This PPT describes various ethical issues in medical reseearch

1. Ethics in Health & Biomedical Research
Dr.CH.Padmavathy
Senior Resident
Dept. of Community Medicine
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2. In Medical profession
oldest prescribed practical guidelines of ethics are in
Charaka samhitha and Susrutha samhitha.
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3. Why this concept?
• Nazi experimentation during World War II was forceful,
without consent of the participants, and collected data that
involved the unnecessary and willful harm of human subjects.
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4. Code of conduct in research
 Development of the Nuremberg Code in 1947
 Helsinki Declaration in 1964.
 Belmont report .
 CIOMS-The Council of International Organizations of
Medical Sciences.
 International Council on Harmonization- ICH.
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5. Purpose of these guidelines
To ensure highest professional and ethical standards
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6. • Any research involving human subjects should follow
international standards of ethics.
• Indian national standards were developed by ICMR
ICMR guide lines are the gold standard ethical guidelines for
India which were based on international standards.
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7. ICMR POLICY
Applies to All
• ICMR scientific/technical staff and students involved in
research at ICMR Headquarters or at ICMR Research
Institutions,
• Centers or field units across the country.
• (irrespective of source of funding).
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8. All stakeholders
• Researchers,
• Institutions,
• Scientific review committees
• and Ethics committees
involved in the conduct, review or reporting of research..
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9. Research Integrity Unit (RIU)
RIU at ICMR Headquarters, New Delhi would facilitate and guide
research integrity.
Through a designated Research Integrity Officer (RIO) at
Institutional/ Divisional level.
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10. ICMR Bioethics Unit (IBU)
• Unit will be responsible for development and timely updation
of policy on research integrity, misconduct and publication
ethics.
• Research Integrity Officer (RIO)-- facilitate implementation of
this policy.
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11. Before initiating research.
Applicable guidelines and regulations must be followed and
required approvals be obtained .
Institutional Animal Ethics Committee (IAEC), Institutional
Committee for Stem Cell Research (IC-SCR),
Genetic Engineering Approval Committee (GEAC),
Review Committee on Genetic Manipulation (RCGM),
Health Ministry’s Screening Committee (HMSC),
Central Drug Standard Control Organization (CDSCO),
Institutional Biosafety Committee (IBSC),
Atomic Energy Regulatory Board (AERB) etc.
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12. • Research should be undertaken by persons who are
competent with qualifications, having relevant
experience/training to collect reliable data, undertake
accurate analysis, interpretation and publication.
• All raw data should be available and securely kept by the lead
investigator for at least 3-5 years after study completion.
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13. • Completed research irrespective of results must be published
and shared on public databases such as CTRI, institute
websites or other available relevant platforms.
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14. What is unethical
1.Plagiarism—Copying.
2.fabrication-The intentional act of making-up data or results.
3. falsification--changing or omitting/-giving completely wrong
information.
4.manipulation of data .
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15. Authorship
• should be duly given to all those who have substantially
scientifically contributed to the research .
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16. Before publication
The researcher/corresponding author should submit- The final
draft along with details of authorship,
1. undertaking (Annexure I)
2. plagiarism check report.
3.Researcher is also required to submit continuing review/
(Common form for EC review - Annexure 3).
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17. Approved only if
• The research documents with acceptable level of plagiarism
(<10%)
• without identified misconduct
shall be forwarded by RIO to Director/ Head for approval before
publication/dissemination.
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18. In case of research misconduct
• Respondent who will be given an opportunity to provide
explanation within a limited time period (15 days).
• enquiry committee to evaluate misconduct and explanation
by respondent to investigate credibility of evidence,
extent/nature of misconduct, personnel involved and
intentions to suggest further course of action, including
punitive/ disciplinary action will be taken by Director.
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19. Guidelines for avoiding Plagiarism
“Acknowledgment” is the ethically right manner of crediting
someone else’s work.
In case of verbatim text is being taken from another source, it
must be enclosed in quotation marks and by providing citation
to indicate its origin.
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20. Types of Plagiarism – by ICMR
• Direct copying or word by word copying of a someone’s work
without acknowledging the original author- Direct Plagiarism
• A situation where the person duplicates his previous works--
Self-Plagiarism.
• Copying of idea- Mosaic Plagiarism
• Accidental Plagiarism
• 'salami' publications/ Redundant publications.
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21. Don’t publish in
In India, ICMR, UGC and other agencies have recommended
the academic as well as scientific community to avoid
publication in predatory journals and conferences.
Any publication in predatory/dubious journals or presentations
in predatory/dubious conferences shall not be considered for
academic credit for selection, confirmation, promotion,
performance appraisal, award of scholarship or academic
degrees or credits in any form.
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22. Reference List of Quality Journals
The Consortium for Academic and Research Ethics (UGC-CARE)
reference List of Quality Journals across various disciplines was
posted at https://ugccare.unipune.ac.in/site/website/index.aspx.
