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Unit 3: Medical Research
Pratik Umesh Parikh
S. Y. M. Pharmacy 3rd semester
(pharmaceutical biotechnology)
Roll no.: 08
Email : pratikparik42@gmail.com
Seminar on
Guided by :
Dr. N. L. Dhas Sir
Research Methodology & Biostatistics
Sanjivani College of Pharmaceutical Education and Research,
Kopargaon
10/12/2021 SANJIVANI COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOPARGAON 1
Contents :
❖Cultural Concerns
❖Truth telling
❖Conflict of Interest
❖Reference
SANJIVANI COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOPARGAON
10/12/2021 2
Cultural Concerns:
A cultural concern is a rule or expectation in any culture that prevents someone, from
outside of that culture, from being included or participating equally.
Culture can be defined as the language ,behavior, customs, values and beliefs that a
particular culture , race or country holds.
Two of the most common cultural barriers are
1. language and
2. religion.
10/12/2021 SANJIVANI COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOPARGAON 3
Cultural Concerns:
Clinical staff as nurses today are providing care, education ,and case management to an
increasingly diverse patient population that is challenged with a triad of cultural, linguistic,
and health literacy barriers .
For such patients ,culture and language set the context for the acquisition and application
of health literacy skills.
How to remove some common cultural barriers in the workplace.
1. Do the work of learning for patients behavior/ culture.
2. 2. Acknowledge the difference between patient need and medical preference.
3. 3. Learn about different cultures.
10/12/2021 SANJIVANI COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOPARGAON 4
Truth Telling:
Truth telling ,or veracity ,can be defined as the avoidance of lying ,deception
,misrepresentation ,and non disclosure in interactions with patients or relevant to patient
care.
Being honest with patients about their diagnosis is relatively new addition to the ethics of
health care.
Until recently ,doctors often avoided telling patients the full extent of serious diagnosis,
particularly when there were limited treatment options .
In addition ,in some cultures ,it is customary to hide a serious diagnosis from the patient
for fear that he or she will lose hope or become demoralized by the truth telling .
10/12/2021 SANJIVANI COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOPARGAON 5
Truth Telling:
Truth- telling also involves being forthright about medical errors.
Many ethicists argue that the primary physician and observing members of a medical
team all have an obligation to report errors not only to oversight committees but directly
to the affected patient .
This is not always easy to do- particularly when the mistakes harm patients and their
families, when it is not obvious that telling the patient will improve the situation, and when
the stakes for admitting errors are high .
However , physicians have an obligation to report errors and to support colleagues who
do so .Only then it is possible to recognize errors when they occur and to develop
systems for avoiding the problems in the future.
10/12/2021 SANJIVANI COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOPARGAON 6
Truth Telling:
One exception involves the patient who directly tells the physician that he/she does not want
to receive any information regarding his /her diagnosis .In this case ,it is ethical to withhold
information because the patient does not wish to receive it, thereby upholding patient
autonomy, or free will to decide. One must never suppose that the patient prefers
nondisclosure, but rather one must ascertain these wishes through direct conversation with
the patient.
This can be achieved by asking the patient how wishes through direct conversation with the
patient .This can be achieved by asking the patient how wishes to receive the information
before the test result even arrive ,their by allowing both the patient and physician to plan the
logistics of breaking possible bad news ahead of time .
Another exception involves a mentally unstable patient who may put himself / herself in
harm´s way after receiving the bad news .In this example ,a doctor may be justified in
delaying the disclosure of information until after the patient ´s mental health improves and the
patient posses appropriate
10/12/2021 SANJIVANI COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOPARGAON 7
Truth Telling:
Also some of the Journals publishing the various articles for the money or various benefits.
Example : Journals send the article acceptance within 24 hours with fake report regarding the
plagiarism of the submitted article by corresponding author.
Example of such Journals:
1. Paid journals which not in UGC Care list
2. Or having UGC approval last 4 – 5 years ago but now not approved.
3. Minimum indexing or fake indexing features
10/12/2021 SANJIVANI COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOPARGAON 8
Conflict of Interest:
Conflict of interest is an ethical issue.
“A Conflict between one’s obligation to the public good and one’s self-interest”
The circumstances of a person, who finds that one of his activities, interests, etc., can be
forwarded only at the expense of another of them.
Conflict of interest is a situation in which personal benefit or economic gain(either direct or
indirect via an individual’s research program, institution or individual reputation) takes priority
over clarity or accuracy of the reporting of the research.
