Research Ethics
……..a gist of the basic scientific
etiquettes.
ETHICS & RESEARCH
The word “Ethic” gives a meaning about some basic
rules that should be followed before implementing
something actually. Ethics has much to play in the
area of scientific research as the later is a long
process which takes lot of time, devotion and deals
with materials where extreme caution and care
must be taken. Research ethics provides guidelines
for the responsible conduct of research based
studies. In addition, it educates and monitors
scientists conducting research to ensure a high
ethical standard.
The atomic veterans
• During and after WWII,
American soldiers were
forced to observe nuclear
blasts within 50 miles of
ground zero.
• Thousands of these
soldiers later died of
leukemia and other rare
forms of cancer.
• Their families were
barred from suing the
federal government
•
Plutonium Study (1947)
–
Doctors injected plutonium into the leg of Elmer Allen, a 36year-old African-American railroad porter.
–
Researchers analyzed tissue sample to determine the
physiological dispersion of plutonium.
–
They wanted to determine the lingering levels of plutonium
remaining in Allen’s body from the injection 26 years earlier.
Radioactive oatmeal!
• More than 100 boys living in
an orphanage were fed
Quaker Oats with
radioactive iron and calcium
in the 1950's.
• The diet was part of an
experiment to prove that the
nutrients in Quaker oatmeal
travel throughout the body.
Cloning Fraud
• 2005: South Korean
researcher, Woo Suk
Hwang, fabricated
evidence that he had
successfully cloned
human embryos.
• The journal Science,
retracted two studies he
had published.
Outsourcing clinical trials
• The price of bringing a new drug
to market is about $1 million per
day
• Much of that cost is devoted to
human clinical trials
• western drug makers are
outsourcing safety and efficacy
studies to developing countries, a
large proportion of them to India
and Russia.
• There are currently some 400
clinical trials underway in India
Where do students learn ethical decision making?
1. Mentor, advisor
2. Fellow graduate students
3. Family
4. Friends not in graduate school
5. Other faculty
6. Religious beliefs
7. Discussions in courses, labs, seminars
8. Professional organizations
9. Courses dealing with ethical issues
J. P. Swazey, K. S. Louis, and M. S. Anderson, “The ethical training of graduate students requires serious
and continuing attention,” Chronicle of Higher Education 9 (March 1994):B1–2; J. P. Swazey, “Ethical
problems in academic research,” American Scientist 81(Nov./Dec. 1993):542–53.
ORIGIN & HISTORY OF RESEARCH ETHICS
 The birth of research ethics took place in order to save human subject
involved in research.
 The first trials, called “Nuremberg Trials were done on Nazi war criminals in
1946-47 where great torture was done with the wounded , crippled men of
war.
 Hence, to prosecute the guilty doctors, a set of ethical guidelines were
formulated which called the “Nuremberg Code” (August, 1947). This code
formed the first step that spoke of ethics in human based research.
 The Nuremberg Guidelines paved the way for the next major initiative
designed to promote responsible research with human subjects, the “Helsinki
Declaration” (June, 1964; Fourth revision: 1996) that lays out basic ethical
principles for conducting biomedical research and specifies guidelines for
research conducted either by a physician, in conjunction with medical care, or
within a clinical setting.
 Following the Helsinki Declaration, the next set of research ethics guidelines
came out in the “Belmont Report” (Issued Sept., 1978; Published: April,
1979) for the protection of Human Subjects of Biomedical and Behavioral
Research.
• Informed Consent
• African-American Slaves and Medical
Experimentation
“…blacks were particularly easy targets, given
their positions as voiceless slaves or ‘free persons
of color’ in a society sensitive to and separated by
race.” Todd L. Savitt (1982). “The Use of Blacks
for Medical Experimentation and Demonstration
in the Old South” Journal of Southern History, Vol.
48 (3):331-348.
Secret Human Experiments
•
Willowbrook Study (Early 1960s)
–
Willowbrook State School in Staten Island, NY conducted
research on vulnerable, mentally retarded children to better
understand the natural history of the highly infectious
hepatitis virus.
–
Only parents who agreed to the research were able to enroll
their children into Willowbrook.
Secret Human Experiments
•
Jewish Chronic Disease Hospital Study (1963)
–
Studies were conducted at what is now the Interfaith Hospital of
Brooklyn
–
Unwitting, unsuspecting, and unconsenting patients were
monitored by doctors to determine the body’s ability to reject
cancer cells.
–
Doctors injected live cancer cells intravenously into patients and
watched for signs of neoplasia (new growth).
–
In reaction to this study, in 1966 the FDA (Food and Drug
Administration) issued clear requirements for informed consent
in research.
Secret Human Experiments
•
The Cincinnati Project (1966)
–
The military’s aim was to determine how much radiation military
personnel could endure before becoming unable to function
effectively in combat.