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23. International level
• Office of Research Integrity (ORI)- to tackle scientific
misconduct.
• Committee on Publication Ethics (COPE)- COPE developed
Guidelines on Good Publication Practice.
• International Committee for Medical Journal Editors (ICMJE)--
ethical standards in the conduct and reporting of research and
other material published in medical journals.
• CONSORT-- to alleviate the problems arising from inadequate
reporting of randomized controlled trials (RCTs).
• National Institutes of Health (NIH)- A Guide to the handling of
research misconduct Allegations
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24. National level
• Department of Biotechnology (DBT).
• ICMR National Ethical Guidelines for Biomedical and Health
Research involving Human Participants 2017.
• University Grants Commission (UGC) Regulations for
promotion of academic integrity and prevention of plagiarism
in Research.
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25. Establishing and Constituting the Institutional Ethics
Committee (IEC)
INSTITUTIONAL Ethics committee is an is independent reviewing
body.
The Dean will select and nominate.
He will ensure that the IEC is established in accordance with the
applicable laws and regulations of the state, country and in
accordance with the value and Principles of communities they
serve .
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26. • The IEC meetings are held once in every three months or in
accordance with the need of the work load.
• All the proposals will be received at least three weeks before
the meeting,
• checked for completeness as per the check list initially by the
office clerk(Form II),
• subsequently by the member secretary (through a nominated
person) using the evaluation form (Form III).
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27. Procedure for submission of research project for review
by Ethics Committee
Applicable to Principal Investigators from institute.
• Every protocol submitted for review to IEC must contain
number, version and date.
• All the research proposals prescribed application form, duly
filled, along with all necessary documents for the review.
• All the members will evaluate the possible risks
• A decision of the IEC will be communicated to the applicant in
writing, within 10 days of the meeting.
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28. A certificate of approval
• At the end of each meeting, every member must return all
the research proposals and documents to IEC office staff.
It will be sent to the applicant within 2 weeks and all the
approvals will be valid for only three years.
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29. Format for submission of Research proposal to IEC
1.Serial No (IEC Office),
2.Date of submission ,
3.Title of the research project,
4.Brief Bio data of the principal investigator name, designation,
department, Educational Qualification, Research experience ,
Address & Tel.no. Email and same for co-investigator also.
5.Departments involved
6. Expected duration of the project.
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30. Format for submission of Research proposal to IEC
1.Attach typed copy of Research Protocol
which need not exceed 5 pages,
2.You must clearly define your role in your project
3. sufficient detail to permit review .
Please also submit a soft copy of the Research Protocol.
Title of the Research Project: - Objectives: (please enumerate) -
Review of Literature (with references) pertaining to the project
(in less than 100 words).
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31. Research Protocol
Rationale of the study (in less than 100 words) Research design
& methodology .
Please include
number of subjects,
Research methods to calculate sample size.
Attach all relevant enclosures like proforma, questionnaires etc
Informed consent process, including patient information sheet
and informed consent form in local language, if applicable.
For any drug / device trial, mention all relevant pre-clinical
animal data and clinical trial data from other centers within the
country /other countries, if available-.
If applicable - Name and signature of Principal Investigator and
co-investigator/s on
research protocol with date.
Signatures of HOD and principal of institute.
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32. Checklist for attached documents
1.Project proposal – 10 Copies
2.Curriculum Vitae of Investigators
3.Brief description of proposal
4.Patient information sheet
5.Informed Consent form
6.Investigator’s brochure for recruiting subject
7.Copy of advertisements/Information brochures 8.Copy of
questionnaire / data collection sheet .
Place ,date and finally the
HOD’s remark with Name & Signature.
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36. • All research proposals must be submitted in English language
only.
• Must be submitted at least three weeks in advance from the
scheduled date of IEC meeting .
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37. Receipt of the application will be acknowledged by the IEC
office.
Every application will be allotted an IEC registration number to
be used for all future correspondence and reference .
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38. Organization of the IEC
1.Chairman – from outside the institution
2.one-two persons from basic medical science area
3.One –two clinicians from various institutions
4.One legal expert or retired judge
5.One social scientist /representative of NGO
6.One philosopher/ethicist
7.One lay person from the community
8.Member secretary
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39. When should we apply to IEC?
It is Before initiation of your research
For all research activities you must take approval from EC.
NOTE :
Even when we are using available data where we say that there
is no risk involved to human participants, ethics review is
required.
Even in these situations ethics review is considered important
and mandatory.
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40. General principles of research are
• Autonomy
• Beneficence
• non maleficence
• Justice
• Confidentiality.
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41. Autonomy
It represents a patient's right to determine his or her own
health-care decisions.
Patient autonomy is the most fundamental principle underlying
all health-care ethics.
