Medicine is an ever-changing field. Have we been taught about bioethics???

Transcription

1 Medicine is an ever-changing field Undergraduate medical education focuses on clinical skills - diagnosis and treatment of diseases Bioethics too is an ever-changing field Have we been taught about bioethics??? Did we have an insight to clinical research when we were undergraduates???

2 Background Bioethics is backbone of clinical research and clinical practice Ethical issues on rise due to advancement in science and increasing consumer awareness India hub of clinical trials!!! Imperative for doctors to get educated in bioethics Unlike in the West, we don t have bioethics training in our medical curriculum Major reason for increased ethical issues Lack of awareness about ethical principles

3 Knowledge, Awareness and Attitude towards Bioethics & Clinical Research among Medical Interns in Tamil Nadu, South India Dr. Harivenkatesh.N 1, Dr.Darling Chellathai David 1, Dr. Haribalaji.N 2, Dr.Muthukumar.J 2, Dr.Dhanaraj.P 3, Dr.Urmila Thatte 4 1 Department of Pharmacology, Sri Ramachandra Medical College and Research Institute, Chennai Madurai Medical College, Madurai-20, 3 Coimbatore Medical College, Cbe-14, 4 Seth G S Medical College and KEMHospital, Mumbai dr_harivenkatesh@yahoo.co.in

4 In next few minutes Bioethics-What is it? Study Rationale Methodology Results Discussion Conclusion

5 Bioethics-Definition * Ethics is the study of morality Biomedical ethics branch of ethics that deals with moral issues in medical practice Includes Clinical ethics, Research ethics & Professional ethics The study of ethics prepares medical students to recognize difficult situations and to deal with them in a rational and principled manner *Definition reproduced from World Medical Association Medical Ethics Manual, 2 nd Edition, 2009

6 Study Rationale In India with huge population of 1.21 billion, general practitioners have large patient base Today s interns are tomorrow s general practitioners & clinical researchers Ought to be aware of basic ethical principles to handle ethical & medico legal issues in day to day clinical practice No information in literature about awareness of biomedical ethics among interns in Tamil Nadu Hence we aimed to study the Knowledge, awareness and attitude towards bioethics and clinical research among medical interns

7 Methodology Approved by Institutional Ethics Committee Informed consent obtained from all study participants Study design Cross-sectional study Study period May 2011 to Aug 2011

8 Methodology Study site Multicentric study (3 centers) Sri Ramachandra Medical College & Research Institute, Chennai-116 Madurai Medical College, Madurai-20 Coimbatore Medical College, Coimbatore-14 Study population Medical Interns who fulfill eligibility criteria

9 Inclusion criteria Exclusion criteria Interns who have completed MBBS in any of above three colleges and currently doing internship in the same college All age groups Both gender Interns who have completed MBBS in other colleges and countries and currently doing internship in any of the above 3 colleges Dental and Para-medical interns Interns not willing to sign informed consent form

10 Study Conduct A structured questionnaire was designed & validated by peer review Divided to 6 sections General demographic information Knowledge Awareness Attitude Clinical scenarios Self response in Likert scale Administered to study participants Responses obtained and analyzed Descriptive statistics used to present data

11 Results Flow of study participants 300 Medical interns approached 230 Interns given the questionnaire 180 Completed the questionnaire & included for analysis 70 Not willing to participate 50 Didn t respond to the questionnaire

12 General & Demographic information

13 Distribution of participants Sex First Generation Doctors n=67, ( 37%) n=113, (63%) n=63, ( 35%) n=117, (65%) Males Females Yes No Mean age of study participants 22.9 ±1.03 years

14 Have you received any formal training in bioethics No 13, 7% 7, 4% Yes No comments 160, 89%

15 Have you ever done a research project during UGstudy period No. I have never thought about it No. I thought of doing one but I didn't do it 39 (22%) 57 (32%) 84 (46%) Yes. I have done a research project

16 Awareness related questions

17 Awareness Clinical & Professional ethics Terminology I don t know I just heardthe name but don t know what it is? I know something about it I am fully aware of it Hippocrates Oath Medical negligence Professional misconduct Declaration of Geneva Bioethics MCI codeof medical ethics regulations, 2002

18 Awareness Clinical & Professional ethics Terminology I don t know I just heardthe name but don t know what it is? I know something about it I am fully aware of it Hippocrates Oath Medical negligence Professional misconduct Declaration of Geneva Bioethics MCI codeof medical ethics regulations,

