| Literature DB >> 26573302 |
Abstract
How are we to appraise new technological developments that may bring revolutionary social changes? Currently this is often done by trying to predict or anticipate social consequences and to use these as a basis for moral and regulatory appraisal. Such an approach can, however, not deal with the uncertainties and unknowns that are inherent in social changes induced by technological development. An alternative approach is proposed that conceives of the introduction of new technologies into society as a social experiment. An ethical framework for the acceptability of such experiments is developed based on the bioethical principles for experiments with human subjects: non-maleficence, beneficence, respect for autonomy, and justice. This provides a handle for the moral and regulatory assessment of new technologies and their impact on society.Entities:
Keywords: Bioethical principles; Ethics; Experiment; Human subjects; Informed consent; Technology
Mesh:
Year: 2015 PMID: 26573302 PMCID: PMC4912576 DOI: 10.1007/s11948-015-9724-3
Source DB: PubMed Journal: Sci Eng Ethics ISSN: 1353-3452 Impact factor: 3.525
Relation between ethical principles for clinical experiments (Emanuel et al. 2008) and bioethical principles (Beauchamp and Childress 2013)
| Principle (Emanuel et al. | Bioethical principle (Beauchamp and Childress |
|---|---|
| Collaborative partnership | Justice, respect for autonomy, non-maleficence |
| Social value | Beneficence |
| Scientific validity | Beneficence |
| Fair participant selection | Justice |
| Favorable risk–benefit ratio | Beneficence, non-maleficence |
| Independent review | (Procedural) justice |
| Informed consent | Respect for autonomy |
| Respect for participants | Respect for autonomy, justice, non-maleficence |
Specification of the moral principles for clinical experiments that can be found in the Nuremberg Code (NC), Helsinki Declaration (HD) and Common Rule (CR)
| Moral principle | Specific rules and considerations | Codes | Conditions in Table |
|---|---|---|---|
| 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. |
An ethical framework for experimental technology
| 1 | Absence of other reasonable means for gaining knowledge about risks and benefits |
| 2 | Monitoring of data and risks while addressing privacy concerns |
| 3 | Possibility and willingness to adapt or stop the experiment |
| 4 | Containment of risks as far as reasonably possible |
| 5 | Consciously scaling up to avoid large-scale harm and to improve learning |
| 6 | Flexible set-up of the experiment and avoidance of lock-in of the technology |
| 7 | Avoid experiments that undermine resilience |
| 8 | Reasonable to expect social benefits from the experiment |
| 9 | Clear distribution of responsibilities for setting up, carrying out, monitoring, evaluating, adapting, and stopping of the experiment |
| 10 | Experimental subjects are informed |
| 11 | The experiment is approved by democratically legitimized bodies |
| 12 | Experimental subjects can influence the setting up, carrying out, monitoring, evaluating, adapting, and stopping of the experiment |
| 13 | Experimental subjects can withdraw from the experiment |
| 14 | Vulnerable experimental subjects are either not subject to the experiment or are additionally protected or particularly profit from the experimental technology (or a combination) |
| 15 | A fair distribution of potential hazards and benefits |
| 16 | Reversibility of harm or, if impossible, compensation of harm |