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42. For example,
• patients have the right to refuse undesired therapy, and they
have the right to choose whether or not they will participate
in experimentation.
• Each patient has the right to have his wishes carried out even
in the event that he loses consciousness or the capacity to
make decisions for himself.
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43. Autonomy is similar to
Freedom of religion,
Freedom of speech,
Freedom of assembly.
The concept of patient autonomy is similar to that of voting.
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44. Minor(< 18 years)
Minors are generally not considered competent to make their
own decisions.
• Only a parent or a legal guardian can give consent for a
minor.
• Neighbors, aunts, uncles, and grandparents cannot give
consent for treatment of a minor.
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45. • All adult patients are considered competent unless specifically
proven otherwise
A patient with mental illness or mental retardation that might
be considered incompetent for other areas of life may still retain
the right to refuse medical procedures.
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46. Beneficence
Doing what is good for people is a high aim and ethical principle,
autonomy is considered more important and takes precedence.
You cannot treat him or her against his or her will even if the
treatment is for her benefit.
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47. confidentiality
You cannot release medical information to anyone about a
patient unless the patient gives you permission to do so.
confidentiality is breached in case of HIV, tuberculosis, or a
sexually transmitted disease because these are legally notifiable
to public health authority and also these conditions can harm an
innocent third party.
The patient has an absolute right to freely access the
information it contains.
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48. Lets us know
.
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49. Let us know some of the ethical issues in health
biomedical research
1.Can you do?
• Automatic HIV testing of patients without their specific
informed consent that you will be testing for HIV.
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50. You cannot do.
When a patient enters the hospital there is general consent
given that allows the routine testing of blood for chemistry and
hematology and so on.
• An additional HIV-related consent required to test for HIV.
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51. A psychiatric patient who told you he was going to harm
someone.
Do you keep this confidential?
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52. 2
You have to disclose.
• Although you have a duty to maintain the confidentiality of
the patient, you also have a duty to inform the person at risk.
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53. • Is it a duty for a health care professional to inform about his
HIV status to patient?
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54. 3
No
But he must follow Universal precautions that are supposed to
be maintained.
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55. Will you breach his confidentiality of a STD patient with
syphillis/HIV?
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56. 4
No
“Encourage him to disclose:' "offer counseling for partner.“
If the patient refuses then you must directly notify his pregnant
wife immediately.
Ask if he has already told his contacts that should be the first
thing to do.
The Department of Health can compile a list of contacts of
patients with STDs and notify the contacts that they are at risk.
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57. 5
• A young husband and wife visit your office to discuss methods
of contraception. The wife decides that she wants a tubal
ligation for sterilization.
Her husband is shocked and strongly objects stating that they
have no children. His wife is clear that she wants the sterilization
and that she wishes to be referred for the procedure.
What should you do?
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58. Refer for the tubal ligation as requested by the wife.
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59. 6
A 35-year-old married woman with four children is in your office
seeking a termination of an unwanted pregnancy in the first
trimester. Later in the day after you give the patient the referral,
her husband calls and is very distressed because he does not want
the abortion to occur. He very much wants to keep the baby.
What should you tell him?
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60. you have an absolute duty to the mother to honor her wishes
no matter what his personal feelings are.
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61. 7
• Is there any legal obligation if a doctor won’t aid a injured
person?
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62. • No.
You may feel a moral obligation to help everyone, but there is no
legal obligation for a doctor. Even laws, which protects
caregivers from liability .
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63. 8
All reproductive issues, including abortion, contraception, and
sterilization can be performed over the objection of the spouse.
Is it correct?
• .
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64. Of course
• Each person has autonomy over his or her own body.
• For any question concerning reproductive rights, decisions are
based entirely on maternal wishes. The father has no legal
right.
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65. 9
• Parental consent is not necessary to obtain contraception for
minors.
• Is it true?
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66. True
Because ,,,,
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67. 10
• For example, an elderly man with COPD progresses to the
point of needing mechanical ventilation on a chronic basis.
• He tells you, after long consideration, that he just does not
want to live on a ventilator. What should you tell him.?
•
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68. • You must honor his wishes.
• This patient is an adult with the capacity to understand his
medical problems, so he has the right to choose whether or
not he wishes to be on a ventilator.
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69. 11
• It is ethically unacceptable for a physician/nurse of any kind
to have other relationship with a current patient.
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70. Professionalism
• It is the behavior displayed in being a professional.
• Fundamentally, these include
• their ethics,
• values,
• behaviors,
• expertise
• and service to the profession as a good doctor/nurse.
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71. Acknowledgements
• The Research Ethics Review Committee of WHO Regional
Office for South-East Asia (SEARO-ERC).
• National ethical guidelines for biomedical and health research
involving human participants –ICMR.
• ICMR Policy on research integrity and publication.
• Medical ethics by Dr.conrad.
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72. Thank you
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