| Clinical drug trials are full of ethical issues. In most | | | | studies free from ethical pitfalls. IRBs review protocol |
| cases, these trials involve experimentation on a | | | | and documents at the beginning of the study and |
| population of humans. The subjects are divided into | | | | through its duration. In many cases, they will "spot |
| groups - each group will receive a treatment or in | | | | check" these documents unannounced so no additions, |
| some cases they may be given a placebo. The drug | | | | deletions or other changes to the documentation can |
| trial tries to determine how the treatments impact the | | | | occur. |
| human subjects and whether or not the drug will help | | | | These review boards also try to create an accurate |
| humans. Clearly, any time humans are involved in | | | | picture of a drug's effects. They look for evidence of |
| medical research, there are a number of ethical issues | | | | potential harms associated with the medications. IRBs |
| at stake. | | | | can have difficulty making these determinations when |
| There are a few issues that have become unique to | | | | information is withheld from the boards. If a researcher |
| the 21st Century. Currently, the World Health | | | | does not share pre-existing conditions of human |
| Organization (WHO) works to keep trials transparent | | | | participants, the review board cannot be expected to |
| and ensures the results are published in clinical | | | | determine a side effect of a drug as the reaction |
| registries. Another common concern is "exporting" | | | | could be related to the aforementioned pre-existing |
| medical research studies. Many human rights | | | | condition. In some cases, IRBs simply are not provided |
| organizations are concerned the medical community | | | | with the information necessary to make a contextually |
| will reach out to poorer countries for human test | | | | correct judgment. |
| subjects. This issue is one of global justice and has | | | | Some in the medical community have suggested three |
| been regulated by organizations such as the WHO. | | | | ways in which independent review boards can expand |
| Protecting the rights and safety of human subjects are | | | | their reach and further assist in the review process. |
| other common concerns. Independent review boards | | | | The first suggestion includes ensuring a monitoring plan |
| have been formed to answer these questions and | | | | is in place for individual study sites. If each site knows |
| ensure every subject understands their rights as a | | | | how it will measure data before the study begins and |
| member of the drug trial. Duplication of efforts is a | | | | communicates that plan with the review board, there |
| worry among these organizations. In some cases, | | | | are fewer opportunities for mistakes. This step will also |
| monitoring is overemphasized while other tasks, such | | | | make the board's job much easier during the study. |
| as communication with patients, are underemphasized. | | | | Next, the IRBs certify investigators to ensure they |
| Other problems include confusion over monitoring | | | | understand their compliance responsibilities. |
| responsibilities, lack of integration and other | | | | Investigators trained in subject safety, adverse |
| communication disconnects. | | | | reaction reporting and collecting study documents will |
| Monitoring groups are also tasked with keeping | | | | help the board gather information it needs. Finally, the |
| research on track. They make sure patients have | | | | boards can review safety monitoring data to make |
| given informed consent, researchers have followed | | | | sure no other safeguards need to be added before |
| protocols, and documents dealing with unanticipated | | | | the trial begins. This will reduce the amount of time |
| events and adverse reactions are properly maintained. | | | | wasted during the trial and any ethical missteps can be |
| Independent review boards, IRBs, are one of the | | | | avoided early on. |
| groups responsible for keeping medical research | | | | |