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Children In Research: Did they ever have a voice?

Updated on March 10, 2012


Research and Research ethics has been and always will be in question when it comes to procedure and protocol. Over the years many issues have arisen over how the process should be approached. Aspects such as design, potential dangers, and the validity of the studies being performed have been questioned. The most important aspect of research ethics however are those involving human beings. Over the years many things have been put into place to protect and assist the participants in making the correct choices in their participation. Informed consent, debriefing, and making sure that the participant’s benefits outweigh any potential disharmony or setbacks that can rise from the research study are just a few. This works out well for adults who can comprehend what the situation is, but what about the humans who are not yet developed enough to understand such stipulations and guidelines. Children have been a controversial subject when it comes to research and procedure. Can children legally be involved in studies if they do not have the mental capabilities to do so? In this hub we will see the way children’s involvement has changed over the years and how laws were eventually passed to ensure their safe harbor. New issues have also arisen due to technological advancements in present day lives.


Historically, human subjects and their safety were not very much of a concern until the late 1800s. Before that people were usually recruited without real knowledge of what exactly the research that was being performed was really about. They were usually not debriefed nor did they have to sign anything that asked for their permission. If this sounds bad for adults, children had it even worse. It’s no secret that children were abused and exploited it when it came to research throughout the centuries. Without any real power or sound of mind, children were prime candidates for even the most dangerous of experiments. Lainie Friedman Ross of MacLean Center for Medical Ethics explains that, “Historically, children were very abused. And if you want to talk about the history of children in research, for many years, there were greater protections for animals than there were for children in research (Thomson and Gale, 1).” Children were put in these risks without any knowledge of what was happening at the time. Even if the children were old enough to comprehend what the whole situation was, this information was not exactly extended to them anyways. Children in orphanages and other institutions were especially at risk as there was no one who really had any authority over their wellbeing (Thomson and Gale, 1). Eventually, there were many tragedies that helped open the eyes of some people who caught wind of this issue.

Such tragedies include pharmaceutical companies that tested varies vaccines or administered them to the children. The worst of this happening was in 1902 in St. Louis where twelve children died when given tetanus vaccines that were tainted (Aphp, 1). These children were not likely to have known that the vaccine was still in the trial phase and that it had not been passed as a viable source for protection. This however was not the only tragedy that struck a cord in the eyes of people. In other places around the country such as In Camden, NJ, there were reported cases where children vaccinated for smallpox also started dying (FDA, 1). In 1938, many children were used to test a new wonder drug that was supposed to be therapeutic. Children and their parents were not informed of the potential dangers of the new drug. Turns out there was some form of anti-freeze in the drug that didn’t go over too well with the children it was tested on and about 100 children died (FDA, 1). These along with a few other small instances started the eventual explosion of laws that began to be passed in order to protect children and their rights.


Laws for protection of participants started to come into place around the 1940’s which were influenced by the Nuremburg Code. Things such as informed consent and debriefing started to become important in order for the participant to understand the risks and benefits of the research being conducted (Thomson and Gale, 1). However, this was not really in place to help children because most of them still could not understand what exactly was being explained to them. Although earlier laws that were put in place such as the 1902 Biologics Act and the 1938 Food, Drug, and Cosmetic . Even after those tragedies above, it still failed to exclude children as a vulnerable population and was generally used more for the general public and not specifically for children. In 1978, the National Commission for Biological and Behavioral Research eventually produced the Common Rule, which was eventually picked up by all federal agencies that deal with research (Thomson and Gale, 1). This deals with even more specific guidelines for researchers to follow such as that the benefits of the research should outweigh the risks the participant is exposed to. It wasn’t until 1983 that the children’s version of this was revised for inclusion. For the most part, these laws stipulate that an adult or guardians permission is required before a child can actually participate in a study. The same factors that are in question for adults such as risk and eventual benefit is weighed evenly or even more so with children. This does not mean that children are not asked if they will participate however though, they are asked and their answer has pull depending on the situation.


