Ethics Opinions

In general, genetic manipulation should be reserved for therapeutic purposes. Efforts to enhance “desirable” traits are contrary to the ethical tradition of medicine. In addition to fundamental ethical requirements for the appropriate conduct of research with human participants, research in gene therapy or genetic engineering must put in place additional safeguards to vigorously protect the safety and well-being of participants and future generations.

Human participants who contribute to research involving DNA databanks have a right to be informed about the nature and scope of the research and must give consent for how their information may be used.

Physicians who conduct research using stem cells obtained from any source must, at a minimum, adhere to institutional review board requirements, ensure that the research is carried out with appropriate oversight and monitoring, and ensure that the research is carried out with appropriate informed consent.

Physicians involved in research with human biological materials should disclose potential commercial applications to the tissue donor, obtain informed consent to use biological materials in research from the tissue donor, and share profits from the commercial use of human biological materials with the tissue donor.

Minimizing and mitigating conflicts of interest in clinical research is required in order to justify and maintain trust in the medical research community.

Physicians with oversight responsibilities in biomedical or health research have a responsibility to ensure that allegations of scientific misconduct are addressed promptly and fairly.

Data obtained from cruel and inhumane experiments should virtually never be published. In the rare instances when ethically tainted data have been validated by rigorous scientific analysis and are the only data of such nature available, and human lives would certainly be lost without the knowledge obtained from the data, it may be permissible to use or publish findings from unethical experiments.

Physicians who develop medical innovations may ethically patent their discoveries or products but should not allow patents to languish or use patents to limit the availability of medical innovations.

Use of placebo in the control arm of a study deprives these patients of the accepted therapy for a period of time. As such, the use of a placebo control will more easily be justified as the severity and number of negative side effects of standard therapy increase.

In certain situations and with special safeguards, it can be appropriate to provide experimental treatment without a participant’s informed consent. To protect the rights and welfare of participants in research on emergency medical interventions, physician-researchers must ensure that the experimental intervention has a realistic probability of providing benefit equal to or greater than standard care and that the risks associated with the research are reasonable in light of the critical nature of the medical condition and the risks associated with standard treatment.