Approval of new drugs by the US Drug Administration (FDA) has been steady since the early 2000, reaching an all-time high in 2014 with the approval of 44 new drugs. In 2004, the FDA established its critical path Initiative, a national strategy "to drive innovation in the scientific processes through which medical products are developed, evaluated, and manufactured. One focus of this initiative is on improving the prevention, diagnosis, and treatment of rare and neglected disorders. The process of drug discovery and manufacturing takes 10 to 12 years with a cost of more than $1 billion for each drug: Out of every 5000 to 10,000 compounds that begin preclinical testing, only one makes it through the FDA approval process.
CORE ETHICAL PRINCIPLES
Three core ethical principles are relevant to research involving human subjects: respect for persons, beneficence, and justice.
Respect for Persons
Patients should be treated as independent persons capable of making decisions in their own best interest. When making health care decisions, patients should be made aware of alternatives available to them as well as the consequences that stem from those alternatives. The patient's choice should be honored whenever possible. Autonomy is an integral component of respect for persons. Autonomy is the right to self-determination. In health care settings, health care personnel must respect the patient's right to make decisions in their own best interest, even if the decision is not what the health care personnel wants, or think is best for the patient.
Informed Consent
Informed consent has its roots in the 1947 Nuremberg Code. The two most relevant aspects of the Code are the right to be informed and that participation is voluntary, without coercion. If coercion is suspected, the nurse is obligated to report this suspicion promptly.
It is the role of the health care provider, not the nurse, to explain the study to the patient, what is expected of the patient, and to respond to questions from the patient. When giving written consent, the patient must be alert and able to comprehend; consent forms should be written at or below the eighth-grade reading level, and words should be kept to fewer than three syllables Nurses are patient advocates. In collaboration with the health care provider and the pharmacist, the nurse must be knowledgeable about all aspects of a drug study--including all inclusion and exclusion criteria for participants, study protocol, and study-related documentation-to
Beneficence
Beneficence is the duty to protect research subjects from harm. It involves ensuring the risks and possible benefits from participating in a research study are clearly defined, and ensuring the benefits are greater than the risk.
Risk-Benefit Ratio
The risk-benefit ratio is one of the most complex problems faced by the researcher. All possible consequences of a clinical study must be ana-lyzed and balanced against the inherent risks and the anticipated benefits. Physical, psychological, and social risks must be identified and weighed against the benefits.
Justice
Justice requires that the selection of research subjects be fair. Research must be conducted so that