Ethics committees application

Applications to the Ethics Committee should be made using the same application form as used for the Competent Authority. Most of the data submitted to the Competent Authority will also need to be included in the application to the Ethics Committee, although the IMPD is usually not required. Similar to the Competent Authority, the Ethics Committee is allowed 60 days to deliver an opinion (90 days for advanced therapy products), having given particular attention to the following ... 

In the absence of any no fault scheme, the participant who suffers injury and believes it to be trial related must rely only on his/her ability to claim compensation through the courts - often a difficult and lengthy process. Most ethical guidelines require a study participant to be told in advance, what provision has been or will be made - if any. However, in practice some ethics committees are unhappy that there are different approaches applicable to compensation in research, depending upon the identity of the sponsor / initiator. 

The applicant undertook to inform the LA of any refusal to permit the trial by an ethical committee and... 

Recently the European Commission (EC) have included an appendix on advertising for trial subjects in the detailed guidance on the application to be submitted for an ethics committee opinion on a clinical trial on a medicinal product for human use. The ABPI guideline set out below takes into account the views of the Medical Committee and additional guidance from the EC guideline. 

The Ethics Committee shall have a maximum of 60 days from the date of receipt of a valid application to give its reasoned opinion to the applicant and the competent authority in the Member State concerned. 

Within the period of examination of the application for an opinion, the Ethics Committee may send a single request for information supplementary to that already supplied by the applicant. The period laid down in paragraph 5 shall be suspended until receipt of the supplementary information. 

The Commission, in consultation with Member States and interested parties, shall draw up and publish detailed guidance on the application format and documentation to be submitted in an application for an ethics committee opinion, in particular regarding the information that is given to subjects, and on the appropriate safeguards for the protection of personal data. 

Clinical trials are regulated by individual member states in the European Union. An applicant (or sponsor) submits data on the investigational medicinal product (IMP), and details of the proposed clinical trial, to the competent authority in the country in which the trial is to be carried out. The ethics committee responsible for the site where the trial is to take place also needs to give approval. 

CTs with prospective new medicines must be authorized by the competent MRA before started. In addition to the scientific evaluation, another prerequisite for the authorization is an approval of the protocol and the trial site by the competent Ethics Committee. The GCP must be obeyed and its compliance monitored by governmental inspectors. Maximal processing time of CT applications is 60 days, a period within which there is not more than 42 days for the ethical approval. 

I, 2004, an investigational new drug application (IND) for studies on healthy volunteers was not required in Europe, as it was and continues to be in the United States. Europe s then more lenient regulatory environment attracted business (Neuer, 2000), but with the advent of the European Directive, regulatory approval by ethics committee is now required to begin phase I testing. 

Figure 11.6 Section 7.4 - Advertising for trial subjects [Source Detailed Guidance on the Application Format and Documentation to be Submitted in an Application for an Ethics Committee Opinion, April 2004]...

Name of ethics committee/IRB (if applicable by local and/or national requirements) and details of contact person on the ethics committee/IRB (if applicable by local and/or national requirements)... 

The basis of the CTX scheme is that, together with a detailed clinical trial protocol, summaries of chemical, pharmaceutical, pharmacological, pharmacokinetic, toxicological and human volunteer studies may be permitted instead of the additional details normally required for a CTC or product license application. This CTX scheme is based on the requirement that (a) a doctor must certify the accuracy of the data (b) the supplier undertakes to inform the Licensing Authority of any refusal to permit the trial by an ethical committee and (c) the supplier also undertakes to inform the Licensing Authority of any data or reports concerning the safety of the product. 

The European Commission issued a set of detailed guidelines on the requirements and format of the CTA application for use by NCAs and ethics committees, as well as templates for application forms. Directive 2001/20has also added a small but... 

Directive 2001/20 has also led to a set of detailed Guidance documents, to help MS interpret the Directive and implement appropriate ethical committee oversight. The Detailed. Guidance on the Application Format and Documentation to be Submitted in an Application for an Ethics Committee Opinion on a Clinical Trial for a Medicinal Products for Human Use (April 2003) is self-explanatory. This document includes a table that collates each special requirements of MS, and it is designed to be used with the national Guidances, where they exist. 

Both sponsors and investigators are empowered to apply for the ethics committee opinion. The Directive states that the applicant can choose to make parallel applications to the NCA and the ethics committee, or do it sequentially. However, in practice national preferences will vary in whether sequential applications may be preferred. It is important to make sure that the version of the reviewed documents at the ethics committee and the RA match. 

The National Competent Authority and ethics committee initially validate the application and the sponsor is informed that the application is valid (i.e. the format is appropriate and that the application appears prima facie to be complete and accurate). Ethics committees have the same review clock as regulatory authorities, including the special situations with extended or eliminated timeframes (see... 

Usually, if, in the course of a trial, a substantial amendment to the protocol becomes necessary, then a repeat opinion of the ethics committee must be sought before implementing any change. Substantial amendments are defined as amendments to the terms of the research ethics committee s (REC s) application, or to the protocol or any other supporting documentation that is likely to affect to a significant degree... 

The core of a CTA application in all MS includes the following, which is submitted both to RAs and ethics committees ... 

COREC New Operational procedures for NHS RECs, guidance for applicants to Research Ethics Committees. 

The investigator(s) should be responsible for medical decisions in case of adverse events and for notifying the relevant health authorities, the sponsor and, when applicable, the ethics committee, without delay. In the... 

At the time of writing, the conduct of studies in non-patient volunteers in the UK is not regulated by the Medicines Act (1968). Similarly, studies in non-patient volunteers in the Netherlands, Belgium and some other European countries do not require regulatory approval. This situation is about to change, as the EU Directive issued in 2001 will require to be implemented in all European countries by 2004. All healthy volunteer studies will then require regulatory approval in addition to that of an ethics committee. The Directive, with which all member states must comply, makes no distinction between healthy volunteer studies and clinical trials in patients who may benefit from treatment. However, the precise details of documentation required for authorisation of healthy volunteer studies may vary from country to country it is possible that the application in the UK will be somewhat less detailed than the current Clinical Trials Exemption. 

Since many trials are being conducted around the world and submitted to a US IND application, the FDA is working on a separate type of 1572 form to be used for these sites. The reason for this is that an ethical committee (EC), (the international version of our IRB), reviewing the research protocols and informed consents, is composed slightly differently from IRBs in the US. Independent ethical committees (IECs) follow ICH GCP guidelines, which differ slightly from CFR regulations. 

All clinical trials must be carried out according to a protocol approved by an ethical committee and according to the GCP rules. Participants must be volunteers. Clinical trials with radiopharmaceuticals must be performed in suitable patients rather than in healthy people in order to avoid any unnecessary exposure to radiation. In addition, administrative authorization is needed in some countries, as well as other specific requirements. Only results obtained by authorized clinical trials may be used in support of a clinical indication for an application for marketing authorization. 

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