Guidelines for ethics-related problems with “non-invasive research on human brain function”

4. Ethical characteristics and testing guidelines for each non-invasive research method

F. Neuropsychological studies

It can be expected that in the future, methods used in neuropsychological studies will be combined with non-invasive measurement methods, such as fMRI, PET, MEG, EEG, TMS, and near infrared spectroscopy for researching high-order functions of the cerebrum. In anticipation of this, it is necessary to take careful measures to also consider the ethical aspects of research methods used in neuropsychological studies.

1) Overview
Neuropsychological methods have been in use for some time. This is a class of methods that attempts to explore cognitive processing in patient or test subjects by observing performance in tests that require the participant to answer questions or carry out tasks. Collected data consists of both verbal and behavioral indices of performance.

2) Effectiveness
This method is effective in exploring the internal processes (i.e. cognitive processing) of the patient or the test subject. There is no known method that can estimate the individual’s cognitive ability more effectively. However, since the obtained data is subjective in nature, the reliability of this method can be said to be low compared to biological methods, which can provide measures of objective phenomena.

3) Problematic points (risks involved in testing)
In neuropsychological tests, relatively large batteries of tasks are often implemented by the person in charge of the test. Because of this, there is a risk that unnecessary psychological stress might be placed on the test subject. It is necessary to consider this point sufficiently.

4) Testing guidelines

  1. Unlike biological tests, neuropsychological tests assess cognitive functions. Because of this, there is a danger that the relationship between the experimenter running the test and the patient or participant might be misconceived as though it were a relationship between a victimizer (the experimenter), whose goal is to expose defects and insufficiencies, and the victim (the test subject or patient). Being put into such a psychological scenario can damage an individual’s self-esteem, and cause unnecessary stress. In addition, video recording equipment is sometimes used to produce an accurate record of test performance and for later detailed analysis, and this can also cause needless stress. Data recording and assessment under such conditions may be seen not to act in agreement with the original purpose, which is to allow for treatment or objective inquiry. Therefore, tests must be carried out in a cooperative atmosphere after sufficient explanations have been provided to the test subject about the importance and necessity of assessment and recording. When the individual is uncooperative, the test should be aborted immediately. Also, consideration must be taken at all times to guide the diagnosis and testing in a direction that is beneficial to the individual. Keeping in mind that a patient is not a healthy volunteer but a sick person, when test subjects are patients with known medical conditions, collecting more than necessary amounts of data must be avoided.
  2. Types of studies that use a specified test battery to evaluate cognitive functions of many patients require a particular consideration for the patient’s standpoint since these protocols do not involve a deeper and more individualized engagement with specific patients as treatments do. In these situations, taking into account the fact that the patient is a disadvantaged person with cognitive impairment, sufficient explanations should be given about the purpose of the test, and the individual’s thorough understanding gained. Also, using comprehensible wording, sufficient explanations should be provided about the individual’s freedom and right to withdraw at any time, and that withdrawing from the experiment will not yield any disadvantages to the individual. Voluntary agreement and cooperation must then be obtained from the individual.
  3. In neuropsychological studies, cognitive data of healthy subjects is also collected often in order to make comparison with pathological data. Sufficient explanations about the purpose of the test must be given to the individual in such cases as well. Moreover, using comprehensible wording, sufficient explanations must be given about the fact that the freedom and right to refuse cooperation are guaranteed, and that such a refusal will not yield any disadvantages. Voluntary agreement and cooperation must be obtained from the individual.

5) Explanatory documents for test subjects
As a general rule, follow the contents indicated in Section 6 of current guidelines. In neuropsychological studies, because of the nature of these tests, there might be cases where written explanatory documents might not be suitable. It is, however, advisable to prepare written documents accordingly.