Informed consent, clinical trials

A related issue is the question of which patients to include in an evaluation. The most usefirl evaluation would be one that included all patients likely to use a service in the real world. However, in order to make evaluations feasible, and because of the need to achieve the informed consent of patients, many prospective clinical trials exclude certain patient groups. For example, many schizophrenia trials exclude patients with... 

EDWARDS s H, LILFORD R J, THRONTON J, HEWisoN J (1998) Informed consent for clinical trials in search of the best method , Soc Sci Med, 47, 1825-40. 

Why are side effects important Imagine that you have been recruited for a clinical trial of an antidepressant medication. As part of the required informed-consent procedure, you are told that you may be given a placebo instead of the active medication, but because this is a double-blind trial, you will not be told which you are getting until the study is over. You are told that... 

Increased incidents in clinical trials have lead to a recognition of the weaknesses of informed consent procedures. Actually, the FDA has reported that such deficiencies are the poorest area of GCP compliance for more than 12 years (FDA Reports, 2000, Office of Inspector General, 2000a, b). 

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. 

Regulatory authorities stipulate the need for ethical principles to be observed when conducting clinical trials. Clinical trials should never be conducted to gain knowledge per se. They should be based on risk-benefit considerations, informed consent, and respect for human individuals. Furthermore, subjects should be protected without being taken advantage of. 

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... 

In the United Kingdom, the information sheet provided to the consenting study subject in a clinical trial sponsored by a pharmaceutical company will usually contain a reference to the clinical trial compensation guidelines of the Association of the British Pharmaceutical Industry (ABPI). It is not included in the information sheet of noncommercial studies. Study subjects taking part in clinical trials are not usually paid, unless it is... 

The Helsinki Declaration covers all the important ethical considerations, such as the involvement of a qualified physician in any clinical trial, putting the well-being of the study subject before science and society, the use of scientific principles in the design of the study, the need for informed consent and a review by an ethics review committee in fact, all areas covered by the ICH GCP. 

In studies where subjects are mentally or physically unable to give proper consent, special arrangements will need to be made. Where appropriate, the ICF will be read to the subject in the presence of a witness, or consent will be provided by the next of kin or the subject s representatives. Studies in which the study subjects cannot provide informed consent will become more frequent as more difficult indications, for example, trauma, stroke, dementia and the handicapped or very young children, become the focus of clinical trials. The pharmaceutical physician should ensure that established mechanisms for consent are followed with agreement of the lEC and in compliance with ICH GCP chapter 4.8, FDA Title 21 CFR Part 50 sections 24-273 gpj p)ii-ective Articles 4 and 5. ... 

The protocol should specify what should be recorded directly into the CRF and what will also be recorded in the medical records. The CRF will contain all the pertinent data associated specifically with the clinical trial but some will be repeated in the medical records, for example, the protocol identification number, date of consent, date of commencement of the study, key baseline medical findings, visit dates, start and finish dates of the study drug/placebo or treatment, concurrent medication, adverse events and key efficacy and any unscheduled or scheduled actions or interventions (such as escape medication). Additional information obtained from biopsy reports, radiographs and similar documents will provide confirmation that the data in the CRF are recorded correctly. Monitors, QA auditors and inspectors need to see all the medical records available to the investigator. It is not appropriate to create copies of data from CRFs or checklists derived from medical records and claim that these are source documents. 

The ICH GCP requires that all clinical trials involving human subjects should be reported, even if only one study subject is involved (ICH GCP 5.22). This is another protective wall, along with ethical approval and informed consent, against unapproved and sloppy experimentation on humans. 

The IRB is responsible for judging all studies to be conducted at the centre concerned by reviewing protocols, the informed consent sheet, the investigator s brochure and other materials relating to the conduct of clinical trials. The IRB is also responsible for monitoring whether the clinical trials are conducted in compliance with both GCP and IRB s requirements, if any. When the study period of a clinical trial exceeds 1 year the IRB should review the study every year. As the new GCP allows the study sponsor to pay a reasonable amount of money to the study subjects, the IRB is expected to review whether the amount and method of payment is reasonable and does not infringe upon the ethical aspects of the study. Also, the advertisement of a trial for patient recruitment is allowed, but the IRB s approval to implement this at the study centre is required. 

The investigator should prepare an informed consent form for every study to be performed at the institute and should obtain an approval by the IRB that covers the institute. GCP listed a dozen points to be covered by the informed consent (1C) form (see Table 23.6). The new GCP allows a reasonable amoimt of pa)unent to the patient, such as transport cost. Patients should allow clinical trial monitors, auditors, IRB members and inspectors from the regulatory authority to verify the source documents. This new requirement of obligatory written 1C is regarded as a... 

The Parties agree to adhere to the principles of medical confidentiality in relation to Clinical Trial Subjects involved in the Clinical Trial. Personal data shall not be disclosed to the Sponsor by the NHS Trust save where this is required directly or indirectly to satisfy the requirements of the Protocol or for the purpose of monitoring or adverse event reporting. The Sponsor shall not disclose the identity of Clinical Trial Subjects to third parties without prior written consent of the Clinical Trial Subject, in accordance with the requirements of the Data Protection Act 1998 and the principles set out in the Report of the Caldicott Committee on the review of patient identifiable information dated December 1997, a copy of which the NHS Trust shall supply to the Sponsor on request. 

Clinical trials on incapacitated adults not able to give informed legal consent... 

In the case of other persons incapable of giving informed legal consent, all relevant requirements listed for persons capable of giving such consent shall apply. In addition to these requirements, inclusion in clinical trials of incapacitated adults who have not given or not refused informed consent before the onset of their incapacity... 

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