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Dr Nehal S. Sawvad

Research ethics in Medicine

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Page 1: Research ethics in Medicine

Dr Nehal S. Sawvad

Page 2: Research ethics in Medicine

"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."

Page 3: Research ethics in Medicine

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

Page 4: Research ethics in Medicine

“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."

Page 5: Research ethics in Medicine

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.

Page 6: Research ethics in Medicine

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.

Page 7: Research ethics in Medicine

Tell participants who is conducting study

Why was subject singled out for participation?e.g. random samplee.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

Page 8: Research ethics in Medicine

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).

Page 9: Research ethics in Medicine

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.

Page 10: Research ethics in Medicine

The role of the IRB is to protect the rights and welfare ofindividual research subjects. This is accomplished byhaving the IRB assure that the following requirementsare 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,

Page 11: Research ethics in Medicine

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?

Page 12: Research ethics in Medicine

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?

Page 13: Research ethics in Medicine

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?

Page 14: Research ethics in Medicine

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.

Page 15: Research ethics in Medicine

One should not cheat, falsify data etc.

One should not plagiarize.

Page 16: Research ethics in Medicine

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.

Page 17: Research ethics in Medicine

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.

Page 18: Research ethics in Medicine

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.

Page 19: Research ethics in Medicine

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.

Page 20: Research ethics in Medicine

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.

Page 21: Research ethics in Medicine

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.

Page 22: Research ethics in Medicine

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