Clinical trials consent forms

Empirical Investigation , Psychological Science 7, no. 3 (1996) 174-76 Moseley, J. Bruce, K. O Malley, N. J. Petersen, T. J. Menke, B. A. Brody, D. H. Kuykendall, J. C. Hollingsworth, C. M. Ashton and Nelda P. Wray, A Controlled Trial of Arthroscopic Surgery for Osteoarthritis of the Knee , New England Journal of Medicine 347 (2002) 81-88 Myers, M. G., J. A. Calms andj. Singer, The Consent Form as a Possible Cause of Side Effects , Clinical Pharmacology dr Therapeutics 42 (1987) ... 

In addition to the elements enumerated in the federal regulations, IRBs must consider whether consent forms should include the fact of randomization in the case of prospective randomized clinical trials. 

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... 

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. 

V. Patient consent form for participation in a phase I clinical trial. 

Applications must propose a clinical trial of one therapy for one indication. The applicant must provide supporting evidence that a sufficient quantity of the product to be investigated is available to the applicant in the form needed for the clinical trial. The applicant must also provide supporting evidence that the patient population has been surveyed and that there is reasonable assurance that the necessary number of eligible patients is available for the study. In addition, subjects must provide informed consent, and the studies must be conducted in accordance with GCP under the oversight of a duly constituted IRB. 

Because the chief investigator had to play a leading role in the clinical trial, the person appointed by the sponsor was usually a physician or professor who was an authority on the subject of the clinical trial. In practice, however, such people were generally too busy to perform the duties mentioned here, and the sponsor wrote a draft protocol and a draft of the explanatory note used when obtaining informed consent from subjects. In addition, the sponsor s monitor conveyed data and information to the physician in charge, as well as collecting and checking the case report forms (CRFs). 

The patient s informed consent was required by the old GCP, with a wording of in writing as a rule . A survey performed in the early 1990s showed that a limited number of informed consents were obtained in writing and the rest were in the form of verbal agreements without witnesses. There was concern about whether patients understood the nature of clinical trials because the informed consent sheet was rarely provided to the patient and, even if it was, the explanation might be too difficult for a layperson to understand. 

Source documents are composed of hospital records, office charts, laboratory data sheets, subject diaries, pharmacy dispensing records, recorded data from automated instruments, x-rays, etc. Source documents should be legible and should document that the subject is participating in a clinical trial. Some of the key areas to cross reference source documents to case report forms and regulatory criteria are the informed consent process, inclusion/exclusion criteria, adverse experiences, investigational product administration, concomitant medications administered to the subject during the trial, withdrawal from the study for any reason, and subjects lost to follow-up. 

The principles of the Directive should remove the complexity of clinical trial application, authorization and regulation in existing, new, and future Member States. Thus, substantial amendments to protocol that impact on safety of the subjects or where there is a change in the interpretation of data on the IMP must be notified under the legislation underpinning the Directive. This common process will obviate current disparate national procedures that range from a simple notification scheme to a complex authorization proce-dure. Implementation of the Directive cannot be expected to alter national requirements for provision to examiners of Information to Subjects and Informed Consent forms in local languages. 

It should be noted that according to the HIPAA privacy rules, in the final form when research has obtained valid consent or waiver of consent from an IRB prior to the enforcement date of April 14, 2003, the research may continue without requiring a HIPAA authorization. Therefore if subjects in a clinical trial gave their informed valid consent prior to that date, the data can be continued to be collected and analyzed after the... 

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