Guidance Regarding Research that Involves the Collection of Information about Illegal Substance or Alcohol Abuse
Version date: November 14, 2012
Some research projects require subjects undergo screening for illegal substance use and alcohol use/abuse either as part of eligibility determinations or during the course of the study as a data collection point or safety monitoring procedure. The IRB considers studies that involve the collection of data on illegal substance use, alcohol abuse, and sometimes alcohol use, to be sensitive because of the potential impact on subjects should a breach of confidentiality occur (e.g. legal repercussions, employment effects, or reputation damage). Cases where information on illegal activities is obtained (e.g. illegal substance use, alcohol consumption by minors) or the information on subject behavior can raise a legal issue (e.g. pregnant women abusing drugs or alcohol are in jeopardy of placement in custody to protect the fetus) typically require additional protections to minimize risks to subjects. If the research team is collecting information about illegal substance use or alcohol use/abuse, they should address the following in the study protocol and IRB application: 1) why this information is necessary and cannot be gathered through other means; 2) how data will be stored and protected, and any cases where the data would be intentionally disclosed, and; 3) the consent process, especially how subjects are made aware of the testing or data collection and the potential risks.
Some studies involve a preliminary oral consent process and an eligibility screen conducted by phone. Given the more limited consent process and confidentiality protections associated with such oral procedures, questions about illegal substance use and alcohol use/abuse are discouraged as part of preliminary screening. The IRB has not typically accepted phone screen questions that result in the identification of illegal activities. It is often possible for questions eliciting this type of information to be worded in such a way that a positive response by a subject will not be an admittance of illegal activity. For example, a subject who answers “Yes” to the question “Have you recently used street drugs and/or alcohol” could be referring to either alcohol or drugs. Subjects could also be provided with a list of excluded drugs, including legal and illegal substances, with subjects merely indicating whether they remain eligible. In cases where information is collected in order to exclude individuals with illegal substance or alcohol use/abuse issues, the retention of such data on individuals who are disqualified from participation is generally not acceptable to the IRB. The IRB recommends that results of screening for illegal substance use are reviewed for eligibility determination and discarded as soon as the determination is made, whenever possible. If a person is excluded because of a positive test for use of illegal substances, the potential subject should be informed of this result and research records should only reflect that the potential subject was found to be ineligible and not record the reason. If some reason for exclusion must be documented, this should be as general as possible, and not indicate that exclusion was due to involvement in illegal activities.
Collection of information about illegal substance abuse after screening
Some studies require the collection and retention of identifiable information on illegal substance use at baseline and/or during the course of the study. Identifiable information includes coded data. The collection of this information could be required as a safety monitoring procedure (e.g. potential interactions with study drugs) or as an additional data collection point (e.g. some psychiatric studies). For these studies, the data typically cannot be discarded because they represent key information for the study. Because this information will be retained, privacy and confidentiality concerns become paramount, and the existence of this data represents an ongoing risk to subjects. In such cases, the IRB typically requires researchers to apply for a Certificate of Confidentiality (CoC). A CoC helps to protect against forced disclosure of research data. The research application should address the reason that illegal substance use information must be retained, and indicate whether a CoC has been obtained or will be sought. The consent form must address the collection and retention of substance abuse information, confidentiality protections, and include standard language describing the protections of a CoC. An exception to the typical requirement to obtain a CoC for studies retaining identifiable information on illegal substance use involves the collection of data from clinical records. In cases where this information already exists as part of clinical records and is not coming into existence as a result of study activities, a CoC is not typically required. The consent form should describe the collection of this information, confidentiality protections, and risks associated with a breach of confidentiality.
Collection of information about illegal drug or alcohol use when subjects are pregnant
Research involving the collection of data on illegal drug use or alcohol abuse in a population that may include pregnant women or women who may become pregnant during their study participation is particularly problematic. Pregnant women abusing drugs or alcohol are in jeopardy of placement in custody to protect the fetus. The collection of such data is generally discouraged, and it is advisable to put procedures in place to prevent the creation of such information. If there is a significant potential for a subject population to include individuals who are, or may become, pregnant, and are engaged in drug or alcohol use harmful to a fetus, it may be advisable to implement plans to provide information about dangers of such behaviors to a pregnancy and provide referral to appropriate clinical care resources.
Related GuidanceWhat is a Certificate of Confidentiality and do I need one for my research?