Jun 27 2022

Important Laws for Researchers Working in USA

Albert Fred


Academic researchers, like the rest of us, are bound by legal obligations and regulations. If academic researchers, whether it be scientific research, historic, or mathematical, do not adhere to the regulations set in stone by their regulatory bodies, they could be in breach of federal regulations and could find themselves in considerable trouble. Because of this, academic institutes strictly monitor and regulate their staff to ensure they do not break any regulations and impose strict punishments upon those that do. Mistakes do happen, yes, but in academic research, a mistake can cause a lot of problems, which is why academic researchers are so strictly vetted.

In this article, as our title likely gives away, we will be discussing a few important laws and regulations that have been introduced to monitor and control academic research. The regulations listed here will cover a broad number of topics and in this article, we will not drill down on a single academic subject – rather we will choose to include laws and regulations from a number of areas of academia. This is a very important subject if you are a researcher, so we ask earnestly that you continue reading.

Here are a few important laws for researchers working in the United States of America.

Federal Regulations

First on our list are federal regulations. These regulations are enforced by the federal government and a breach of one of these can lead to serious trouble – including subpoenas and fines. If you have been unlucky enough to receive a subpoena and visited this article with hopes of discerning key information from subpoena content, we suggest you look elsewhere. All we can offer is advice you contact an attorney and do not breach federal regulations again in the future. Now, moving on…

45 CFR Part 46 [‘The Common Rule’]

45 CFR Part 46 also known as The Common Rule is a Health and Human Services [‘HHS’] policy that ensures the protection of human subjects involved in federally funded, licensed, and proposed research. There are a number of protections in place under this rule to ensure that human beings involved in research are treated fairly and that their wellbeing is prioritized. Breaching this can have serious consequences.

21 CFR Part 50 Human Subjects Protections and Additional Safeguards for Children in Clinical Investigations

21 CFR Part 50 Human Subjects Protections and Additional Safeguards for Children in Clinical Investigations was introduced to describe the informed consent requirements which are mandatory by all clinical investigations carried out by the Food and Drug Agency [‘FDA’] underneath the Federal Food, Drug, and Cosmetics Act.

21 CFR Part 56 Institutional Review Boards

The 21 CFR Part 56 Institutional Review Boards contains general standards and practices for the administration of drugs for human use, as well as medical devices, biological products, electronic products, and medicinal products. It also contains the responsibility of an Institutional Review Board [‘IRB’] in reviewing clinical investigations.

21 CFR Part 312 Investigational New Drug Application

This rule was written up to detail the procedures, requirements, and things that the FDA must do when they are investigating new drugs and how to administer them to people. The investigation of new drugs is carefully monitored, for if any errors were to be made, there would be grave consequences.

21 CFR Part 812 Investigational Device Exemptions

21 CFR Part 812 IDE provides researchers with the proper procedures and conduct for clinical investigations of devices. Approved investigational devices must be handled and used properly. This is another area that is strictly regulated and one that must be adhered to by all researchers, academic or not.

State Statutes

State statutes vary from state to state, so for the purposes of this article, we will be using California as an example, being that all of their statutes can easily be found online. Many of the statutes introduced in California are the same or similar to those introduced in other states across North America. State statutes are enforced by the state government, not the federal government. Here are a few state statutes that must be adhered to:

Human Cloning

Under California law, the cloning of human beings, human reproductive cloning, or the sale of embryo’s, foetuses, zygotes, and ovum’s are illegal. If a person were to be caught trading these or to be engaged in the act of human cloning, they would face grave consequences and would likely be prosecuted to the full extent of the law. This is an important area researchers must adhere to, especially since we now live in a modern age wherein cloning and artificial intelligence are extremely relevant. Do not get caught breaching this law – lest you never work in academia again.

State Death Data Records

In California, researchers are required to attain IRB review should they want to use death data records sourced in California, as well as identifying information, such as death certificates. If you intend on researching and examining death statistics, you must first see the IRB review.

Human Subjects in Medical Experimentation

As with federal law, state law also regulates the use of human subjects in medical experiments and their protection. It is important that this bill, which can be found as Section 24170-24179.5 is adhered to. This law, known as a ‘subject’s bill of rights’ must be provided to every single research subject in medical experiments. It is very important, as with federal law, that this is adhered to. Additionally, if a researcher was to breach this, there is a strong chance they could break federal law and state law, which would yield a serious punishment.

Opioid, Stimulant, and Hallucinogenic Drugs

In California, research projects that hope to use specific opioid, stimulant, and hallucinogenic drugs which are classified as Schedule I and Schedule II must be reviewed by the Attorney’s General Office and by the Research Advisory Panel of California. If a researcher were to investigate these drugs and possess them without consent, they would undoubtedly be arrested and prosecuted to the full extent of the law, potentially receiving a period of imprisonment as a punishment.

In this article, we hope to have explained a few federal and state laws that researchers must adhere to. It’s important to never breach these, for the consequences could be severe. We thank you for reading and hope you return to join us soon.


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