Ethical committees

The confidentiality of records that could identify subjects should be protected to assure their privacy The trials must be accepted by an Independent Ethics Committee (lECj/lnstitutional Review Board (IRB) before commencing the study... 

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 ... 

Copy of ethics committee opinion in the MS concerned when available... 

In the case of multi-centre, multi-state trials a single opinion should be delivered from each Member State. Only vhen a positive response has been obtained from an Ethics Committee and a Competent Authority can a trial commence. 

During the course of its conduct, the sponsor may need to amend a clinical trial, as a consequence of the emergence of new information. If the amendments are deemed to be substantial, in that they may impact on the safety of trial subjects, or change the interpretation of the scientific documents in support of the conduct of the trial, or are otherwise significant, the sponsor shall notify the Competent Authority and the Ethics Committee, using a Trial Amendment Form. The Ethics Committee are permitted 35 days to approve the amendment. 

If the events are classified as Suspected Unexpected Serious Adverse Reactions (SUSARs) that are fatal or life-threatening, the sponsor must then report them to the Ethics Committee and the Competent Authority within 7 days. Other SUSARs must be reported within 15 days. The sponsor must also inform all other investigators involved in the trial. The Competent Authority is required to enter the information... 

In addition to the expedited reporting described above, sponsors shall submit, once a year throughout the clinical trial, or on request, a safety report to the Competent Authority and the Ethics Committee. This should cover SUSARs, other serious adverse reactions, and an analysis of the subjects safety during the course of the trial. 

The sponsor must inform the Competent Authority and the Ethics Committee of the end of a trial within 90 days of its completion. The sponsor will then prepare a trial report, where the data are analysed and assessed, with conclusions presented. 

Dated, documented approvai / favourabie opinion of Institutional Review Board / Independent Ethics Committee... 

Under US regulations, each institution conducting research with human subjects must have its own IRB. These perform the same functions as the Independent Ethics Committees in Europe, and should contain at least five members, one of which should be independent of the institution. There should be available a mixture of scientific and non-scientific expertise capable of assessing research proposals from legal, ethical and scientific perspectives. The IRB must grant written authorisation to the investigator before a study can commence. They are also responsible for on-going reviews of research, and must report to the FDA ... 

Unlike human trials. Institutional Review Boards/Independent Ethics Committees are not involved, while informed consent is only required from the owner of the trial animals. In addition to the standard items associated with human trials, aspects such as management and housing of animals, diet and disposal of trial animals and their produce should be included in the trial protocol. Studies may be blinded from the investigators in order to avoid bias in the reporting of animal observations. 

The opinion of the ethics committee concerned and details of the aspects covered by... 

Savulescu J. Two deaths and two lessons Is it time to review the structure and function of research ethics committees J Med Ethics 2002 28 1-2. 

When conducting a clinical trial, the well-being of the study subjects is primary. Subjects must be treated fairly and with respect. The two primary methods of ensuring fair treatment of study subjects are review of the study protocol by an Institutional Review Board (IRB) or Ethics Committee and... 

The conduct of clinical trials is regulated in all the countries, except Cypms. In Cypms, the policy of the Ministry of Health is not to permit clinical trials for experimental medical products. Multicountry clinical trials for products licensed in developed countries are undertaken in some institutions and regulated by ethics committees (Table 8.5). In these countries, approval of clinical trials is carried out either by the DRA, as in Estonia, Malaysia, Tunisia, Venezuela and Zimbabwe, or by ethics committees. When the DRA itself is responsible for control, information about the trials is processed centrally. In Tunisia, clinical trials form part of the registration process. Trials are requested, when deemed necessary, by the specialized committee charged with reviewing the new dmg. The trial proposal is then evaluated by the technical committee, and forwarded to the Health Minister for final approval. Cuba has a National Centre for the Coordination of... 

Regulation of clinical trials through use of a specialized ethics committee at the trial site constitutes a decentralized approach. This approach is used in the Netherlands, where a local medical ethics committee at the site of the trial is responsible for the evaluation. 

In Australia, approval of clinical trials involves both the regulatory authority and an ethics committee. Under the Clinical Trial Exemption (CTX) scheme, a clinical trial proposal must first be evaluated by the TGA, and then approved by an ethics committee on-site. Under the Clinical Trial Notification (CTN) scheme, a trial is evaluated and approved by the local ethics committee, and then notified to the TGA. 

Approving body Local ethics committees DRA N/A DRA regional ethics committees DRA Local medical ethics committees Specialized commission but approved by Min of Health NDA INH As part of MCAZ... 

Animals Male Dunkin-Hartley albino guinea pigs (Harlan) (350-400 g) were used. The ambient temperature was regulated between 20-22°C. Relative humidity was kept over 50%. Animals had free access to food and water. The experiments received approval by an ethical committee. 

HUGO Ethics Committee, Statement on Benefit Sharing (April 9, 2000), available at http //www.gene.ucl.ac.uk/hugo/benefit.html. 

Bayer A and Tadd W (2000) Unjustified exclusion of elderly people from studies submitted to research ethics committee for approval descriptive study. BMJ 321(7267) 992-993... 

Experimental use of animals is controlled under Good Laboratory Practice (GLP), and study protocols are submitted to the Animal Research Ethics Committee for approval. Studies using animals can only proceed with the approval of the Ethics Committee, which consists of technical personnel. 

Independent Review Board/Independent Ethics Committee (IRB/IEC)... 

The Sponsor must inform the MHRA of any refusal by an ethics committee to permit the trial. 

Venous blood samples are collected from clinical subjects after approval by the regulatory authorities for the evaluation of medicines and the local ethical committees for the sampling and the experiments to be performed. The identities of the clinical subjects are blinded. The collection should contain samples of healthy infants or children of both genders and minorities, with at least five clinical subjects per group. If adverse event reactions are to be studied, the collection should also contain at each time-point of the study one group of clinical subjects who were reported to experience adverse events after vaccination. The clinical subjects are vaccinated intramuscularly with one dose of the vaccine at 3, 5, and 12mo of age. Samples are collected at 3 mo before the first vaccination and at 6 and 13 mo, with the second samples taken after their second vaccination at 5 mo of age and the third vaccination at 12mo of age, respectively. 

Fetal liver was collected after surgical termination of a pregnancy for social reason. The tissue was obtained under full Ethical Committee approval at the Institute for Problems of Cryobiology in Kharkov, Ukraine. Fetal liver was disrupted using vibration (Kravchenko et al., 2002). The single cell suspension thus formed was centrifuged at 1000 g for lOmin and the cell pellet... 

It should always be remembered that the IB is not a promotional document aimed at presenting the NME in its best light on the contrary, it is intended to inform investigators and ethics committees about every aspect of the drug, to enable them to make wise judgements in the interest of study subjects, be they healthy volunteers or patients. The IB is necessarily a summary, but less than full disclosure of important information about the drug, whatever the source, is not acceptable and all documents should be referenced and made available on request. 

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