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When you design, develop, and manufacture a vaccine, you make decisions that could affect the health of your fellow Whyvillians. How you make these decisions with this in mind is known as BioEthics. BioEthics in medicine, particularly in vaccines, has evolved over the last century as drug discovery has evolved into a multi-billion dollar industry. One of the most important ethical guidelines was established in 1964 called the Declaration of Helsinki. This declaration governs biomedical research involving human participants. 1. Laboratory and Animal Experimentation. Research should be based on the results from laboratory and animal experimentation. When you create your vaccine, you first test it in a laboratory setting and if all goes well you begin running clinical trials starting with animals. Patient and public safety override all decision making. 2. Independent Review. Clinical trials involving humans must be reviewed by an independent committee before being allowed to proceed. Independence is important due to bias. When you spend long hours and lots of money developing a new vaccine, you really like the vaccine; you really believe it's going to work. Unfortunately, you are biased and have lost a critical component of scientific research: objectivity. That is ok; you are supposed to be passionate about the new vaccine. But, you need to bring in unbiased people to balance your bias. 3. Informed Consent. Subjects enrolled in the clinical trials must be volunteers who fully understand the potential risk of the unapproved vaccine. Each volunteer must sign a consent form agreeing to their understanding of the risks and trial regimen. A volunteer may exit the trial at anytime. This brings us to the question of the more vulnerable individuals and populations in our world. Vaccines are often given to children to prevent disease yet a child would not be able to provide informed consent. Third world countries have millions of people without healthcare who could provide many willing, motivated participants for clinical trials. Their motivation is derived by the fact the trial would provide some means of hope even if it is experimental. To prevent such exploitation, fair subject selection is a critical component of an ethically run clinical trial. Fair subject selection ensures the selected volunteers are chosen mainly for their scientific value to the study. In the case of vaccines, the best patient population to test the vaccine would be groups where the virus is actively present. Methods you use to recruit volunteers through advertising and payments can also become ethical issues. 4. Risk vs Benefits. The potential benefits of participating in the trial or taking the vaccine must exceed the risks. Perhaps vaccine development and approval would be sped along if we just gave our new vaccine to some unsuspecting Whyvillian and then exposed them to live virus. Even though the opportunity for a quick solution may be at hand, history has proven that this type of behavior would be considered unethical. Some other important ethical issues regard confidentiality and transparency. Patient confidentiality must be respected during a clinical trial. Their identity must remain anonymous and their medical records private except for what they consented to release. Your company must remain transparent by providing the public with accurate safety information regarding the vaccine.

When you design, develop, and manufacture a vaccine, you make decisions that could affect the health of your fellow Whyvillians. How you make these decisions with this in mind is known as BioEthics.

BioEthics in medicine, particularly in vaccines, has evolved over the last century as drug discovery has evolved into a multi-billion dollar industry. One of the most important ethical guidelines was established in 1964 called the Declaration of Helsinki. This declaration governs biomedical research involving human participants.

1. Laboratory and Animal Experimentation. Research should be based on the results from laboratory and animal experimentation. When you create your vaccine, you first test it in a laboratory setting and if all goes well you begin running clinical trials starting with animals. Patient and public safety override all decision making.

2. Independent Review. Clinical trials involving humans must be reviewed by an independent committee before being allowed to proceed. Independence is important due to bias. When you spend long hours and lots of money developing a new vaccine, you really like the vaccine; you really believe it's going to work. Unfortunately, you are biased and have lost a critical component of scientific research: objectivity. That is ok; you are supposed to be passionate about the new vaccine. But, you need to bring in unbiased people to balance your bias.

3. Informed Consent. Subjects enrolled in the clinical trials must be volunteers who fully understand the potential risk of the unapproved vaccine. Each volunteer must sign a consent form agreeing to their understanding of the risks and trial regimen. A volunteer may exit the trial at anytime. This brings us to the question of the more vulnerable individuals and populations in our world. Vaccines are often given to children to prevent disease yet a child would not be able to provide informed consent. Third world countries have millions of people without healthcare who could provide many willing, motivated participants for clinical trials. Their motivation is derived by the fact the trial would provide some means of hope even if it is experimental. To prevent such exploitation, fair subject selection is a critical component of an ethically run clinical trial. Fair subject selection ensures the selected volunteers are chosen mainly for their scientific value to the study. In the case of vaccines, the best patient population to test the vaccine would be groups where the virus is actively present. Methods you use to recruit volunteers through advertising and payments can also become ethical issues.

4. Risk vs Benefits. The potential benefits of participating in the trial or taking the vaccine must exceed the risks.

Perhaps vaccine development and approval would be sped along if we just gave our new vaccine to some unsuspecting Whyvillian and then exposed them to live virus. Even though the opportunity for a quick solution may be at hand, history has proven that this type of behavior would be considered unethical. Some other important ethical issues regard confidentiality and transparency.

Patient confidentiality must be respected during a clinical trial. Their identity must remain anonymous and their medical records private except for what they consented to release. Your company must remain transparent by providing the public with accurate safety information regarding the vaccine.

The Bioplex is sponsored by the State of Texas through the Texas Workforce Commission.