Ethical consideration

Issues of ethical behavior are central to health professions. In conducting clinical trials and research projects ethical
issues should be taken in to consideration. It is unethical for an investigator not to give patients the best possible
treatment. Other way, it is unethical not to discover whether a new treatment is an improvement, since this would deny
future patients the possibility of a cure. It is also unethical to perform bad trials that give misleading results, and there
by encourage others not to use a treatment that is beneficial, or to use a treatment that is not beneficial, or may indeed
have harmful effects. Two important areas of ethical consideration are rights of human subjects and freedom from
harm. Three factors are important regarding the rights of the participants, confidentiality, anonymity and the voluntary
participation. It can be ensured through an informed consent which clearly explains the study objectives and states
participants’ right to accept or refuse to participate (Fowler & Chevannes, 2002).

Research Participants at Risk

Research participants at risk are individuals who may be harmed physically, emotionally, spiritually, economically,
socially, or legally through participation in a research study. A basic responsibility of the researcher and those assisting
in carrying out the project, is to protect all research participants from harm and while they are participating in an
investigation or as a result of the study.

Informed Consent

Informed consent is the process of providing an individual with sufficient understandable information regarding his or
her participation in a research project. It includes providing potential participants with information about their rights and
responsibilities with in the project and documenting the nature of the agreement. All consent forms need to assure
potential participants of their right to withdraw from a research study at any time. . Informed consent is the
researcher’s conscious and deliberate attempt to clearly and fully provide the potential participant with information
about the study. It is a fundamental responsibility of the investigator in human research to ensure research participants
understand the nature of the project and the implications of participation and the individual is able to decide freely
whether to participate in a project, without fear or reprisal. When the researcher fails to adequately inform potential
research participants about full nature of the research, there by preventing them from making an informed decision on
their participation is called deception.

Confidentiality & Anonymity

Confidentiality refers to the researcher’s responsibility to protect all data gathered within the scope of the project from
being divulged to others. Anonymity refers to the act of keeping individuals nameless in relation to their participation in
a research project.

Regulatory Bodies

The researcher may need to take permission from regulatory bodies for conducting research investigations, mainly when
subjects are human beings. There are regulatory bodies in most of the countries which grant permission after
considering ethical issues of the study. Indian Council of Medical Research (ICMR) released 'Ethical guidelines for
biomedical research in human subjects' in the year 2000which are similar to Good Clinical Practice (GCP) guidelines and
the prevalent international guidelines. These guidelines regulate all biomedical research in human subjects in India.