Legal Issues
Any breach of ethical principles has potential to be a matter for litigation. Common legal concerns with research fall into three categories.
Professional Indemnity: Where a researcher is collecting research data in a field outside of their place of employment, the issue of indemnity needs to be addressed. This is often achieved through an contract between the hospital and the researcher. Privacy legislation: Specifically, ethics committees need to know how patient data will be kept confidential and how participants will be recruited. Recruitment processes thus require the researcher to advertise the study and participants to volunteer their involvement. Ownership of data: This can be a issue for research which is the subject of a contract, and can also arise with competitive research grants. |
Ethical Issues
When conducting research involving human beings, investigators are bound by ethical guidelines. The basic ethical principles that have been identified are 1) respect for persons, 2) beneficence, and 3) justice.
- Respect for persons addresses two ethical issues. The first being research individuals should be treated as autonomous agents. An autonomous person is capable of weighing options and making decisions pertaining to personal goals. The second issue addressed is that of a person with diminished autonomy should be protected. This refers to protecting those incapable of weighing the information needed in decision making. An example of this would be children, those mentally disabled, or individuals under duress. The ethical principle of respect for persons is responsible for the requirement of obtaining informed consent from the research participant (or representative) prior to beginning research. Information presented to the participant must include adequate information to allow the weighing of risks and benefits (discussed next).
- Next, beneficence is simply requiring the researcher to do no harm and maximize the benefits and minimize the possible harms to the test subject. Essentially, the researcher is bound to develop investigations that will minimize harm and produce benefits greater than potential harm to the subjects. This requires assessments of risks and benefits during the development of the research. Likewise, ongoing assessments are required to monitor the effects of research on the subjects. Should the potential harm shift to outweighing the potential benefits, the research must halt. In research, risk to humans cannot ever be completely eliminated. However, assessment and reduction of risk through alternative procedures must be maintained to adhere to ethical behavior.
- Finally, justice addresses the issue of fairness in research. Withholding a benefit a person is entitled to without good reason or purposefully imposing an undue burden on test subject are examples of injustice in research. Justice is required in the selection process of research. All subjects must be considered fairly and equally. Preferential treatment may not be given to one person over another. Likewise, negative aspects of research should not be imposed on a less desirable group. By this it is meant no distinction should be made between races, gender, age etc. within the potential research pool. All qualified persons should have the same opportunities within the research.
References
Endacott, R. (2004). Clinical research 2: Legal and ethical issues in research. Intensive & Critical Care Nursing, 20(5), 313-5. doi:http://dx.doi.org/10.1016/j.iccn.2004.04.006
Endacott, R. (2004). Clinical research 2: Legal and ethical issues in research. Intensive & Critical Care Nursing, 20(5), 313-5. doi:http://dx.doi.org/10.1016/j.iccn.2004.04.006