Apparent benefits are typically related to money or funding, but they may not necessarily be
financial in short term.
10/12/2021 SANJIVANI COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOPARGAON 9
Conflict of Interest may develop if:
All authors agreed to sign a statement revealing
1. Any financial interest in or arrangement with a company whose product was used in a study
or is referred to in a manuscript
2. Any financial interest in or arrangement with a competing company
3. Any direct payment to an authors from any source for the purpose of writing the
manuscript.
If the manuscript is published, such information may be communicated in a note following the
text and references
10/12/2021 SANJIVANI COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOPARGAON 10
Some examples of Conflict of Interest:
Example 1.
Delay of review of benefited the reviewers
This example involved the development of a new analytical procedure
A reviewer of the manuscript delayed review until the reviewer’s date of similar research were
submitted for publication.
The direct benefit to the reviewer was recognition as first to publish.
10/12/2021 SANJIVANI COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOPARGAON 11
Some examples of Conflict of Interest:
Example 2.
Author mispresented data for personal benefit. Date were mispresented to show specific positive
results.
The author accrued personal benefits through increased support for his research program
(indirect) and recognition as a scientist (direct).
Subsequently the scientist published padded data. The scientist was fired immediately, and his
supervisor published a disclaimer of previous publications.
10/12/2021 SANJIVANI COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOPARGAON 12
Managing Conflict of Interest:
➢Regulation of the individual
➢Design and regulation of the research process
➢Critical assessment of the research products
10/12/2021 SANJIVANI COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOPARGAON 13
Reference :
1. A book of research methodology and biostatics by Dr Vinod Kumar Bias Page no 198 to 200.
2. https://www.slideshare.net/nidhi20/conflict-of-interest-3973074
3. https://www.slideshare.net/walidw2001/medical-research-methodology
4. Conflict of interest in research by Prof. Dr. Naeem Aslam Channa, Institute of Biochemistry,
University of Sindh https://www.youtube.com/watch?v=-LgAxqnsTVc&t=297s
5. https://www.slideshare.net/tambepriyanka/seminar-on-ethics-committee-cultural-
concerns-183551861
SANJIVANI COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOPARGAON
10/12/2021 14
SANJIVANI COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOPARGAON
10/12/2021 15

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Medical Research - Cultural concerns, Truth telling & Conflict of interest

  • 1. Unit 3: Medical Research Pratik Umesh Parikh S. Y. M. Pharmacy 3rd semester (pharmaceutical biotechnology) Roll no.: 08 Email : pratikparik42@gmail.com Seminar on Guided by : Dr. N. L. Dhas Sir Research Methodology & Biostatistics Sanjivani College of Pharmaceutical Education and Research, Kopargaon 10/12/2021 SANJIVANI COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOPARGAON 1
  • 2. Contents : ❖Cultural Concerns ❖Truth telling ❖Conflict of Interest ❖Reference SANJIVANI COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOPARGAON 10/12/2021 2
  • 3. Cultural Concerns: A cultural concern is a rule or expectation in any culture that prevents someone, from outside of that culture, from being included or participating equally. Culture can be defined as the language ,behavior, customs, values and beliefs that a particular culture , race or country holds. Two of the most common cultural barriers are 1. language and 2. religion. 10/12/2021 SANJIVANI COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOPARGAON 3
  • 4. Cultural Concerns: Clinical staff as nurses today are providing care, education ,and case management to an increasingly diverse patient population that is challenged with a triad of cultural, linguistic, and health literacy barriers . For such patients ,culture and language set the context for the acquisition and application of health literacy skills. How to remove some common cultural barriers in the workplace. 1. Do the work of learning for patients behavior/ culture. 2. 2. Acknowledge the difference between patient need and medical preference. 3. 3. Learn about different cultures. 10/12/2021 SANJIVANI COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOPARGAON 4
  • 5. Truth Telling: Truth telling ,or veracity ,can be defined as the avoidance of lying ,deception ,misrepresentation ,and non disclosure in interactions with patients or relevant to patient care. Being honest with patients about their diagnosis is relatively new addition to the ethics of health care. Until recently ,doctors often avoided telling patients the full extent of serious diagnosis, particularly when there were limited treatment options . In addition ,in some cultures ,it is customary to hide a serious diagnosis from the patient for fear that he or she will lose hope or become demoralized by the truth telling . 10/12/2021 SANJIVANI COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOPARGAON 5
