Consent clinical research

L D. The principle of justice is a relevant consideration when subjects are selected for clinical research. It requires that members of a vulnerable population, such as institutionalized patients with mental retardation, not be exploited. The principle of autonomy would be most relevant to the parents ability to consent or refuse on the child s behalf, something Dr. Martin thinks is handled satisfactorily. Dr. Martin believes risks have been minimized and the overall study drug is likely to help the participants, so the study has satisfied the principles of nonmaleficence and beneficence. The principle of medical priority is not mentioned in the chapter and pertains to treating the most medically needy patients first, which is not at issue here. 

Institutional Review Board/ Independent Ethics Committee and Informed Consent Protecting Subjects Throughout the Clinical Research Process... 

Legislation that ensures the protection of human research subjects in the United States includes the 1979 publication of the Belmont Report on the Ethical Principles and Guidelines for the Protection of Human Subjects of Research.f This report concerns the fine line between biomedical research and the routine practice of medicine and explores the criteria that determine the risk-benefit ratio in the consideration of conducting clinical research. It also addresses basic guidelines for the proper selection of human research subjects and further defines the elements of informed consent. 

Guarino, R.A. Institutional review board/independent ethics committee and informed consent. Protecting subjects throughout the clinical research process. In New Drug Approval Process, 3rd Ed. Marcel Dekker, Inc. New York, 2000 100, 271. 

Henry Beecher (1904—1976) discussed12 the key concepts in human research of consent and autonomy, and the inherent difficulties in achieving these. People in positions of dependency may be termed vulnerable groups these can include minors, prisoners, employees and family members. Conversely, Beecher established that there is no duty to participate in clinical research - an example in which public or societal good cannot outweigh personal risk. 

Further evaluation of this tragic event has identified that vector-associated toxicity was not the sole cause for this patient s death. The FDA determined that human subjects in this investigation were not adequately protected and that there was substantial financial conflict of interest. Subsequently, the NIFl has discovered hundreds of unreported adverse events among volunteers enrolled in gene transfer experiments. These findings have catalyzed broad examination of the entire clinical research process, with the Secretary of Health and Human Services calling for broad reforms in informed consent, clinical monitoring, and conflict of interest. 

As stated, law and ethics coincide in their aim to protect the interests of volunteers recruited for clinical research purposes. The issues of consent, confidentiality and access to compensation for personal injury tend to be uppermost in the minds of lawyers and ethicists. 

In 1996, the DHHS passed the Health Insurance Portability and Accountability Act (HIPAA) to facilitate the sharing of information while protecting patient confidentiality (medical records) subsequently, associated privacy regulations were issued in 2000 (Privacy Rule). Amendments to the Privacy Rule were proposed on March 27, 2002, to address research-related situations, and become effective on April 14, 2003. In essence, the Privacy Rule is the governing law for the use and disclosure of individually identifiable protected health information (PHI) by covered entities, defined as health care providers, health plans, or health clearing houses. HIPAA-compliant consents that include elements specified in federal regulations (45 CFR 164.508) will have to be provided by covered entities that carry out the activities of health care payment, treatment, or operations (PTO). Clinical research-related uses and/or disclosures of PHI beyond PTO will require that a specifically defined authorization be obtained from a research subject. HIPAA-compliant authorizations will have to include the following core elements ... 

Investigators participating in clinical research must obtain from each subject authorization that accurately describes the uses and potential disclosure of PHI. The authorization (2) may be presented as part of the Informed Consent (see p. 565). In any event, authorization for access to PHI generated prior to research must be obtained from the subject (e.g., past medical history, previous treatments, hospitalizations). The authorization will state who will have access to the PHI and detail the specific duration of the use of the PHI the expiration of use can be referred to a specific event, e.g., an FDA approval. If data will be used as a research database, then an expiration of none might be acceptable to the subjects. The authorization must disclose whether there is compensation to the researcher from a third party and the use or disclosure of the PHI, but the amount of compensation is not required. If the subject revokes the PHI authorization, information already obtained under the authorization may still be used to preserve the integrity of the clinical trial such as marketing application or ADR reporting. If this is the case, no new PHI on that subject may be collected or disclosed. 

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