Justification for Screening Heroin Users in Clinical Trials
In the case of a client with a history of IV drug abuse who still uses heroin on a daily basis, the participation in a research drug trial may be canceled due to the necessity to follow protocol and the unclear consequences of making an exception for him. However, the client may be included if the sponsors assume that the continued use of heroin would not interfere with the study’s medication, and heroin users may participate. At the same time, the protocol change does not exclude the necessity of screening to collect all reliable information that may impact the results in the future. Therefore, the screening of all participants for the detection of potential drug users is justified. However, they could not be excluded from a trial.
Privacy Concerns and Informed Consent in Additional Questioning
Concerning informed consent, requiring the client to answer the additional questions may be regarded as both an invasion of his privacy if questions are not connected with the subject and purpose of the research and an unjustified departure from participation requirements. In general, informed consent is based on providing all necessary information to a subject to ensure the validity of their agreement (“Informed consent,” n.d.). Therefore, asking questions cannot refer to the stage of receiving informed consent, as this procedure should be performed before defining a client’s inclusion.
Moreover, as previously mentioned, questions cannot be connected with any topic unrelated to the research. Therefore, only the last two questions could be included if a protocol were redesigned. The quantity of heroin use per day may be identified to evaluate if this aspect impacts the results. At the same time, the question about transportation may refer to the organizational aspects of the study. For instance, sponsors may want to ensure whether a client needs assistance reaching the clinic.
Safeguards Ensuring Patient Protection in Research
Moreover, research ethics emphasize the necessity of equality and respect for people’s dignity regardless of their peculiarities. In this case, heroin users and non-users should have the same informed consent for their participation in the drug trial. In addition, to ensure that all patients’ rights are protected, a nurse should ensure that they receive unbiased assistance, that their personal data related to their health is available only for researchers, and that all clients understand the risks of being involved before giving consent.
Reference
Informed consent. (n.d.). AMA Code of Medical Ethics. Web.