I. What are Safety and Ethics in Research?
WIthin this section, we’ve discussed many different experimental techniques and their application towards biological and medical research. With research, however, comes many ethical dilemmas that should be considered, especially in the context of DNA technology.
Embryonic stem cell use, DNA viral vectors, genetic screening in unborn infants, and many more are all topics of great discussion and debate when it comes to the ethics of medical research. While in many cases there is no right or wrong answer, we do have some established guidelines that can help us.
The Belmont Report is an extensive document outlining basic ethical research principles that should be abided by when undergoing research. Though this topic is particularly low yield, take this as some food for thought and see if you can make any similar connections in other subjects!
II. The Belmont Report
The document outlines three main principles to abide by in conducting research: 1) Respect for Persons, 2) Beneficence, and 3) Justice. Let’s cover them briefly and see how they apply!
A. Respect for Persons
Though we should all do it in our daily lives, the respect for persons in research centers around patient autonomy and protection. A big component of this is that the patient receives informed consent about the research they’re partaking in.
Similarly, informed consent has 3 main components: voluntariness, information, and comprehension.
Informed consent requires that a patient freely volunteers for the research study while being informed about the study & potential risks in a way that’s fully comprehensible to the patient.B. Beneficence
This principle centers around the idea of maximizing the potential benefits for both the patient and the afflicted population while also minimizing possible harm, also known as nonmaleficence.
A good way to think about this is to ask the question “is there a more efficient and less risky way to obtain the data?”.
While overall we want to obtain a net positive result, it’s important to do so in a way that minimizes the possible discomfort and harm that can occur.
C. Justice
While definitely another staple we should all live by, justice in research scenarios is most applicable when recruiting subjects for a research study. More specifically, this principle ensures equal representation and fair distribution of the benefits and risks of research.
One way to think about this is that it wouldn’t be fair for a study group composed of lower income to bear all the harmful risks of the research study while the wealthy, upper class population will reap the research benefits.
Although now morally obvious, this hasn’t been the case historically. The Tuskegee Syphilis Study was a highly immoral research study performed on uninformed, Black men suffering with syphilis, where researchers wanted to observe disease progression when left untreated.
III. Bridge/Overlap
Now having talked about the above mentioned ethical principles that have been set in place, let’s see an example of them applied in the context of DNA biotechnology.
I. Safety and Ethics in DNA Biotechnology
Viral vector gene therapy is a highly encouraging research procedure which has been used for the delivery of functional genes with the hopes of curing genetic disorders where genes are defective.
However, we can potentially use the principle of beneficence to argue against the use of viral vectors, as the viral vector can potentially cause a severe immune reaction possibility during more harm than good.
What would you say? Do the potential benefits outweigh the risks? Take this as some food for thought and maybe take this discussion up with friends and professors!IV. Wrap Up/Key Terms
Let’s take this time to wrap up & concisely summarize what we covered above in the article!
A. Respect for Persons
This principle ensures that patient autonomy and protection are met first and foremost when conducting research studies, with a big component being informed consent.
Informed consent is achieved via 3 main components: voluntariness, information, and comprehension.B. Beneficence
When conducting research, the principle of beneficence allows us to assess if the study is maximizing the potential benefits while also minimizing possible harm, also known as nonmaleficence.
Overall we want a net positive result in terms of benefits, but what to do so by minimizing the possible occurrence of harm and discomfort.C. Justice
This principle heavily applies during recruitment of subjects for the study, as it ensures there is equal representation in the group and that there’s a fair distribution of the benefits and risks of research.
V. Practice
Take a look at these practice questions to see and solidify your understanding!
Sample Practice Question 1
As mentioned above, when the Black Americans were participating in the Tuskegee Syphilis Study, they were not informed that they were indeed diagnosed with syphilis. Which Belmont Report principle was violated by this act?
A. Respect for Persons
B. Beneficence
C. Justice
D. None of the above were violated
Ans. A
Recall that the “Respect for Persons” principle in the Belmont Report ensures patient autonomy and informed consent is protected. Because they were not informed of their diagnosis, this is a clear violation of autonomy and informed consent!
Sample Practice Question 2
In order to save funds, a research group aims to recruit subjects suffering from diabetes for a new clinical drug trial targeting a minority community with a fairly cheap monetary incentive. Which of the following Belmont Report was violated by this act?
A. Respect for Persons
B. Beneficence
C. Justice
D. None of the above were violated
Ans. C
Here, we see that equal representation and fair distribution of the benefits and risks are not present, as the researchers are only targeting a minority community. This limits the equal representation of the entire population and also unequally distributes the burden of the risks of the research study to just the minority community,
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