Clinical research compensation

Peter Lacouture, Associate Director, Clinical Research, The Purdue Frederick Company, Norwalk, Connecticut Dr. Fumio Matsumura, Associate Director, Toxic Substances Program, Institute of Toxicology and Environmental Health, University of California, Davis, California Dr. Frederick Oehme, Director, Comparative Toxicology Laboratories, Kansas State University, Manhattan, Kansas and Dr. Jack Radomski, Private Consultant, Jonesport, Maine. These experts collectively have knowledge of heptachlor and heptachlor epoxide s physical and chemical properties, toxicokinetics, key health end points, mechanisms of action, human and animal exposure, and quantification of risk to humans. All reviewers were selected in conformity with the conditions for peer review specified in Section 104(i)(13) of the Comprehensive Environmental Response, Compensation, and Liability Act, as amended. 

Should a study subject suffer any deterioration in health or well-being caused by participation in a study, the sponsors of the clinical research must provide appropriate compensation without regard to the question of legal liability. A statement to that effect should be present in the protocol. Frequently, the insurance policy of the sponsor includes the pharmaceutical company, clinical investigators and the institution where the clinical study is being undertaken. 

How much information is necessary for potential subjects to be informed Should investigators tell the subjects how much money they are compensated per subject recruited It is probably unnecessary for subjects to understand how clinical research is funded (e.g., overhead fees, fees for certain services), unless this information would influence any reasonable person to participate (or not to participate). The pharmacy profes-... 

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. 

Since all clinical research investigations entail more than minimal risk, a statement describing compensation (if any) that will be paid and an explanation as to whether any medical treatment is available if an adverse reaction occurs, what the treatment consists of, and/or where further information can be obtained. 

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. 

Guidelines for Compensation in Clinical Trials (1991) (ABPI) The Use of Healthy Volunteers in Research (ABPI 1988) as amended. 

The vast majority of research in this area involves iron-oxide particles, as they are highly biocompatible, cheap, can be made in a variety of ways and sizes, and can be made as superparamagnets or ferrimagnets. Iron oxides are metabolized into elemental iron and oxygen by hydrolytic enzymes in the body. The iron joins the normal body stores and the body compensates by taking up less iron from the stomach. Intravenous injections of up to 250 mg iron/kg body weight does not produce chronic or acute hepatotoxicity in rats [14], while 1-3 mg/kg has been used clinically in humans [15]. 

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