7.Statement of general principles & general ethical issues:
General Principles:
Every research has some inherent probabilities of harm or risk and thus, the protection of research participants and/or communities should be built into the design of the study. Ethics Committee must ensure that the research is conducted in accordance with the basic principles. The basic principles have been expanded into 12 general principles (as listed below), which are applicable to all biomedical and health research involving human participants or research using their biological material or data.
1. Principle of Essentiality
Principle of Voluntariness
Principle of Non-exploitation
Principle of Social Responsibility
Principle of Ensuring Privacy & Confidentiality
Principle of Risk Minimization
Principle of Professional Competence
Principle of Maximization of Benefit
Principle of Institutional Arrangements
Principle of Transparency & Accountability
Principle of Totality of Responsibility
Principle of Environmental Protection
General Ethical Issues:
There are some general issues that must be kept in focus during the conduct of biomedical and health research involving human participants (listed below):
Benefit-risk assessment
Informed consent process
Privacy and confidentiality
Distributive justice
Payment for participation
Compensation for research-related harm & ancillary care
Conflict of interest
Selection of vulnerable and special groups as research participants
