Presents guidelines for participation by human subjects in studies involving potentially addicting drugs; discusses informed consent, and conditions for exclusion of subjects.
1. Introduction
In developing and testing new drugs with therapeutic potential it is usually necessary to conduct studies on human volunteers. This remains true for drugs, including but not limited to opiate analgesics, which are known to have significant potential for addiction in some individuals. In order to serve the goal of minimizing potential risk to human subjects, these guidelines review special features of studies involving human volunteers receiving potentially addicting drugs.
2. Informed Consent
Human volunteer subjects who may receive drugs with significant potential for addiction (examples include but are not limited to opiates, cocaine, alcohol) in a study must be informed that the drug(s) they may (or will) receive are known to have a significant potential for addiction in some individuals. If the magnitude of the risk of addiction in relevant populations is known it should be specified.
3. Exclusion of Subjects with a History of Addiction
With some exceptions, potential volunteer subjects who have a known history of addiction should be excluded from studies of drugs with a significant potential for addiction. The informed consent should indicate that potential subjects should not participate in the study if they have any history of addiction to a drug or to alcohol. Subjects should be asked to check off a box on the consent form to indicate that they do not have such a history.
Furthermore, investigators may wish to incorporate a confidential pre-screening questionnaire about prior drug use history in such studies. Investigators may also choose to perform urine drug screening of subjects. If pre-screening questionnaires or urine testing is utilized, subjects should be informed as to how the confidentiality of these data will be maintained, and to whom they may be released.
The exceptions to this exclusion policy are those protocols which require the participation of addicted patient subjects to answer a scientific question (e.g., the effect of moderate doses of alcohol on a biologic variable which might predict subsequent relapse or give insight into the etiology of the disorder.) The justification for experimental ingestion or intoxication must be included in the application.
4. Exclusion of Subjects with Direct Access to the Class of Addicting Drug Under Study
Potential volunteer subjects who have direct physical access to and routine handling of addicting drugs in the regular course of their work duties should be excluded from studies of drugs with a significant potential for addiction and to which the subject has access.
It is known clinically that addiction to certain types of medications is an occupational hazard of certain groups of health care workers. Although the prevalence within each group is not well-established, it is a well-described hazard for personnel who meet the following functional definition: personnel with direct physical access to and routine handling of addicting drugs in the regular course of their work duties. In particular, there is a risk for addiction to opiates, sedative-hypnotics, and cocaine. The health care workers in this group may vary depending on the drug involved and on the practice setting of the worker. However, typically the group with regular access includes: anesthesiologists; emergency room physicians; ward, operating room, post-anesthesia care unit, emergency room, and intensive care unit nurses; pharmacists. The exclusion stated above applies to those who meet the functional definition above, and not specifically to any general title or job description.
It is also known that health care workers who are addicted to medications can often effectively hide the signs and symptoms of their addiction. This exclusion guideline would therefore operate to prevent the harm that would result if an addicted subject was inadvertently included in a study of the drug to which the subject is addicted.
Health care workers who would be excluded under this Guideline make up a small component of the available volunteer pool for the testing of new therapeutic drugs. Thus, their participation is not required to ensure proper testing and validation of the safety of new or existing addicting drugs. Therefore, any risk of addiction in this group, no matter how small, cannot ordinarily be justified by the scientific benefit to be gained by their participation in studies of addicting drugs. It is generally expected that potential subjects who are health care workers who have direct physical access to and/or routine handling of addicting drugs in the regular course of their clinical duties will be excluded from studies in which an addicting drug to which they have access will be administered. If an investigator believes that inclusion of such personnel is necessary for the scientific goal of the study, a special application that justifies inclusion of these personnel must be made in the submission to the IRB.
The informed consent should indicate that potential subjects who meet the functional definition should not participate in the study, and subjects should be asked to check off a box indicating that they do not meet this functional definition.