Ethical Considerations and Clinical Trials

¶ … approved drugs are used in children and pregnant women, although these drugs have never been tested in these vulnerable populations. Do you think clinical trials should be conducted in children and pregnant women to determine the efficacy and safety of these drugs? Why or why not? Although clinical trials remain the gold standard for evaluating the efficacy of drugs, when it comes to vulnerable populations, there is little or no room for experimentation, especially when it involves potentially harmful substances.

While some social science researchers might disagree with this view, an acid-test for these advocates would be to ask them if they would approve of such clinical trials being conducted on their wives, mothers, sisters and daughters if they represented any type of risk.

It is reasonable to suggest that proponents of such clinical trials support their position only to the extent that such trials are conducted outside their own circle of family and personal relationships, and they would prefer that any such trials be conducted as far away from them as possible, preferably in a developing country where people have less to lose, after all.

Because researchers are able to accurately extrapolate the effects of drugs on women and children using other methods (Miller & Prosek, 2013), it is also reasonable to conclude that using women and children in clinical drug trials is not only unnecessary, it is downright unethical as well.

This is not to say that clinical trials are inappropriate in certain situations such as adult women who are not pregnant and are otherwise in a position to give their unqualified informed consent, but it is to say that such trials have the potential to exploit vulnerable populations and any such attempt must be viewed with close scrutiny for this potential.

What special issues might be encountered when conducting a clinical trial in an emergency-room setting? The overarching issue that must be taken into account is the need to conduct any clinical trial in ways that do not interfere with the life-saving efforts of the emergency room staff. Beyond this special issue, other issues that might be important include the same constraints that affect clinical trials with any vulnerable population.

Patients and family members in emergency room settings are under a great deal of stress already, and decisions concerning requests for informed consent to participate in a clinical trial of any sort will inevitably be affected by these circumstances. Should special efforts be made to increase the enrollment of cultural and ethnic minorities in clinical trials, and if so, what steps would you propose? Given the U.S.

government's sorry track record of exploiting vulnerable populations for medical research (i.e., the Tuskegee syphilis experiment and the "Atomic veterans"), the first thing that needs to be done to increase the enrollment of cultural and ethnic minorities in clinical trials is to educate these populations concerning the need for specialized research for the types of health care issues that affect them the most (i.e., diabetes, obesity, high blood pressure, cancer, substance abuse and others).

Moreover, while these differences are well documented, there remains a lack of awareness among cultural and ethnic minority populations that will need to be addressed before any recruitment efforts can be effective (Epstein, 2007). In addition, although it is reasonable to suggest that some members of cultural.