Anatomy research under the knife of medical ethics.

There is increased awareness and anxiety in conducting research for publication and at the same time ignorance about getting Ethical Committee clearance at least in Anatomy Departments among Basic Medical Sciences. While people are actively presenting papers, collect data, Indian Council for Medical Research guidelines does not cover aspects pertaining to Anatomy oriented research activities. This review article is an eye opener for fraternity in the medical field, especially in anatomy.

Dissection of human cadaver is the most exciting part of the medical curriculum for a beginner. Prior to 80 s, 1st year students had to study Physics, English, Statistics etc., and entered portals of anatomy dissection hall only during 2nd year of study. In revised curriculum, they enter the portals of Medical subjects straight away. The students are not mentally prepared psychologically to face the challenge. Some dissection halls do carry messages that cadavers are to be given respect. Dissection of the dead body is a time honored part of medical education. Undergraduate and postgraduate students do dissection as a part of learning human Anatomy. According to the state regulations, most of the cadavers are obtained from the forensic mortuary declared as “unclaimed body.” Some are collected through “body donation” as well.[1]

As the publication of scientific papers is now linked to professional career up gradation as per the new DCI/MCI rule, the pressure for publication of papers is tremendous.[2]

As a career is related to publication with adage publish or perish, there is a manifold increase in the number of journals, indexing bodies and host of publications. The institutions have their journals to encourage students and faculty to learn the art of scientific writing. For the postgraduate students, presenting papers in conferences and publications have become mandatory to appear for university examination. In the changed circumstances, there is a possibility of deviating from ethics in doing research or subsequently publishing the article.

There is a pressing need to create awareness among postgraduates and faculty doing research about ethics, aspects of misconduct and related issues.

In addition to career-related advancement, there is also an emerging trend to compete for funded projects. In recent years, international research collaborations have been growing rapidly. Multinational pharmaceutical companies and academic institutions have expanded their research to developing countries.[3] This in part is driven by the increased awareness of health as a global issue, the challenges imposed by new and resurgent global epidemics, the increased demand for new treatments, and practical and financial considerations of the pharmaceutical industry.[4]

However, this research is often poorly regulated and does not meet widely accepted ethical standards.[5]

In attempting to do research and publish papers, researchers in Anatomy indulge in studies using dry bones from the store of the department, use expelled fetuses and report variations in the dissected cadaver. Most of the conference papers fall into this category apart from histological studies. None of the presentations or the subsequent publication resulting from the presentation, mention about Ethical Committee (EC) clearance for the study. Are these work exempted from the purview of Institutional Ethical Committee (IEC)?

Having raised the question, I want to enlighten the fellow anatomists about some features of medical ethics.

What is ethics? “Ethics” in simple terms is defined as “norms for conduct” that distinguishes between acceptable and unacceptable behavior. Ethics is the process of determining right and wrong conduct. It is derived from the Greek word “ethikos” which means arising out of the habits. The Nuremberg code 1947, Belmont Report 1979 and Helsinki declaration (of word medical association) form the basis for medical ethics. Ethics is more learnt than taught. People learn out of life experiences. That is why there is wide variation in interpretation of ethics. The challenges faced in research are - it's not a structured profession, involves learning from various ways, involves time and effort.

In research, ethics in simple terms can be explained as respect for the person (subject). This is ensured by International Recommendations, National Regulation and Institutional guidelines.

In any research, there should be a commitment and ethical conduct in addition to the knowledge in the area of research. The ingredients of ethical conduct are, reporting the work honestly, accurately, efficiently and objectively. By all means, informed consent should be obtained, beneficence, nonmaleficence taken care. Government regulations, institutional policies, should be adhered to with a personal conviction.

Why Research Integrity Matters?

Science is built on trust. Lack of integrity in research will undermine advancement of knowledge, erode public support and jeopardize human subjects. There is a responsibility to be a role model for future generations.

What is Affecting Trust on Science/Research?

Public perception, lawsuits against corporates and individuals, unnecessary research all affects the trust in research. Worst case is retractions in scientific publications.

Misconduct/Deviations in Research

Misconduct in research includes fabrication and falsification of results and plagiarism (of idea, process, and results). There is a lot of competition for grants and publications. Giving/demanding authorship to a colleague or relation who has not contributed substantially to the research study. Designated authors should have contributed significantly in the conceptualization design, execution, and/or interpretation of the study and should be willing to take responsibility for the study. Those who do not meet these criteria, but have still helped in some way to the study like providing technical help, writing assistance, or department/institutional head for providing access to the institutional infrastructure for the conduct of the research study, etc., should be relegated to the acknowledgement section.[2]

Current Status of Institutional Ethics Committees in India

The primary purpose of EC is to protect the rights, safety and well-being of human subjects who participate in a research project. The Indian Council for Medical Research (ICMR) in February 1980, framed the first official guidelines for the formation of EC. These guidelines included recommendations for membership criteria and ethical standards for review, which laid down the foundation for the establishment of ECs in India. This was followed by release of the ICMR guidelines in bioethics, which was a guidance document for research in medical, epidemiology, and public health, in the year 2000, which was further revised in 2006.

There is no available data on the total number of IEC in India, their level of functioning, availability of Standard operating systems for them, frequency of their meeting, composition, quality of ethics review.

Awareness and training has to improve even for IEC members regarding review process.

Institutional Ethics Committee

The composition has to be multidisciplinary, adequate gender representation; chairperson has to be an outsider, that is not a member of the institution. The IEC should review the circulated proposal informed consent and sponsor agreement well ahead of the scheduled IEC meeting.

As far as external regulation is concerned only the recent “Drugs and cosmetics (3rd amendment) rule 2013 vide GSR72 (E) dt 8/2/2013 Appendix VIII schedule” relating to new applications is there.

However, it is better, for IEC to get Strategic Initiative for Developing Capacity in Ethical Review Recognition.

Where do we stand?

Promoting research integrity model should be based on (1) internal component-honesty and integrity. This should come from within. (2) Deontological - rules and regulation, specified by statutory bodies like ICMR from time to time. (3) External framework - social values, learnt from home, office, religious places etc.

From anatomy research standpoint, there seems to be no set guidelines. Regarding the research in a cadaver procured as unclaimed - does not a cadaver while being alive had an option to give an informed consent for research, subsequent to death? Is it taken for granted that unclaimed bodies are prone for research and reporting for selfish career advances? Who gives the right? It is alright with voluntary body donation, where I can understand.

Next area of research in anatomy is osteology. Dry bones supplied by few vendors are used - are they legally entitled to sell? Who regulates the sale? Age old colleges did have burial system and bones reclaimed. But now?

The other common area of anatomy papers is dysmorphology/congenital anomalies. Is proper consent obtained from parents? Are these presentations/publications getting approval of IEC? Are journals insisting the submission of IEC approval letter?

If anatomy researchers have to go for ethical clearance, where are the guidelines? If ICMR is only for patients welfare, who is responsible for the ethics related to posthumous events? Nobody. Why not somebody?