The essential components of a research that is undertaken in the field of Medicine as well as the protocol that should be followed while undertaking a research project is highlighted.

1. Dr Nehal S.
Sawvad

2. "a systematic investigation, including research development,
testing and evaluation, designed to develop or contribute to
generalizable knowledge.... (S)ome demonstration and
service programs may include research activities."

3. Ethical Principles in Research
 Autonomy: Do not use people as a means to an end
Allow people to make choices for themselves
 Beneficence: Maximize benefits and minimize harms
 Non-malfeasance: Doctor’s attempt to avoid any act or
research plan that would harm the patient or violate the
patient’s trust
 Confidentiality: maintaining the privacy of patient
information, research plan and the outcome of the research.
 Justice: Equitable distribution of research risks and benefits

4. “Beginning in the 1930s, 399 men signed up with the
U.S. Public Health Service for free medical care. The
service was conducting a study on the effects of
syphilis on the human body. The men were never told
they had syphilis. They were told they had "bad blood"
and were denied access to treatment, even for years
after penicillin came into use in 1947. By the time the
study was exposed in 1972, 28 men had died of
syphilis, 100 others were dead of related
complications, at least 40 wives had been infected and
19 children had contracted the disease at birth."

5.  Nazis
The need for regulation and codes of behavior emerged from
revelations of the research atrocities committed by the Nazis.
 Nuremberg Code
This 1947 code for biomedical research was the first to focus
on the importance of informed consent.
 Helsinki Declaration
This 1964 declaration provided guidance in such areas as the
use of animals for research purposes.
Of course, while it’s essential to have codes, the
responsibility for ethical research ultimately lies with the
individual researcher.

6.  No Pressure: Never any pressuring of participants.
 Safety: Safety of participants essential.
 Credit: Every researcher must receive precise,
appropriate credit.
 Communicate: One should try to make results known
to participants.
 Ill Usage of Research: One should be conscious of
possible bad uses of research.

7.  Tell participants who is conducting study
 Why was subject singled out for participation?
e.g. random sample
e.g. recently given birth to 1st child etc.
 What is the time commitment?
e.g. 45 minutes to complete the survey
 Any benefits for the participant to be expected?
Realistically, there are often few direct benefits.
 Any potential risks, and how have these been managed?
 Explain the study and offer to answer questions

8. Participation is always voluntary.
Provide participants with copy of informed consent form (if
relevant).
Confidentiality
(Anonymity, on the other hand, means that no one, including
the researcher, will know the subject’s identity).

9.  Fake an assault in the street to gauge reaction of bystanders
– e.g. who will intervene and who will do nothing.
 Element of surprise is essential.
 Problem with the preceding:
- witnessing such an attack may be very disturbing to some.
- Those who do not intervene may be upset and suffer
feelings of low worth.
- Those who do intervene may be injured.
 Debriefing is mandatory.

10. The role of the IRB is to protect the rights and welfare of
individual research subjects. This is accomplished by
having the IRB assure that the following requirements
are satisfied:
1. risk to subjects are minimized
2. risk to subjects are reasonable in relation to anticipated
benefits,
3. selection of subjects is equitable, i.e. fair
4. informed consent is sought form each subject or his/her
legally authorized representative,

11.  About the Investigator
 Who is the primary investigator, and who is supervising the
study?
 About Research Participants
 What are general characteristics of participants (e.g. age, sex
etc.)?
 Any special characteristics of participants (e.g. children,
alcoholics, mentally retarded etc.)?
 Any other institutions/individuals cooperating/cosponsoring
the study?
 What is general state of health (mental and physical) of the
participants?
 How will subjects be selected for, or excluded from,
participation in this study?

12.  Procedure:
 What will the subjects be asked to do, or what behaviors
will be observed by the researchers?
 Will deception be used? If yes, why is it necessary?
 What is nature of the deception, and when will the
debriefing take place?
 Material:
 E.g., if electrical or mechanical equipment will be used, how
has it been checked for safety?

13.  Risks
 Any immediate risks to the subjects, including
possibly causing them embarrassment,
inconvenience, or discomfort?
 Are there any long-range risks to the subjects?
 If there are risks, what is the necessity for them,
and how will subjects be compensated for facing
such risks?

14.  E.g.: a project involving interviewing of women who’ve been
raped.
 Obviously consent must be obtained.
 They’re free to withdraw at any time.
 Perhaps have psychological counseling available in case of
distress.

15.  One should not cheat, falsify data etc.
 One should not plagiarize.

16.  Plagiarism is taking another’s work and passing it off as your own.
 In a broad sense we are all guilty of plagiarism many times each
day. We often take ideas from others and don’t attribute them to
their original source.
 More often than not we don’t even know the original source!
 When we talk about the decline and fall of the Roman Empire or
say, “To be or not to be, that is the question” in normal
conversation, we rarely attribute the words to Gibbon and
Shakespeare respectively.

17.  True plagiarism is, quite bluntly, stealing.
 Sometimes a person just copies text word for word from a
book or article and pretends that he is the author.
 Or buys an already written paper on the web.
 These are quite deliberate aims to deceive.

18.  Make sure that you write it precisely, word-for-word as
in the original.
 Also essential that you enclose the quoted text in
quotation marks.
 Failing to put someone else’s direct text in quotation
marks and crediting the author, may lead to accusations
of plagiarism.

19.  One should always provide references for any
 statistics
 graphs
 tables
 numbers, etc. that one wishes to use in one's own paper.
 It’s often preferable to take down the substance of an author’s
idea in your own words, i.e. to paraphrase.
 The greater part of your paper should be in your own words
with appropriate documentation of the ideas of others.
 Of course, some direct quotation is fine – but always with
citation.

20.  Many instances of plagiarism stem from sloppy research rather
than through a deliberate desire to cheat.
 Many students during the research process take bad notes, e.g.
they write down someone else’s text verbatim but forget to
include the quotation marks.
 Later when they are writing the actual paper and they refer to
their notes, they fail to remember that the text is another author’s
and not their own.
 A reader who recognizes the original text might think that the
student has cheated. And this may lead to tough penalties.
 So, the golden rule is to take excellent notes, write your whole
paper yourself and to document your sources as well and as
honestly as possible.

21.  It is not necessary to document every single statement.
 One need not give a reference for stating that President
John F. Kennedy was assassinated in 1963.
 This fact is common knowledge and belongs in the public
domain.
 However, if you are referring to Historian X’s thesis that
Kennedy was killed by a crime syndicate and not by Lee
Harvey Oswald, proper citation to such a theory is
requisite.

22. Results of research studies should be reported in a honest,
accurate manner
 Researchers cannot “massage” data to fit their hypotheses
 Researchers cannot make up or report false results
 Researcher must report what they find, even if the data
does not support their initial hypotheses
 Researchers should ensure that data is being collected
consistently (do checks of research assistants)
 Researchers should give the proper credit (authorship) to
those who have earned it