Awareness about Research Ethics among General Practitioners not Attached with Research Institutions

Dear sir,

Research in medical field is important to help and improve our knowledge in medicine. Especially there is increase in research in India in the past few decades. Research ethics is an important factor in any research protecting the welfare of participants. Many International guidelines exist for the same [1,2]. Complaints regarding research show that there is increase of awareness among public as well as the practices of doctors. General practitioners working in a hospital do conduct clinical trials. This study was designed with the aim to evaluate the awareness and knowledge of general practitioners about research ethics.

After obtaining approval from Institutional Ethics committee, a cross sectional study was conducted among 25 general practitioners in the local town. They were explained about the study and asked for willingness to participate. After getting informed written consent, they were recruited. A questionnaire was made by the authors based on literature. First part of questionnaire included demographic data, details about research involving human participants in the past and present and participation in any programs on research ethics. Second part contained a series of questions or statements which tested the knowledge of the doctors in research ethics.

Twenty five general practitioners or working in hospitals participated in the study. All the participants filled up the questionnaire and returned it to us whose identity was blinded. Mean age of the participants was 41.5 years. Of 25, three were MBBS, three were PG Diploma, 15 were MD/MS/ DNB holders and two were super specialty. Currently one was involved in research.

Eight participants had conducted clinical trials before and 76% were interested in future research. 8% participants had undergone formal training but, 52% felt that they are familiar with Research Ethics. All the 25 participants were aware that patient confidentiality has to be maintained. A 96% participants knew that ethical clearance has to be obtained for all the projects and all potential risks has to be explained to patients before enrolling them in the study. A 92% participant knew that patients had the right to withdraw from study without forgoing their right for treatment.

A total of 16% participants responded that stored samples can be used in other research projects without patient permission. A 16% were also not clear about conflict of interest while conducting clinical trials, 16% felt that ethical committee need not be informed about the progress of the study. Considerable number of participants (28%), were unclear about consent issues in vulnerable populations namely – children, students, etc.

Medicine is a growing field and research and it forms the platform for expansion of knowledge. Doctors working in research institutes undergo formal training in research ethics and general practitioners have less access to the same. Most of the participants knew the importance of patient confidentiality which is similar to the study conducted by Gopinath NM et al., to study the knowledge about research ethics among dental faculty [3]. But they were not aware of the ethical issues involving vulnerable population. Participants were knowledgeable about the need for ethics committee approval before starting the research but they felt that reporting study progress only delayed research. This is similar with El-Dessouky HF et al., study among dental faulty [4].

Though half of the participants said they are knowledgeable about research ethics, only 2 out of 25 participants had undergone any formal training which indicates a need for workshops or Seminars to general practitioners.

Knowledge about research ethics involving human subjects among Doctors not associated with research institutions is fairly good even though majority of them have not undergone formal training. Probably this knowledge was acquired during their PG training. However complete knowledge about research ethics involving human subjects is mandatory for all Doctors. This gap can be covered by conducting periodic training on Research ethics for all medical practitioners.

[1]. Declaration of Geneva (1948). Adopted by the General Assembly of World Medical Association at Geneva Switzerland  [Google Scholar]

[2]. The Nuremberg Code (1949) Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Washington DC: USGovernment Printing Office. 2;181–182  [Google Scholar]

[3]. Gopinath NM, John J, Senthil kumar E, Nagappan N, Knowledge Awareness and Attitude about Research Ethics among Dental Faculties in India J Contemp Dent Pract 2014 15(5):608-13.  [Google Scholar]

[4]. El-Dessouky HF, Abdel-Aziz AM, Ibrahim C, Moni M, Fadl RA, Silverman H, Knowledge, Awareness, and Attitudes about Research Ethics among Dental Faculty in the Middle East: A Pilot Study International Journal of Dentistry 2011 2011(694759):13  [Google Scholar]