–
Subjects were treated with high doses of radiation.
–
Amelia Jackson was treated with 100 rads of full-body radiation
(equivalent to 7,500 chest X-rays) and was never able to care for
herself after the treatment.
Research with human subjects
• With research involving
human subjects the risks
and costs must be balanced
against the potential
benefits
• Trivial or repetitive research
is may be unethical where
the subjects are at risk
After years of experimentation the
scientist proved that children
become addicted to nicotine
15
Autonomy
• The ethical principle of
autonomy means that each
person should be given the
respect, time, and
opportunity necessary to
make his or her own
decisions.
• Prospective participants
must be given the
information they will need
to decide to enter a study or
not to participate.
• There should not be
pressure to participate.
16
Vulnerable participants
• Potentially vulnerable participants such
as children, the elderly, the mentally ill
may be incapable of understanding
information that would enable them to
make an informed decision about study
participation.
• Consequently, careful consideration of
their situation and needs is required,
and extra care must be taken to protect
them.
• For example, how will you assess the
diminished capacity of an elderly
individual, who will be the guardian, and
how and when will you involve another
individual as guardian in the process?
17
The process of obtaining consent
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Identify participant population
Produce information sheet and consent document
Obtain permission from school’s ethics committee
Present research information to participant and discuss
its contents – indicating that withdrawal at any time is
possible
Answer participants questions
Give a copy of the consent document
Allow the participant time to consider
Meet participant and discuss documents, to answer any
more questions and assess participants understanding
Obtain appropriate signed consent
Start research
18
The participants
• The participants may not have
the experience or educational
background in order to fully
understand the implications of
the research
• They may be swayed because of
their respect of and trust in the
researcher who stands as an
authority figure
• If they are being paid for their
participation they may be
swayed by economic
considerations from a free
judgement of the risks
19
Peer pressure
• The participants
may be subject to
social pressure of
their peer group
• This is particularly
prevalent in
research groups
20
Assessing Participant Understanding
An important part of the process is for
the researcher to ensure that the
prospective participants understands
the research, their role in it, and any
risks they may be taking.
During discussion the use of open-ended
and nondirective questions (i.e. those
that begin with words such as "what,"
"where," "how often," "when," and
"please describe.“) is most effective at
doing this .
21
Contact Information
Give the names of people who can
answer questions about the research;
include the principal investigator.
If the researcher is a student, include
the names and phone numbers of
the principal investigator and, where
applicable, the chair of the school
ethical committee for questions.
Furnish the contact name of a neutral
third party who can explain the rights
of research participants if the
participant has any questions.
22
Withdrawal
• Always stress the fact that participation
is voluntary and that the participant
can withdraw at any time
• State that refusing to participate will
involve no penalty or decrease in
benefits to which the participant is
otherwise entitled.
• Emphasize that the individual may
discontinue participation at any time
without penalty or loss of benefits.
• If there are limitations or risks involved
in withdrawal, such as a danger to the
participant's well being, these must
also be clearly explained.
23
Ethical problems may arise
The requirements of effective
research sometimes conflict
with the simple fulfillment
of the obligation to obtain
informed consent.
For example
• in psychological research
information and foreknowledge may bias the
results
24
Reasons for limiting information
• The most common reason for
limiting information is that valid
data could not be obtained if the
participants were fully informed
about the purposes and procedures
of the research.
• Methodological requirements of the
research may demand that the
participants remain unaware of the
specific hypotheses under
investigation.
• In other situations, incomplete
information or misinformation may
have to be provided to elicit the
behavior of a naive individual or to
create psychological reality under
conditions that permit valid
inference.
25
Deception or concealment
Fully informed consent cannot be obtained in
some kinds of research without the possibility
that the results may be biased
In those circumstances where a methodological
requirement may necessitates the use of
concealment or deception, the researcher has
a special responsibility
1. to determine whether the use of such
techniques is justified by the study's
prospective scientific, educational, or applied
value
2. whether alternative procedures are available
that do not use concealment or deception
3. that the participants are provided with
sufficient explanation as soon as possible.
These issues should be explored before
undertaking the research with colleagues,
supervisor(s) and the school/departmental
ethics committee.
26
Risk assessment
Research is by nature uncertain.
• The researcher may not be
fully aware of the possible
hazards involved in the
proposed research.
• For example in the early stages
of the development of new
drugs their long term effects
may not be known.
• In these circumstances the
participant may not be fully
informed of potential risks.
27
The perception of risk is central to informed
consent
Perceived through investigation
e.g. in science by experiment and observation
RISK
Perceived directly by
the participant’s own
senses or experience
e.g. such as driving a car
Virtual risk
that is not known or
cannot be known,
or where there are
different opinions
A participant in research will probably not have the experience to
perceive the risk directly and may be confused by mixed messages
of virtual risk and so rely on the researcher’s understanding of risk
28
Consent
Form
• Might take
the following
form
I have read the Information Sheet and have had the
details of the study explained to me. My questions
have been answered to my satisfaction, and I may ask
further questions at any time.
