Table 12.4 Review by ethics committees/IRBs before clinical studies begin
The following items should be reviewed by ethics committees/IRBs before clinical studies begin:
Protocol (including annexes, such as the CRF)
Consent procedures (described in the protocol and the appended information sheet and consent form),
which specify who will provide information and who will obtain consent, how consent will be documented,
and whether or not a witness will be present
Consent form/information sheet. Most committees will be particularly interested in these documents to ensure
that all necessary information is provided to study subjects
Suitability of investigator and facilities, including support personnel. Some committees may request a copy
of investigator and other site personnel CVs. The committee will be particularly interested in allocation of
resources, whether the investigator has enough time and study subjects to conduct the study, and whether use
of resources for clinical studies will detract from normal medical care requirements
Delegation of responsibility by investigators
Source of study subjects and means of recruitment. The committee will wish to know if study subjects are
known to investigators and, if not (i.e. referred patients), how investigators will confirm eligibility and
whether primary care practitioners will be informed. The committee will wish to determine that advertisements
are not unduly coercive or misleading or too ‘inviting’
Appropriateness (eligibility) of study subjects (described in the protocol)
Primary care physician to be informed of study participation
Number of subjects to be studied and justification for sample size (this information should be in the protocol). The
committee will be interested in how many subjects will be exposed to the risk of treatment. In a multicenter study,
the local ethics committee/IRB should be informed of the number of subjects to be enrolled at each site and the
total number of subjects to be enrolled in the study
Investigator brochure or other authorized summary of information (e.g. pre-clinical and clinical summaries) about
the investigational products, including comparator products and placebo. If the study medication/device is a
marketed product, the ethics committee/IRB must review the most current data sheet, product monograph and so
on. The brochure is particularly important for confirming the formal declared safety profile of the study treatment
and therefore is of great assistance to committees in assessing the relevance of AEs. Also, the committee can
verify, by reviewing the brochure or product labeling, that the information sheet for obtaining consent provides
sufficient information with regard to safety
Evidence of regulatory submission and review/approval (if applicable). Committees particularly wish to know
whether the drug/device is on the market in their country or in other countries, and the details of the stage of the
submission
Adequacy of confidentiality safeguards, with regard to protection of identification of the study subject (described
in the protocol and the appended information sheet and consent form)
Insurance provisions, if any, for injury to study subjects (described in the protocol or provided as a separate
document). Committees must confirm that there is insurance for protection of the study subjects
Indemnity/insurance provisions for the sponsor/CRO, investigator, institution and so on (as relevant to the study
and if required by local regulations)
Payments or rewards to be made to study subjects, if any. Committees must determine that the amount, and
schedule of payments, is not unduly coercive
Benefits, if any, to study subjects
Payments or rewards to be made to investigators. Many committees are beginning to realize that the financial
interests of the investigator might have a strong influence on some aspects of the study, particularly recruitment
patterns
Assurance of quality/stability of medication/device to be administered
Review decision of other ethics committees/IRBs in multicenter studies
Duration of study
Plans to review data collected to ensure safety
12.4 MONITORING AND SAFETY ASSESSMENT 145