The regulation of risks in human subject research

Risks are regulated in the way that all human researches should be based on three ethical principles:-

1. Respect for persons:

- the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy;

- protect those who are incapable of self-determination e.g. mental disability;

- enter the research voluntarily and provide with adequate information;

- not to coerce.

2. Beneficence:

- to secure their well-being;

- do not harm, minimize possible harms;

- maximize possible benefits;

- make sure it is justifiable to seek certain benefits despite the risks involved and when the benefits should be foregone because of the risks;

- consider long term or immediate benefits.

3. Justice:

- fairness in distribution or what is deserved

(1) to each person an equal share

(2) to each person according to individual need

(3) to each person according to individual effort

(4) to each person according to societal contribution

(5) to each person according to merit;

- selection of research subjects (not because of their simple availability / compromised position) should be directly related to the problem being studied.

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