Question

please give a brief overview of your understanding of the following: foundational documents and principles of research ethics, sensitive research questions, confidentiality, and community-based research ethics.

2. What is the IRB?

3. Explain what is mean by exempted research? What are conflicts of interest (COI)?

Answer 1

Ans) Foundational documents and principles of research ethics:

- All research involving human subjects should be conducted in accordance with four basic ethical principles, namely respect for persons, beneficence, non-maleficence, and justice. It is usually assumed that these principles guide the conscientious preparation of proposals for scientific studies.

Sensitive research: studies in which there are potential consequences or implications, either directly for the participants in the research or for the class of individuals repre- sented by the research'. This definition of sensitive research is very general and by.

Confidentiality is the keeping of another person or entity's information private. Certain professionals are required by law to keep information shared by a client or patient private, without disclosing the information, even to law enforcement, except under certain specific circumstances.

Community-based research ethics:

Ethical challenges in CBPR include matters relating to: partnership, collaboration and power; community rights, conflict and representation; ownership and dissemination of data, findings and publications; anonymity, privacy and confidentiality; institutional ethical review processes; and blurred boundaries

2) In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research.

3) Exempt studies involve human subjects research: research involving a living individual about whom data. or biospecimens are obtained/used/studied/analyzed through interaction/intervention, or identifiable, private information is used/studied/analyzed/generated.

- A conflict of interest (COI) is a situation in which a person or organization is involved in multiple interests, financial or otherwise, and serving one interest could involve working against another. In business, a conflict of interest arises when a person chooses personal gain over duties to their employer, or to an organization in which they are a stakeholder, or exploits their position for personal gain in some way. Conflicts of interest often have legal ramifications.