Volunteers consent procedures

Probably the most controversial aspect of our consent procedures was the omission of the name of the particular agent we intended to administer. Regrettably, this was usually unavoidable, due to security regulations. Furthermore, most of the compounds of interest had no recognizable names, only numbers. To provide their names and chemical structures would not be very useful, except to a few biochemists and pharmacologists (in the case of BZ or LSD, most of the volunteers found out their names, anyway). 

Communication with the potential volunteers prior to the study is essential. Prior to the initiation of the field phase of the study, a meeting should be held with the potential volunteers to explain the details of the procedures of the study, present the consent form, and inform the potential volunteers of the risks and benefits (including any monetary compensation to the worker) of participating in the study. At this meeting, consent in writing should be obtained from the worker. If there is any language barrier between the researcher and the potential volunteers, an interpreter should be present at the meeting. 

The study was performed in patients exposed to ionizing radiation after Chernobyl accident. Comparison groups included patients and healthy individuals exposed to the natural radiation levels. Control group included healthy volunteers who resided in Kyiv since Chernobyl accident Distribution by diagnosis is presented at table 1. Investigated persons were at the age of 43-72 (mean+SD for the exposed group 52,3 + 10,1 yrs for control group- 46,3 + 11,3 yrs). All studied persons participated by informed consent. Peripheral blood and bone marrow samples were obtained by a standard procedure (National. Committee for Clinical Laboratory Standards, 1991). Flow... 

People who volunteer to be subjects in a drug study have a right to know what can and will happen to them if they participate (informed consent). The investigator is responsible for ensuring that each subject receives a full explanation, in easily understood terms, of the purpose of the study, the procedures to be employed, the nature of the substances being tested, and the potential risks, benefits, and discomforts. 

Informed consent and experimental procedures were consistent with the Declaration of Helsinki All volunteers were in good health except an elderly subject who was studied because he had gluten enteropathy All volunteers living in the metabolic unit were fed constant mixed diets prepared from conventional foods All subjects were chaperoned when they left the metabolic unit to prevent ingestion of unauthorized foods or loss of excreta samples ... 

As in any study involving human research volunteers, an Institutional Review Board (IRB) must approve the study protocol and consent from. When the IRB office has released the stamped consent form to the investigator, participants can he enrolled in the study. The consent form consists of a description of study procedures, any risks that are involved, monetary compensation if any, and investigators contact information should participants have questions or concerns. When a participant understands all aspects of the study and potential risks, the investigator and participant sign the consent form a copy is given to the participant. 

Four final year male students of a physiotherapy graduation course were recruited. Participant age (25.25 + 2.06 years), weight and height were collected and body mass index was calculated (22.13 + 1.43 kg/m ). The volunteers were healthy and were screened to exclude history of pathology. No cardiovascular, neurological, metabolic or musculoskeletal diseases and no medication affecting these systems were self-reported. The study was approved by the ethics committee of the Fernando Pessoa University and all participants gave their written consent to participate in the study after the procedures and any risk or discomfort associated with the... 

Before the experiments, each subject was informed in detail about the purpose and procedures of the study. Then they were asked to fill out a questionnaire which was kept confidential and included patient s identification, age and gender. Informed consent and health information inquiry form that had been filled out by the volunteers was also obtained. 

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