Informed consent, clinical trials participation

Freely given informed consent should be obtained from every subject prior to clinical trial participation. 

Arzneimittelgesetz III a) BGA must approve drugs, based on quality, safety, and efficacy tests b) Medical profession sets testing standards c) Pharmaceutical companies must document the informed consent of patients participating in clinical trials and purchase special liability insurance... 

Academic, cultural (including religious), ethical and medical attitudes also diverge within the EEA. For example, with the exception of clinical trial participation, in many European countries a requirement for written informed consent is seen as unethical no informed consent means no therapy, and therefore the patient may be under duress, or provide uninformed consent in order to gain access to medical treatment. Furthermore, the notion that some of the burden of responsibility for drug exposure could shift to the patient can also be seen as an abrogation of the responsibility of the prescriber or pharmacist. 

Freely given informed consent should be obtained from every subject prior to clinical trial participation. Informed consent of a subject includes informing the subject that the trial involves research, their participation is voluntary, and they may refuse to participate or withdraw at any time without penalty or loss of benefits. The subject is also informed of the purpose of the trial and the probability of being assigned to each treatment in the trial, the trial procedures to be followed, and the subject s responsibilities in the trial. The subject is informed of any reasonably foreseeable risks and potential benefits of the study and any alternative courses of treatment other than participation in the study. 

Children and prisoners are considered to be vulnerable populations because of issues of potential ethical issues related to informed consent and coercion. Participation in clinical trials is permitted for vulnerable populations, but only if the risks of the trial are minimal. Finally, cancer patients in general can be considered vulnerable because many subjects are terminally ill by the time they enroll in clinical trials [23]. It is important to be aware of the potential ethical issues and similar to other vulnerable populations, minimize the risks and ensure proper informed consent. 

Regulations also exist to protect the confidentiality of the research participant. All information collected throughout the clinical trial remains with the study staff. For the purposes of data capture, each subject is identified by initials or study number only. In addition, the informed consent discusses who will have access to the trial documents. 

Informed consent must always be obtained from a patient participating in any clinical trial. In the trial of a psychotropic drug, the mental status... 

Modern medical research expects the proposed procedures and protocols of clinical trials to be submitted for peer review and that the human study subjects involved are provided with trial information before freely consenting to participate in that clinical trial. 

The underlying principle is that subjects should only participate in a clinical trial if they agree to do so after they have fully understood the trial and its implications. In all studies, informed consent must be obtained from the subject or, where special situations occur, from his or her representative. How this is achieved depends on the study design, procedure and the country where the study is being conducted. Typically, it requires a... 

L Joel Martin, a pediatrician at a residential facility for mentally retarded children, has been approached by the Modem Pharmaceutical Company. The company would like Dr. Martin to enroll children aged 4 to 7 in one of their clinical trials for a new drug to treat conjunctivitis (pinkeye). Dr. Martin recognizes that the children s parents would be able to give informed consent or refusal on behalf of their children, that risks have been minimized, and that overall, the study drug is likely to help the participants. He is concerned, however, about the drug companies decision to enroll retarded children before... 

The second approach is to recruit participants, who must provide informed consent to take part in clinical trials of medications, through advertisements in newspapers or other media. This is a reasonable alternative to facilitating clinical trials that meet scientific and ethical standards, but one that has just begun to be used among adults. 

A basic ethical issue in several areas of psychiatric research is whether participants are able to provide informed consent, particularly for protocols entailing medication washout and/or placebo treatment. The majority of psychiatric patients who are asked to participate in clinical trials have adequate capacity to provide consent. Thus, in a study specifically designed to examine the capacity of schizophrenic patients to give informed consent, cognitive dysfunction and negative symptoms (apathy and avolition). but not psychotic symptoms (hallucinations, delusions), were found to be associated with impaired decisional capacity (Moser et al., 2002). These features are probably not unique to schizophrenia but are likely to apply to many other forms of illness. 

IRBs approve the clinical trial protocols, which describe the type of people who may participate in the clinical trial, the schedule of tests and procedures, the medications and dosages to be studied, the length of the study, the study s objectives, and other details. IRBs make sure the study is acceptable, that participants have given consent and are fully informed of their risks, and that researchers take appropriate steps to protect patients from harm. 

IRBs also review participant inclusion and exclusion requirements to be sure that appropriate people have been identified as eligible for the trial. They often look at how and where recruitment for clinical trials will occur. IRBs review the adequacy of the informed consent document to ensure that it includes all the elements required by law, and that it is at an appropriate reading level and understandable to study participants. 

IRBs are concerned with which of the following a clinical trial design b informed consent c proper enrollment criteria d confidentiality of participants e all of the above. 

Informed consent is governed by both federal and state law [14],These laws generally require that before participating in clinical trials, human research subjects state in writing that they understand the risks of the trial and are participating voluntarily. Each informed consent document must contain several elements required by FDA regulations [15]. 

There is a tendency to assume that the principles of informed consent are self-evident. In fact, evidence that this is not the case comes from many sources, such as ethics committees that are frequently dissatisfied with proposed informed consent documents, and sophisticated Western governments that, from time to time have conducted clinical trials without it (e.g. the Tuskeegee travesty). A recent gene therapy accident in the eastern United States, which led to the death of the participant, led to litigation which was centered not around whether the clinical trial was unduly hazardous but rather on whether the consent that the patient gave was truly and fully informed. 

---