Question

medical ethics:

an example of biomedical research on human subjects and evaluate its ethical status with explicit reference to the common rule

Answer 1

Ethical Principles for protecting study participants (human subjects)

The Belmont report articulated 3 primary ethical principles on which standards of ethical standards are based

• Benefience
• Respect for human dignity
• Justice

Beneficience

This is the most fundamental and basic principle , which imposes a duty on researcher to minimize harm and maximize benefits.This principle covers multiple dimensions

1. Right to freedom from harm and discomfort

Participants must not be subjected to unnecessary risks , harm or discomfort and their research must focus on acheiving scientifically and societally important aims. In research iof humans , harm and discomfort has many forms such as physical (eg: injury), emotional (eg: stress), social (eg: loss of social support and financial (eg: loss of wages).Ethical Researchers must be prepared to terminate the research if it is reason to suspect that continuation should bring in injury, death or undue distress to the participants. The need for sensitivity is greatly involved in qualitative studies which involve in-depth analysis of an individual's personal experience such as fears and anxieties

2. Right to Protection from Exploitation

Involvement in study should not place participants to a situation in which they have not been prepared . Participants should be assured that information provided by them should not be used against them in anyway. For Eg: a person describing his or her ecnomic circumstances should not place them in the risk of losing public health benefits. usually in qualitative researchers are better than quantitative researchers in 'to do good' rather than just to avoid doing harm. This is because of the close-relationship that a researcher develops with study participants during the course of study

Ex: Participants in the Beck's study(2005) on birth trauma and post traumatic stress disorder expressed a range of benefits they derived from e-mail exchanges with Beck

Respect for Human Dignity

The principle include Right to self-determination and Right to Disclosure

It means that prospective study participants have the right for determinine voluntarily whether to participate in a study without risking penalty or prejudicial treatment. It also includes freedom from coercsion of all types. Coercsion means explicit or implicit threats of penalty from failing to participate in a study or excesive rewards from agreeing to participate

Right to full disclosure

It encompasses people's right to make informed,voluntary decisions about study participation, which requires full disclosure ( nature of study, participants right to reuse or participate in a study. responsibilities of a researcher, risks and benefits)

Justice

Which includes participants Right to Fair treatment and Right to privacy

Right to fair treatment

selection of study participants should be based on research requirements not on vulnerability of population

Right to privacy

The information provided by the participants should be kept as highly confidential and privcy should be maintained throughout the study