The Food and Drug Administration issued a rulingin 1980 that allowed data from foreign clinical drug trials to
be used in new drug applications. This has resulted in an increase in pharmaceutical drug trials being
performed in developing countries. There is a strong incentive for drug companies to move human subject
testing to developing countries because it is less expensive to run trials and patientsare easier to recruit.
This research project exploreswhat can be done to ensure the rights of vulnerable trial subjects are not
violated.
Why does this research study need to be conducted?
Recent reports in the media detailing cases of unethical clinical trials have created public interest and
concern. The balance between ethics and profits in regards to doing clinical trials offshore needs to be
examined.
What specific issues does this study raise that have not been observed in other literature pertaining to the
topic?
There are currently laws in place to prevent clinical trial abuses; however, they are difficult toenforce.
This is especially true when dealing with multinational corporations. Instead of enacting more laws, the
organizations involved in the drug approval process should be self- regulating. In other words, these
organizations should voluntarily protect the rights of vulnerable research subjects.
Internet services have become more accessible in developing countries. A website should be set up that would
allow clinical trial patientsto report alleged ethical violations. Credible reports shouldbe investigated by
the World Health Organization (WHO). Once the ethical violations have been verified and confirmed by WHO, the
findings should be forwarded to the US regulators who determine if a drug should get market approval. Drugs
that have been developed using unethical research practices should not be allowed in the US market. Drug
companies would be discouraged from developing drugs using unethical practices because of the potential loss
of profits.
in this class do you find most convincing and why? Lay out the aspects of the thinker’s views you find most
compelling and defend your reasons for finding these ideas attractive. Be able to discuss the ideas of another
thinker covered in this class you find has the most plausible alternative to your “most compelling” thinker.
In the end, however, you will argue that your “most compelling” thinker is more convincing on balance.
Incorporate information from both of our course texts for evidence. Feel free to use outside evidence, but you
will mostly use our text(s) for support.