Up until recently, children were not used in pharmaceutical trials. It is not only because of what had happened with the tragedies from earlier trials, but also because there was no real market it for it. Companies have had fear of being sued and only tested children on a voluntary basis. Medication and dosage requirements for children were never tested on children, but instead were based off percentages used for adults. This has been proven to be risky because children’s bodies differ from adults and smaller dosages may still be harmful if a drug is too severe for a child’s body. The FDA had growing concerns about these factors which eventually, “led to the FDA's passage of the Best Pharmaceuticals for Children Act that encourages drug trials for children (CDER, Section 3).” This mandate states that pharmacy companies must research on children if what they are releasing to the public is supposed to be used specifically for children. This guarantees safe practice for children while also encouraging better dosages and treatment for them in the long run. However, off the label basis can still be used by physicians if no tests have been done on children, this uses the old method of basing it off adult dosages. IRB’s have a huge responsibility in protecting children’s rights because they are considered a vulnerable population. If any single part of the population needs to benefit from such an institution such as the IRB, its children. They must adhere to the possibilities and outcomes of the research and its possible long term consequences on the children, be it mental or physical health. The IRB’s must follow the federal regulations in place in 45 CFR part 46 subpart D, also titled “Additional Protections for Children ( Shamoo and Resnik, 200).” This is tied in with the previous legislation for children added in 1983. This again stipulates the need for the adults or guardians of a child to have the authorized consent for involvement in research. This also explains that the child may also be required to give his assent or permission to be allowed to participate, but this is not always the case. They must also classify each research proposal into a certain category depending on the nature of the study and its subparts. These categories are based on the basis of risk with the first one being of very minimal research risk. The next category is some risk with some benefit to the child and the third one is some risk with no benefit to the child. The third one requires the IRB’s to, “consider whether the risk is a minor increase over minimal risk (Shamoo and Resnik, 200).” Then we finally have the fourth category with considerably risk with no benefits to the experiments. These are usually very hard to pass through the board and must try to prove that the eventual beneficiary outcomes outweigh the potential risks.

The National Institutes of Health or NIH also eventually went on to add their own policy including children while still adhering to 45 CFR 46. Their background explanation explains that, “The policy was developed because medical treatments applied to children are often based upon testing done only in adults, and scientifically evaluated treatments are less available to children due to barriers to their inclusion in research studies (NIH, 1).” This was made to companion the FDA’s passage of the pharmaceutical act which supports research on children in all aspects unless it is unethical or dangerous. This policy goes on to explain that researchers must make a section solely for the child. They must also explain his reasoning for including the child in research and how the experimenter will go about doing this. He must also explain the procedure, the facilities used, and the age of children wanted for the research. A committee then evaluates the proposal and either passes or dismisses the research (NIH, 1). Children’s rights in experiments have come a long way from what was in place as little as 50 years ago. A lot has been accomplished, but new sophisticated methods and technology has arisen that once again puts children at risk.



As a vulnerable population, children are at risk consistently throughout their lives. As new technologies arise, so do new problems children are faced with. With the new found glory of the internet, the way people live their lives has changed. The internet has changed the way people function from running businesses to making a living. It also gives researches a broader audience to administer their experiments on and to attain more data then was ever possible before. This audience however also includes children which may not understand what they are getting themselves into while playing around on the internet. There are no real guidelines set up to protect children and this lack of coverage does not seem to alarm many as of yet. If anything experimenters may not even consider this a real problem in terms of safety. Things on the internet can be faked and plagiarized with the simplest of ease. Children may forge consent forms or all together skip the process and pretend to be of age. There have been developments in the protection of children on the internet. As of 2001, “The Children's Internet Protection Act” has put in place to protect children on the internet. However, this mostly protects children against pornography, obscenities, other things considered dangerous for a child to view (NSBF, 1). No real stipulations have really been put into place for the protection of the exploitation of children in research or in studies. Sadly, a tragedy or outrage is probably what it will take to bring the real attention this deserves just like in the early 1900’s. Another problem plaguing this research is that there is a lack of validity involved when doing internet studies. Many times children even in the very most controlled studies seem to have a problem doing a certain task. Over the internet there would probably be even more cohorts and external variables interfering with the data collection process. Also the new passage of the FDA’s pharmaceutical children’s act is now also a new area of concern for modern biomedical research done on children. Although it is a good idea to have correct dosages applied to children’s prescriptions, there are risks involved when including children in such clinical trials. Memories of the past vaccines that killed numerous children are also invoked with this new act. The FDA is not a group such as the IRB and does not require that informed consent be attained from the parent or child (CDER, Section 9). This is a huge setback considering all the work it took to have the current laws in place to protect such a thing. The FDA is not required to adhere to the guidelines set down by 45 CFR46 which has many activists fuming, but has some companies in smiles. Placebo control groups are also acceptable if there is a lack of other results or previous groups to compare it too (CDER, Section 9). This is an ethical issue simply because how can you not treat a child who may possibly benefit from the medication in question. If the child ends up dying from the lack of treatment, is it still considered positive if it saves millions of others? Hardly, these along with the rest of the previous examples have proven to be huge issues that have arisen with the new passage of the act. It is not all negative though, the act does try to accomplish something inherently good by making companies better prescribe dosages better suited for children. It is the techniques and methods that need to be tweaked before optimum benefits can be reached from such a provision.


Children rights in research has come a long way from being treated worse then animals. As being considered a vulnerable population, they constantly need the protection from the dangers that go along with research. Many people may have never really thought about children involved in research other then the parties involved in actual experimental research. They may reap the benefits without knowing the numerous amounts of laws that had to passed down to protect children. Ethical concerns have and always will be an issue when our children are involved. As new and more technological advancements in research methods develop, it is the responsibility of every true researcher to keep or create new guidelines in order to protect the future generation of experimenters.

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