It is a a simple question, but people usually forget to ask when they enter the pharmaceutical industry.
Yes, human research can be conducted without an IND(investigational new drug) in certain cases. The FDA has a number of exemptions for clinical investigations that do not require an IND. These exemptions include:
Studies of marketed drugs that are being used for their approved indication.
Studies of marketed drugs that are being used for an unapproved indication, but only if the study is not intended to support a new indication and there is no intent to use the results of the study to support any other significant change in the labeling of the drug.
Studies of drugs that are being used for a serious or life-threatening disease, if the study is intended to support a new indication and there is no other way to obtain the needed information.
Studies of drugs that are being used for a rare disease, if the study is intended to support a new indication and there is no other way to obtain the needed information.
Studies of drugs that are being used in a clinical trial that is being conducted outside of the United States.
In addition to these exemptions, the FDA may also grant an individual exemption for a clinical investigation that does not meet the criteria for any of the standard exemptions. To request an individual exemption, the investigator must submit a written request to the FDA.
It is important to note that even if a clinical investigation is exempt from the IND requirements, it is still subject to the ethical requirements of the FDA’s Institutional Review Board (IRB) regulations. These regulations require that all human research be conducted in a way that protects the rights and welfare of human subjects.
If you are planning to conduct a human research study, it is important to consult with an attorney or other qualified professional to determine whether your study requires an IND and to ensure that your study complies with all applicable laws and regulations.