To begin a clinical research study, it is mandatory to obtain approval from an ethics committee or institutional review board (IRB). These entities are responsible for ensuring the protection of participants' rights, welfare, and safety in research studies.
In clinical trials, the investigator, specifically the principal investigator (PI) or the study site's designated investigator, is typically responsible for preparing essential documents such as the protocol, investigator's brochure, informed consent form, and case report form.
All clinical trials progress through all four phases. Some treatments may be discontinued or face regulatory hurdles at any stage, while others may skip certain phases depending on the nature of the study or regulatory requirements.
Informed consent forms (ICFs) are mandatory documents that individuals must review and sign before enrolling in a clinical research study. The purpose of an informed consent form is to ensure that potential participants are adequately informed about the study's purpose, procedures, potential risks and benefits, confidentiality measures, and their rights as participants. By signing the ICF, individuals indicate that they understand the study's nature and voluntarily agree to participate.
Preclinical studies are an essential part of the drug development process, and they are conducted using animals and artificial cells in laboratory settings. These studies are conducted before any testing is done on human subjects in clinical trials.
Conflict of interest is indeed considered a risk factor for scientific misconduct in clinical research studies. A conflict of interest occurs when an individual or institution has competing interests that could potentially bias their actions, decisions, or judgment.
The Tuskegee syphilis study was conducted by the U.S. Public Health Service (USPHS) from 1932 to 1972. It is one of the most well-known examples of unethical research in the history of medicine.
