agriculture is fundamental to the economies and
environments of the entire world. Agricultural
biotechnology is used

-To modify plants and animals to meet

consumer demand for more healthful, nutritious
foods

-To produce foods in more environmentally

sustainable ways

32
 Agriculture and foods
BIO member companies affirm and uphold the
science-based regulation and government oversight of
agricultural biotechnology by the
Food and Drug Administration
U.S. Department of Agriculture
Environmental Protection Agency

This oversight ensures the safety and quality of the

food supply and has established effective performance
standards for developing safe techniques to reduce
agricultural losses to plant disease, insect pests and
weeds.

To request public to participate in the introduction of

these new products both through an open, accessible
and accountable regulatory system and through
exercise of free market choice via market 33
mechanisms.
 Agriculture and foods

To request public to participate in the introduction

of these new products both through an open,
accessible and accountable regulatory system and
through exercise of free market choice via market
mechanisms.

To conduct increased awareness and

understanding programmes -how agricultural
biotechnology is being applied and its impact on
farming practices, the environment and biological
diversity.

34
 3. GENE THERAPY

The field of gene therapy continues to focus on

patients with severe and life-threatening diseases
who usually have few treatment options or who have
failed all available therapies.

Thousands of patients have now received somatic

cell (nonreproductive cell) gene therapies targeted
at life-threatening genetic diseases, cancer and
AIDS.

BIO recommends that any system of oversight for

gene therapy provide the agencies with safety data
while ensuring patient confidentiality and protection
of trade secrets.
35
It is important to appreciate the different between somatic cell
therapy and germ-line therapy.
∙ Somatic cell therapy means genetically altering
specific body (or somatic) cells, such as bone marrow
cells, pancreas cells, or whatever, in order to treat the
disease. This therapy may treat or cure the disease,
but any genetic changes will not be passed on their
offspring.
∙ Germ-line therapy means genetically altering those
cells (sperm cells, sperm precursor cell, ova, ova
precursor cells, zygotes or early embryos) that will
pass their genes down the "germ-line" to future
generations. Alterations to any of these cells will affect
every cell in the resulting human, and in all his or her
descendants. 36
GERM-LINE GENE THERAPY MORATORIUM
For more than a decade, the academic and industrial
research communities have observed a voluntary
moratorium on gene therapy procedures that would
affect the germ-line cells-the egg and sperm-that pass
on genetic composition.

37
 4. USE OF STEM CELLS

Researchers can now separate early, undifferentiated

stem cells from blastocysts-the 5-day-old ball of cells
that eventually develops into an embryo.

Such embryonic stem cells can differentiate into any

cell type found in the human body, and they also have
the capacity to reproduce themselves.

The ability to maintain stem cell lines in culture and

direct their development into specific cell types holds
the potential to save many lives by controlling cancer,
re-establishing function in stroke victims, curing
diabetes, regenerating damaged spinal cord or brain
tissue and successfully treating many diseases
associated with aging. 38
 5. MEDICAL PRIVACY & GENETIC
DISCRIMINATION
To respect to an individual's medical information

To avoid misuse of personal medical information

To treat patients confidentially

To safeguard patients from discriminatory misuse

To make legislation that prohibits insurers from

denying individuals insurance based on their genetic
information.

39
 6. CLONING

Cloning is a generic term for the replication in a

laboratory of genes, cells or organisms from a single
original entity.

As a result of this process, exact genetic copies of

the original gene, cell or organism can be produced.

A clone’s DNA is exactly the

same as that of the original
organism.
40
Human cloning

Human somatic cell nuclear transfer, otherwise

known (somewhat inaccurately) as creating an
embryo by “cloning,” involves.

The starvation and subsequent implantation of DNA

from specialized, non-sexual cells of one organism
(e.g., cells specialized to make that organism’s hair or
milk) into an egg whose DNA nucleus has been
removed.

The resulting egg and nucleus are shocked or

chemically treated so that the egg begins to behave
as though fertilization has occurred, resulting in the
beginning of embryonic development of a second
organism containing the entire genetic code of 41the
first organism.
 Bioethics in Sri
Lanka-Organization and
Administration
National ethics committees
Institution Committee name, year established
Sri Lanka Medical Association Ethics committee, 1992
(SLMA)

Sri Lanka Association for the Ethics committee, 1996

Advancement of Science (SLASS)

Ministry of Health National Health Research Council

National Science and Technology Study group 2000, 2003

Commission (NASTEC)

National Science Foundation (NSF) National Bioethics Committee,

2002

Sri Lanka Medical Council (SLMC) Assisted Reproductive

Technologies Guideline
Committee, 2004
Institutional ethics committees
Colombo South Teaching Hospital, 2004.

National Hospital of Sri Lanka, 2004

Sri Jayewardenepura General Hospital, 2003

Sri Lanka College of Paediatricians 2002

Lady Ridgeway Hospital for Children, 2002

Medical Research Institute, 2000

Sri Lanka Medical Association, 1999

Faculty of Dental Sciences, University of Peradeniya,

1995
Faculty of Medicine, University of Kelaniya, 1995

Faculty of Medical Sciences, University of Sri

Jayewardenepura, 1994

Postgraduate Medical Centre, Kandy 1992

Faculty of Medicine, University of Jaffna, Jaffna 1985

Faculty of Medicine, University of Ruhuna, 1984

Faculty of Medicine, University of Peradeniya, 1980

Faculty of Medicine, University of Colombo, 1981

Bioethics legislation/Guidelines

Ministry of Justice Act 1987, Human tissue

Transplantation act

National Science Foundation (NSF)

National Science and Technology Commission (NASTEC)

1. A wide variety of ethical issues are associated with recombinant
gene technology-based research, product development and
commercialization. Name ethical issues associated with these
recombinant gene technology –based activities (30 marks)
- Use of animals
- Biopatent and biopiracy
- Food and agriculture
- Gene therapy
- Use of stem cells
- Medical privacy & genetic discrimination
- Human cloning

2. Biotechnology offers great promise for further reducing use of

animals in research. Explain briefly judicious use of animals in
biotechnology research (30 marks)
- Reduce the number of animals used for research
- Replace animal experiments with non-animal methods when possible
- Refine the use of animals in research (such as using cell and tissue
cultures and computer modeling in early screening of the toxic
potential of a substance)
3. What is the Cartagena Protocol (10 marks)
An international agreement which aims to ensure the safe handling,
transport and use of GMOs that may have adverse effects on biological
diversity and human health. Sri Lanka has signed the protocol in 2000.

4. State five (05) country specific Guidelines for import of

Genetically Modified Organisms and products, Sri Lanka (30 marks)

National Focal Point - 5 marks

GMOs-Country specific Guidelines 25 marks
- Apply for an import permit National Focal Point (NFP) before importation
(4 months) by the applicant
- Forward the application to the relevant Competent Authorities (Health,
Agricultural, Veterinary, Environmental etc.) to examine assess and to
make recommendations by the NFP.
- Send back to the application the NFP by the competent authority by the
competent authority
- Send an appeal within 30 days for denied application by the applicant.
- Issue the permit in quadruplicate to the applicant by the NFP.
- Import the permitted goods by the applicant.