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Table 2 Specification of the moral principles for clinical experiments that can be found in the Nuremberg Code (NC), Helsinki Declaration (HD) and Common Rule (CR)

From: An Ethical Framework for Evaluating Experimental Technology

Moral principle Specific rules and considerations Codes Conditions in Table 3
Non-maleficence 1a. No other means for acquiring knowledge (first other modes of acquiring knowledge) NC2 1
1b. Monitoring of data and of risks CR6, HD17 2
1c. Possibility and willingness to adapt or terminate the experiment NC10, HD18 3
1d. Avoid unnecessary harm, minimize risks NC4, CR1, HD14, HD17, HD28 4, 5, 6, 7
1e. Avoid death or disabling injury NC5 4, 5, 6, 7
1f. Measures to protect against possible risk NC7, HD17 4, 5, 6, 7
1g. Minimize harm to the environment HD11 4, 5, 6, 7
1h. Protect privacy of experimental subjects CR7, HD24, HD32 2
Beneficence 2a. Benefits to society NC2 8
2b. Anticipated results justify performance of experiment NC3 8
2c. Positive benefit/risk ratio NC6, CR2, HD16 n.a.
2d. Qualified experimenters NC8, HD12 9
2e. Scientifically and methodologically sound NC3, HD21 2, 4
2f. Publication and dissemination of outcomes of study HD36 n.a.
2g. Access to unproven but hopeful intervention if no effective intervention available HD37 n.a.
2h. Physician should promote and safeguard the health, well-being and rights of patients HD3, HD4, HD7 n.a.
Respect for autonomy 3a. Informed consent NC1, CR4, HD 25–32 10, 11, 12
3b. Possibility to withdraw from the experiment NC9, HD29, HD31 13
Distributive justice 4a. Equitable selection of subjects CR3 14
4b. Protect vulnerable subjects CR8, HD19 14
4c. Only vulnerable groups if they also profit from the research HD20 15
4d. Appropriate access to experiment and results for underrepresented or vulnerable groups HD13, HD20, HD28 15
4e. Test against best proven intervention HD33 15
4f. Post-trial access to intervention for all experimental subjects HD34 15
4g. Rights and interests of research subjects are more important than knowledge acquisition HD8 15
4h. Compensation and treatment for harm HD15 16
Procedural justice 5a. Documentation of informed consent CR5 n.a.
5b. Presence of adequate research protocol HD22 9
5c. Ethics committee/IRB HD23 11
5d. Registration in publicly available database HD35 n.a.
Responsibility 6a. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment NC1 n.a.
6b. Physician remains responsible for health of patients even if informed consent has been given HD9 n.a.