Describe the differences among ethics standards, guidelines, regulations, and institutional policies.

Question

What will be an ideal response?

Answer 1

Ans: Ethical standards are the guiding principles that should govern the design and conduct of the research. They are generally considered universal, and are reflected across all guidelines, regulations, and policies. Guidelines can be issued by international bodies, such as the UNAIDS or more focused organizations like the HIV Prevention Trials Network. Guidelines do not carry the weight of law and are therefore not enforceable. However, they are often considered to represent best practices. Regulations, which are typically developed at the national level, set the rules for implementing the ethical standards. Unlike guidelines, regulations can be enforced by regulatory authorities. Regulations identify specific requirements for conducting the research as well as for the documentation of compliance, and impose penalties for non-compliance. Institutional policies are developed by organizations that conduct research to define at the institutional level how all relevant standards, guidelines, and regulations will be incorporated in the research implemented by the organization.