Bioethics Symposium 2012 - Reviving Ethics in Research, Restoring Integrity

Taste may differ from one faction to another but ethics are universal. The 4^th Annual YRG Care Bioethics Symposium 2012, in collaboration with the National Institute of Epidemiology, ICMR, Chennai, through the National Institutes of Health Project “Centrally Co-ordinated Bioethics Education for India” and National Institute for Research in Tuberculosis, ICMR, Chennai, Co-Sponsored by Public Responsibility in Medicine and Research (PRIM&R), Boston, USA, was organized on Friday, January 6^th, 2012 at Robert Koch Auditorium, National Institute for Research in Tuberculosis, ICMR, Chetpet, Chennai.

Business of Ethics

Clinical Trials | Drug Trials - Types Protocol Development and Approval FAQs
Clinical trials are experiments that yield useful information to clinicians if a particular treatment is of any value to a patient.

Differences in cultural diversity, food preferences and expression through arts are destined to be celebrated while disparity in the amenities threatening the basic survival of the underprivileged and undermining people by reducing them to lab rats and guinea pigs call for condemnation. But unless a person is aware of being taken for granted, war on unethical practices will remain an ordeal. During clinical trials, Dr. M.D. Nair, Consultant to Healthcare Industry and Chairperson emphasized on the regulation against suppression of any information. Samples on why clinical trials fail included deliberate fraud, faulty protocols, improper records and documentation, defaulting in Adverse Drug Reaction (ADR) reporting, deficiency in Informed Consent and neglect in drug accounting. Drugs are given to patients to take home and they comply but “you don’t know how many drugs are taken and how many pills are taken and how many are not taken. And that’s an important bearing on the final outcome.” Dr. Nair also insisted that the Ethics Committee has a role in minimising the deficiencies and ensuring that trials are conducted in a proper, established manner.

Informed Consent, Most Violated Norm

Components of ethics are concerned with disclosure of information. However the disclosure is insufficient. It is the duty of the researcher to ensure the subject understands the disclosure such as technical components, language components, communication components and understanding of the components regarding the patient involved, enabling voluntary decision making. Some standards set for proper clinical trials violated in the past in many developing countries such as Uganda, Cameroon, Nepal, Uganda, Peru, China to name a few have now been terminated due to gross unethical practices.

An Introduction to Biomedical Ethics
Ethics is the application of values and moral rules to human activities. Bioethics is a subsection of ethics, actually a part of applied ethics that uses ethical principles and decision-making.

Dr. Suniti Solomon M.D. with 22 years of teaching experience at the Madras Medical College explained the background of HeLa Immortal cell line used for growing viruses and recommended the audience read ‘Immortal Life of Henrietta Lacks’ by Rebecca Skloot. The book traces the heart wrenching life story of Henrietta Lacks out of whose cells millions of dollars were made , for making cell lines that researchers bought . Her family gets nothing, making it a true story exposing the ugly face of abusing ethics. Dr. Solomon wondered if Informed Consents were taken during the late 1940s. Only after a book on her was released the proceeds made their way to the family helping them to do better than before.

Grave Disparities

Drug Toxicity - Prescriptions Pharmacokinetics Medication Information Ratings Categorizations Therapeutic
Drug toxicity is an adverse reaction of the body towards a drug that results as a side effect of a drug, reaction to a drug or drug abuse.

Dr. Nandini Kumar. M.D., Former Deputy Director General Sr. Grade Co-Investigator, elaborated on the importance of remuneration cautioning that it should not lead to undue influence. Further explaining the compensation, she listed the differences in the bodies providing the compensation reading from the recently released report by the US Presidential Commission for the study of Bioethical issues in December 2011. The list has the positioning of compensation in countries like Australia, Brazil, Bulgaria, and China where the insurance has to be provided by the sponsors. However in European Union (EU), Canada, Italy and other countries there are more systems to sponsor. While finishing her presentation Dr. Kumar showed a slide of a survivor of Nazi experiments. Taking it from there Dr. Ravi Rengachari, M.D. (Former) Senior Deputy Director, provided shocking details of USPHS, the accusers and judges of Nazi trials, were conducting a study deliberately infecting men and women in Guatemala with syphilis which happened about the same time 1947-48 of the Nuremberg Trials.

Issues in Bioethics

Drug Resistance – Antibiotic or Antimicrobial Resistance
Drug resistance is often a problem in malaria, tuberculosis, HIV, sexually transmitted diseases and hospital acquired diseases. Judicious use of antibiotics can control the problem.

Dispelling doubts series of presentations were offered beginning with ‘Ethical Challenges in HIV/AIDS Research’ presented by Dr. Sanjay Mehendale. M.D. Director, National Institute of Epidemiology, Chennai and Principal Investigator, NIH Bioethics Project, National Institute of Epidemiology, ICMR, Chennai. ‘Ethical Issues in Research with Specimens’ and ‘Responsiveness: Must Clinical Trials be Responsive to Host Country Health Priorities?’ by Dr. Liza Dawson, M.D. Team Leader, Research Ethics Team, Basic Sciences Program, Division of AIDS, NIAID/NIH/DHHS, Bethesda, MD. ‘Ethical Issues in Clinical Trials’ by Dr. M.D. Nair, Consultant to Healthcare Industry and Chairperson, Ethics Committee, Madras Diabetes Research Foundation, ‘Compensation for Participation in Research Projects’ by Dr. Nandini Kumar, M.D. Former Deputy Director General Sr. Grade Co-Investigator, NIH Bioethics Project, National Institute of Epidemiology, ICMR, Chennai. ‘International Public Health Research Ethics’ by Dr. Ravi Rengachari, M.D.(Former) Senior Deputy Director, (Scientist -7), Indira Vector Control Research (ICMR), Pondicherry. ‘Ethical Aspects in Paediatric Clinical Trials’ by Dr.Soumya Swaminathan, M.D. Deputy Director (Senior Grade), Head of Division of HIV/AIDS, National Institute of Tuberculosis, Chennai. ‘ICMR Initiatives in Bioethics Education’ by Dr. Nandini Kumar .M.D. ‘Implementation of the UNESCO Regional Bioethics Education Action Plan for Asia-Pacific’ by Dr. Darryl Macer, M.D. regional Adviser in Social and Human Sciences in Asia and the Pacific (RUSHSAP), UNESCO Bangkok, Thailand. ‘On Public Responsibility in Medicine and Research (PRIM&R)’ by Dr. S. Swarnalakshmi IRB Manager, YRG CARE.

Ethics in research especially while dealing with lives of many has many facets to consider. While the Ethics Committee can only enlighten and do its best to keep a check on violation of laws which are meant to protect, the integral value of bioethics in everyday research is evolving. Just like the universal nature of ethics, so is the joint effort to maintain ethical practices.

Source-Medindia