I understand I have the right to withdraw from the
study at any time and decline to answer any particular
questions.
I agree to provide information to the researcher(s) on
the understanding that my name will not be used
without my permission.
I agree/do not agree to the interview being recorded
electronically.
I understand that I have the right to ask for the tape to
be turned off at any time during the interview
I agree to participate in this study under the conditions
set out in the information sheet
Signature – Name - Date
29
Research Publication and Ethics
Scientific Knowledge
The object of research is to extend human
knowledge beyond what is already known.
But an individual’s knowledge enters the
domain of science only after it is presented to
others in such a fashion that they can
independently judge its validity.
(NAP, “On Being a Scientist” 1995)
Three sets of obligations of a researchers to
adhere to professional standards.
1. An obligation to honour the trust that their
colleagues place in them.
2. An obligation to themselves. Irresponsible conduct
in research can make it impossible to achieve a goal.
3. An obligation to act in ways that serve the public.
On Being Scientist
http://www.nap.edu/catalog/12192.html
Available free for one download
Sharing Scientific Knowledge
“Science is a shared knowledge based on a common
understanding of some aspect of the physical or social
world”
Presentations
-Social conventions play an important role in establishing the
reliability of scientific knowledge
Publications in peer reviewed journals
-Research results are privileged until they are published
Thesis
(NAP, “On Being a Scientist” 1995)
Why Publish?
• “A paper is an organized description of
hypotheses, data and conclusions, intended to
instruct the reader. If your research does not
generate papers, it might just as well not have
been done” (G. Whitesides, Adv. Mater., 2004,
16, 1375)
• “if it wasn’t published, it wasn’t done” - in
(E.H. Miller 1993)
Research with human subjects
Research with animals
Research misconduct
Data management
Conflicts of interest
Peer review
Plagiarism
Authorship
BASIC ISSUES IN RESEARCH ETHICS
The following drawing shows the basic research ethics issues.
RESEARCH ETHICS
1. Authorship
It is the process of deciding whose names belong on a research paper.
Basic guidelines:
• Each person listed as an author on an article should have significantly contributed
to both the research and writing. The list of authors establishes accountability as
well as credit.
• Policies at most scientific journals state that a person should be listed as the
author of a paper only if that person made a direct and substantial intellectual
contribution to the design of the research, the interpretation of the data, or the
drafting of the paper.
• All listed authors must be prepared to accept full responsibility for the content of
the research article.
• Colleagues who helped in the research indirectly must not be treated as authors
rather their names should be acknowledged at the end of the paper.
• All the contributing co-authors of an article must jointly decide the order of the
listing of names. The first person listed should be the person most closely involved
with the research.
Including “honorary,” “guest,” or “gift”
authors dilutes the credit due the
people who actually did the work,
inflates the credentials of the added
authors, and makes the proper
attribution of credit more difficult.
(“On Being a Scientist” , NAP)
Great Manuscript!
But LAB CHIEF
always gets listed
as FIRST author!
What is publishable….
Journals like to publish papers that are going to be
widely read and useful to the readers
• Papers that report “original and significant” findings
that are likely to be of interest to a broad spectrum of its
readers
• Papers that are well organized and well written, with
clear statements regarding how the findings relate to and
advance the understanding/development of the subject
• Papers that are concise and yet complete in their
presentation of the findings
What is not acceptable…
• Papers that are routine extensions of previous reports
and that do not appreciably advance fundamental
understanding or knowledge in the area
• Incremental / fragmentary reports of research results
• Verbose, poorly organized, papers cluttered with
unnecessary or poor quality illustrations
• Violations of ethical guidelines, including plagiarism of
any type or degree (of others or of oneself) and questionable
research practices (QRP)
2. Plagiarism
It is the act of passing off somebody else’s ideas, thoughts, pictures,
theories, words, or stories as your own. If a researcher plagiarizes the
work of others, they are bringing into question the integrity, ethics, and
trustworthiness of the sum total of his or her research.
Basic guidelines:
A researcher preparing a written manuscript should cite the original
source if he or she:
 “Quotes another person’s actual words, either oral or written;
 Paraphrases another person’s words, either oral or written;
 Uses another person’s idea, opinion, or theory; or
• Borrows facts, statistics, or other illustrative material, unless the
information is common knowledge.
3. Peer review
It is the process in which an author (or authors) submits a written manuscript
or article to a journal for publication and the journal editor distributes the
article to experts working in the same, or similar, scientific discipline.