  • 6. Truth Telling: Truth- telling also involves being forthright about medical errors. Many ethicists argue that the primary physician and observing members of a medical team all have an obligation to report errors not only to oversight committees but directly to the affected patient . This is not always easy to do- particularly when the mistakes harm patients and their families, when it is not obvious that telling the patient will improve the situation, and when the stakes for admitting errors are high . However , physicians have an obligation to report errors and to support colleagues who do so .Only then it is possible to recognize errors when they occur and to develop systems for avoiding the problems in the future. 10/12/2021 SANJIVANI COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOPARGAON 6
  • 7. Truth Telling: One exception involves the patient who directly tells the physician that he/she does not want to receive any information regarding his /her diagnosis .In this case ,it is ethical to withhold information because the patient does not wish to receive it, thereby upholding patient autonomy, or free will to decide. One must never suppose that the patient prefers nondisclosure, but rather one must ascertain these wishes through direct conversation with the patient. This can be achieved by asking the patient how wishes through direct conversation with the patient .This can be achieved by asking the patient how wishes to receive the information before the test result even arrive ,their by allowing both the patient and physician to plan the logistics of breaking possible bad news ahead of time . Another exception involves a mentally unstable patient who may put himself / herself in harm´s way after receiving the bad news .In this example ,a doctor may be justified in delaying the disclosure of information until after the patient ´s mental health improves and the patient posses appropriate 10/12/2021 SANJIVANI COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOPARGAON 7
  • 8. Truth Telling: Also some of the Journals publishing the various articles for the money or various benefits. Example : Journals send the article acceptance within 24 hours with fake report regarding the plagiarism of the submitted article by corresponding author. Example of such Journals: 1. Paid journals which not in UGC Care list 2. Or having UGC approval last 4 – 5 years ago but now not approved. 3. Minimum indexing or fake indexing features 10/12/2021 SANJIVANI COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOPARGAON 8
  • 9. Conflict of Interest: Conflict of interest is an ethical issue. “A Conflict between one’s obligation to the public good and one’s self-interest” The circumstances of a person, who finds that one of his activities, interests, etc., can be forwarded only at the expense of another of them. Conflict of interest is a situation in which personal benefit or economic gain(either direct or indirect via an individual’s research program, institution or individual reputation) takes priority over clarity or accuracy of the reporting of the research. Apparent benefits are typically related to money or funding, but they may not necessarily be financial in short term. 10/12/2021 SANJIVANI COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOPARGAON 9
  • 10. Conflict of Interest may develop if: All authors agreed to sign a statement revealing 1. Any financial interest in or arrangement with a company whose product was used in a study or is referred to in a manuscript 2. Any financial interest in or arrangement with a competing company 3. Any direct payment to an authors from any source for the purpose of writing the manuscript. If the manuscript is published, such information may be communicated in a note following the text and references 10/12/2021 SANJIVANI COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOPARGAON 10
  • 11. Some examples of Conflict of Interest: Example 1. Delay of review of benefited the reviewers This example involved the development of a new analytical procedure A reviewer of the manuscript delayed review until the reviewer’s date of similar research were submitted for publication. The direct benefit to the reviewer was recognition as first to publish. 10/12/2021 SANJIVANI COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOPARGAON 11
  • 12. Some examples of Conflict of Interest: Example 2. Author mispresented data for personal benefit. Date were mispresented to show specific positive results. The author accrued personal benefits through increased support for his research program (indirect) and recognition as a scientist (direct). Subsequently the scientist published padded data. The scientist was fired immediately, and his supervisor published a disclaimer of previous publications. 10/12/2021 SANJIVANI COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOPARGAON 12
  • 13. Managing Conflict of Interest: ➢Regulation of the individual ➢Design and regulation of the research process ➢Critical assessment of the research products 10/12/2021 SANJIVANI COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOPARGAON 13
  • 14. Reference : 1. A book of research methodology and biostatics by Dr Vinod Kumar Bias Page no 198 to 200. 2. https://www.slideshare.net/nidhi20/conflict-of-interest-3973074 3. https://www.slideshare.net/walidw2001/medical-research-methodology 4. Conflict of interest in research by Prof. Dr. Naeem Aslam Channa, Institute of Biochemistry, University of Sindh https://www.youtube.com/watch?v=-LgAxqnsTVc&t=297s 5. https://www.slideshare.net/tambepriyanka/seminar-on-ethics-committee-cultural- concerns-183551861 SANJIVANI COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOPARGAON 10/12/2021 14
  • 15. SANJIVANI COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KOPARGAON 10/12/2021 15