19 Awareness Clinical research Terminology I don t know I just heardthe name but don t know what it is? I know something about it I am fully aware of it Informed consent Evidence based medicine Pubmed database Schedule Y of Drugs & Cosmetics Act Clinical Trials Registry- India(CTRI) Conflict of Interest Plagiarism

20 Awareness Clinical research Terminology I don t know I just heardthe name but don t know what it is? I know something about it I am fully aware of it Informed consent Evidence based medicine Pubmed database Schedule Y of Drugs & Cosmetics Act Clinical Trials Registry- India(CTRI) Conflict of Interest Plagiarism

21 Awareness Research ethics Terminology I don t know I just heardthe name but don t know what it is? I know something about it I am fully aware of it Nuremberg code Institutional Ethics Committee / Institutional Review Board ICH-GCP(Good Clinical Practice) guidelines Declaration of Helsinki ICMRguidelines for biomedical research on human participants Belmont report

22 Awareness Research ethics Terminology I don t know I just heardthe name but don t know what it is? I know something about it I am fully aware of it Nuremberg code Institutional Ethics Committee / Institutional Review Board ICH-GCP(Good Clinical Practice) guidelines Declaration of Helsinki ICMRguidelines for biomedical research on human participants Belmont report

23 Are you aware of drug discovery & development process? I don't know 1, 1% 10, 5% I know something about it 57, 32% I am fully aware of it 112, 62% Not sure/ No comments

24 Knowledge related questions

25 In your clinical practice, if you want to find the latest modality of treatment for a disease/ disorder, what will you do? I will clarify with my colleagues & seniors I will search in standard text books I will search in Google 16% 11% 11% 19% I will search in Wikipedia I will search in medical journals Combination of above 18% 25%

26 Do you know the regulatory body in India that gives permission for the conduct of clinical trial in our country? No Yes 1, 0% 37, 21% Not sure/ No comments 142, 79%

27 Please mark whether the following acts are ethical or not? Getting commission from a laboratory / scan center Ethical Unethical Not sure Advertising the clinic daily in the media Giving steroids to a patient when there is no indication Accepting cash from pharma company Falsifying data for the sake of publication Getting consultationfees from another doctor Testinga drug in animals before testing it in humans Euthanasia

28 Please mark whether the following acts are ethical or not? Getting commission from a laboratory / scan center Ethical Unethical Not sure Advertising the clinic daily in the media Giving steroids to a patient when there is no indication Accepting cash from pharma company Falsifying data for the sake of publication Getting consultationfees from another doctor Testinga drug in animals before testing it in humans Euthanasia

29 Attitude related questions

30 What do you think about the need for biomedical ethics education in this era of consumer awareness? No need of bioethics education Little need for bioethics education 30, 17% 3, 2% 33, 18% Huge need for bioethics education 114, 63% Not sure/ No comments

31 Are you interested in learning about research ethics & research methodology Not interested Little interested 35, 19% 10, 6% 19, 11% Highly interested 116, 64% No comments

32 Are you interested in doing clinical research? Not at all interested 26 (14%) 21 (12%) 27 (15%) Somewhat interested Very much interested 106 (59%) No comments

33 According to you, what is the major hindrance for clinical research in India There is no proper funding for research Salary in research field is low 17% 7% 43% Recognition in society is poor 33% No guidance & lack of awareness

34 Do you think that bioethics education & research methodology should be a part of UGmedical curriculum? Yes. I strongly agree Yes. I somewhat agree 15, 8% 17, 9% 75, 42% No. Not required 73, 41% Not sure/no comments

35 Clinical case scenarios

36 1. Being an intern how will you get consent from the patient for a surgical procedure or any intervention? I will ask the staff nurse to get the patient's signature in the consent form I will ask the patient to sign in the consent form without giving much explanation about the procedure I will explain the benefits of the procedure and then ask the patient to sign in the consent form I will explain the benefits and risks of the procedure and then ask the patient to sign in the consent form Not sure 47% 4% 12% 35% 2%

37 Case scenario 2 A 25 year old newly married male comes to you for treatment of recurrent cough with expectoration of sputum. Based on history, clinical and laboratory investigations, you diagnose him as a case of Tuberculosis and start the treatment. He requests you not to reveal the presence of Tuberculosis to anybody including his wife. His wife anxiously enquires you about the health of her husband. In this situation what will you do?

