Written informed consent

The written informed consent form should be presented to potential participants in a language that they understand and written in terms that they can comprehend. This is one of the important functions of an IRB. The IRB members review every informed consent form to determine if it contains all of the required elements and any additional required elements of an informed consent form as sef forth in the governing regulations. The informed consent form is also reviewed to determine that complete, accurate, and pertinent study-related information is being provided to the potential participants and that medical terms are clearly defined, in simple language at the study population can understand. 

Written informed consent document and consent form updates (which include aU of the required elements of an informed consent — asee Section 22.6)... 

Based on the ICH guidelines, fully written informed consent is now required for all participating patients. If the patient caimot consent due to his/her health condition, a responsible caretaker is allowed to give consent in lieu of the patient. 

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 variety of features may be included in protocols to improve the process of obtaining informed consent. These include repeated exposure to the information in the protocol multiple avenues of communication (verbal, written, etc.) language use that is simple, in small units, and comprehensible use of patient educators who can review relevant information with the potential subject, explain the study s purpose and process, and answer any questions and attention to personal aspects of consent, including motivation, cultural and developmental issues, expectations, and investigator-participant relationship issues (Applebaum and Grisso, 1988 1995 Sutherland, et al. 1994 Bonnie, 1997 Roberts, 1998a,b). 

Of the 96 patients selected, 55 were positive for Dermatophagoides (57%) and 41 were positive for Graminaceae or Parietaria (43%). The patients selected were randomized into two groups the active group that received specific LNIT and the placebo group that received a lactose powder formulation in order to be taste-masked. Ah patients gave written informed consent. 

Figure 7.3 A. Human psoriatic tissue (200x). B. Normal human skin (200x). Both samples were immunostained with caspase 14 antibody. Punch biopsies (4 mm) of normal and psoriatic skin samples were obtained from different patients who provided written, informed consent under an IRB-approved protocol. Samples were fixed in 10% neutral-buffered formalin, paraffin embedded, cut to 5-pm sections, and stained with caspase 14 antibody by immunohistochemistry.

The review of the protocol ensures that there are adequate selection criteria and procedures to protect vulnerable study populations. In addition, information within the protocol, the informed consent, and the Investigator s Brochure are reviewed to assess safety information that may affect subjects. Institutional review boards are empowered with the authority to approve or disapprove research activities that are covered by regulations, as well as to require modifications to secure approval. Informed consents will be reviewed to assure that all the information provided is in accordance with 21 CFR 50.25 the IRB may also require that additional information be provided to study subjects in a separate format, such as a patient information sheet. If this requirement is waived, a written statement may be given to the subject. If a very short window of opportunity exists to dispense a research treatment to avoid a devastating or fatal outcome, a waiver for this requirement may be requested. It is important to note, however, that the sponsor must clearly describe or define the situations that would require testing without administering a written informed consent. Also, provisions that will be made to obtain the consent from family members must be in place. This issue will be discussed in more detail in the section on informed consent. In summary, the following criteria are used by IRBs to approve research ... 

The guideline specifically states that an explanation of the subject s responsibilities must be referenced during the informed consent discussion and included in the consent form and any other written information. Also, the person responsible for conducting the informed consent discussion is required to sign and date the informed consent. The document must specify the parties granted direct access to the patient s original medical records. 

A short form written consent document, stating that the elements of informed consent required by 21 CFR 50.25 have been presented orally to the subject or the subject s legally authorized representative, is included in the regulations. However, clinical investigators do not recognize oral consent as a practical or appropriate alternative to obtaining documented informed consent whenever possible. The following requirements are necessary when the use of a short form informed consent is implemented ... 

In an emergency use situation in which an investigator has determined that there is insufficient time to obtain informed consent from a subject or legally authorized representative, the investigator is required to have the determination reviewed by a physician who is not participating in the clinical investigation and to obtain a written certification of the following informed consent requirements (21 CFR 50.23) before use ... 

Institutional Review Board letter of approval for protocol, informed consent, advertisements (newspapers, flyers, television) to be used to recruit study subjects and any other written information to be provided to subjects. 

Plan usually includes diagnostic tests as indicated, medications prescribed, referrals written, and follow-up plans if medication is prescribed, this section often refers to the informed consent that was obtained. 

Written informed consent from the patient is required before initiating treatment A/ith pemoline... 

As with the evaluation of corneal abrasions, the application of one or two drops of 0.5% proparacaine is often necessary to allow adequate examination of the eye with a corneal or conjunctival foreign body, ft is advisable to obtain informed consent, preferably written, before proceeding with any minor surgical procedure. 

Written informed consent must be obtained before any minor surgical procedure. Patient safety and comfort during the procedure must be maximized. Controlling the patient s movement and continually reassuring the patient can accomplish this objective. 

The large majority of clinical trials use a written informed consent document. In the absence of any special circumstances, the essential elements of such a document are as follows ... 

Written informed consent documents should be signed by both the patient and the investigator, and ideally the patient should sign before an impartial witness. Informed consent documents should be written in a language that is understandable to the patient, and ideally at a level of complexity that could be understood by a young adolescent of average intelligence from the same community as the patient. There should be adequate time for the patient to review the document. All written informed consent documents should be approved by an ethics committee or an institutional review board (IRB). 

For children, most ethics committees agree that provision of written informed consent by a parent or guardian is acceptable. If the childis of sufficient age, then his or her concurrence may also be sought although this is not sufficient evidence of informed consent, the refusal to provide concurrence by a child that is likely to be competent to understand the clinical trial conditions should be sufficient to exclude the child from a study. 

If a generic subject information sheet and informed consent form are attached to the protocol, these documents should also be reviewed for compliance with any requirements for informed consent, such as GCP, SOPs and the Declaration of Helsinki, and for consistency with the trial protocol. The information sheet and informed consent forms must be written in a language understandable to the trial participant and should include information on data protection/privacy. Further information on protocol and informed consent audits is available in literature (Bohaychuk and Ball, 1999 DGGF, 2003). 

The informed consent of patient to participate into the trial, which was not originally a written consent. 

The informed consent becomes a written consent and necessitates true and complete information... 

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