Reflection on NIH Ethics Course 1

Reflection on NIH Ethics Course

Kristina Patton

University of South Florida

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Reflection on NIH Ethics Course

The National Institutes of Healths web-based course Protecting Human Research

Participants is very eye-opening reading. What should have been common decency

consideration during any kind of study was not the case when it came to the rights and welfare of

human research subjects. The Belmont Report Ethical Principles and Guidelines for the

Protection of Human Subjects of Research, put out by the National Commission in 1979,

identifies three principles that serve as the foundation of the Department of Health and Human

Services (HHS) current regulations for ethical conduct when doing research with human

subjects. All NIH-funded human subject research must be reviewed and approved by an

Institutional Review Board, also called IRB. The IRB is responsible for making sure all human

subject studies are in compliance with federal policy, and remain in compliance throughout the

research. The IRB is also in place to conduct reviews of research in other countries that fall

under similar guidelines that govern each country. The course covered a lot of information, such

as the regulations and policy for researchers to follow. Those policies are important to know, but

they are readily available through the office of the Department of Health and Human Services

(HHS), and easily accessed when needed. However, the three principles of Respect for Persons,

Beneficence, and Justice, are the foundations to conducting an acceptable and lawful experiment.

Understanding what each of these principles entail and always applying them to any potential

experiment involving human subjects is very important. No matter how important the results of

an experiment may seem to a researcher, it is always critical to remember to remain humane in

the search for answers.

The first principle, Respect for Persons, basically says research participants must be able

to give informed consent without any coercion. This means a human subject must be given full
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disclosure about the research, and must be able to understand the risks and potential benefits

relating to personal values, and be able to weigh any potential harms and benefits involved in the

research. Plus there must be adequate time given to make a completely voluntary decision. This

also applies to people with diminished capacity who are given additional protection. For

instance, children must have informed parental consent, and guardians of those with diminished

mental capacity must also give permission before any research can be conducted. Beneficence is

another principle, and it has two rules that researchers must keep in mind as they consider if the

benefits outweigh the risks of their study. They are Do no harm and Maximize possible

benefits and minimize possible harms (NIH). Lastly, researchers must apply the principle of

Justice as well. This means that research results will be equitably distributed among the populace

and that the results will not compromise or harm any particular group. For instance, if the results

of the research being released will it adversely affect a particular group of people, then it should

not be released or even conducted.

The course gave two examples of unethical and inhumane studies that involved testing

human subjects where they were treated as objects rather than people. The first example is The

Syphilis Study at Tuskegee, in which many men died unnecessarily in the name of research due

to unethical conduct of the researchers involved. Because respect for persons and beneficence

were not considered, men suffered and died. They should have been informed of the experiment

and should have been treated for their conditions rather allowing a whole group to suffer and die.

Another example of how important it is to have policies in place to regulate behaviors of

researchers involving human subjects involves the atrocities that came to light at the Nazi

Medical War Crimes at Nuremberg. Once again, because there were no policies in place and a

blatant disregard for respect of life, lack of beneficence and justice in conducting experiments,
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there were so many people who suffered and died in the name of research. Scientists and doctors

committed inhumane crimes against humanity by torture, mutilation, and killing people in

concentration camps (NIH). So the laws are in place to hold researchers accountable for their

conduct and treatment of human subjects, plus to hold them responsible for the results of their

experiments. By keeping in mind the principle of Justice, researchers must really look deep,

analyze, and weigh the benefits verses the risks of whether or not to conduct an experiment.

They must determine whether the good outweighs any potential risks involved. We saw two

separate cases where these three principles were not considered and so many unethical

experiments were conducted resulting in permanent injury or death to thousands of people.

Understanding these key principles and knowing the regulations that govern conduct in research

involving human subjects is essential for investigators in research. It guides them in all aspects of

the research. All decisions as to what kind of research, how relevant it is, how beneficial or

harmful the research is and even how the results can effect a population or sub-group of the

population, then how to conduct the research itself.

As future educators, we will need to rely on research studies to guide us in some of our

decisions about which theories work best in our schools and with our students. We need to make

sure we find and use reliable case study results, those that applied the principles expressed in this

course and followed the guidelines set by the Department of Health and Human Services.

Educators must understand human behavior in order to be effective teachers, so we may be

involved in research studies that have human subjects. When that is the case, we must know how

to go about deciding what is an acceptable study to conduct, how and who the human subjects

will be, whether the experiment will be just or not all these must be carefully considered before

any experiment can be done. Plus if investigators or researchers do not know about these
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principles that are part of our federal regulations and policies, they will not be granted funding

nor approval for their experiment. In order to get funding to assist in a study, the study must be

within the rules and regulations of federal, state, and local policies. Just by keeping in mind and

applying the three principles of Respect for Persons, Beneficence, and Justice when considering

and writing up a case study, a researcher will know whether it is a viable experiment or not and if

it will be beneficial or not, and more likely to get support and funding from NIH.
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Certificate of
Completion
The National Institutes
of Health (NIH) Office of
Extramural Research
certifies that Kristina
Patton successfully
completed the NIH
Web-based training
course Protecting
Human Research
Participants.

Date of completion:
08/28/2015

Certification Number:
1824816