Basic guidelines:
 Reviewers should not know the author (or authors) they are reviewing, and
the author (or authors) should not be told the names of the reviewers.
 No person involved in the peer review process – either the editor, reviewers,
or other journal staff – can publicly disclose the information in the article or
use the information in a submitted article for personal gain.
 Peer reviewers, in addition to maintaining confidentiality, can be neither
conflicted nor political in their review.
 Peer reviewers should disclose all conflicts of interest that may unduly
influence their review to the journal editor and disqualify themselves when
appropriate.
 All submitting authors and readers should be fully aware of a journal’s process
of peer review.
 Editors must not relinquish too many of their own responsibilities to peer
reviewers.
 Editors should have full and complete freedom over the content of a published journal.
4.Conflicts of interest
Conflicts of interest arise when a person’s (or an organization’s) obligations to a
particular research project conflict with their personal interests or obligations. A
researcher should attempt to identify potential conflicts of interest in order to
confront those issues before they have a chance to do harm or damage.
Basic guidelines:
According to the “Objectivity in Research NIH Guide,” an investigator should:
• Disclose to their institution any major or significant financial conflicts of interest
that might interfere with their ability to conduct a research project objectively.
• Disclose any such financial conflicts of interest of their spouses or dependent
children
5. Data management
Data management, in respect to research ethics, references three issues:
• The ethical and truthful collection of reliable data;
• the ownership and responsibility of collected data; &
• retaining data and sharing access to collected data with colleagues and the public.
Basic guidelines:
Researchers must accurately identify answers to the following questions to resolve
and address all data management issues in a timely manner:
 Who is in charge of the data?
 How will data be collected?
• How will data be stored and what privacy and protection issues will result from
the method of storage?
• Who will ensure that no data were excluded from the final results and ensure
accuracy of result interpretation?
• How long after the project is over will data be kept?
6.Research misconduct
Research misconduct is defined as fabrication, falsification, or plagiarism in
proposing, performing, or reviewing research, or in reporting research results. It is
the process of identifying and reporting unethical or unsound research.
Basic guidelines:
 A person suspecting a scientist of research misconduct should report the incident
to a research integrity officer who should immediately look into the allegation to
assess if it is both: a)research misconduct; and b) within the jurisdiction of the
research institution.
 The person who informs the research integrity officer of suspected misconduct
(the whistleblower) should be treated with “fairness and respect” by the
research institution and efforts should be made to protect their job and
reputation as necessary.
 The person suspected of research misconduct (the respondent) should be
protected and treated with “fairness and respect” by the research institution.
 The research integrity officer should strive to maintain the confidentiality of both
the whistleblower and the respondent.
 If the misconduct issue is a criminal one the research integrity officer should
report the misconduct allegations to the proper authorities or agencies.
Oneway ANOVA
• Analysis of variance is used to test for differences among
more than two populations. It can be viewed as an extension
of the t-test we used for testing two population means.
• The specific analysis of variance test that we will study is often
referred to as the oneway ANOVA. ANOVA is an acronym for
ANalysis Of VAriance. The adjective oneway means that there
is a single variable that defines group membership (called a
factor). Comparisons of means using more than one variable
is possible with other kinds of ANOVA analysis.
Why Not Use Multiple T-tests
• It might seem logical to use multiple t-tests if we wanted to
compare a variable for more than two groups. For example,
if we had three groups, we might do three t-tests: group 1
versus group 2, group 1 versus group 3, and group 2 versus
group3.
• However, doing three hypothesis tests to compare groups
changes the probability that we are making an error (the
alpha error rate). When conducting multiple tests of
significance, the chance of making at least one alpha error
over the series of tests is greater than the selected alpha
level for each individual test. Thus, if we do multiple t-tests
on the same variables with an alpha level of 0.05, the
chances that we are making a mistake in applying our
findings to the population is actually greater than 0.05.
Logic of Analysis of Variance
• The logic of the analysis of variance test is the same as the
logic for the test of two population means.
• In both tests, we are comparing the differences among
group means to a measure of dispersion for the sampling
distribution.
• In ANOVA, differences of group means is computed as the
difference for each group mean from the mean for all
subjects regardless of group. The measure of dispersion for
the sampling distribution is a combination of the dispersion
within each of the groups.
Data Sheet
Control
32
34
31
Mean
32
S.Dev
1.50
Arrangement for ANOVA
Treatment Observation
Control-1
32
Control-2
34
Control-3
31
T2R1
34
T2R2
34
T2R3
33
T3R1
33
T3R2
33
T3R3
33
T4R1
33
T4R2
32
T1
34
34
33
Mean S.Dev T2 Mean S.Dev
34
0.42 33
33
0.38
33
33
T3 Mean S.Dev
33
32
0.25
32
32
T4 Mean S.Dev
35 35
0.38
35
34