A warning letter from the U.S. The Food and Drug Administration (FDA) has placed the spotlight on one of the most basic promises made to people who volunteer for medical research: the right to fully understand what they are agreeing to before taking part in a study.

The FDA said an inspection conducted at the Alembic Research Centre in Vadodara, Gujarat, between March 3 and 7, 2025, found shortcomings in the informed consent process during a clinical bioequivalence study—research designed to confirm that a test medicine behaves in the body in the same way as an approved drug. The inspection formed part of the FDA's Bioresearch Monitoring Programme, which evaluates whether clinical studies protect the rights, safety and welfare of human participants.

According to the FDA Warning Letter, the informed consent form stated: "This study is a clinical research project, but no part of it is of an experimental nature." The regulator said that wording could wrongly lead volunteers to believe they were not taking part in experimental research, limiting their ability to make a fully informed decision.

The agency noted that informed consent is more than obtaining a signature. It is a process that gives prospective participants enough time, information and freedom to decide whether the possible risks and benefits are acceptable. International ethical standards, including the Declaration of Helsinki and ICH Good Clinical Practice guidelines, similarly stress that research volunteers must receive clear and complete information before enrolment.

Alembic acknowledged the observation, explaining that the wording reflected its understanding of the purpose of bioequivalence studies. The organisation said it has since removed the disputed phrase, revised its standard operating procedures, retrained clinical staff and begun updating consent forms for ongoing and planned studies with ethics committee approval.

However, the FDA said those corrective measures did not fully address how the investigator would ensure future compliance with regulations protecting human subjects. It also noted that supporting documents for revised consent forms and additional regulatory training were not provided for review.

The warning assumes the medicine was effective and safe. Instead, it highlights a principle that underpins every ethical clinical trial: people can only give genuine consent when they clearly understand they are participating in research. The FDA has asked the investigator to respond within 15 business days, warning that failure to adequately address the deficiencies could lead to further regulatory action.