Ethical examination of clinical trials. Necessity and absence of necessity

Not all studies involving people require a prospective examination or approval of an ethical committee. There are six categories of research that, although conducted with the participation of people, are exempted from the requirements of part 46 of section 46 of the CFR and the examination of the ethics committee. The general basis for these six categories is that research does not expose people involved in it to physical, social, psychological or other risks, except for those that are possible in daily life.

One example is the examination of available medical documents (for example, samples of biological material or disease histories) if these resources are publicly available or if the information is recorded by the researcher in such a way that the study participants cannot be identified directly or through the identifiers assigned to them.

However, many clinics have a stricter policy regarding the use of case histories and biomaterial samples for research, and researchers should be familiarized with the relevant policies of the institution.

In the United States, studies are often conducted according to surveys and questionnaires. Such studies may be exempted from ethical review if the information disclosed, if disclosed outside the scope of the study, does not subject the study participants to the risk of criminal or civil liability, or harm the person’s financial position, ability to seek employment or reputation.

Thus, questionnaires and questionnaires containing questions about illegal behavior, such as drug use, domestic violence or other confidential matters, such as sexual behavior and other particular behaviors, cannot be exempt from examination.

Before the beginning of the test, researchers should be familiarized with the requirements of the institution for obtaining an exemption from ethical examination.

The minimum risk means that «the probability and degree of expected harm and discomfort resulting from the study do not exceed the likelihood and extent of harm and discomfort in daily life or during routine medical or psychological examination or tests» (45 CFR 46.102)). The definition of minimal risk is necessary since in the examination by the ethics committee under accelerated review procedures, a certain minimum risk is allowed as a result of research activities. The accelerated process of examination was introduced with the aim of streamlining and accelerating the examination by the ethical committee of some research activity with minimal risks.