38 I wont reveal the patient's condition to his wife I will inform the patient's condition to his wife I will escape from the situation by referring the patient to chest specialist Not sure 6% 10% 35% 49%

39 Case scenario 3 You are doing a clinical study comparing the effects of Drug A and Drug B in the treatment of childhood obesity in obese children 10 years of age. In this situation how will you get the consent for including the child in the study?

40 I will get the consent from the parents for including the child in the study I will get the consent from the child for participating in the study I won't get the consent and I will ask the child to take the drug I will get the consent from the child as well as the parents Not sure 50% 12% 31% 3% 4%

41 Case scenario 4 40 years old male patient was brought to casualty by public in an unconscious state following Road Traffic Accident. Imagine yourself as the duty neurosurgeon posted in emergency unit. CT brain showed a large Subdural Hematoma. You want to do an emergency craniotomy and evacuate the hematoma. In this situation how will you proceed? (There are no relatives with the patient since he was brought by the public)

42 Since the patient is unconcious, I can't get his informed consent for surgery. But I will proceed with the surgery I will wait for the patient's relative to come and sign the informed consent and then I will take the patient for surgery I will refer the patient to another hospital Not sure/ No comments 27% 40% 5% 28%

43 Case scenario 5 You see a rare case of a disease in the ward. You want to take a photograph of that patient and present it in a conference or scientific meet. How will you proceed? (Using the photograph may reveal the identity of the patient)

44 I will simply take the photograph of the patient without his/her knowledge and present it I will get the oral consent from the patient for taking the photograph and then present it I will get written informed consent from the patient for taking the photograph and then present it Not sure/ No comments 12% 8% 36% 44%

45 Self response in Likert scale

46 Level of importance paid by our current UG medical curriculum Level of importance paidby our UG curriculum towards No importance Very little importance Little importance Moderate importance High importance Extremely high importance Professional ethics Research methodology & clinical research Research ethics

47 Your level of confidence after finishing your internship Afterfinishing your internship how confident are you in No confidence Very little confidence Little confidence Moderate confidence High confidence Extremely high confidence Diagnosing & treating a diseasein your clinical practice Dealing with ethical & medico-legal issuesin your clinical practice

48 Your level of knowledge as an intern in the given field Level of knowledge as an intern in the field of No knowledge Very little knowledge Little knowledge Moderate knowledge High knowledge Extremely high knowledge Medicine & surgery Professional ethics Research methodology Research ethics

49 Discussion The knowledge and awareness about bioethics was found to be very low among medical interns The knowledge & awareness about professional ethics was comparatively better than that of research ethics Professional ethics taught in Forensic medicine No statistically significant difference in the responses was seen with respect to gender & first generation doctor status Most of our interns agreed that their level of knowledge in bioethics & clinical research is low and that no importance is being paid to clinical research & research ethics in our medical curriculum Majority of them accepted that bioethics education should be a part of medical curriculum

50 Discussion Lack of proper funding, less salary and lack of guidance & awareness were the major hindrance for clinical research, according to them In spite of not having received any formal training in bioethics, at least 40% of our interns were able to take right decisions in the clinical scenarios If bioethics training is inculcated in to our medical curriculum, then India will produce better clinicians and researchers that will further strengthen our global position in medical tourism and clinical research Study limitations Not a qualitative study Convenience sampling

51 Conclusion Ethical practice Rational decision making process Ultimate improvement in patient care Clinical Expertise

52 Conclusion

53 Conclusion

54 References Medical Ethics Manual. World Medical Association; 2009 [updated 2009]; 2nd edition: Available from: El-DessoukyHF, Abdel-Aziz AM, Ibrahim C, MoniM, AbulFadlR, Silverman H. Knowledge, Awareness, and Attitudes about Research Ethics among Dental Faculty in the Middle East: A Pilot Study. Int J Dent.2011: HeitmanE, Olsen CH, AnestidouL, BulgerRE. New graduate students' baseline knowledge of the responsible conduct of research. Acad Med Sep;82(9): Pimentel D, Barbosade Oliveira C, Vieira MJ. Teaching of medical ethics: students' perception in different periods of the course. Rev Med Chil Jan;139(1): PlemmonsDK, Brody SA, KalichmanMW. Student perceptions of the effectiveness of education in the responsible conduct of research. Sci Eng Ethics Jul;12(3):

55 Dr.N.Harivenkatesh